Page last updated: 2024-11-04

alendronate

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Description

alendronic acid : A 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID2088
CHEMBL ID870
CHEBI ID2567
SCHEMBL ID18898
MeSH IDM0028852

Synonyms (92)

Synonym
BIDD:GT0180
AB01274863-01
gtpl3141
bph 1
(4-amino-1-hydroxybutane-1,1-diyl)bis(phosphonic acid)
acido alendronico [inn-spanish]
arendal
4-amino-1-hydroxybutylidene-1,1-bisphosphonate
acidum alendronicum [inn-latin]
4-amino-1-hydroxybutylidene-1,1-bis(phosphonic acid)
alendronic acid [inn:ban]
(4-amino-1-hydroxybutylidene)diphosphonic acid
acide alendronique [inn-french]
phosphonic acid, (4-amino-1-hydroxybutylidene)bis-
alendronic acid (inn)
D07119
OPREA1_422906
HSCI1_000337
bisphosphonate, 65
bdbm25313
chembl870 ,
(4-amino-1-hydroxy-1-phosphonobutyl)phosphonic acid
phosphonic acid, (4-amino-1-hydroxybutylidene)bis
4-amino-1-hydroxybutane-1,1-diphosphonate
(4-amino-1-hydroxy-1-phosphono-butyl)phosphonic acid
alendronate ,
C07752
alendronic acid
66376-36-1
(4-amino-1-hydroxybutylidene)bisphosphonic acid
1YHM
DB00630
NCGC00096054-03
4-amino-1-hydroxybutane-1,1-diphosphonic acid
abdp
NCGC00096054-04
NCGC00096054-01
SPECTRUM1505166
acido alendronico
CHEBI:2567 ,
acide alendronique
acidum alendronicum
bisphosphonate
alendronate acid
AKOS001015793
A835441
(4-azanyl-1-oxidanyl-1-phosphono-butyl)phosphonic acid
FT-0641064
hsdb 7990
unii-x1j18r4w8p
x1j18r4w8p ,
abdp-d6
p,p'-(4-amino-1-hydroxybutylidene)bisphosphonic acid
alendronic acid [mi]
alendronate [vandf]
alendronic acid [inn]
alendronic acid [who-dd]
alendronic acid [ema epar]
.alpha.-hydroxy-.delta.-aminobutylidenediphosphonic acid
phosphonic acid, p,p'-(4-amino-1-hydroxybutylidene)bis-
alendronate [mart.]
S5536
BRD-K75527158-323-01-3
SCHEMBL18898
(4-amino-1-hydroxybutane-1,1-diyl)diphosphonic acid
(4-amino-1-hydroxybutylidene)-bisphosphonic acid
4-amino-1-hydroxybutylidene-bisphosphonic acid
(4-amino-1-hydroxybutane-1,1-diyl)bisphosphonic acid
Q-200607
2-butyldecahydronaphthalene-1-carboxylicacid
DTXSID5022568 ,
alpha-hydroxy-delta-aminobutylidenediphosphonic acid
Z56771118
sr-05000001906
SR-05000001906-1
SBI-0206778.P001
Q420057
mfcd00868112
4-amino-1-hydroxybutane-1,1-diyldiphosphonic acid
HY-B0631
AS-10963
CS-0009566
D88506
4-amino-1- hydroxybutane-1,1-diphosphonate-d6
66376-36-1 (unlabeled)
alendronic-d6 acid
acido alendronico (inn-spanish)
dtxcid202568
m05ba04
alendronate (mart.)
acide alendronique (inn-french)
acidum alendronicum (inn-latin)

Research Excerpts

Overview

Alendronate (ALN) is a drug routinely available across the NHS in both tablet and injection form. Doctors and scientists believe that it might prevent ongoing hip deterioration and result in fewer patients requiring a total hip replacement.

ExcerptReferenceRelevance
"Alendronate is a drug routinely available across the NHS in both tablet and injection form, and doctors and scientists believe that it might prevent ongoing hip deterioration and result in fewer patients requiring a total hip replacement."( Assessing a 12-month course of oral alendronate for adults with avascular necrosis of the hip: MANTIS RCT with internal pilot.
Akanni, M; Barber, V; Beard, D; Board, T; Davies, L; Dritsaki, M; Dutton, SJ; Glyn-Jones, S; Javaid, MK; Kerslake, R; Khanduja, V; Knight, R; McBryde, C; Newton, J; Peckham, N; Rombach, I; Sexton, S; Skinner, J, 2022
)
1.72
"Alendronate (ALN) is a second-generation bisphosphonate widely used for osteoporosis and cancer-induced bone lesions. "( Novel insights into the pharmacological modulation of human periodontal ligament stem cells by the amino-bisphosphonate Alendronate.
Antonelli, A; Barni, T; Baudi, F; Biamonte, F; Bria, J; Chiarella, E; Di Vito, A; Giudice, A; Perrotta, ID; Sacco, A; Salatino, A; Sovereto, J, 2023
)
2.56
"Alendronate (ALN) is a bisphosphonate, which is prescribed as an anti-osteoporotic drug. "( Geranylgeraniol reverses alendronate-induced MC3T3 cell cytotoxicity and alteration of osteoblast function via cell cytoskeletal maintenance.
Korjai, N; Matchimapiro, M; Patntirapong, S; Sungkaruk, P; Suthamporn, Y, 2021
)
2.37
"Alendronate (ALN) is a bisphosphonate used to treat osteoporosis."( The Effect of Alendronate on Osteoclastogenesis in Different Combinations of M-CSF and RANKL Growth Factors.
Buzgo, M; Filová, E; Hedvičáková, V; Rampichová, M; Žižková, R, 2021
)
1.7
"Alendronate (ALN) is an osteoclast deactivation drug."( Serial administration of rhBMP-2 and alendronate enhances the differentiation of osteoblasts.
Choi, HJ; Kim, SH; Son, CN; Yoon, DS, 2021
)
1.62
"Alendronate (ALN) is a nitrogen-bisphosphonate that may induce an anabolic effect on craniofacial bone repair when administrated in low doses. "( Would Be Prophylactic Administrations of Low Concentration of Alendronate an Alternative for Improving the Craniofacial Bone Repair? A Preliminary Study Focused in the Period of Cellular Differentiation and Tissue Organization.
Cunha, EJ; Deliberador, TM; Giovanini, AF; Göhringer, I; Muller, CLS; Passoni, GNS; Scariot, R; Vieira, JS; Zielak, JC, 2017
)
2.14
"Alendronate (ALN) is a key therapeutic used to treat glucocorticoid-induced osteoporosis (GIOP), but may induce severe side effects. "( Promotion effect of extracts from plastrum testudinis on alendronate against glucocorticoid-induced osteoporosis in rat spine.
Huang, J; Jiang, X; Qiu, T; Ren, H; Shen, G; Tang, J; Yang, Z; Yao, Z; Yu, X; Zhang, Z; Zhao, W, 2017
)
2.14
"Alendronate (ALN) is a BCS III bone resorption inhibitor, with very poor oral bioavailability. "( Alendronate-loaded, biodegradable smart hydrogel: a promising injectable depot formulation for osteoporosis.
Boraie, N; Nafee, N; Zewail, M, 2018
)
3.37
"Alendronate (ALN) is a nitrogen-containing bisphosphonate (NBP) that inhibits bone resorption. "( Alendronate augments lipid A-induced IL-1β release and Smad3/NLRP3/ASC-dependent cell death.
Kiyoura, Y; Tamai, R, 2018
)
3.37
"Alendronate is a widely used drug for osteoporosis in the elderly and postmenopausal women."( Preventing muscle wasting by osteoporosis drug alendronate in vitro and in myopathy models via sirtuin-3 down-regulation.
Chan, DC; Chiang, CK; Chiu, CY; Chiu, HC; Liu, SH; Yang, RS, 2018
)
1.46
"Alendronate is a widely-used drug for treating osteoporosis and would be an ideal drug to be loaded and released from these replacement systems."( Effects of polycaprolactone on alendronate drug release from Mg-doped hydroxyapatite coating on titanium.
Bandyopadhyay, A; Bose, S; Emshadi, K; Vu, AA, 2018
)
1.49
"Alendronate is a bisphosphonate widely used for the treatment of osteoporosis; however, one of its main adverse reactions is gastric ulcer. "( Alendronate-induced gastric damage in normoglycemic and hyperglycemic rats is reversed by metformin.
Alencar, MS; Alves, EHP; Araújo, AJ; Araújo, AR; Filho, JDBM; Iles, B; Leal, LKAM; Lopes, ALF; Medeiros, JVR; Nolêto, IRSG; Oliveira, AP; Pacheco, G; Sousa, FBM; Vasconcelos, DFP, 2019
)
3.4
"Alendronate sodium is a bisphosphonate agent used for the treatment of osteoporosis and other bone diseases. "( In vivo lung deposition and sub-acute inhalation toxicity studies of nano-sized alendronate sodium as an antidote for inhaled toxic substances in Sprague Dawley rats.
Ahmad, FJ; Ali, R; Bhatnagar, A; Mittal, G; Sultana, S; Talegaonkar, S, 2013
)
2.06
"Alendronate is a bisphosphonate drug which inhibits the function of bone-resorbing osteoclasts, ultimately leading to an increase in bone mineral density (BMD) and reduction in fracture risk."( Follow-up of six patients with neurofibromatosis 1-related osteoporosis treated with alendronate for 23 months.
Heervä, E; Huilaja, L; Leinonen, P; Peltonen, J; Peltonen, S, 2014
)
1.35
"Alendronate is a nitrogen-containing bisphosphonate that is widely used for the treatment of osteoporosis in postmenopausal women. "( [Development of a novel transdermal delivery system of alendronate, a nitrogen containing bisphosphonate, using a new type of hydrophilic patch and dissolving microneedle arrays].
Katsumi, H, 2014
)
2.09
"Alendronate (ALN) is a potent inhibitor of osteoclastic bone resorption and results in reduced bone remodeling."( Inhibited osteoclastic bone resorption through alendronate treatment in rats reduces severe osteoarthritis progression.
de Blois, E; de Jong, M; Groen, HC; Koelewijn, SJ; Müller, C; Siebelt, M; Verhaar, JA; Waarsing, JH; Weinans, H, 2014
)
1.38
"Alendronate sodium is a bisphosphonate drug used for the treatment of osteoporosis and acts as a specific inhibitor of osteoclast-mediated bone resorption. "( Development of dry powder inhaler formulation loaded with alendronate solid lipid nanoparticles: solid-state characterization and aerosol dispersion performance.
Ezzati Nazhad Dolatabadi, J; Hamishehkar, H; Valizadeh, H, 2015
)
2.1
"Alendronate is an antiosteoporotic drug that targets the mevalonate pathway. "( Genetic polymorphisms in the mevalonate pathway affect the therapeutic response to alendronate treatment in postmenopausal Chinese women with low bone mineral density.
Fu, WZ; Gu, JM; He, JW; Hu, WW; Hu, YQ; Li, M; Liu, YJ; Shao, C; Wang, C; Yue, H; Zhang, H; Zhang, ZL; Zheng, H, 2015
)
2.08
"Alendronate is a second generation bisphosphonate which has been widely used in medical practice for two decades to treat osteoporosis and prevent fragility fractures both in elderly people and in younger patients."( Alendronate: new formulations of an old and effective drug to improve adherence avoiding upper gastrointestinal side effects.
Auriemma, R; Migliore, A; Neglia, C; Piscitelli, P, 2014
)
3.29
"Alendronate (ALN) is an antiresorptive agent widely used for the treatment of osteoporosis. "( Effect of Alendronate on Bone Formation during Tooth Extraction Wound Healing.
Koi, K; Tanoue, R; Yamashita, J, 2015
)
2.26
"Alendronate is a bisphosphonate frequently used to reduce bone resorption. "( The effects of systemic alendronate with or without intraalveolar collagen sponges on postextractive bone resorption: a single masked randomized clinical trial.
Cei, S; Gabriele, M; Graziani, F; La Ferla, F; Rosini, S, 2008
)
2.1
"Alendronate (aln) is a potent bisphosphonate with a prolonged duration of action. "( Subtrochanteric and diaphyseal femur fractures in patients treated with alendronate: a register-based national cohort study.
Abrahamsen, B; Eastell, R; Eiken, P, 2009
)
2.03
"Alendronate is a known inhibitor of root resorption and the development of alendronate paste would enhance its utilization as intracanal medication. "( Biocompatibility evaluation of alendronate paste in rat's subcutaneous tissue.
Capaldi, ML; Castilho, LR; de Moraes, IG; Mori, GG; Nunes, DC; Poi, WR, 2009
)
2.08
"Alendronate sodium is a Bisphosphonate drug used to treat and prevent osteoporosis and several other bone diseases. "( Bioavailability and bioequivalence of two oral formulations of alendronate sodium 70 mg: an open-label, randomized, two-period crossover comparison in healthy Korean adult male volunteers.
Kang, JS; Kim, DS; Lee, MH; Park, JH; Park, YS; Rhim, SY; Shaw, LM; Yang, SC, 2009
)
2.04
"Alendronate is a bisphosphonate that inhibits bone resorption, thereby increasing bone mineral density (BMD), while also reducing bone formation closely coupled with bone resorption."( Low serum levels of undercarboxylated osteocalcin in postmenopausal osteoporotic women receiving an inhibitor of bone resorption.
Aonuma, H; Hongo, M; Kasukawa, Y; Miyakoshi, N; Shimada, Y, 2009
)
1.07
"Alendronate is a well-established treatment for osteoporosis and suppresses bone resorption by a direct effect on osteoclasts and their precursors. "( The effect of the alendronate on OPG/RANKL system in differentiated primary human osteoblasts.
Alvarez, L; Combalia, A; Enjuanes, A; Guañabens, N; Martínez de Osaba, MJ; Monegal, A; Ozalla, D; Pares, A; Peris, P; Ruiz-Gaspà, S, 2010
)
2.14
"Alendronate is a well-established treatment for osteoporosis and suppresses bone resorption by a direct effect on osteoclasts and their precursors. "( The effect of the alendronate on OPG/RANKL system in differentiated primary human osteoblasts.
Álvarez, L; Combalia, A; Enjuanes, A; Guañabens, N; Martínez de Osaba, MJ; Monegal, A; Ozalla, D; Pares, A; Peris, P; Ruiz-Gaspà, S, 2010
)
2.14
"Alendronate is a poorly absorbed bisphosphonate with an oral bioavailability of 0.7%. "( Positively-charged microemulsion for improving the oral bioavailability of alendronate: in-vitro and in-vivo assessment.
Hu, L; Meng, J, 2011
)
2.04
"Alendronate sodium is a medicine, which is commonly used in osteoporosis treatment. "( The effect of alendronate sodium on human erythrocytes.
Bukowska, B; Duda, W; Janiszewska, S; Kopka, A; Szwed, M, 2011
)
2.17
"Alendronate is an important representative of bisphosphonates, strongly polar compounds that lack chromophores. "( Trimethylsilyldiazomethane derivatization coupled with solid-phase extraction for the determination of alendronate in human plasma by LC-MS/MS.
Chen, M; Chen, X; Liu, K; Zhong, D, 2012
)
2.04
"Alendronate is a widely used bisphosphonate in the treatment of osteoporosis. "( Nephrotic syndrome after oral bisphosphonate (alendronate) administration in a patient with osteoporosis.
Kara, E; Ozagari, A; Taninmis, H; Unsal, A; Yilmaz, M, 2012
)
2.08
"Alendronate is a nitrogen-containing bisphosphonate that is widely used for the treatment of osteoporosis. "( Development of a novel self-dissolving microneedle array of alendronate, a nitrogen-containing bisphosphonate: evaluation of transdermal absorption, safety, and pharmacological effects after application in rats.
Hayashi, R; Hirai, Y; Hitomi, K; Kamiyama, F; Katsumi, H; Kusamori, K; Liu, S; Quan, YS; Sakane, T; Tanaka, Y; Yamamoto, A, 2012
)
2.06
"Alendronate is an agent for the treatment of osteoporosis that has established safety with regards to bone quality since it neither inhibits bone calcification nor influences fracture healing in chronic administration."( [Pharmacological and clinical properties of alendronate sodium hydrate].
Komatsu, S; Ohta, T; Tokutake, N, 2002
)
1.3
"Alendronate sodium is a potent inhibitor of bone resorption which has been effectively used to control osteolysis, and to treat Paget's disease and osteoporosis. "( The effect of alendronate sodium on alveolar bone loss in periodontitis (clinical trial).
El-Shinnawi, UM; El-Tantawy, SI, 2003
)
2.12
"Alendronate is a potent bisphosphonate that is effective in preventing osteoporotic fractures. "( The clinical tolerability profile of alendronate.
Daifotis, A; Freedholm, D; Watts, N, 1999
)
2.02
"Alendronate is a well-tolerated new treatment that reduces the risk and severity of new vertebral fractures, reduces height loss and may reduce the risk of nonvertebral fractur"( The antifracture efficacy of alendronate.
Seeman, E, 1999
)
1.32
"Alendronate sodium is an aminobiphosphonate, an analog of inorganic pyrophosphate, indicated for the treatment of osteoporosis in post-menopausal women. "( Pharmacovigilance study of alendronate in England.
Biswas, PN; Shakir, SA; Wilton, LV, 2003
)
2.06
"Alendronate is a bisphosphonate compound used to treat diseases of pathologic bone resorption. "( Superficial gyrate erythema as a cutaneous reaction to alendronate for osteoporosis.
Cockerell, CJ; Cohen, JB; High, WA; Wetherington, W, 2003
)
2.01
"Alendronate is a drug that is being used to increase bone mineral content in patients with poor bone quality."( [Simulation through the method of finite element of alendronate in a model of bone remodeling based on damage mechanics].
Doblaré, M; García, JM; Zeman, ME, 2003
)
1.29
"Alendronate is a useful adjunctive therapy in combination with enzyme replacement therapy (ERT) for the treatment of GD-related osteopenia in adults, but it cannot be expected to improve focal lesions."( Gaucher disease: alendronate disodium improves bone mineral density in adults receiving enzyme therapy.
Bailey, L; Grabowski, GA; Moskovitz, J; Oestreich, AE; Sun, S; Wenstrup, RJ; Wu, W, 2004
)
1.38
"Alendronate is an efficacy and safety drug in treatment of osteoporosis."( [Clinic effect of alendronate sodium treatment in osteoporosis patients with hip fracture].
Jin, J; Lin, J; Luo, XZ; Qiu, GX; Shen, JX; Tang, H; Tian, Y; Wang, YP; Weng, XS; Wu, ZH; Yang, XY; Zhang, JG; Zhao, H, 2004
)
2.1
"Oral alendronate is suggested to be a useful option in the treatment of polyostotic fibrous dysplasia."( Oral alendronate treatment for polyostotic fibrous dysplasia: a case report.
Ito, H; Kitagawa, Y; Tamai, K, 2004
)
1.29
"Alendronate is a bisphosphonate used in treating osteoporosis. "( Alendronate-induced chemical laryngitis.
Bhutta, MF; Gillett, D; Rance, M; Weighill, JS, 2005
)
3.21
"Alendronate (ALN) is a bisphosphonate compound that can be administered orally and has potential use in pediatric osteoporotic conditions."( Single-dose pharmacokinetics and tolerability of alendronate 35- and 70-milligram tablets in children and adolescents with osteogenesis imperfecta type I.
Denker, AE; Deutsch, P; Glorieux, FH; Kline, W; Larson, P; Maes, A; Mao, C; Porras, A; Rauch, F; Shugarts, S; Travers, R; Ward, LM, 2005
)
2.03
"Alendronate is a potent inhibitor of osteoclast-mediated bone resorption, but its use results in serious esophageal damage. "( Inhibitory effects of alendronate on cholinergic responses in rat lower esophageal sphincter.
Azuma, YT; Hata, F; Nakajima, H; Nakamura, A; Takeuchi, T, 2006
)
2.09
"Alendronate is an aminobisphosphonate, a selective inhibitor of osteoclast-mediated bone resorption. "( [Prediction of changes in bone density during alendronate treatment in postmenopausal women].
Letkovská, A; Masaryk, P; Rovenský, J; Stancíková, M, 2002
)
2.02
"Alendronate is a potent inhibitor of osteoclast-mediated bone resorption with no adverse effect on the mineralization of bone."( Inhibitory effect of alendronate on bone resorption of autogenous free bone grafts in rats.
Altundal, H; Göker, K; Sayrak, H; Yurtsever, E, 2007
)
1.38
"Alendronate is an amino-bisphosphonate with proved efficacy for increasing bone mineral density in men with idiopathic or secondary osteoporosis and has demonstrated an ability to prevent vertebral fractures in men with low bone mass. "( Alendronate for the treatment of osteoporosis in men.
Davison, KS; Olszynski, WP, 2008
)
3.23
"Alendronate is a potent aminobisphosphonate that has been used worldwide to decrease fracture risk in millions of post-menopausal women with and without osteoporosis, men with low bone mass, and in those with glucocorticoid- induced osteoporosis. "( Effect of inappropriate and continuous therapy with alendronate for ten years on skeletal integrity - observations in two elderly patients.
Tucci, JR, 2008
)
2.04
"Alendronate sodium (ALD) is a bisphosphonate medication used in the treatment and prevention of osteoporosis. "( The absorption of (99m)Tc-alendronate given by rectal route in rabbits.
Asikoğlu, M; Guneri, T; Koseoğlu, K; Orumlu, O; Ozcan, I; Ozguney, I; Ozkilic, H, 2008
)
2.09
"Alendronate is an aminobisphosphonate that acts as a potent inhibitor of osteoclastic bone resorption. "( Alendronate distributed on bone surfaces inhibits osteoclastic bone resorption in vitro and in experimental hypercalcemia models.
Azuma, Y; Kiyoki, M; Ohta, T; Okabe, K; Oue, Y; Sato, H; Tsuchimoto, M, 1995
)
3.18
"Alendronate is an antiosteolytic agent under investigation for the treatment of a number of bone disorders. "( On the absorption of alendronate in rats.
Chen, IW; deLuna, FA; Lin, JH, 1994
)
2.05
"Alendronate sodium (ALN) is a potent amino bisphosphonate which specifically inhibits osteoclastic bone resorption and has been found to reverse bone loss in several animal models. "( Treatment of postmenopausal osteoporosis with continuous daily oral alendronate in comparison with either placebo or intranasal salmon calcitonin.
Adami, S; Baroni, MC; Broggini, M; Carratelli, L; Caruso, I; Gnessi, L; Laurenzi, M; Lombardi, A; Norbiato, G; Ortolani, S, 1993
)
1.96
"Alendronate is a bisphosphonate which inhibits bone resorption. "( Effects of the bisphosphonate, alendronate, on parturition in the rat.
Manson, JM; Minsker, DH; Peter, CP, 1993
)
2.01
"Alendronate (ALN) is an aminobisphosphonate used in the treatment of diseases characterized by increased bone resorption including osteoporosis."( Long-term safety of the aminobisphosphonate alendronate in adult dogs. II. Histomorphometric analysis of the L5 vertebrae.
Balena, R; Gentile, M; Markatos, A; Peter, CP; Rodan, GA; Seedor, JG; Stark, C, 1996
)
1.28
"Alendronate is a drug with considerable potential. "( Alendronate: a new bisphosphonate for the treatment of osteoporosis.
Keen, RW; Spector, TD, 1996
)
3.18
"Alendronate appears to be a highly effective treatment for Paget's disease of bone that offers an important therapeutic advance over etidronate."( Comparative study of alendronate versus etidronate for the treatment of Paget's disease of bone.
Altman, R; Conte, JM; Favus, M; Lombardi, A; Lyles, K; McIlwain, H; Murphy, WA; Reda, C; Rude, R; Seton, M; Siris, E; Thompson, D; Tiegs, R; Tucci, JR; Weinstein, RS; Yates, AJ; Zimering, M, 1996
)
1.33
"Alendronate is a potent new oral aminobisphosphonate that has shown promising effects on Paget's disease in preliminary studies."( Biochemical and radiologic improvement in Paget's disease of bone treated with alendronate: a randomized, placebo-controlled trial.
Cundy, T; Dufresne, S; Hosking, DJ; Kotowicz, MA; Lombardi, A; Murphy, WA; Musliner, TA; Nicholson, GC; Reid, IR; Thompson, DE; Weinstein, RS; Yates, AJ; Yeap, S, 1996
)
1.24
"Oral alendronate appears to be a safe and effective therapy for Paget's disease and results in healing of lytic bone lesions."( Biochemical and radiologic improvement in Paget's disease of bone treated with alendronate: a randomized, placebo-controlled trial.
Cundy, T; Dufresne, S; Hosking, DJ; Kotowicz, MA; Lombardi, A; Murphy, WA; Musliner, TA; Nicholson, GC; Reid, IR; Thompson, DE; Weinstein, RS; Yates, AJ; Yeap, S, 1996
)
1.04
"Oral alendronate sodium is a potent, specific inhibitor of osteoclast-mediated bone resorption. "( Effect of three years of oral alendronate treatment in postmenopausal women with osteoporosis.
Emkey, RD; Kher, U; Peverly, CA; Santora, AC; Tonino, RP; Tucci, JR, 1996
)
1.1
"Alendronate (ALN) is an aminobisphosphonate employed as an antiresorptive agent in the treatment of osteoporosis. "( Dose-response relationships for alendronate treatment in osteoporotic elderly women. Alendronate Elderly Osteoporosis Study Centers.
Bone, HG; Downs, RW; Gertz, BJ; Hale, E; Harris, ST; Kimmel, DB; Licata, AA; McClung, MR; Polvino, WJ; Tucci, JR; Weinstein, RS, 1997
)
2.02
"Alendronate is an aminobisphosphonate which appears to attenuate, rather than completely inhibiting bone turnover, by suppressing the activity of osteoclasts. "( Alendronate. A review of its pharmacological properties and therapeutic efficacy in postmenopausal osteoporosis.
Barradell, LB; Jeal, W; McTavish, D, 1997
)
3.18
"Alendronate (Alen.) is a new generation bisphosphonate having far greater antiresorptive potency than previous bisphosphonates."( Alendronate prevents cyclosporin A-induced osteopenia in the rat.
Bowman, AR; Epstein, S; Jee, WS; Ma, Y; Sass, DA; Yuan, Z, 1997
)
2.46
"Alendronate seems to be a safe and effective nonhormonal option for prevention of postmenopausal bone loss."( Alendronate prevents postmenopausal bone loss in women without osteoporosis. A double-blind, randomized, controlled trial. Alendronate Osteoporosis Prevention Study Group.
Clemmesen, B; Daifotis, A; Eisman, J; Gilchrist, NL; McClung, M; Ravn, P; Reda, C; Weinstein, RS; Yates, AJ, 1998
)
2.46
"Alendronate is an aminobisphosphonate with a potent anti-reabsorptive action that does not appear to interfere with bone mineralization, and is even able to increase bone mineral density in osteoporotic postmenopausal women through a still not fully understood mechanism. "( Effect of alendronate on cultured normal human osteoblasts.
Aubía, J; Ballester, J; Carbonell, J; Díez, A; Farré, M; García-Moreno, C; Mariñoso, ML; Mellibovsky, L; Nacher, M; Nogués, X; Serrano, S, 1998
)
2.15
"Alendronate is a potent inhibitor of bone resorption. "( Effects of continuous alendronate treatment on bone mass and mechanical properties in ovariectomized rats: comparison with pamidronate and etidronate in growing rats.
Azuma, Y; Kanatani, H; Kiyoki, M; Komoriya, K; Ohta, T; Oue, Y, 1998
)
2.06
"Alendronate is an aminobisphosphonate that is able to increase bone mass mainly by inhibiting bone resorption."( Effectiveness of chronic treatment with alendronate in the osteoporosis of Cushing's disease.
Colao, A; Di Somma, C; Faggiano, A; Klain, M; Lombardi, G; Merola, B; Pivonello, R; Salvatore, M; Tripodi, FS, 1998
)
1.29
"Alendronate is a bisphosphonate that can decrease osteoclastic activity. "( Alendronate did not inhibit instability-induced bone resorption. A study in rats.
Aspenberg, P; Astrand, J, 1999
)
3.19
"Alendronate is a potent bisphosphonate that has been studied for the treatment of osteoporosis and Paget's disease of the bone. "( Pharmacokinetics of intravenous alendronate.
Cocquyt, V; De Grève, J; DeSmet, M; Gertz, BJ; Holland, SD; Kline, WF; Porras, AG; Quan, H; Van Belle, SJ; Vyas, KP; Zhang, KE, 1999
)
2.03
"Alendronate is an antiresorptive therapy for osteoporosis and results in a decrease in bone turnover. "( Monitoring alendronate therapy for osteoporosis.
Braga de Castro Machado, A; Eastell, R; Hannon, R, 1999
)
2.14
"Alendronate is a powerful therapeutic agent for the treatment of hypercalcemia in malignancy and osteoporosis and has recently been developed as a treatment for hypercalcemia of malignancy. "( Reversibility of alendronate-induced contraction in human osteoclast-like cells formed from bone marrow cells in culture.
Azuma, Y; Ishibashi, H; Karube, S; Kodama, S; Koshihara, Y; Ohta, T, 1999
)
2.09
"Alendronate is a bisphosphonate that is secreted via a saturable pathway in rat kidney. "( Renal handling of biphosphonate alendronate in rats.
Kato, Y; Kino, I; Lin, JH; Sugiyama, Y, 1999
)
2.03
"Alendronate seems to be a promising and safe agent for treatment of CIH."( Effect of alendronate treatment on the clinical picture and bone turnover markers in chronic idiopathic hyperphosphatasia.
Bereket, A; Demir, E; Ozkan, B; Topçu, M, 2000
)
1.43
"Alendronate is an aminobisphosphonate that inhibits bone resorption in osteoporotic humans and rats but does not induce osteomalacia. "( Alendronate administration and skeletal response during chronic alcohol intake in the adolescent male rat.
Emanuele, MA; Lapaglia, N; Moskal, SF; Steiner, J; Wezeman, FH, 2000
)
3.19
"Alendronate is a nitrogen-containing bisphosphonate analog used in the treatment of postmenopausal osteoporosis."( Alendronate stimulates collagenase 3 expression in osteoblasts by posttranscriptional mechanisms.
Canalis, E; Varghese, S, 2000
)
2.47
"Alendronate is an effective, well-tolerated therapy for the prevention and treatment of glucocorticoid-induced osteoporosis, with sustained treatment advantages for up to 2 years."( Two-year effects of alendronate on bone mineral density and vertebral fracture in patients receiving glucocorticoids: a randomized, double-blind, placebo-controlled extension trial.
Adachi, JD; Block, JA; Brown, J; Carofano, W; Correa-Rotter, R; Czachur, M; Daifotis, A; Delmas, PD; Dumortier, T; Emkey, RD; Gruber, BL; Hawkins, F; Kaufman, JM; Lane, NE; Leite, MO; Liberman, UA; Malice, MP; McIlwain, HH; Melo-Gomes, JA; Menkes, CJ; Nevitt, MC; Poubelle, PE; Rodriguez-Portales, JA; Saag, KG; Schnitzer, TJ; Seeman, E; Sharp, JT; Siminoski, KG; Westhovens, R; Wing, J; Yanover, MJ, 2001
)
2.08
"Alendronate (ALN) is an aminobisphosphonate commonly used for osteoporosis in postmenopausal women. "( Clinical and radiological improvement of periodontal disease in patients with type 2 diabetes mellitus treated with alendronate: a randomized, placebo-controlled trial.
Garay-Sevilla, ME; Malacara, JM; Nava, LE; Rocha, M; Sánchez-Márin, F; Vázquez de la Torre, C, 2001
)
1.96
"Alendronate (ALN) is a third generation bisphosphonate with demonstrated osteoclast inhibitory activity that may slow down the resorptive process after severe traumatic injuries. "( Effect of topical alendronate on root resorption of dried replanted dog teeth.
Bryson, EC; Caplan, D; Levin, L; Trope, M, 2001
)
2.09
"Alendronate sodium is an aminobisphosphonate indicated for the treatment of osteoporosis in post-menopausal women and has been associated with esophagitis in many reports. "( [Esophagus-enteric anastomosis ulceration caused by alendronate].
Araújo, RS; de Amorim, WP; Duques, P,
)
1.82
"Alendronate is a pyrophosphate analogue of bisphosphonate that has been shown to inhibit osteoclastic bone resorption. "( Alendronate does not inhibit early bone apposition to hydroxyapatite-coated total joint implants: a preliminary study.
Akisue, T; Bauer, TW; Brown, PR; Mochida, Y, 2002
)
3.2
"Alendronate is a third-generation bisphosphonate that blocks osteoclastic bone resorption."( Effects of alendronate on particle-induced osteolysis in a rat model.
Allen, MJ; Bostrom, MP; Millett, PJ, 2002
)
1.43

Effects

Alendronate (ALN) was used to fabricate double ALN-conjugated poly (ethylene glycol) 2000 material. It has a positive effect on secondary osteopenia/osteoporosis in children with connective tissue diseases.

Alendronate (ALN) has been reported to increase bone mass by suppressing bone resorption mainly by inducing apoptosis of osteoclasts. The drug has higher risk for AFF (HR 1.51, 95% CI 1.23-1.84) but similar risk for esophageal cancer (HR 0.95, 95%.

ExcerptReferenceRelevance
"Alendronate (ALN), which has a high ability to target to hydroxyapatite, was used to fabricate double ALN-conjugated poly (ethylene glycol) 2000 material (ALN-PEG"( Calcium phosphate nanoparticles functionalized with alendronate-conjugated polyethylene glycol (PEG) for the treatment of bone metastasis.
Chu, W; Cui, S; Huang, Y; Liao, Y; Yan, M; Yang, C; Zhang, X; Zhao, C, 2017
)
1.43
"Alendronate, which has a negative charge, was ion-paired with organic cations, such as tetraheptylammonium bromide (THAB) or tetrabutylammonium iodide (TBAI), to confer hydrophobicity to alendronate, and increase its intestinal permeability."( Studies on the formation of hydrophobic ion-pairing complex of alendronate.
Cho, CW; Kwon, HH; Lee, JM; Shin, SC; You, SK, 2009
)
1.31
"Alendronate has a positive effect on secondary osteopenia/osteoporosis in children with connective tissue diseases."( Efficacy and safety of alendronate for the treatment of osteoporosis in diffuse connective tissue diseases in children: a prospective multicenter study.
Bardare, M; Bianchi, ML; Boncompagni, A; Brandi, ML; Cimaz, R; Corona, F; Falcini, F; Galbiati, E; Giuntini, D; Lepore, L; Luisetto, G; Picco, P; Zulian, F, 2000
)
1.34
"Alendronate has higher risk for AFF (HR 1.51, 95% CI 1.23-1.84) but similar risk for esophageal cancer (HR 0.95, 95% CI 0.53-1.70), and ONJ (HR 1.62, 95% CI 0.78-3.34)."( Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis.
Duke, J; Hripcsak, G; Huser, V; Jin, P; Kim, Y; Lambert, CG; Madigan, D; Park, H; Park, RW; Reich, C; Rijnbeek, PR; Ryan, PB; Schuemie, MJ; Shah, NH; Suchard, MA; Tian, Y; Van Zandt, M; Vashisht, R; Wu, Y; Yang, J; You, SC, 2020
)
1.55
"Alendronate (Aln) has been the first-line drug for osteogenesis imperfecta (OI), while the comparable efficacy of Aln and strontium ranelate (SrR) remains unclear. "( Comparable Effects of Strontium Ranelate and Alendronate Treatment on Fracture Reduction in a Mouse Model of Osteogenesis Imperfecta.
Chen, R; He, H; Ma, C; Shi, C; Sun, B; Wu, H; Zhang, Y, 2021
)
2.32
"Alendronate (ALN) has antiresorptive and osteostimulative properties. "( One percent alendronate and aloe vera gel local host modulating agents in chronic periodontitis patients with class II furcation defects: A randomized, controlled clinical trial.
Dileep, P; Ipshita, S; Kumar, S; Kurian, IG; Pradeep, AR; Singh, P, 2018
)
2.3
"Alendronate has been used to prevent or treat glucocorticoid-induced osteoporosis (GIO), data regarding its efficacy are inconsistent. "( Effects of alendronate for treatment of glucocorticoid-induced osteoporosis: A meta-analysis of randomized controlled trials.
Guo, JB; Luo, ZJ; Ma, T; Qin, SQ; Wang, X; Wang, YK; Zhang, YM; Zhu, C, 2018
)
2.31
"Alendronate has evident benefits in the treatment of these diseases, but it is associated with jaw osteonecrosis, although less frequently compared with intravenous bisphosphonates."( Important aspects concerning alendronate-related osteonecrosis of the jaws: a literature review.
Cherubini, K; Figueiredo, MA; Iglesias, JE; Salum, FG, 2015
)
1.43
"Alendronate has been widely used in the treatment of osteoporosis. "( Alendronate for the Treatment of Osteoporosis in Men: A Meta-Analysis of Randomized Controlled Trials.
Xu, Z,
)
3.02
"Alendronate (ALN), which has a high ability to target to hydroxyapatite, was used to fabricate double ALN-conjugated poly (ethylene glycol) 2000 material (ALN-PEG"( Calcium phosphate nanoparticles functionalized with alendronate-conjugated polyethylene glycol (PEG) for the treatment of bone metastasis.
Chu, W; Cui, S; Huang, Y; Liao, Y; Yan, M; Yang, C; Zhang, X; Zhao, C, 2017
)
1.43
"Alendronate, which has a negative charge, was ion-paired with organic cations, such as tetraheptylammonium bromide (THAB) or tetrabutylammonium iodide (TBAI), to confer hydrophobicity to alendronate, and increase its intestinal permeability."( Studies on the formation of hydrophobic ion-pairing complex of alendronate.
Cho, CW; Kwon, HH; Lee, JM; Shin, SC; You, SK, 2009
)
1.31
"Alendronate has been used in childhood osteoporosis of other aetiologies with good results and no adverse effects."( [Alendronate treatment of osteoporosis secondary to Duchenne muscular dystrophy].
Ballester Herrera, MJ; Carmona Vilchez, RM; Márquez de La Plata, MA; Medina Cano, E; Palomo Atance, E, 2011
)
2
"Alendronate has no obvious effect on preventing the necessity for THA, reducing disease progression, or improving life quality."( Alendronate in the prevention of collapse of the femoral head in nontraumatic osteonecrosis: a two-year multicenter, prospective, randomized, double-blind, placebo-controlled study.
Chang, CH; Chang, JK; Chen, CH; Hou, SM; Lai, KA; Wang, GJ, 2012
)
3.26
"Alendronate (ALN) has been reported to increase bone mass by suppressing bone resorption mainly by inducing apoptosis of osteoclasts."( Combination therapy with eldecalcitol and alendronate has therapeutic advantages over monotherapy by improving bone strength.
Endo, K; Mihara, M; Sakai, S; Shiraishi, A; Takeda, S, 2012
)
1.36
"Alendronate has been approved for treatment of osteoporosis in men, and other treatments for men are under evaluation."( Osteoporosis in elderly: prevention and treatment.
Deal, C; Srivastava, M, 2002
)
1.04
"Alendronate has been found to induce clinically significant increases in bone mineral density at the spine, hip and other cortical and trabecular sites while maintaining bone quality thereby reducing the rate of vertebral fracture."( Alendronate in the treatment of postmenopausal osteoporosis.
Favus, M; Hosking, DJ; Yates, AJ, 1999
)
2.47
"Alendronate has no effect on vascular markers or sex hormone-binding globulin."( Effects of hormone therapy and alendronate on C-reactive protein, E-selectin, and sex hormone-binding globulin in osteoporotic women.
Eviö, S; Tiitinen, A; Välimäki, M; Ylikorkala, O, 2003
)
1.33
"Alendronate has been shown to reduce bone turnover and increase bone mass. "( Alendronate has a residual effect on bone mass in postmenopausal Danish women up to 7 years after treatment withdrawal.
Alexandersen, P; Bagger, YZ; Christiansen, C; Ravn, P; Tankó, LB, 2003
)
3.2
"Alendronate has recently been approved for the prevention and treatment of postmenopausal osteoporosis, and its efficacy has been demonstrated in many Western countries. "( Effect of alendronate on bone mineral density and bone turnover in Thai postmenopausal osteoporosis.
Chailurkit, LO; Jongjaroenprasert, W; Ongphiphadhanakul, B; Rajatanavin, R; Rungbunnapun, S; Sae-tung, S, 2003
)
2.16
"Alendronate has been shown to be effective for the treatment of osteoporosis and for reducing the rate of osteoporotic fractures."( The effect of alendronate on bone mineral density in the distal part of the femur and proximal part of the tibia after total knee arthroplasty.
Chen, HS; Hsu, CC; Huang, CC; Wang, CJ; Wang, JW; Weng, LH, 2003
)
1.4
"Alendronate has demonstrated significant reductions in vertebral and nonvertebral fracture risk after 3 years."( An approach to postmenopausal osteoporosis treatment: a case study review.
Kessenich, C, 2003
)
1.04
"Alendronate has been proven to be effective in the prevention and treatment of postmenopausal osteoporosis with the recommended daily dose of 10 mg. "( Efficacy of intermittent low dose alendronate in Thai postmenopausal osteoporosis.
Aunphongpuwanart, S; Chailurkit, LO; Jongjaroenprasert, W; Ongphiphadhanakul, B; Rajatanavin, R; Sae-tung, S, 2004
)
2.05
"Alendronate has been shown to prevent osteolysis in a canine total hip arthroplasty (THA) model. "( Effect of oral alendronate on net bone ingrowth into canine cementless total hips.
Bragdon, CR; Doherty, AM; Harris, WH; Jasty, M; Rubash, H, 2005
)
2.12
"Alendronate has been found to reduce the risk of fractures in postmenopausal women as demonstrated in multiple randomized controlled trials enrolling thousands of women. "( Does alendronate reduce the risk of fracture in men? A meta-analysis incorporating prior knowledge of anti-fracture efficacy in women.
Adachi, JD; Gafni, A; Hanley, DA; Papaioannou, A; Sawka, AM; Thabane, L, 2005
)
2.29
"Alendronate has positively influenced quality of life in paediatric patients with osteogenesis imperfecta. "( Effect of alendronate therapy in children with osteogenesis imperfecta.
Kutílek, S; Pikner, R; Vyskocil, V, 2005
)
2.17
"Alendronate has been described to have a bone-sparing effect in patients treated with moderate and high dosages of prednisone for heterogeneous diseases, however no data are available on groups of patients with the same underlying diseases who receive chronic low-dose prednisone treatment. "( Positive effect of alendronate on bone mineral density and markers of bone turnover in patients with rheumatoid arthritis on chronic treatment with low-dose prednisone: a randomized, double-blind, placebo-controlled trial.
Bijlsma, JW; Dijkmans, BA; Geusens, P; Lems, WF; Lips, P; Lodder, MC; Schrameijer, N; van de Ven, CM, 2006
)
2.1
"Alendronate has been studied extensively by large trials of high quality and its efficacy to reduce the risk of vertebral and nonvertebral fractures is in line with the criteria of evidence-based medicine."( [Drug therapy for prevention of falls and fractures].
Ringe, JD, 2006
)
1.06
"Alendronate has demonstrated its ability to increase bone mass significantly above the placebo values at any studied skeletal site in a wide variety of patient subgroups regardless of age, race, baseline rate of bone turnover or baseline bone mineral density."( A risk-benefit assessment of alendronate in the treatment of involutional osteoporosis.
Devogelaer, JP, 1998
)
1.31
"Alendronate has been shown to increase bone density among early postmenopausal women. "( Skeletal benefits of two years of alendronate treatment are similar for early postmenopausal Asian and Caucasian women.
Cizza, G; Ross, PD; Thompson, DE; Wasnich, RD; Yates, AJ, 1999
)
2.03
"Alendronate has been reported to increase bone mineral density (BMD) and reduce fracture risk in women with osteoporosis. "( Effects of alendronate on bone density in men with primary and secondary osteoporosis.
Frauman, AG; Ho, YV; Seeman, E; Thomson, W, 2000
)
2.14
"Alendronate has the greatest positive effect on BMD and reduces the incidence of vertebral and nonvertebral fractures."( Prevention and treatment of osteoporosis in women with breast cancer.
Mincey, BA; Moraghan, TJ; Perez, EA, 2000
)
1.03
"Alendronate has a positive effect on secondary osteopenia/osteoporosis in children with connective tissue diseases."( Efficacy and safety of alendronate for the treatment of osteoporosis in diffuse connective tissue diseases in children: a prospective multicenter study.
Bardare, M; Bianchi, ML; Boncompagni, A; Brandi, ML; Cimaz, R; Corona, F; Falcini, F; Galbiati, E; Giuntini, D; Lepore, L; Luisetto, G; Picco, P; Zulian, F, 2000
)
1.34
"Alendronate has been approved as a first antiresorptive drug for treatment of osteoporosis in men. "( Treatment of osteoporosis in men with fluoride alone or in combination with bisphosphonates.
Ringe, JD; Rovati, LC, 2001
)
1.75
"Alendronate (10 mg daily) has been shown in long term clinical trials to be an effective treatment for postmenopausal osteoporosis. "( The upper GI safety and tolerability of oral alendronate at a dose of 70 milligrams once weekly: a placebo-controlled endoscopy study.
Daifotis, A; Lanza, F; Leung, A; Musliner, T; Quan, H; Reyes, R; Sahba, B; Schwartz, H; Torosis, J; Winograd, S, 2002
)
2.02

Actions

Alendronate (ALN) can increase bone mass and improve the microstructure of osteoporotic vertebrae. It can cause mucosal ulcerations in the oral cavity, affecting patients with intense pain and causing severe morbidity.

ExcerptReferenceRelevance
"Alendronate (ALN) can increase bone mass and improve the microstructure of osteoporotic vertebrae, which might be helpful in preserving disc morphology and mechanical properties."( Alendronate retards the progression of lumbar intervertebral disc degeneration in ovariectomized rats.
Hu, QF; Luo, Y; Song, HP; Su, YL; Wang, WY; Zhang, L; Zhang, YZ, 2013
)
2.55
"Alendronate caused an increase in the pain threshold value and inhibited c-Fos expression."( Inhibitory effect of bisphosphonate on osteoclast function contributes to improved skeletal pain in ovariectomized mice.
Abe, Y; Amizuka, N; Chiba, H; Iba, K; Kanaya, K; Kawamata, T; Oda, K; Sasaki, K; Sasaki, M; Yamashita, T, 2015
)
1.14
"The alendronate group had an increase in areal BMD in normal bone at the lumbar spine (P = .006), and in predetermined regions of FD (P < .001)."( A randomized, double blind, placebo-controlled trial of alendronate treatment for fibrous dysplasia of bone.
Bianco, P; Boyce, AM; Brillante, BA; Collins, MT; Kelly, MH; Kushner, H; Riminucci, M; Robey, PG; Wientroub, S, 2014
)
1.13
"Alendronate can inhibit bone absorptive factors expression induced by wear particles and may be used in the prevention and treatment of aseptic loosening of prosthesis."( [Experiment study of alendronate in the prevention and treatment of aseptic loosening of prosthesis].
Chen, M; Fang, ZH; Kan, WS; Zheng, Q, 2008
)
2.11
"Oral alendronate produces an increase in BMD in these patients, with good tolerance and no need for hospitalization, and so improves quality of life and reduces health care costs."( [Alendronate treatment of osteoporosis secondary to Duchenne muscular dystrophy].
Ballester Herrera, MJ; Carmona Vilchez, RM; Márquez de La Plata, MA; Medina Cano, E; Palomo Atance, E, 2011
)
1.79
"Alendronate can cause mucosal ulcerations in the oral cavity, affecting patients with intense pain and causing severe morbidity. "( Oral ulcers, a little known adverse effect of alendronate: review of the literature.
Kharazmi, M; Sjöqvist, K; Warfvinge, G, 2012
)
2.08
"Alendronate users had a lower risk of incident gastric cancer [odds ratio (OR) 0.61; 95% confidence interval (CI): 0.39-0.97) and no increased risk of esophageal cancer (OR 0.71; 95% CI: 0.43-1.19)."( Esophageal and gastric cancer incidence and mortality in alendronate users.
Abrahamsen, B; Eastell, R; Eiken, P; Pazianas, M; Russell, RG, 2012
)
1.35
"Alendronate may inhibit rat aorta calcification by up-regulating osteopontin and osteoprotegerin expression."( The effect of alendronate on the expression of osteopontin and osteoprotegerin in calcified aortic tissue of the rat.
Jia, P; Li, Y; Liu, K; Wang, J; Wang, Z; Zhang, F, 2012
)
1.46
"Alendronate is known to increase bone mineral density (BMD) at the lumbar spine and hip in women, but less information is available in men. "( A systematic review of the effect of alendronate on bone mineral density in men.
Adachi, JD; Gafni, A; Hanley, DA; Papaioannou, A; Sawka, AM; Thabane, L, 2005
)
2.04
"Alendronate can inhibit the artery calcification in rats."( [The effect of alendronate on arterial calcification in rat model].
Hu, T; Jia, GL; Li, H; Lü, R; Tao, HR; Wang, HC; Wang, J; Zhang, RQ, 2006
)
2.13
"Alendronate may cause mucosal ulcerations in the mouth and esophagus."( Intragastric alendronate therapy in two infants with vitamin D intoxication: a new method.
Caner, I; Doneray, H; Karakelleoglu, C; Ozkan, A; Ozkan, B, 2008
)
1.44
"Alendronate prevented the increase in bone turnover and increased bone volume above control values without interfering with the recruitment of osteoclasts."( The aminobisphosphonate alendronate inhibits bone loss induced by thyroid hormone in the rat. Comparison between effects on tibiae and vertebrae.
Balena, R; Gentile, M; Markatos, A; Masarachia, P; Rodan, GA; Seedor, JG; Yamamoto, M,
)
1.16
"Alendronate can cause chemical esophagitis, including severe ulcerations, in some patients. "( Esophagitis associated with the use of alendronate.
Daifotis, A; de Groen, PC; Freedholm, D; Hirsch, LJ; Lubbe, DF; Pinkas, H; Pryor-Tillotson, S; Seleznick, MJ; Stephenson, W; Wang, KK, 1996
)
2.01
"Alendronate did not increase bone mineral density of the forearm, but it slowed the loss."( Prevention of bone loss with alendronate in postmenopausal women under 60 years of age. Early Postmenopausal Intervention Cohort Study Group.
Balske, A; Chilvers, CE; Christiansen, C; Daley, M; Hosking, D; McClung, M; Ravn, P; Ross, P; Thompson, D; Wasnich, R; Yates, AJ, 1998
)
1.31
"Alendronate failed to inhibit MMP-2 activity directly, but instead appeared to block cellular secretion of MMP-2."( Alendronate blocks TGF-beta1 stimulated collagen 1 degradation by human prostate PC-3 ML cells.
Stearns, ME, 1998
)
2.46
"Alendronate did not increase the risk of gastrointestinal or other adverse effects."( Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial.
Applegate, WB; Barrett-Connor, E; Black, DM; Cummings, SR; LaCroix, AZ; Musliner, TA; Palermo, L; Prineas, R; Rubin, SM; Scott, JC; Thompson, DE; Vogt, T; Wallace, R; Yates, AJ,
)
1.26
"Alendronate did not inhibit isopentenyl diphosphate isomerase or GGPP synthase, partially purified from liver cytosol."( Alendronate is a specific, nanomolar inhibitor of farnesyl diphosphate synthase.
Bergstrom, JD; Bostedor, RG; Masarachia, PJ; Reszka, AA; Rodan, G, 2000
)
2.47
"Alendronate does not cause predictable esophageal, gastric, or duodenal mucosal damage when used as directed."( Upper gastrointestinal toxicity of alendronate.
Depew, WT; Lowe, CE; Meddings, JB; Paterson, WG; Vanner, SJ, 2000
)
2.03
"Alendronate promotes apoptosis of the OCLs and it is related with the expression of the Fas gene."( Apoptosis of osteoclast-like cells induced by alendronate is related to Fas gene expression.
Wang, XM; Yang, ZP; Yu, SF, 2000
)
2.01
"Alendronate sodium could cause lesions of the inferior esophageal portion or in distal segments of the gastrointestinal tube, in patients with a fast gastrointestinal transit. "( [Esophagus-enteric anastomosis ulceration caused by alendronate].
Araújo, RS; de Amorim, WP; Duques, P,
)
1.82

Treatment

Alendronate treatment decreased urinary NTX level by 39.2% in men and 45.4% in postmenopausal women at 3 months and serum ALP level by 17.8 and 21.0%, respectively, at 12 months. Alendronates prevented much of the decrease in ultimate load that occurs in the first 21 days.

ExcerptReferenceRelevance
"Alendronate treatment was administered and well tolerated during the entire follow-up period (median, 9.5 months; interquartile range [IQR], 6.3; 27) in all cats from Group 1, except in 1 cat that developed severe hypophosphatemia, prompting treatment discontinuation."( Alendronate treatment in cats with persistent ionized hypercalcemia: A retrospective cohort study of 20 cases.
Benchekroun, G; Canonne-Guibert, M; Da Riz, F; Desquilbet, L; Kurtz, M; Maire, J; Maurey, C, 2022
)
2.89
"Alendronate treatment increased the bone volume fraction by 139% (p < .001) in the region distal to the implant and 60% (p < .05) in the peri-implant region."( Alendronate enhances osseointegration in a murine implant model.
Bostrom, MP; Greenblatt, MB; Ji, G; Mun, S; Niu, Y; Park-Min, KH; Sosa, BR; Suhardi, V; Turajane, K; Vertesich, K; Windhager, R; Xu, R; Yang, X, 2021
)
2.79
"Alendronate treatment resulted in a higher trabecular tissue stiffness and strength, associated with higher levels of TMD."( Effects of anti-resorptive treatment on the material properties of individual canine trabeculae in cyclic tensile tests.
Allen, MR; Burr, DB; Frank, M; Grabos, A; Pahr, DH; Reisinger, AG; Thurner, PJ, 2021
)
1.34
"Alendronate treatment was not associated with increased risk of mild upper gastrointestinal tract symptoms (alendronate vs no alendronate, 15.6 [95% CI, 11.6-21.0] vs 12.9 [95% CI, 9.3-18.0] per 1000 person-years; P = .40) or peptic ulcers (10.9 [95% CI, 7.7-15.5] vs 11.4 [95% CI, 8.0-16.2] per 1000 person-years; P = .86)."( Association Between Alendronate Use and Hip Fracture Risk in Older Patients Using Oral Prednisolone.
Axelsson, KF; Lorentzon, M; Lundh, D; Nilsson, AG; Wedel, H, 2017
)
1.5
"Alendronate treatment increases bone mass and reduces the risk of fractures in patients with osteoporosis by suppressing bone resorption."( Risk of long-term infection-related death in clinical osteoporotic vertebral fractures: A hospital-based analysis.
Chen, YC; Lin, WC, 2017
)
1.18
"Alendronate treatment was associated with a decreased risk of hip fracture in crude (hazard ratio (HR) 0.62 (0.49-0.79), P < 0.001) and multivariable models (HR 0.66 (0.51-0.86), P < 0.01)."( Hip fracture risk and safety with alendronate treatment in the oldest-old.
Axelsson, KF; Johansson, H; Lorentzon, M; Lundh, D; Wallander, M, 2017
)
1.46
"Alendronate treatment significantly increased BMD of the lumbar spine and femoral neck during 6 to 24 months."( Effects of alendronate for treatment of glucocorticoid-induced osteoporosis: A meta-analysis of randomized controlled trials.
Guo, JB; Luo, ZJ; Ma, T; Qin, SQ; Wang, X; Wang, YK; Zhang, YM; Zhu, C, 2018
)
1.59
"Alendronate treatment did not affect radiographic progression."( Periarticular and generalised bone loss in patients with early rheumatoid arthritis: influence of alendronate and intra-articular glucocorticoid treatment. Post hoc analyses from the CIMESTRA trial.
Abrahamsen, B; Andersen, LS; Ellingsen, T; Hansen, I; Hansen, MS; Hetland, ML; Hyldstrup, L; Hørslev-Petersen, K; Jensen, TW; Junker, P; Jurik, AG; Langdahl, B; Lauridsen, UB; Lindegaard, H; Lottenburger, T; Pedersen, JK; Pødenphant, J; Skjødt, H; Stengaard-Petersen, K; Svendsen, AJ; Tarp, U; Vestergaard, A; Zerahn, B; Østergaard, M, 2014
)
1.34
"Alendronate treatment before fracture did not cause a significant increase in cartilage retention in fracture callus."( Fracture healing with alendronate treatment in the Brtl/+ mouse model of osteogenesis imperfecta.
Begun, DL; Caird, MS; Goldstein, SA; Kozloff, KM; Marini, JC; McElderry, JD; Meganck, JA; Morris, MD; Swick, A, 2013
)
1.43
"Alendronate treatment by standard dose for osteoporosis showed clinical efficacy for decreasing pain but failed to show preventive effects for structural progression of hip osteoarthritis."( Alendronate treatment for hip osteoarthritis: prospective randomized 2-year trial.
Nishii, T; Shiomi, T; Sugano, N; Tamura, S; Yoshikawa, H, 2013
)
2.55
"Alendronate treatment was associated with a reduced risk of lower limb ischemic vascular events among hip or vertebral fragility fracture patients."( Alendronate and risk of lower limb ischemic vascular events: a population-based cohort study.
Chang, HL; Chang, HT; Chen, CK; Chen, TJ; Chen, YC; Chou, HP; Huang, YC; Lee, MH; Shih, CC, 2014
)
3.29
"Alendronate treatment led to a reduction in the bone resorption marker NTX-telopeptides, and improvement in aBMD, but no significant effect on serum osteocalcin, pain, or functional parameters."( A randomized, double blind, placebo-controlled trial of alendronate treatment for fibrous dysplasia of bone.
Bianco, P; Boyce, AM; Brillante, BA; Collins, MT; Kelly, MH; Kushner, H; Riminucci, M; Robey, PG; Wientroub, S, 2014
)
2.09
"The alendronate-treated cases had a reduced eroded surface (ES/BS, p<0.001) and a higher bone mineralisation in comparison to non-treated controls (p=0.037), which is indicative of low turnover associated with treatment."( Effects of long-term alendronate treatment on bone mineralisation, resorption parameters and biomechanics of single human vertebral trabeculae.
Amling, M; Breer, S; Busse, B; Glueer, CC; Hahn, M; Hapfelmeier, A; Kornet, J; Krause, M; Morlock, M; Püschel, K; Soltau, M; Wulff, B; Zimmermann, EA, 2014
)
1.2
"Alendronate treatment resulted in a decrease in iCa in all 12 cats. "( Treatment of ionized hypercalcemia in 12 cats (2006-2008) using PO-administered alendronate.
Braudaway, SR; Chew, DJ; de Brito Galvao, JF; DiBartola, SP; Green, TA; Hardy, BT; Lord, L, 2015
)
2.09
"Alendronate treatment was discontinued and, while a suitable kidney donor was sought, the patient was treated for 6 months with teriparatide, which significantly reduced the osteomalacia."( Reversible Deterioration in Hypophosphatasia Caused by Renal Failure With Bisphosphonate Treatment.
Collins, JF; Cundy, T; Dray, M; Fratzl-Zelman, N; Gamsjaeger, S; Klaushofer, K; Michigami, T; Paschalis, EP; Roschger, A; Roschger, P; Tachikawa, K, 2015
)
1.14
"Alendronate treatment did not ameliorate muscle degeneration, but demonstrated a limited enhancement on muscle function test."( Glucocorticoid Steroid and Alendronate Treatment Alleviates Dystrophic Phenotype with Enhanced Functional Glycosylation of α-Dystroglycan in Mouse Model of Limb-Girdle Muscular Dystrophy with FKRPP448L Mutation.
Blaeser, A; Bollinger, LE; Cox, MD; Harper, AD; Lu, P; Lu, QL; Luckie, TM; Madden, KL; Richardson, SM; Shah, SN; Sparks, S; Sun, Y; Wu, B, 2016
)
1.45
"Alendronate treatment was ceased."( Surgical treatment of bilateral femoral stress fractures related with long-term alendronate therapy.
Ataoğlu, MB; Çetinkaya, M; Kanatlı, U; Özer, M; Topçu, HN, 2017
)
1.4
"Alendronate-treated patients discontinued alendronate and were followed."( Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial.
Austin, M; Bolognese, MA; Ding, B; Lewiecki, EM; Liu, Y; McClung, MR; Miller, PD; San Martin, J, 2008
)
1.07
"Alendronate treatment enhanced bone thickness in TRPV5(+/+) mice but also normalized the disturbed bone morphometry parameters in TRPV5(-/-) mice."( Bone resorption inhibitor alendronate normalizes the reduced bone thickness of TRPV5(-/-) mice.
Bindels, RJ; Hoenderop, JG; Nijenhuis, T; van der Eerden, BC; van Leeuwen, JP; Weinans, H, 2008
)
1.37
"Alendronate treatment alone had no effect on CYP2B or CYP3A mRNA expression in the hepatocyte cultures, but alendronate cotreatment completely suppressed squalestatin 1-mediated CYP2B mRNA induction at concentrations (60 and 100 microM) that effectively inhibited cellular farnesyl diphosphate synthase activity, as assessed by reductions of squalestatin 1-mediated FPP accumulation, and that were not toxic to the cells, as indicated by a lack of effect on 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide activity."( Suppression of CYP2B induction by alendronate-mediated farnesyl diphosphate synthase inhibition in primary cultured rat hepatocytes.
Jackson, NM; Kocarek, TA, 2008
)
1.35
"Alendronate treatment resulted in similar levels of turnover in both sites, suggesting that a lower limit of bone turnover suppression with alendronate may exist."( Alendronate treatment results in similar levels of trabecular bone remodeling in the femoral neck and vertebra.
Allen, MR; Burr, DB; Diab, T, 2009
)
2.52
"Alendronate treatment resulted in similar absolute levels of bone turnover in the femoral neck and vertebrae, although the femoral neck had 33% lower pre-treatment surface-based remodeling rate than the vertebra (p < 0.05). "( Alendronate treatment results in similar levels of trabecular bone remodeling in the femoral neck and vertebra.
Allen, MR; Burr, DB; Diab, T, 2009
)
3.24
"Alendronate treatment may result in a lower limit of trabecular bone turnover suppression, suggesting that sites of low pre-treatment remodeling rate are not more susceptible to oversuppression than those of high pre-treatment remodeling rate."( Alendronate treatment results in similar levels of trabecular bone remodeling in the femoral neck and vertebra.
Allen, MR; Burr, DB; Diab, T, 2009
)
3.24
"Alendronate treatment decreased TRACP values determined with assays 1, 2 and 3, and had no effect on the values determined with assays 4, 5 and 6."( Clinical performance of six different serum tartrate-resistant acid phosphatase assays for monitoring alendronate treatment.
Cheng, S; Fagerlund, KM; Halleen, JM; Janckila, AJ; Nenonen, A; Tiitinen, SL; Uusi-Rasi, K; Väänänen, HK; Yam, LT; Ylipahkala, H, 2008
)
1.28
"Alendronate treatment is estimated to result in increases in hip bone density >or=0.019 g/cm(2) in 97.5% of patients."( Value of routine monitoring of bone mineral density after starting bisphosphonate treatment: secondary analysis of trial data.
Bauer, DC; Bell, KJ; Craig, JC; Ensrud, K; Hayen, A; Irwig, L; Macaskill, P, 2009
)
1.07
"Alendronate treatment resulted in significant decreases in bone metabolism and turnover in the lumbar spine. "( Effects of alendronate on bone metabolism in glucocorticoid-induced osteoporosis measured by 18F-fluoride PET: a prospective study.
Baba, H; Fujibayashi, Y; Kawahara, H; Kobayashi, S; Miyazaki, T; Nakajima, H; Okazawa, H; Tsuchida, T; Uchida, K; Yayama, T, 2009
)
2.19
"Alendronate treatment enhanced early bone formation and mineralization in the osteochondral defect for the first 8 weeks."( Positive effect of alendronate on subchondral bone healing and subsequent cartilage repair in a rabbit osteochondral defect model.
Azuma, Y; Kobayashi, M; Kuroki, H; Nakagawa, Y; Nakamura, T; Nishitani, K; Shirai, T, 2009
)
1.4
"Alendronate treatment decreased urinary cross-linked N-terminal telopeptides of type I collagen and serum alkaline phosphatase levels, and maintained metacarpal bone mineral density in postmenopausal Japanese women with osteoporosis. "( Factors affecting discontinuation of alendronate treatment in postmenopausal Japanese women with osteoporosis.
Iwamoto, J; Matsumoto, H; Miyata, A; Sato, Y; Takeda, T, 2009
)
2.07
"Alendronate treatment increased phosphorus concentration and decreased water concentration in a dose-dependent manner, the higher dose yielding significant changes relative to values found in OVX animals: (31)P-MRI (+14%; p<0.0001), (31)P-NMR (+9%; p<0.0001), ash content (+1.5%; p<0.005), micro-CT mineralization density (+2.8%; p<0.05), and (1)H-MRI, (-19%, p<0.0001)."( Ultra-short echo-time MRI detects changes in bone mineralization and water content in OVX rat bone in response to alendronate treatment.
Anumula, S; Magland, J; Wehrli, FW; Wehrli, SL; Wright, AC, 2010
)
1.29
"Alendronate-treated rats did not show morphological alterations in the secretory-stage enamel organic ECM, however, they presented significant reduction in optical retardation of birefringence brightness when compared with control and etidronate rats (p < 0.01)."( Birefringence of the secretory-stage enamel organic extracellular matrix from rats submitted to successive injections of bisphosphonates.
do Espírito Santo, AR; Frozoni, MR; Line, SR; Novaes, PD; Ramos-Perez, FM, 2010
)
1.08
"Alendronate treatment reduced bony osteophyte development."( In vivo microfocal computed tomography and micro-magnetic resonance imaging evaluation of antiresorptive and antiinflammatory drugs as preventive treatments of osteoarthritis in the rat.
Doschak, MR; Jones, MD; Li, G; Maksymowych, WP; Tran, CW; Zernicke, RF, 2010
)
1.08
"Alendronate-treated patients are at higher risk of hip and subtrochanteric/diaphyseal fracture than matched control subjects. "( Cumulative alendronate dose and the long-term absolute risk of subtrochanteric and diaphyseal femur fractures: a register-based national cohort analysis.
Abrahamsen, B; Eastell, R; Eiken, P, 2010
)
2.19
"Alendronate treatment increased BMD and reduced the level of bone turnover markers."( Evaluation of bone remodelling parameters after one year treatment with alendronate in postmenopausal women with osteoporosis.
Alimanovic-Alagić, R; Brković, A; Hadžović-Džuvo, A; Kučukalić-Selimović, E; Skopljak-Beganović, A; Valjevac, A, 2011
)
1.32
"Alendronate treatment increased the peak mineral content above the other treatment groups at the trabecular (tibia: 6% above PTH, 6% above combined, L4: 4% above PTH, 4% above combined) and endocortical (tibia: 4% above PTH, 3% above combined, L4: 1% above PTH, 2% above combined) surfaces, while no differences in mineralization between the PTH and combined groups were observed."( The bone architecture is enhanced with combined PTH and alendronate treatment compared to monotherapy while maintaining the state of surface mineralization in the OVX rat.
Bernhardt, R; Boyd, SK; Campbell, GM; Scharnweber, D, 2011
)
1.34
"Alendronate treatment achieves normocalcemia four times earlier than prednisolone treatment and shortens hospital stay in infants with vitamin D intoxication."( Comparison of oral alendronate versus prednisolone in treatment of infants with vitamin D intoxication.
Bereket, A; Bozaykut, A; Guran, T; Paketçi, C; Seren, LP; Sezer, RG, 2012
)
2.15
"Alendronate treatment significantly increased not only ALP activity but also the expression of ALP, Col 1, and OCN, Id-1 and Id-2. "( Up-regulation of inhibitors of DNA binding/differentiation gene during alendronate-induced osteoblast differentiation.
Choi, JS; Choi, WJ; Ji, YI; Joo, BS; Jung, MH; Kang, AR; Kim, HY; Lee, JY; Oh, YR; Park, MJ, 2012
)
2.05
"Alendronate treatment appeared to have a similar effect on surrogate markers in postmenopausal osteoporotic Japanese women with or without RD. "( Three-year experience with alendronate treatment in postmenopausal osteoporotic Japanese women with or without renal dysfunction: a retrospective study.
Iwamoto, J; Matsumoto, H; Sato, Y; Takeda, T; Uzawa, M, 2012
)
2.12
"Oral alendronate treatment reduces the incidence of bone fracture and improves physical activity and life quality in OI children, and as a well-tolerated regimen, it is both safe and effective in clinical practice."( [Clinical study of oral alendronate in the treatment of pediatric osteogenesis imperfecta].
Cai, QX; Chen, Q; Gu, XF; Qiu, WJ; Wang, XL; Wei, SS; Ye, J; Zhao, L, 2012
)
1.2
"Alendronate treatment inhibited osteophyte development by 40% and 51% quantified by micro-CT volumetric measurements at 4 and 8 weeks after surgery, respectively."( Potential mechanism of alendronate inhibition of osteophyte formation in the rat model of post-traumatic osteoarthritis: evaluation of elemental strontium as a molecular tracer of bone formation.
Doschak, MR; Maksymowych, WP; Panahifar, A, 2012
)
1.41
"Alendronate treatment did not impede the recruitment and fusion of osteoclasts at the ossification zone during condyle growth, but they presented inactivated phenotype."( Effect of alendronate on endochondral ossification in mandibular condyles of growing rats.
Arana-Chavez, VE; Barrence, FA; Bradaschia-Correa, V; Ferreira, LB; Massa, LF, 2012
)
1.5
"Alendronate treatment for 12 months in pediatric patients with rheumatic diseases and secondary low bone mass was reported to result in a substantial increase in bone mineral density (BMD). "( Changes in markers of bone turnover and inflammatory variables during alendronate therapy in pediatric patients with rheumatic diseases.
Bardare, M; Bianchi, ML; Chiesa, S; Cimaz, R; Corona, F; Dubini, A; Falcini, F; Gattorno, M; Lenhardt, A; Lepore, L; Martini, G; Masi, L; Sormani, MP; Zulian, F, 2002
)
1.99
"Alendronate-treated patients gained bone at all sites [lumbar spine (LS), 1 yr gain, +7.3 +/- 1.7%; P < 0.001; 2 yr, +7.3 +/- 3.1%; P = 0.04)."( Alendronate in the treatment of primary hyperparathyroid-related osteoporosis: a 2-year study.
Blackwell, PJ; Fairbairn, KJ; Hosking, DJ; Parker, CR, 2002
)
2.48
"Alendronate treatment did not impair bone mineralisation, induce the formation of woven bone or have any other adverse effects on bone quality."( The effects of alendronate on bone turnover and bone quality.
Arlot, M; Chavassieux, P; Meunier, PJ; Yates, AJ, 1999
)
1.38
"Alendronate-treated rats showed less bone resorption, but etanercept, intermittent parathyroid hormone treatment, or saline did not reduce the fluid pressure-induced bone resorption."( A rat model for testing pharmacologic treatments of pressure-related bone loss.
Aspenberg, P; Astrand, J; Skoglund, B; Skripitz, R, 2003
)
1.04
"Alendronate treatment was associated with a 2.3% mean increase (95% confidence interval [CI], 1.7%-3.0%) in spine BMD compared with a mean loss of 3.2% (95% CI, - 4.6% to - 1.7%) in patients receiving placebo, for a difference of 5.5% (95% CI, 4.2%-6.8%) between alendronate and placebo. "( Alendronate prevents loss of bone density associated with discontinuation of hormone replacement therapy: a randomized controlled trial.
Ascott-Evans, BH; Guanabens, N; Kivinen, S; Magaril, CH; Melton, ME; Stuckey, BG; Stych, B; Vandormael, K, 2003
)
3.2
"The alendronate-treated patients gained (mean +/- SD) 4.9 +/- 3.0% and 2.8 +/- 3.2% bone density after 1 year versus placebo, which lost (mean +/- SD) 1.8 +/- 4.0% and 0.7 +/- 4.7%, in spine and femur bone density, respectively (p < or = 0.001 for the spine; p = 0.003 for the femur)."( Efficacy of alendronate in adults with cystic fibrosis with low bone density.
Aris, RM; Blackwood, AD; Brown, SA; Caminiti, M; Chalermskulrat, W; Guillen, U; Hecker, TM; Hensler, M; Lark, RK; Lester, GE; Neuringer, IP; Ontjes, DA; Renner, JB, 2004
)
1.18
"Alendronate treatment had significantly increased lumbar spine BMD by 4.2% at year 1, by 6.3% at year 2, and 8.8% at year 3."( Alendronate treatment in men with primary osteoporosis: a three-year longitudinal study.
Breschi, M; Bruni, D; Caffarelli, C; Cepollaro, C; Gennari, C; Gennari, L; Gonnelli, S; Montagnani, A; Nuti, R, 2003
)
2.48
"Alendronate-treated patients sustained less bone loss at the spine than those in the reference group, and both intervention groups sustained less bone loss at the hip than the reference group."( Alendronate versus calcitriol for the prevention of bone loss after cardiac transplantation.
Addesso, V; Lo, SH; Mancini, D; Maybaum, S; McMahon, DJ; Namerow, PB; Pardi, S; Shane, E; Staron, RB; Zucker, M, 2004
)
2.49
"Alendronate-treated women with at least a 30% reduction in bone ALP had a lower risk of non-spine (RH = 0.72; CI: 0.55, 0.92) and hip fractures (RH = 0.26; CI: 0.08, 0.83) relative to those with reductions <30%."( Change in bone turnover and hip, non-spine, and vertebral fracture in alendronate-treated women: the fracture intervention trial.
Bauer, DC; Black, DM; Delmas, PD; Ewing, SK; Garnero, P; Hochberg, M; Orloff, J; Ott, S; Thompson, DE, 2004
)
1.28
"The alendronate-treatment group compared to controls had a significant decrease in serum N-telopeptides, 1914 +/- 1433.4 vs."( Alendronate reduces bone resorption in HIV-associated osteopenia/osteoporosis.
Campostrini, S; Caudarella, R; Esposito, R; Guaraldi, G; Madeddu, G; Mura, MS; Orlando, G; Parise, N; Ventura, P; Vescini, F,
)
2.05
"The alendronate-treated rats were administered 0.25 mg/kg alendronate subcutaneously daily."( The influence of alendronate on bone formation after autogenous free bone grafting in rats.
Altundal, H; Gursoy, B, 2005
)
1.15
"Alendronate treatment in this study decreased fusion mass remodeling without inhibiting fusion rate. "( The influence of alendronate treatment and bone graft volume on posterior lateral spine fusion in a porcine model.
Bünger, C; Bünger, M; Christensen, FB; Egund, N; Li, H; Lind, M; Xue, Q; Zou, X, 2005
)
2.11
"Alendronate treatment of OPG-/- mice resulted in enhancement of the volume of heterotopic new bone."( Enhancement of crude bone morphogenetic protein-induced new bone formation and normalization of endochondral ossification by bisphosphonate treatment in osteoprotegerin-deficient mice.
Goto, S; Kameyama, Y; Kawai, T; Kimura, M; Maeda, H; Miyazawa, K; Tabuchi, M, 2005
)
1.05
"Oral alendronate treatment, which is convenient for the school-age group, was found to be a tolerable and efficacious treatment for children with moderate or severe osteogenesis imperfecta."( Efficacy of oral alendronate in children with osteogenesis imperfecta.
Cho, TJ; Choi, IH; Chung, CY; Park, MS; Park, YK; Yoo, WJ,
)
0.93
"Alendronate treatment decreased urinary NTX level by 39.2% in men and 45.4% in postmenopausal women at 3 months and serum ALP level by 17.8 and 21.0%, respectively, at 12 months."( Comparison of the effect of alendronate on lumbar bone mineral density and bone turnover in men and postmenopausal women with osteoporosis.
Iwamoto, J; Sato, Y; Takeda, T; Uzawa, M, 2007
)
1.35
"Alendronate treatment prevented much of the decrease in ultimate load that occurs in the first 21 days."( Alendronate prevents bone loss and improves tendon-to-bone repair strength in a canine model.
Gelberman, RH; Matsuzaki, H; Silva, MJ; Thomopoulos, S; Zaegel, M, 2007
)
2.5
"Alendronate treatment reduced the intra-tumor neoangiogenesis compared with that in the non-treated mice, although tumor-derived VEGF expression was not altered."( Alendronate suppresses tumor angiogenesis by inhibiting Rho activation of endothelial cells.
Hashimoto, K; Kimura, T; Morishige, K; Ogata, S; Sakata, M; Sawada, K; Shimizu, S; Tahara, M; Tasaka, K, 2007
)
2.5
"Alendronate treatment (25 or 75 mg kg(-1) day(-1)) resulted in a decrease in the colonic damage score and loss of body weight (at 25 mg kg(-1) day(-1) only). "( The bisphosphonate alendronate improves the damage associated with trinitrobenzenesulfonic acid-induced colitis in rats.
Ballester, I; Daddaoua, A; López-Posadas, R; Martínez-Augustin, O; Nieto, A; Sánchez de Medina, F; Suárez, MD; Zarzuelo, A, 2007
)
2.11
"Alendronate treatment, at a dosage previously shown to improve bone strength in ovariectomized rats, neither blunted nor enhanced these training adaptations and had no independent effect on muscle contractility."( Relative effects of exercise training and alendronate treatment on skeletal muscle function of ovariectomized rats.
Fuchs, R; Maddalozzo, GF; Marley, K; Snow, C; Widrick, JJ,
)
1.12
"Alendronate treatment after PTH therapy can maintain gains in BMD at lumbar spine and hip as well."( [Parathyroid and bone. Role of parathyroid hormone in the treatment of osteoporosis].
Nakamura, T, 2007
)
1.06
"Alendronate treatment not only increased the mRNA level of bone morphogenetic protein-2, runt-related transcription factor 2, osteopontin, bone sialoprotein, and alkaline phosphatase activity after osteogenic induction, but also decreased the mRNA level of peroxisome proliferator activated receptor gamma 2 and total droplet number indicated by Oil Red O staining after adipogenic induction."( Stimulation of osteogenic differentiation and inhibition of adipogenic differentiation in bone marrow stromal cells by alendronate via ERK and JNK activation.
Dai, K; Fu, L; Miao, Y; Qu, Z; Tang, T; Zhang, S, 2008
)
1.28
"The alendronate-treated group had significantly greater decreases in both serum alkaline phosphatase (79% vs."( Comparative study of alendronate versus etidronate for the treatment of Paget's disease of bone.
Altman, R; Conte, JM; Favus, M; Lombardi, A; Lyles, K; McIlwain, H; Murphy, WA; Reda, C; Rude, R; Seton, M; Siris, E; Thompson, D; Tiegs, R; Tucci, JR; Weinstein, RS; Yates, AJ; Zimering, M, 1996
)
1.09
"Alendronate treatment normalized alkaline phosphatase in 48% of patients."( Biochemical and radiologic improvement in Paget's disease of bone treated with alendronate: a randomized, placebo-controlled trial.
Cundy, T; Dufresne, S; Hosking, DJ; Kotowicz, MA; Lombardi, A; Murphy, WA; Musliner, TA; Nicholson, GC; Reid, IR; Thompson, DE; Weinstein, RS; Yates, AJ; Yeap, S, 1996
)
1.24
"Alendronate treatment by itself decreased osteocalcin by day 28 and resulted in a marginal decrease in serum total calcium on day 14."( Alendronate prevents cyclosporin A-induced osteopenia in the rat.
Bowman, AR; Epstein, S; Jee, WS; Ma, Y; Sass, DA; Yuan, Z, 1997
)
2.46
"The alendronate-treated group did not show significant alteration of the breaking load or the cross-sectional shape of the femoral midshaft."( Effects of continuous alendronate treatment on bone mass and mechanical properties in ovariectomized rats: comparison with pamidronate and etidronate in growing rats.
Azuma, Y; Kanatani, H; Kiyoki, M; Komoriya, K; Ohta, T; Oue, Y, 1998
)
1.1
"Alendronate treatment of peripheral blood mononuclear cells also resulted in an increased production of interleukin-1beta (IL-1beta), tumor necrosis factor-alpha (TNF-alpha), and interferon-gamma (IFN-gamma)."( The effect of alendronate on cytokine production, adhesion molecule expression, and transendothelial migration of human peripheral blood mononuclear cells.
Brosch, S; Peterlik, M; Pietschmann, P; Smolen, JS; Steiner, G; Stohlawetz, P, 1998
)
1.38
"Alendronate pretreatment of the SCID mice (0.1 mg/kg biweekly for 3 weeks) (or the tumor cells) blocked both MMP production by the tumor cells (and the osteoclasts) and collagen I release, providing direct evidence that alendronate might be utilized to prevent bone destruction by metastatic tumor cells."( Alendronate blocks metalloproteinase secretion and bone collagen I release by PC-3 ML cells in SCID mice.
Stearns, ME; Wang, M, 1998
)
2.46
"Alendronate treatment results in an early and dose-dependent inhibition of skeletal resorption, which can be followed clinically with biochemical markers, and which ultimately reaches a plateau and is slowly reversible upon discontinuation of the drug."( Pharmacokinetics of alendronate.
Gertz, BJ; Holland, SD; Porras, AG, 1999
)
1.35
"Alendronate plus calcium treatment led to a significant reduction in total alkaline phosphatase and hydroxy prolinuria as well as to a significant increase in lumbar and femoral bone density."( Calcitriol and alendronate combination treatment in menopausal women with low bone mass.
Gnudi, S; Malavolta, N; Ripamonti, C; Veronesi, M; Zanardi, M, 1999
)
1.38
"Alendronate sodium treatment reduces the risk of new vertebral fracture by 50% in postmenopausal women with osteoporosis."( Effect of alendronate on limited-activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures. Fracture Intervention Trial Research Group.
Black, DM; Cummings, SR; Ensrud, K; Nevitt, MC; Rubin, SR; Thompson, DE; Yates, AJ, 2000
)
1.43
"Alendronate treatment increased the bone mineral density in the femoral neck, the trochanter, the Ward's triangle and the total hip by +3.2, +1.6, +3.5, +2.2% respectively, meanwhile the changes in the placebo group were -1.2%; -0.7%; -0.9%; -0.8%, respectively, the difference was not significant."( [The effect of a one-year alendronate therapy on postmenopausal osteoporosis. (Results in Hungary of an international multicenter clinical study)].
Balogh, A; Bettembuk, P, 1999
)
1.32
"Alendronate treatment was not associated with any qualitative abnormalities."( Effects of alendronate on bone quality and remodeling in glucocorticoid-induced osteoporosis: a histomorphometric analysis of transiliac biopsies.
Arlot, ME; Chavassieux, PM; Daifotis, A; Freedholm, D; Hamdy, NA; Malice, MP; Meunier, PJ; Portero, N; Roux, JP; Yates, AJ, 2000
)
1.42
"Alendronate treatment for 1 year resulted in significant improvement in BMD at all sites measured when compared with placebo."( The efficacy and tolerability of alendronate in postmenopausal osteoporotic Chinese women: a randomized placebo-controlled study.
Chu, LW; Kung, AW; Yeung, SS, 2000
)
1.31
"The alendronate-treated group gained more bone at both the spine (p < 0.01) and femoral neck (p < 0.001), with a mean difference (+/-SE) of 2.4% (+/-0.86%) at the spine and 3.98% (+/-0.95%) at the femoral neck."( Alendronate prevents bone loss in Chinese women with osteoporosis.
Chan, YH; Griffith, J; Lau, EM; Woo, J, 2000
)
2.23
"Alendronate treatment prevented a decrease in bone mineral density and maintained bone mechanical properties after ovariectomy without impairment of bone mineralization in aged rats."( Comparison of calcitonin, alendronate and fluorophosphate effects on ovariectomized rat bone.
Aldini, NN; Carpi, A; Fini, M; Giardino, R; Giavaresi, G; Gnudi, S; Rocca, M, 2001
)
1.33
"Alendronate pretreatment also inhibited migration, which was partially reversed by geranylgeraniol and trans-trans-farnesol."( Alendronate inhibits invasion of PC-3 prostate cancer cells by affecting the mevalonate pathway.
Härkönen, PL; Lakkakorpi, PT; Väänänen, HK; Virtanen, SS, 2002
)
2.48
"Alendronate treatment maintained all parameters of bone turnover at control (nonovariectomized) levels and prevented the bone loss in a dose-dependent manner."( The bisphosphonate, alendronate, prevents bone loss in ovariectomized baboons.
Clair, J; Davidson, J; Fioravanti, C; Frankenfield, D; Jackson, R; Klein, H; Quartuccio, H; Seedor, JG; Solomon, H; Thompson, DD, 1992
)
1.33
"Treatment with alendronate altered the dynamics of healing by preventing callus volume decreases later in the healing process."( Fracture healing with alendronate treatment in the Brtl/+ mouse model of osteogenesis imperfecta.
Begun, DL; Caird, MS; Goldstein, SA; Kozloff, KM; Marini, JC; McElderry, JD; Meganck, JA; Morris, MD; Swick, A, 2013
)
1.04
"Treatment with alendronate (1 μg/kg/day), LIPUS (20 min/day), or a combination of both was administered for 2 or 4 weeks, after which changes in bone mineral density (BMD), bone histomorphometric parameters, and the rate of cancellous bony bonding were measured."( Effects of combined therapy of alendronate and low-intensity pulsed ultrasound on metaphyseal bone repair after osteotomy in the proximal tibia of aged rats.
Aonuma, H; Kamo, K; Kasukawa, Y; Miyakoshi, N; Sasaki, H; Segawa, T; Shimada, Y; Tsuchie, H, 2014
)
1.03
"Treatment with alendronate, pamidronate, and zoledronate, but not clodronate, led to a decrease in the number of chondrocytes per column in the hypertrophic chondrocyte layer."( Effect of bisphosphonates on the rapidly growing male murine skeleton.
Bouxsein, ML; Brooks, DJ; Demay, MB; Louis, L; Zhu, ED, 2014
)
0.74
" Treatment with alendronate."( Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study.
Abrahamsen, B; Eastell, R; Eiken, P; Prieto-Alhambra, D, 2016
)
1
"Treatment with alendronate could lead to a significant reduction in fracture risk in MGUS patients with skeletal fragility."( The effects of alendronate treatment in osteoporotic patients affected by monoclonal gammopathy of undetermined significance.
Fassino, V; Mascia, ML; Minisola, S; Pepe, J; Petrucci, MT; Piemonte, S; Romagnoli, E, 2008
)
1.04
"Pretreatment with alendronate augmented IL-1beta, but not TNFalpha, production by macrophages infected with P."( Alendronate augments interleukin-1beta release from macrophages infected with periodontal pathogenic bacteria through activation of caspase-1.
Deng, X; Endo, Y; Kiyoura, Y; Tamai, R, 2009
)
2.12
"untreated cells. Alendronate had no effects on the expression of MMP-2 or MT1-MMP (membrane type-1 MMP) in the conditioned media or membrane extracts, and of MMP-1 or TIMP-2 in the conditioned media."( Effects of alendronate on human osteoblast-like MG63 cells and matrix metalloproteinases.
Sexton, BE; Song, F; Sun, J; Windsor, LJ; Zhang, W, 2012
)
1.1
"Treatment with alendronate reduced hypercalciuria; however, normocalciuria was only obtained with the association of thiazide diuretic."( Potential effects of alendronate on fibroblast growth factor 23 levels and effective control of hypercalciuria in an adult with Jansen's metaphyseal chondrodysplasia.
Correa, PH; Ferraz-de-Souza, B; Martin, RM; Mendonca, BB; Onuchic, L, 2012
)
1.04
"Treatment with alendronate increased bone volume fraction by 9.5%, 7.7%, 7.4%, and 18.4%, respectively, in L-1, L-2, humeral greater tuberosity, and humeral head trabecular bone."( Effects of short-term alendronate treatment on the three-dimensional microstructural, physical, and mechanical properties of dog trabecular bone.
Bechtold, JE; Danielsen, CC; Day, JS; Ding, M; Hu, JH; Hvid, I; Søballe, K, 2002
)
0.97
"Treatment with alendronate and etidronate had no effect on the synthesis of IL-6 or IL-11, and IL-6 and IL-11 mRNA levels."( Alendronate and etidronate do not regulate interleukin 6 and 11 synthesis in normal human osteoblasts in culture.
Carbonell, J; Diez-Pérez, A; Engel, E; Lloreta, J; Mariñoso, ML; Nogués, X; Serrano, S; Ulloa, F, 2003
)
2.1
"Treatment with alendronate increased or maintained both spine and hip BMD and prevented the increase in bone resorption seen with withdrawal of HRT in this population."( Alendronate prevents loss of bone density associated with discontinuation of hormone replacement therapy: a randomized controlled trial.
Ascott-Evans, BH; Guanabens, N; Kivinen, S; Magaril, CH; Melton, ME; Stuckey, BG; Stych, B; Vandormael, K, 2003
)
2.1
"Treatment with alendronate increased LPS-induced secretion of IL-1beta, IL-6 and TNF-alpha from RAW 264 macrophages 2.4-, 1.4- and 1.8-fold, respectively."( Inhibition of mevalonate pathway is involved in alendronate-induced cell growth inhibition, but not in cytokine secretion from macrophages in vitro.
Mönkkönen, J; Ollikainen, J; Taskinen, M; Töyräs, A, 2003
)
0.91
"Treatment with alendronate increased bone volume fraction by 9.5% and 7.7% in L1 and L2 respectively. "( Effects of alendronate on structural properties of trabecular bone in dogs.
Gongyi, H; Jianhua, H; Liang, Z; Lilian, Z, 2002
)
1.06
"Treatment with alendronate over 2 yr was associated with a significant (6.85%; micro(d) = 0.052; +/-0.94% se; P < 0.001) increase in LS BMD in comparison with baseline."( Alendronate in primary hyperparathyroidism: a double-blind, randomized, placebo-controlled trial.
Ahmed, MM; Bilezikian, JP; Dubois, SJ; Ho, AY; Khan, AA; Kung, AW; Rubin, MR; Schussheim, D; Shaikh, AM; Silverberg, SJ; Standish, TI; Syed, Z; Syed, ZA, 2004
)
2.11
"Treatment with alendronate, a potent and specific inhibitor of bone resorption, is known to significantly reduce fracture risk among women with postmenopausal osteoporosis. "( Meta-analysis of the efficacy of alendronate for the prevention of hip fractures in postmenopausal women.
Hochberg, MC; Liberman, UA; Papapoulos, SE; Quandt, SA; Thompson, DE, 2005
)
0.96
"Treatment with alendronate reduced the width of the fibrous loosening membrane and the number of osteoclasts at the bone-screw interface."( Alendronate inhibits bone resorption at the bone-screw interface.
Azuma, Y; Miyaji, T; Nakase, T; Shimizu, N; Uchiyama, Y; Yoshikawa, H, 2005
)
2.11
"Treatment with alendronate 70 mg once weekly for one year resulted in significant BMD improvement of 6.1% at the spine, 5.6% at the femoral neck, and 3.5% at the total hip. "( Efficacy and tolerability of alendronate once weekly in Asian postmenopausal osteoporotic women.
Ho, AY; Kung, AW, 2005
)
0.97
"3 Pretreatment with alendronate at 100 microM for 24 h prior to the stimulation with tumor necrosis factor-alpha or insulin partially inhibited the IkappaB phosphorylation and degradation."( The inhibitory effect of alendronate, a nitrogen-containing bisphosphonate on the PI3K-Akt-NFkappaB pathway in osteosarcoma cells.
Abe, K; Hirata, M; Inoue, R; Jing, G; Kanematsu, T; Matsuki, NA, 2005
)
0.95
"Treatment with alendronate has been shown to improve short-term bone mineral density after total knee arthroplasty; however, the long-term effects of this therapy are unknown."( Three-year changes in bone mineral density around the knee after a six-month course of oral alendronate following total knee arthroplasty. A prospective, randomized study.
Huang, CC; Ko, JY; Wang, CJ; Wang, JW; Weng, LH, 2006
)
0.89
"Treatment with alendronate and vitamin D2 increases BMD in elderly women with PD and leads to the prevention of hip fractures."( Alendronate and vitamin D2 for prevention of hip fracture in Parkinson's disease: a randomized controlled trial.
Iwamoto, J; Kanoko, T; Sato, Y; Satoh, K, 2006
)
2.12
"Treatment with alendronate plus HRT resulted in a 10.1% increase at the L-spine BMD and a 7.7% increase at the trochanter BMD at the end of the 3-year study period (P < .01, compared with baseline at both sites)."( Effects of alendronate combined with hormone replacement therapy on osteoporotic postmenopausal Chinese women.
Ho, ES; Hu, CC; Kao, CH; Lan, HH; Sheu, WH; Tseng, LN, 2006
)
1.06
"Treatment with alendronate over 2 years was associated with a significant (5.3+/-0.4%; p<0.01) increase in LS BMD in comparison with baseline."( [Alendronate increases bone mineral density in patients with symptomatic primary hyperparathyroidism].
Misiorowski, W,
)
1.38
"Treatment with alendronate reduced the risk of clinical fractures to a similar degree in those with (OR: 0.78; 95% CI: 0.51-1.21) and without reduced renal function (OR: 0.80; 95% CI; 0.70-0.93; p for interaction = 0.89)."( Alendronate treatment in women with normal to severely impaired renal function: an analysis of the fracture intervention trial.
Bauer, DC; Cauley, JA; Cummings, SR; Ensrud, KE; Hochberg, M; Ishani, A; Jamal, SA, 2007
)
2.12
"Treatment with alendronate (Fosamax) has been shown to significantly reduce the risk of fragility fractures. "( Cost-effectiveness of alendronate in the treatment of postmenopausal women in 9 European countries--an economic evaluation based on the fracture intervention trial.
Boonen, S; Borgström, F; Haentjens, P; Johnell, O; Kanis, JA; Sen, SS; Ström, O, 2007
)
1.01
"Treatment with alendronate (Fosamax) reduces the risk of osteoporotic fractures at the spine, hip and wrist in women with and without prevalent vertebral fracture. "( Cost-effectiveness of alendronate in the treatment of postmenopausal women in 9 European countries--an economic evaluation based on the fracture intervention trial.
Boonen, S; Borgström, F; Haentjens, P; Johnell, O; Kanis, JA; Sen, SS; Ström, O, 2007
)
1.01
"Oral treatment with alendronate, 70 mg once a week, yielded alleviation of symptoms within 12 weeks."( Idiopathic sporadic tumoral calcinosis of the hip: successful oral bisphosphonate therapy.
Jacob, JJ; Mathew, K; Thomas, N,
)
0.45
"Treatment with alendronate improved trabecular volume and number by reducing bone resorption, although bone formation was also reduced through coupling of bone remodeling."( Age-related changes in marmoset trabecular and cortical bone and response to alendronate therapy resemble human bone physiology and architecture.
Andresen, CJ; Bagi, CM; Berryman, E; Hanson, N; Moalli, M; Olson, E; Shen, V; Volberg, M, 2007
)
0.91
"Treatment with alendronate decreased both urinary markers of bone resorption (pyridinolines, hydroxyproline, and calcium) and serum markers of bone formation (osteocalcin and alkaline phosphatase) in a dose-dependent fashion."( The effect of short term treatment with alendronate on vertebral density and biochemical markers of bone remodeling in early postmenopausal women.
Chesnut, CH; DeBrock, J; Eyre, DR; Genant, HK; Gertz, BJ; Harris, ST; Ricerca, E; Survill, TT; Ventura, JN, 1993
)
0.89
"Treatment with alendronate produced a decrease in bALP after 3 months, reaching a plateau after 6 months: for bALP-I a mean change of -34%, (P < 0.0001), bALP-E, -19% (P < 0.001), and total ALP, -19% (P < 0.0001)."( Clinical usefulness of bone alkaline phosphatase in osteoporosis.
Fairney, A; Kerkhoff, F; Kyd, PA; Thomas, E; Vooght, KD, 1998
)
0.64
"Treatment with alendronate caused a transient decrease in serum calcium concentrations associated with an increase in the serum level of intact parathyroid hormone."( A double-masked multicenter comparative study between alendronate and alfacalcidol in Japanese patients with osteoporosis. The Alendronate Phase III Osteoporosis Treatment Research Group.
Fukunaga, M; Inoue, T; Kaneda, K; Kishimoto, H; Kushida, K; Minaguchi, H; Morii, H; Nagata, Y; Nakamura, T; Nakashima, M; Orimo, H; Shiraki, M; Taga, M; Tomita, A; Yamamoto, K, 1999
)
0.89
"The treatment with alendronate resulted in a significant and progressive increase in BMD of the lumbar spine and femoral neck."( Comparison of biochemical markers of bone remodelling in the assessment of the effects of alendronate on bone in postmenopausal osteoporosis.
Stĕpán, JJ; Vokrouhlická, J, 1999
)
0.84
"Treatment with alendronate, 10 mg daily, significantly increased BMD in patients with Crohn's disease and was safe and well tolerated."( Alendronate increases lumbar spine bone mineral density in patients with Crohn's disease.
Haderslev, KV; Sorensen, HA; Staun, M; Tjellesen, L, 2000
)
2.1
"Treatment with alendronate 10 mg/day improved bone density and back pain."( Male osteoporosis associated with longterm cyproterone treatment.
Swinson, DR; Vasireddy, S, 2001
)
0.65

Toxicity

teriparatide can be more effective than the alendronate in the treatment of osteoporosis in renal transplant patients, while having more adverse effects. These adverse drug reactions are not limited to alendronsate and may also be induced by etidronate and risedronate.

ExcerptReferenceRelevance
" The purpose of this study was to rule out possible adverse effects of the chronic administration of ALN on the quality of bone."( Long-term safety of the aminobisphosphonate alendronate in adult dogs. II. Histomorphometric analysis of the L5 vertebrae.
Balena, R; Gentile, M; Markatos, A; Peter, CP; Rodan, GA; Seedor, JG; Stark, C, 1996
)
0.56
" In addition, alendronate was shown to have no adverse effects on bone mineralization or microstructure."( Alendronate for osteoporosis. Safe and efficacious nonhormonal therapy.
Adachi, JD, 1998
)
2.1
"This evidence shows alendronate to be safe and effective; it should be considered the nonhormonal therapy of choice for treating osteoporosis in postmenopausal women at risk for hip and vertebral fractures."( Alendronate for osteoporosis. Safe and efficacious nonhormonal therapy.
Adachi, JD, 1998
)
2.07
" In conclusion, rapid infusion of alendronate brings about no major adverse effects, and makes it easier for many patients with bone metastasis to receive alendronate therapy on an outpatient basis."( [A study of the safety of rapid infusion of alendronate].
Kokawa, Y; Oura, S; Sakurai, T; Tamaki, T; Umemura, T; Yoshimura, G, 1999
)
0.84
" The manuscript then reviews therapies available for osteoporosis in the United States and makes recommendations about choosing therapies that minimize GI adverse effects in RA patients at high risk for such events."( Osteoporosis therapies for rheumatoid arthritis patients: minimizing gastrointestinal side effects.
Schein, JR; Sewell, K, 2001
)
0.31
" Repeat BMD measurements were obtained in 88 patients, including 11 who stopped their bisphosphonate therapy within the first year of use because of adverse events."( Comparative efficacy and safety study of etidronate and alendronate in postmenopausal osteoporosis. effect of adding hormone replacement therapy.
Béra-Louville, A; Cortet, B; Delcambre, B; Gauthier, A; Gauthier, P; Marchandise, X, 2001
)
0.56
" Conversely, adverse effects, most notably gastrointestinal symptoms, were more common with alendronate, so that premature treatment discontinuation because of adverse events were more common in the alendronate group."( Comparative efficacy and safety study of etidronate and alendronate in postmenopausal osteoporosis. effect of adding hormone replacement therapy.
Béra-Louville, A; Cortet, B; Delcambre, B; Gauthier, A; Gauthier, P; Marchandise, X, 2001
)
0.78
"(1) The ocular adverse effects of pamidronic acid are rare but well documented."( Ocular adverse effects of alendronic acid.
, 2001
)
0.31
" The risk of an adverse upper GI event increases when these drugs are used concurrently with nonsteroidal anti-inflammatory drug (NSAID) therapy, but this incidence is no more than that observed with concurrent placebo and NSAID therapy."( Alendronate and risedronate: what you need to know about their upper gastrointestinal tract toxicity.
Baker, DE, 2002
)
1.76
"Acute toxicity studies showed that the LD50 values of oral alendronate in female animals corresponded to human oral doses of 27,800 mg in rats and 48,300 mg in mice; LD50 values in male animals were even higher."( Preclinical safety profile of alendronate.
Peter, C; Rodan, GA, 1999
)
0.84
" Clinical trials often underestimate the rate of adverse events in clinical practice, and ethics prohibit direct evaluation of toxicity in high-risk patients."( The gastrointestinal tolerability and safety of oral bisphosphonates.
Marshall, JK, 2002
)
0.31
"The aim of our study was to evaluate the upper gastrointestinal (GI) tract side effect profile in 759 female patients that had taken alendronate (10 mg/day), for at least 6 months, for the treatment of osteoporosis, in relation to the safety of alendronate and the compliance of patients to its absorption rules."( Gastrointestinal side effect profile due to the use of alendronate in the treatment of osteoporosis.
Akarirmak, U; Aki, S; Akyüz, G; Alper, S; Arpacioğlu, O; Atalay, F; Eryavuz, M; Eskiyurt, N; Kavuncu, V; Kokino, S; Kuru, O; Nas, K; Ozerbil, O; Savaş, G; Sendur, OF; Soy, D; Tüzün, F, 2003
)
0.77
" The nitrogen-containing bisphosphonate pamidronate was significantly more toxic on a panel of eight neuroblastoma cell lines than the non-nitrogen-containing bisphosphonates, clodronate and tiludronate."( In vitro toxicity of bisphosphonates on human neuroblastoma cell lines.
Boos, J; Lanvers-Kaminsky, C; Vorotnjak, M, 2004
)
0.32
" Current reports have focused on therapy-resistant osteonecrosis of the jaws as a possible side effect of bisphosphonates."( [Osteonecrosis of the jaws as a possible adverse effect of the use of bisphosphonates].
Eufinger, H; Hoefert, S, 2005
)
0.33
" The presentation of these cases is intended to call attention to this clinically important side effect of bisphosphonate medication."( [Osteonecrosis of the jaws as a possible adverse effect of the use of bisphosphonates].
Eufinger, H; Hoefert, S, 2005
)
0.33
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
"Oral daily bisphosphonates carry a potential for gastrointestinal (GI) adverse events, which has been partly addressed by introducing once-weekly regimens."( Oral ibandronate in the management of postmenopausal osteoporosis: review of upper gastrointestinal safety.
Delmas, PD; Emkey, R; Epstein, S; Hiltbrunner, V; Schimmer, RC; Wilson, KM, 2006
)
0.33
" RCTs have demonstrated that the incidence of gastrointestinal tract adverse events in postmenopausal osteoporotic women treated with bisphosphonates and placebo are similar, and also the long-term efficacy and safety of alendronate and risedronate."( Efficacy and safety of alendronate and risedronate for postmenopausal osteoporosis.
Iwamoto, J; Sato, Y; Takeda, T, 2006
)
0.83
" No side effect was observed due to alendronate treatment during the study."( Efficacy and safety of oral alendronate treatment in children and adolescents with osteoporosis.
Abaci, A; Bober, E; Büyükgebiz, A; Unal, E, 2006
)
0.9
" Hepatotoxicity due to alendronate therapy is a rare but possible adverse effect."( Hepatotoxicity induced by alendronate therapy.
Atalar, H; Turkay, C; Yanik, B, 2007
)
0.95
"To examine in a major cohort of patients whether or not musculoskeletal adverse effects (MAEs), similar to those seen in intravenous bisphosphonates (BP), might occur also in high dosage oral treatment regimens with alendronate (ALN) and risedronate (RSN)."( Common musculoskeletal adverse effects of oral treatment with once weekly alendronate and risedronate in patients with osteoporosis and ways for their prevention.
Bock, O; Boerst, H; Degner, C; Felsenberg, D; Stephan-Oelkers, M; Thomasius, FE; Valentine, SM,
)
0.55
" The review specifically considers upper gastrointestinal (UGI) adverse events (AEs), renal toxicity, influenza-like illness, osteonecrosis of the jaw and evidence on how to treat or prevent these events."( Safety considerations with bisphosphonates for the treatment of osteoporosis.
Civitelli, R; Emkey, R; Strampel, W, 2007
)
0.34
" The aim of this study was to compare the adverse effects (AEs) of alendronate, etidronate and risedronate prescribed in a non-selected population, attending a single institution on an outpatient basis."( Oral bisphosphonate adverse effects in 849 patients with metabolic bone diseases.
Anastasilakis, AD; Avramidis, A; Goulis, DG; Kita, M,
)
0.37
" Alendronate was well tolerated, without significant adverse events."( Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV.
Alston-Smith, B; Benson, C; Gopalakrishnan, G; Hogg, E; Kendall, MA; McComsey, GA; Suckow, C; Swindells, S; Tebas, P; Wohl, DA, 2007
)
2.69
"Once-weekly alendronate is safe and effective in the treatment of decreased BMD in HIV-infected patients."( Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV.
Alston-Smith, B; Benson, C; Gopalakrishnan, G; Hogg, E; Kendall, MA; McComsey, GA; Suckow, C; Swindells, S; Tebas, P; Wohl, DA, 2007
)
2.16
" Although these agents are generally well tolerated, serious gastrointestinal adverse events, including hospitalization for gastrointestinal bleed, may arise."( Comparative gastrointestinal safety of weekly oral bisphosphonates.
Brookhart, MA; Cadarette, SM; Katz, JN; Levin, R; Solomon, DH; Stedman, MR; Stürmer, T, 2009
)
0.35
"The objective of this study was to compare the changes on bone mineral density, and the effects on persistence and adverse events in patients treated for postmenopausal osteoporosis with generic alendronate or with branded alendronate (Fosamax®) or branded risedronate (Actonel®) once weekly."( Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: 1-year results of a retrospective patient chart review analysis.
Möller, G; Ringe, JD, 2009
)
0.54
"A rise in gastrointestinal (GI) adverse events (AEs) and a decline in bone mineral density (BMD) was observed in patients previously tolerant to brand alendronate shortly after generic versions were introduced in July 2005 to the Canadian market."( Adverse events, bone mineral density and discontinuation associated with generic alendronate among postmenopausal women previously tolerant of brand alendronate: a retrospective cohort study.
Adachi, JD; Airia, P; Grima, DT; Ioannidis, G; Papaioannou, A, 2010
)
0.79
" The incidence of adverse events and serious adverse events was similar in the treatment groups."( Efficacy and safety of a once-yearly i.v. Infusion of zoledronic acid 5 mg versus a once-weekly 70-mg oral alendronate in the treatment of male osteoporosis: a randomized, multicenter, double-blind, active-controlled study.
Adachi, JD; Adler, RA; Brown, J; Bucci-Rechtweg, C; Kendler, D; Mesenbrink, P; Miller, PD; Orwoll, ES; Readie, A; Weinstein, RS, 2010
)
0.57
" Outcomes of adverse events were defined as inflammatory conditions of the jaw, including osteonecrosis; major jaw surgery for necrotic or inflammatory conditions; or jaw surgeries for malignancies."( Adverse events and intravenous versus oral bisphosphonate use in patients with osteoporosis and cancer in the U.S.
Hay, JW; Jeffcoat, MK; Seal, B; Skrepnek, GH; Tangirala, M; Watts, NB,
)
0.13
"Bone neoplasms, such as osteosarcoma, exhibit a propensity for systemic metastases resulting in adverse clinical outcome."( Enhanced anti-tumor activity and safety profile of targeted nano-scaled HPMA copolymer-alendronate-TNP-470 conjugate in the treatment of bone malignances.
Benayoun, L; Kopeček, J; Kopečková, P; Pan, H; Satchi-Fainaro, R; Segal, E; Shaked, Y, 2011
)
0.59
" No serious adverse events were observed in either group and safety profiles were similar."( The safety and efficacy of early-stage bi-weekly alendronate to improve bone mineral density and bone turnover in chinese post-menopausal women at risk of osteoporosis.
Chen, JY; Chen, L; Pan, L; Sheng, ZY; You, L, 2011
)
0.62
" In two trials involving 1189 and 504 women, the incidence of clinical fractures, recorded as simple adverse effects, did not differ significantly between the groups."( Denosumab. Limited efficacy in fracture prevention, too many adverse effects.
, 2011
)
0.37
"To review the published data on a hitherto not widely known adverse effect of alendronate manifesting as mucosal ulcers in the oral cavity."( Oral ulcers, a little known adverse effect of alendronate: review of the literature.
Kharazmi, M; Sjöqvist, K; Warfvinge, G, 2012
)
0.87
"The electronic database PubMed was searched for reports of this adverse effect."( Oral ulcers, a little known adverse effect of alendronate: review of the literature.
Kharazmi, M; Sjöqvist, K; Warfvinge, G, 2012
)
0.64
" This adverse effect of alendronate is a rare entity in published reports but careful monitoring of patients at risk is recommended."( Oral ulcers, a little known adverse effect of alendronate: review of the literature.
Kharazmi, M; Sjöqvist, K; Warfvinge, G, 2012
)
0.94
" A once monthly 150 mg regimen produced greater increases in lumbar spine, total hip, femoral neck, and trochanter BMD than daily treatment, with a similar incidence of adverse events between the groups."( Efficacy and safety of monthly 150 mg oral ibandronate in women with postmenopausal osteoporosis: a systematic review and meta-analysis of randomized controlled trials.
Lee, YH; Song, GG, 2011
)
0.37
" And adverse events (AEs), including incidence of neoplasms and infections, were considered as secondary outcomes."( Comparison of clinical efficacy and safety between denosumab and alendronate in postmenopausal women with osteoporosis: a meta-analysis.
Cai, XZ; Guo, C; Lin, T; Shi, MM; Wang, C; Yan, SG; Ying, ZM; Yuan, FZ; Zhao, X, 2012
)
0.62
" However, there seems to be a limited awareness that oral bisphosphonates can also induce adverse effects in the soft tissues of the oral cavity, as indicated by the paucity of reported cases in the literature."( Pharmacovigilance of oral bisphosphonates: adverse effects manifesting in the soft tissue of the oral cavity.
Kharazmi, M; Persson, U; Warfvinge, G, 2012
)
0.38
"The database of the Medical Products Agency-Sweden was searched for adverse effects from oral bisphosphonates manifesting in the oral and maxillofacial region."( Pharmacovigilance of oral bisphosphonates: adverse effects manifesting in the soft tissue of the oral cavity.
Kharazmi, M; Persson, U; Warfvinge, G, 2012
)
0.38
"A total of 83 cases of adverse reactions to oral bisphosphonates were retrieved from the search."( Pharmacovigilance of oral bisphosphonates: adverse effects manifesting in the soft tissue of the oral cavity.
Kharazmi, M; Persson, U; Warfvinge, G, 2012
)
0.38
" These adverse drug reactions are not limited to alendronate and may also be induced by etidronate and risedronate."( Pharmacovigilance of oral bisphosphonates: adverse effects manifesting in the soft tissue of the oral cavity.
Kharazmi, M; Persson, U; Warfvinge, G, 2012
)
0.63
" Hematology, serum biochemistry and lung toxicity biomarkers in BAL fluid performed in the sub-acute toxicity studies indicated no adverse effects of alendronate sodium inhalation except for a significant increase in cholesterol levels and marginal increase in BAL fluid protein."( In vivo lung deposition and sub-acute inhalation toxicity studies of nano-sized alendronate sodium as an antidote for inhaled toxic substances in Sprague Dawley rats.
Ahmad, FJ; Ali, R; Bhatnagar, A; Mittal, G; Sultana, S; Talegaonkar, S, 2013
)
0.82
") ibandronate versus oral alendronate, (2) a correlation exists between adherence and persistence to medication and drug efficacy, and (3) any unexpected adverse events/serious adverse events (AEs/SAEs) may occur."( The non-interventional BonViva Intravenous Versus Alendronate (VIVA) study: real-world adherence and persistence to medication, efficacy, and safety, in patients with postmenopausal osteoporosis.
Amling, M; Felsenberg, D; Hadji, P; Hofbauer, LC; Kandenwein, JA; Kurth, A, 2014
)
0.96
" Overall and serious adverse events were similar between groups."( Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study.
Brown, JP; Fahrleitner-Pammer, A; Ferreira, I; Hawkins, F; Ho, PR; Hofbauer, LC; Micaelo, M; Minisola, S; Papaioannou, N; Roux, C; Siddhanti, S; Stone, M; Wagman, RB; Wark, JD; Zillikens, MC, 2014
)
0.63
"To elucidate the efficacy and adverse events of alendronate (Aldren70) after 12 months of treatment in 50 to 70 years old postmenopausal women."( A prospective analytical study of the effects and adverse events of alendronate (Aldren70) treatment in Thai postmenopausal women.
Jaruwangsanti, N; Tienboon, P, 2014
)
0.89
" Adverse events found in five patients were the symptoms of stomachache (2."( A prospective analytical study of the effects and adverse events of alendronate (Aldren70) treatment in Thai postmenopausal women.
Jaruwangsanti, N; Tienboon, P, 2014
)
0.64
"The data on gastrointestinal side effects (47 trials) indicated that alendronate, risedronate etidronate, and zolendronate have similar rates of the adverse effects; application of Bayesian network meta-analysis showed that equivalence was demonstrated according to margins around ±10%."( Gastrointestinal and renal side effects of bisphosphonates: differentiating between no proof of difference and proof of no difference.
Fadda, V; Maratea, D; Messori, A; Trippoli, S, 2015
)
0.65
" For this reason, new dosages and formulations of alendronate have been developed, alone or in combination with vitamin D, which have shown to reduce the impact of gastro-oesophageal adverse events, and minimize discomfort due to the need of adopting unfavourable postural positions every day, fasting for at least one hour."( Alendronate: new formulations of an old and effective drug to improve adherence avoiding upper gastrointestinal side effects.
Auriemma, R; Migliore, A; Neglia, C; Piscitelli, P, 2014
)
2.1
" The increasing use of the 70 mg weekly dosages and newest formulations of this drug are expected to reduce adverse events and increase adherence to the antifracture therapy, thus resulting in better clinical outcomes when treating osteoporotic patients."( Alendronate: new formulations of an old and effective drug to improve adherence avoiding upper gastrointestinal side effects.
Auriemma, R; Migliore, A; Neglia, C; Piscitelli, P, 2014
)
1.85
"A cell line-specific, dose-related cytotoxicity was observed for 5-FdU-ale in all cancer cell lines tested, which was significantly less toxic than 5-FdU alone when compared to the benign osteoblasts or stromal cells."( In vitro and in vivo toxicity of 5-FdU-alendronate, a novel cytotoxic bone-seeking duplex drug against bone metastasis.
Busch, C; Noor, S; Schem, C; Schott, S; Tiwari, S; Tower, RJ; Vallet, S, 2015
)
0.69
" No patient had bone fractures or expressed adverse effects during treatment."( Efficacy and safety of alendronic acid in the treatment of osteoporosis in children.
Áreas Del Águila, VL; Encinas Barrios, C; Fernández Marchante, AI; Franco Sereno, MT; Martín Siguero, A; Pérez Serrano, R, 2015
)
0.42
"Many adverse drug reactions are caused by the cytochrome P450 (CYP)-dependent activation of drugs into reactive metabolites."( Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
Jones, LH; Nadanaciva, S; Rana, P; Will, Y, 2016
)
0.43
"This study showed that bisphosphonate was safe and effective for the treatment of bone disorders in stage 4 chronic kidney disease (CKD) rats."( Efficacy and safety of osteoporosis medications in a rat model of late-stage chronic kidney disease accompanied by secondary hyperparathyroidism and hyperphosphatemia.
Hamano, H; Hiratsuka, S; Iwasaki, N; Kameda, Y; Kanehira, Y; Kimura-Suda, H; Ota, M; Sato, D; Shimizu, T; Takahata, M, 2017
)
0.46
" Both ALN and TPD had no adverse effect on renal function and mineral metabolism."( Efficacy and safety of osteoporosis medications in a rat model of late-stage chronic kidney disease accompanied by secondary hyperparathyroidism and hyperphosphatemia.
Hamano, H; Hiratsuka, S; Iwasaki, N; Kameda, Y; Kanehira, Y; Kimura-Suda, H; Ota, M; Sato, D; Shimizu, T; Takahata, M, 2017
)
0.46
"BP is safe and effective for the treatment of bone disorders in stage 4 CKD rats."( Efficacy and safety of osteoporosis medications in a rat model of late-stage chronic kidney disease accompanied by secondary hyperparathyroidism and hyperphosphatemia.
Hamano, H; Hiratsuka, S; Iwasaki, N; Kameda, Y; Kanehira, Y; Kimura-Suda, H; Ota, M; Sato, D; Shimizu, T; Takahata, M, 2017
)
0.46
" A random-effects model within a Bayesian framework was applied to compare treatment effects as standardized mean difference (SMD) with their corresponding 95% credible interval (CrI), while odds ratio (OR) was applied to compare adverse events with 95% CrI."( Efficacy and safety of medical therapy for low bone mineral density in patients with Crohn disease: A systematic review with network meta-analysis.
Chen, H; Ma, H; Ma, J; Wang, P; Zhang, H; Zhang, Y; Zhao, X; Zhou, C; Zhu, Y, 2017
)
0.46
" For safety assessment, the incidence of adverse events (AEs) demonstrated no statistical difference between agents and placebo."( Efficacy and safety of medical therapy for low bone mineral density in patients with Crohn disease: A systematic review with network meta-analysis.
Chen, H; Ma, H; Ma, J; Wang, P; Zhang, H; Zhang, Y; Zhao, X; Zhou, C; Zhu, Y, 2017
)
0.46
" Tolerability was evaluated by patient self-reporting of adverse experiences."( Randomized clinical trial comparing efficacy and safety of brand versus generic alendronate (Bonmax®) for osteoporosis treatment.
Jarusriwanna, A; Songcharoen, P; Unnanuntana, A, 2017
)
0.68
" No significant differences in the amount of biochemical bone marker reduction or incidence of adverse events were observed between groups."( Randomized clinical trial comparing efficacy and safety of brand versus generic alendronate (Bonmax®) for osteoporosis treatment.
Jarusriwanna, A; Songcharoen, P; Unnanuntana, A, 2017
)
0.68
" In addressing key issues of reducing toxic side effects and improving pharmacokinetic profiles of the therapeutic agents, we have developed a new formulation by co-packaging DAC and ATO into alendronate-conjugated bone-targeting nanoparticles (BTNPs)."( Bone-targeting nanoparticle to co-deliver decitabine and arsenic trioxide for effective therapy of myelodysplastic syndrome with low systemic toxicity.
Ferrari, M; Hu, Z; Nizzero, S; Ramirez, MR; Shen, H; Shi, C; Wu, X; Zhang, G; Zhou, J, 2017
)
0.64
"A network meta-analysis was conducted to compare the short-term efficacy and adverse events of different drugs for the treatment of postmenopausal osteoporosis (PMO), providing a more effective treatment for PMO."( A network meta-analysis on the short-term efficacy and adverse events of different anti-osteoporosis drugs for the treatment of postmenopausal osteoporosis.
Liu, GF; Liu, L; Miao, YY; Wang, ZQ; Yu, SN; Zhang, BT, 2018
)
0.48
" rhPTH (1-34) and ALN were safe in the treatment of postmenopausal osteoporosis."( Efficacy and safety of recombinant human parathyroid hormone (1-34) are similar to those of alendronate in the treatment of postmenopausal osteoporosis.
Deng, J; Feng, Z; Li, Q; Li, Y; Pan, T; Zhao, C, 2018
)
0.7
" They are associated with gastrointestinal adverse reactions the most severe being an esophageal ulcer."( Upper gastrointestinal safety of oral bisphosphonate in hospitalized patients.
Bouin, M; Nguyen, PV; Ste-Marie, LG, 2021
)
0.62
"The incidence of adverse reaction was similar to that reported in community trials."( Upper gastrointestinal safety of oral bisphosphonate in hospitalized patients.
Bouin, M; Nguyen, PV; Ste-Marie, LG, 2021
)
0.62
" We also show that temporary administration of the bisphosphonate alendronate, either just before or just after pregnancy, to female mice was protective against bone loss due to pregnancy or lactation and had no adverse effects on offspring, such as growth retardation."( Transient alendronate administration to pregnant or lactating mothers prevents bone loss in mice without adverse effects on offspring.
Ito, E; Kimura, A; Kobayashi, T; Matsumoto, H; Matsumoto, M; Matsumoto, T; Miyamoto, K; Miyamoto, T; Nakamura, M; Sato, K; Sato, Y; Soma, T, 2021
)
1.26
"05), while the incidence of adverse effects was higher in the teriparatide group than alendronate group (P < ."( Analysis of the Efficacy and Safety of Teriparatide and Alendronate in the Treatment of Osteoporosis After Renal Transplantation.
Deng, J; Lin, C; Qiu, Z; Wu, M; Zhang, Y, 2021
)
1.09
"teriparatide can be more effective than the alendronate in the treatment of osteoporosis in renal transplant patients, while having more adverse effects."( Analysis of the Efficacy and Safety of Teriparatide and Alendronate in the Treatment of Osteoporosis After Renal Transplantation.
Deng, J; Lin, C; Qiu, Z; Wu, M; Zhang, Y, 2021
)
1.13
" Among the data extracted in this meta-analysis, bone mineral density (BMD) was the primary outcome measurement, while total effective rate, VAS, osteoprotegerin (OPG), bone Gla protein (BGP), bone alkaline phosphatase (BAP), blood P and Ca, and adverse effects were secondary outcome measurements."( Meta-Analysis of the Efficacy and Safety of Alendronate Combined with Atorvastatin in the Treatment of Osteoporosis in Diabetes Mellitus.
Shu, L; Tang, X; Xiong, Z; Yi, P; Zhang, C, 2022
)
0.98
"The results of this meta-analysis indicate that alendronate combined with atorvastatin is a better treatment for osteoporosis in diabetes mellitus, showing more effective and higher BMD and fewer adverse events than alendronate alone."( Meta-Analysis of the Efficacy and Safety of Alendronate Combined with Atorvastatin in the Treatment of Osteoporosis in Diabetes Mellitus.
Shu, L; Tang, X; Xiong, Z; Yi, P; Zhang, C, 2022
)
1.24
" Incidences of adverse events, asymptomatic decreases in serum calcium, and evolution of kidney function during the studies were similar across all baseline kidney function groups."( Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease.
Adachi, JD; Albergaria, BH; Cheung, AM; Chines, AA; Gielen, E; Langdahl, BL; Miller, PD; Miyauchi, A; Oates, M; Reid, IR; Santiago, NR; Vanderkelen, M; Wang, Z; Yu, Z, 2022
)
0.72
" However, there was no significant difference in the incidence of non-vertebral fracture and adverse events between the two groups."( The efficiency and safety of alendronate versus teriparatide for treatment glucocorticoid-induced osteoporosis: A meta-analysis and systematic review of randomized controlled trials.
Guan, XQ; Liu, ZM; Shen, ZB; Yin, F; Zhang, D; Zhang, M; Zong, Y, 2022
)
1.01
" Cinacalcet and vitamin D may have a small or no increase in overall adverse events."( The Efficacy and Safety of Medical and Surgical Therapy in Patients With Primary Hyperparathyroidism: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Bakaa, L; Bilezikian, JP; Brandi, ML; Chang, Y; Clarke, B; Couban, RJ; Guyatt, G; Khan, AA; Manja, V; Mannstadt, M; Silverberg, SJ; Sreekanta, A; Tangamornsuksun, W; Tong, K; Wang, Y; Ye, Z; Zhang, M; Zhang, Y, 2022
)
0.72
" The PubMed, Embase, and the Cochrane Library databases were searched from the establishment of each database to April 2022 for comparative studies on the topic, including randomized controlled trials (RCTs) and cohort studies, and 2 authors individually extracted information and data concerning study design, baseline characteristics, bone mineral density (BMD), bone turnover markers, and adverse events (AEs)."( Efficacy and Safety of Annual Infusion of Zoledronic Acid and Weekly Oral Alendronate in the Treatment of Primary Osteoporosis: A Meta-Analysis.
Ai, W; Wang, Q; Yu, Q; Zeng, P, 2023
)
1.14
" Aim We conducted a pharmacovigilance safety study of cardiac events using real-life adverse event reports from alendronate, zoledronic acid and teriparatide users."( Cardiac adverse events in bisphosphonate and teriparatide users: An international pharmacovigilance study.
Ebeling, PR; Nerlekar, N; Rodríguez, AJ, 2023
)
1.12
"Osteoporosis medication use is associated with adverse cardiac events, except for MI, and these appear to be more common with oral and intravenous bisphosphonates than teriparatide."( Cardiac adverse events in bisphosphonate and teriparatide users: An international pharmacovigilance study.
Ebeling, PR; Nerlekar, N; Rodríguez, AJ, 2023
)
0.91
" Abaloparatide and teriparatide reduced clinical and radiographic vertebral fractures but increased the risk for withdrawals due to adverse events (WAEs; moderate to high CoE)."( Effectiveness and Safety of Treatments to Prevent Fractures in People With Low Bone Mass or Primary Osteoporosis: A Living Systematic Review and Network Meta-analysis for the American College of Physicians.
Ayers, C; Fu, R; Harrod, C; Kansagara, D; Kwon, A; Lazur, B, 2023
)
0.91
" The primary measures of romosozumab efficacy used in this study were vertebral, non-vertebral, and clinical fracture events, and secondary outcomes were bone mineral density (BMD) changes at the lumbar spine, total hip, and femoral neck and the incidence of adverse events (AEs), RESULTS: Nine RCTs including 12 796 participants were included in the analysis, and romosozumab was compared with placebo, alendronate, and teriparatide in the treatment of osteoporosis in postmenopausal women."( Evaluation of the efficacy and safety of romosozumab (evenity) for the treatment of osteoporotic vertebral compression fracture in postmenopausal women: A systematic review and meta-analysis of randomized controlled trials (CDM-J).
Guo, S; Huang, W; Nagao, M; Nishizaki, Y; Tanigawa, T; Yonemoto, N, 2023
)
1.08
" We calculated the standard mean deviations with 95% confidence intervals (CI) for bone mineral density (BMD) and T scores after 6 and 12 months treatment, pooled odds ratio and 95% CI for fracture risk, and summarized adverse events."( Efficacy and safety of medications for osteoporosis in kidney transplant recipients or patients with chronic kidney disease: A meta-analysis.
Leng, Y; Xia, Y; Yang, Y; Yu, X, 2023
)
0.91
"Atypical femur fracture (AFF) is a rare but catastrophic adverse event first reported in the long-term use of alendronate, one of the most commonly used drugs for osteoporosis currently."( Atypical femur fracture associated with common anti-osteoporosis drugs in FDA adverse event reporting system.
Chen, Y; Huang, Y; Xiao, Y, 2023
)
1.12

Pharmacokinetics

A simple and rapid high performance liquid chromatographic (HPLC) method for quantifying alendronate in beagle dog plasma was developed, validated and applied to a pharmacokinetic study. The findings suggest that there is no pharmacodynamic advantage for continuous infusion of al endronate.

ExcerptReferenceRelevance
" administrations of alendronate to demonstrate that previous exposure does not alter the pharmacokinetic behavior of the drug."( Pharmacokinetics of intravenous alendronate.
Cocquyt, V; De Grève, J; DeSmet, M; Gertz, BJ; Holland, SD; Kline, WF; Porras, AG; Quan, H; Van Belle, SJ; Vyas, KP; Zhang, KE, 1999
)
0.91
" The pharmacokinetic properties of alendronate are evident pharmacodynamically."( Pharmacokinetics of alendronate.
Gertz, BJ; Holland, SD; Porras, AG, 1999
)
0.9
" The findings suggest that there is no pharmacodynamic advantage for continuous infusion of alendronate."( Pharmacokinetic and pharmacodynamic evaluation of intermittent versus continuous alendronate administration in rats.
Golomb, G; Hoffman, A; Stepensky, D, 2002
)
0.76
" The assay was applied to the analysis of samples from a pharmacokinetic study."( High-performance liquid chromatography method for determining alendronate sodium in human plasma by detecting fluorescence: application to a pharmacokinetic study in humans.
Kwon, KI; Yun, MH, 2006
)
0.57
" The maximum plasma drug concentration (Cmax) and the time to reach Cmax (Tmax) were derived from the plasma concentration-time data."( Bioequivalence and pharmacokinetics of 70 mg alendronate sodium tablets by measuring alendronate in plasma.
Kwon, KI; Woo, JS; Yun, MH, 2006
)
0.59
"A simple and rapid high performance liquid chromatographic (HPLC) method for quantifying alendronate in beagle dog plasma was developed, validated and applied to a pharmacokinetic study."( A simple and rapid high-performance liquid chromatography method for determination of alendronate sodium in beagle dog plasma with application to preclinical pharmacokinetic study.
Meng, J; Meng, Q; Zheng, L, 2010
)
0.81
" It was successfully applied to evaluate the pharmacokinetic parameters of alendronate in human volunteers following single oral administration."( Determination of alendronate in low volumes of plasma by column-switching high-performance liquid chromatography method and its application to pharmacokinetic studies in human plasma.
Ban, E; Kim, CK; Kim, HT; Park, JY, 2011
)
0.94
" Here we disclose the pharmacokinetic profile of JTT-305/MK-5442 and its activity on bone remodeling in ovariectomized (OVX) osteopenic rats."( Pharmacodynamic responses to combined treatment regimens with the calcium sensing receptor antagonist JTT-305/MK-5442 and alendronate in osteopenic ovariectomized rats.
Cusick, T; Duong, L; Fisher, JE; Glantschnig, H; Karanam, B; Scott, K; Tijerina, M; Wei, N; Zhao, JZ, 2012
)
0.59
" Thus, pharmacokinetic characteristics of alendronate have been described in many reports based on urinary excretion data; and plasma pharmacokinetics and the simultaneous pharmacokinetic models of alendronate in plasma and urine are not available."( A simple pharmacokinetic model of alendronate developed using plasma concentration and urine excretion data from healthy men.
Baek, IH; Chae, JW; Kim, DH; Kwon, KI; Lee, BY; Mahat, B; Seo, JW; Yun, HY, 2014
)
0.95

Compound-Compound Interactions

Study examined the effect of once-weekly parathyroid hormone (PTH) combined with alendronate. In conclusion, the anabolic action of intermittent PTH in combination with cathepsin K inhibitor or al endronate differs depending on the remodeling status of bone in OVX mice.

ExcerptReferenceRelevance
"To investigate the cost-effectiveness of universal bone densitometry in women aged 65 and older combined with alendronate treatment for those diagnosed with osteoporosis (femoral neck T-score < or = -2."( Universal bone densitometry screening combined with alendronate therapy for those diagnosed with osteoporosis is highly cost-effective for elderly women.
Ensrud, KE; Kane, RL; Melton, LJ; Nyman, JA; Schousboe, JT, 2005
)
0.79
"Universal bone densitometry combined with alendronate therapy for those found to have osteoporosis is highly cost-effective for women aged 65 and older and may be cost saving for ambulatory women aged 85 and older (whether independently living or residing in nursing homes)."( Universal bone densitometry screening combined with alendronate therapy for those diagnosed with osteoporosis is highly cost-effective for elderly women.
Ensrud, KE; Kane, RL; Melton, LJ; Nyman, JA; Schousboe, JT, 2005
)
0.84
"To evaluate the effect of alendronate combined with hormone replacement therapy (HRT) on postmenopausal osteoporotic Chinese women living in Taiwan, we treated 151 women (age range, 47-70 years; mean, 61 years) with conjugated equine estrogen (0."( Effects of alendronate combined with hormone replacement therapy on osteoporotic postmenopausal Chinese women.
Ho, ES; Hu, CC; Kao, CH; Lan, HH; Sheu, WH; Tseng, LN, 2006
)
1.02
"We sought to compare the treatment modalities of alendronate, alfacalcidol, and alendronate combined with alfacalcidol in renal transplant recipients with low bone mineral density."( Treatment of renal transplant recipients with low bone mineral density: a randomized prospective trial of alendronate, alfacalcidol, and alendronate combined with alfacalcidol.
Altiparmak, MR; Apaydin, S; Sariyar, M; Serdengecti, K; Trabulus, S,
)
0.6
" The purpose of our study was to verify the effect of laser therapy in combination with bisphosphonate on osteopenic bone structure."( Effect of low-power gallium-aluminum-arsenium laser therapy (830 nm) in combination with bisphosphonate treatment on osteopenic bone structure: an experimental animal study.
de Melo Ocarino, N; de Oliveira Pereira, RD; Diniz, JS; do Carmo Magalhães, F; Nicolau, RA; Serakides, R, 2009
)
0.35
" In conclusion, the anabolic action of intermittent PTH in combination with cathepsin K inhibitor or alendronate differs depending on the remodeling status of bone in OVX mice."( The anabolic action of intermittent PTH in combination with cathepsin K inhibitor or alendronate differs depending on the remodeling status in bone in ovariectomized mice.
Mori, T; Moridera, K; Nakamura, T; Sakai, A; Tanaka, S; Yamane, H, 2009
)
0.79
" In this study, the efficacy of cinacalcet in combination with alendronate has been retrospectively evaluated in patients with PHPT."( Cinacalcet hydrochloride in combination with alendronate normalizes hypercalcemia and improves bone mineral density in patients with primary hyperparathyroidism.
Colao, A; Coppola, A; Di Somma, C; Faggiano, A; Gasperi, M; Lombardi, G; Panico, F; Ramundo, V; Savastano, S; Severino, R; Vuolo, L, 2011
)
0.87
" The aim of this current study was to test if the anti-resorption effects of ALN may be enhanced when used in combination with OPG."( Alendronate (ALN) combined with osteoprotegerin (OPG) significantly improves mechanical properties of long bone than the single use of ALN or OPG in the ovariectomized rats.
Chan, KM; Huang, P; Li, G; Tang, PF; Wang, Y, 2011
)
1.81
" Since bisphosphonates may not only inhibit osteoclasts, but also osteoblasts and thus bone formation, we studied different bisphosphonate concentrations combined with allograft bone."( Impregnation of bone chips with alendronate and cefazolin, combined with demineralized bone matrix: a bone chamber study in goats.
Bloem, RM; Buma, P; Hannink, G; Mathijssen, NM; Pilot, P; Schreurs, BW, 2012
)
0.66
"5 mg/mL, 1 mg/mL, 2 mg/mL, and 10 mg/mL) were tested in combination with allograft bone and supplemented with cefazolin (200 μg/mL)."( Impregnation of bone chips with alendronate and cefazolin, combined with demineralized bone matrix: a bone chamber study in goats.
Bloem, RM; Buma, P; Hannink, G; Mathijssen, NM; Pilot, P; Schreurs, BW, 2012
)
0.66
" The present study was carried out to compare the effect of a novel agent glucosamine alendronate (GA) alone and is combination with dihydroquercetin (DHQ) against the effect of a known drug alendronate (ALN) in the senescence-accelerated OXYS rats as model of osteoporosis."( Efficacy of glucosamine alendronate alone & in combination with dihydroquercetin for treatment of osteoporosis in animal model.
Kolosova, NG; Muraleva, NA; Ofitserov, EN; Tikhonov, VP, 2012
)
0.91
" Only one study so far has proven the therapeutic efficacy of L-ALD, in combination with γδ T cell immunotherapy, after intraperitoneal administration of γδ T cell resulting in delayed growth of ovarian cancer in mice."( In vitro potency, in vitro and in vivo efficacy of liposomal alendronate in combination with γδ T cell immunotherapy in mice.
Al-Jamal, KT; Al-Jamal, WT; Hodgins, NO; Liu, M; Maher, J; Parente-Pereira, AC; Wang, JT, 2016
)
0.68
"This study examined the effect of once-weekly parathyroid hormone (PTH) combined with alendronate upon osteoporotic fracture healing after long-term alendronate anti-osteoporosis therapy."( Once-weekly parathyroid hormone combined with ongoing long-term alendronate treatment promotes osteoporotic fracture healing in ovariectomized rats.
Guan, Z; Jia, J; Leng, H; Song, C; Sun, T; Wang, H; Yuan, W; Zhang, C; Zhang, W; Zhu, J, 2021
)
1.08
" The aim of this study was to perform a meta-analysis of the effects of alendronate combined with atorvastatin compared with alendronate alone in the treatment of osteoporosis in diabetes mellitus."( Meta-Analysis of the Efficacy and Safety of Alendronate Combined with Atorvastatin in the Treatment of Osteoporosis in Diabetes Mellitus.
Shu, L; Tang, X; Xiong, Z; Yi, P; Zhang, C, 2022
)
1.21
" Our results showed that alendronate combined with atorvastatin is more effective than alendronate alone, with higher BMD, OPG, BGP, and BAP, more significant pain relief, and fewer adverse events."( Meta-Analysis of the Efficacy and Safety of Alendronate Combined with Atorvastatin in the Treatment of Osteoporosis in Diabetes Mellitus.
Shu, L; Tang, X; Xiong, Z; Yi, P; Zhang, C, 2022
)
1.29
"The results of this meta-analysis indicate that alendronate combined with atorvastatin is a better treatment for osteoporosis in diabetes mellitus, showing more effective and higher BMD and fewer adverse events than alendronate alone."( Meta-Analysis of the Efficacy and Safety of Alendronate Combined with Atorvastatin in the Treatment of Osteoporosis in Diabetes Mellitus.
Shu, L; Tang, X; Xiong, Z; Yi, P; Zhang, C, 2022
)
1.24

Bioavailability

The bioavailability of oral alendronate is poor and the agent has to be taken in a fasting state, at least 30 minutes before breakfast, with a full glass of water. Despite its poor bioavailability after oral administration, alendromate is highly effective at preventing bone loss associated with the absence of estrogen.

ExcerptReferenceRelevance
"Bisphosphonates are poorly absorbed when given orally and their absorption is subject to a large inter- and intraindividual variability."( Sodium EDTA enhances intestinal absorption of two bisphosphonates.
Fleisch, H; Janner, M; Mühlbauer, RC, 1991
)
0.28
"Clinical studies were performed to examine the oral bioavailability of alendronate (4-amino-1-hydroxy-butylidene-1,1-bisphosphonate monosodium)."( Studies of the oral bioavailability of alendronate.
Freeman, A; Gertz, BJ; Holland, SD; Kline, WF; Lasseter, KC; Matuszewski, BK; Mucklow, JC; Porras, AG; Quan, H, 1995
)
0.79
" Despite its poor bioavailability after oral administration, alendronate is highly effective at preventing bone loss associated with the absence of endogenous estrogen."( Alendronate. A review of its pharmacological properties and therapeutic efficacy in postmenopausal osteoporosis.
Barradell, LB; Jeal, W; McTavish, D, 1997
)
1.98
" The drug should be absorbed after an overnight fast to improve its bioavailability and with a big glass of plain water to reduce the risk of oesophageal ulcerations."( [Drug clinics. The drug of the month. Alendronate (Fosamax)].
Scheen, AJ, 1998
)
0.57
" The bioavailability of oral alendronate is poor and the agent has to be taken in a fasting state, at least 30 minutes before breakfast, with a full glass of water."( A risk-benefit assessment of alendronate in the treatment of involutional osteoporosis.
Devogelaer, JP, 1998
)
0.88
"To validate our hypothesis that a bisphosphonate (BP) having a nitrogen-containing heterocyclic ring on the side chain, and with no hydroxyl on the geminal carbon would possess increased activity, and better oral bioavailability due to enhanced solubility of its calcium complexes/salts and weaker Ca chelating properties."( Synthesis and preclinical pharmacology of 2-(2-aminopyrimidinio) ethylidene-1,1-bisphosphonic acid betaine (ISA-13-1)-a novel bisphosphonate.
Alferiev, IS; Breuer, E; Cohen, H; Ezra, A; Golomb, G; Hägele, G; Hoffman, A; Mönkkönen, J; Ornoy, A; Patlas, N; Pinto, T; Sagi, H; Seibel, MJ; Solomon, V; Stepensky, D, 1999
)
0.3
" Although newer bisphosphonates are more potent, oral bioavailability remains < 1%."( Oral bisphosphonates: A review of clinical use in patients with bone metastases.
Berenson, J; Hortobagyi, G; Lipton, A; Major, PP, 2000
)
0.31
" Low oral bioavailability is the most likely reason for this difference."( Oral bisphosphonates: A review of clinical use in patients with bone metastases.
Berenson, J; Hortobagyi, G; Lipton, A; Major, PP, 2000
)
0.31
" Since ISA-13 is well absorbed through mucose tissues, we suggest that ISA-13 efficacy on reducing bone loss should be tested by its application on the mucosal tissue."( The effect of topical delivery of novel bisacylphosphonates in reducing alveolar bone loss in the rat model.
Binderman, I; Breuer, E; Golomb, G; Yaffe, A, 2000
)
0.31
" Alendronate, like all bisphosphonates, is absorbed poorly in animals and humans; oral bioavailability is less than 2% in all species studied, including humans."( Pharmacokinetics of alendronate: an overview.
Gertz, B; Lin, JH; Russell, G, 1999
)
1.54
"Total urinary excretion and oral bioavailability of ALN, blood and urine safety parameters, and adverse events were the main outcome measures."( Single-dose pharmacokinetics and tolerability of alendronate 35- and 70-milligram tablets in children and adolescents with osteogenesis imperfecta type I.
Denker, AE; Deutsch, P; Glorieux, FH; Kline, W; Larson, P; Maes, A; Mao, C; Porras, A; Rauch, F; Shugarts, S; Travers, R; Ward, LM, 2005
)
0.58
" The mean oral bioavailability of alendronate or colecalciferol is similar when administered alone or as one once-weekly tablet containing alendronate/colecalciferol 70 mg/2800 IU."( Alendronate/colecalciferol.
Curran, MP; Reynolds, NA, 2005
)
2.05
" However, copies of alendronic acid tablets are approved based on the results of single-dose bioavailability studies in healthy subjects and this is not adequate to establish similar disintegration characteristics."( In vitro disintegration and dissolution studies of once-weekly copies of alendronate sodium tablets (70 mg) and in vivo implications.
Crail, DJ; Dansereau, RJ; Perkins, AC, 2008
)
0.58
" Its bioavailability can decrease with food effect."( The absorption of (99m)Tc-alendronate given by rectal route in rabbits.
Asikoğlu, M; Guneri, T; Koseoğlu, K; Orumlu, O; Ozcan, I; Ozguney, I; Ozkilic, H, 2008
)
0.65
"Copies of generic alendronate sodium tablets are approved based on the results of single-dose bioavailability studies in healthy subjects and this is not considered adequate to establish similar disintegration characteristics."( In vitro disintegration studies of weekly generic alendronate sodium tablets (70 mg) available in the US.
Crail, DJ; Dansereau, RJ; Perkins, AC, 2009
)
0.94
"The aims of the present study were to compare the bioavailability and pharmacokinetic (PK) properties, and to determine the bioequivalence, of a test and reference formulation of alendronate sodium 70 mg in a healthy Korean adult male population."( Bioavailability and bioequivalence of two oral formulations of alendronate sodium 70 mg: an open-label, randomized, two-period crossover comparison in healthy Korean adult male volunteers.
Kang, JS; Kim, DS; Lee, MH; Park, JH; Park, YS; Rhim, SY; Shaw, LM; Yang, SC, 2009
)
0.78
"A hydrophobic ion-pairing (HIP) concept considering the high dissociation property of alendronate was used as a strategy to improve the bioavailability of alendronate."( Studies on the formation of hydrophobic ion-pairing complex of alendronate.
Cho, CW; Kwon, HH; Lee, JM; Shin, SC; You, SK, 2009
)
0.82
" In these formulations, alendronate oral bioavailability in cats was approximately 3%."( Alendronate binds to tooth root surfaces and inhibits progression of feline tooth resorption: a pilot proof-of-concept study.
Feeney, WP; Halley, B; Harvey, CE; Hickey, G; Hill, SL; Jacks, TM; Miller, B; Mohn, KL; Schleim, KD, 2009
)
2.1
"This study examined a novel alendronate formulation that was developed to overcome the shortcomings of alendronate, such as its low bioavailability and gastric adverse effects."( Alendronate-loaded microparticles for improvement of intestinal cellular absorption.
Baek, JS; Cho, CW; Hwang, JS; Kim, YR; Kwon, HH; Lee, JM; Shin, SC; Sung, HC, 2011
)
2.11
" The bioavailability of vitamin D(3) is similar in the combination tablets and when administered alone."( Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet.
Chavez-Eng, C; Constanzer, M; Denker, AE; Gottesdiener, K; Larson, P; Lazarus, N; Maganti, L; Porras, A; Ramakrishnan, R; Scott, BB; Wagner, JA; Woolf, E, 2011
)
0.7
", Fosamax(®)), is effective in the treatment of osteoporosis, and the Fosamax(®) package insert advises that the bioavailability is reduced when taken with mineral water containing high levels of metal cations (Ca(2+), Mg(2+), etc."( [Influence of mineral water on absorption of oral alendronate in rats].
Akagi, Y; Aoyama, T; Sakaue, T; Yoneyama, E, 2011
)
0.62
" The bioavailability of alendronate from the microemulsion was compared with the commercially available tablet (Fosmax) for beagle dogs."( Positively-charged microemulsion for improving the oral bioavailability of alendronate: in-vitro and in-vivo assessment.
Hu, L; Meng, J, 2011
)
0.91
"Based on the results, the oral bioavailability of alendronate could be significantly improved by the positively-charged microemulsion, which opened the tight junctions and thus increased absorption through the paracellular route."( Positively-charged microemulsion for improving the oral bioavailability of alendronate: in-vitro and in-vivo assessment.
Hu, L; Meng, J, 2011
)
0.85
"The goal of this study was to evaluate the bioavailability and single-dose tolerability of alendronate (ALN) in children receiving a stable dose of GCs."( Bioavailability and short-term tolerability of alendronate in glucocorticoid-treated children.
Carpenter, TO; Connor, JD; Denker, AE; Freeman, A; Larson, P; Matthews, CZ; Nakhla, M; Porras, AG; Wagner, JA; Walson, PD; Ward, LM, 2011
)
0.85
" The main outcome measures were total urinary excretion rates, oral bioavailability of ALN, and adverse events."( Bioavailability and short-term tolerability of alendronate in glucocorticoid-treated children.
Carpenter, TO; Connor, JD; Denker, AE; Freeman, A; Larson, P; Matthews, CZ; Nakhla, M; Porras, AG; Wagner, JA; Walson, PD; Ward, LM, 2011
)
0.63
"The mean oral bioavailability of ALN was similar to previous pharmacokinetic studies in children with osteogenesis imperfecta and slightly lower than that observed in historical adult controls."( Bioavailability and short-term tolerability of alendronate in glucocorticoid-treated children.
Carpenter, TO; Connor, JD; Denker, AE; Freeman, A; Larson, P; Matthews, CZ; Nakhla, M; Porras, AG; Wagner, JA; Walson, PD; Ward, LM, 2011
)
0.63
" The absorption of alendronate after the application of alendronate-loaded microneedle array was almost equivalent to that after subcutaneous administration, and the bioavailability of alendronate was approximately 90% in rats."( Development of a novel self-dissolving microneedle array of alendronate, a nitrogen-containing bisphosphonate: evaluation of transdermal absorption, safety, and pharmacological effects after application in rats.
Hayashi, R; Hirai, Y; Hitomi, K; Kamiyama, F; Katsumi, H; Kusamori, K; Liu, S; Quan, YS; Sakane, T; Tanaka, Y; Yamamoto, A, 2012
)
0.95
"This study aimed to design the chitosan coated liposomes of alendronate and optimize their in vitro/in vivo characteristics to improve the bioavailability as well as potentially to reduce the mucosal irritation of alendronate."( Improved oral bioavailability of alendronate via the mucoadhesive liposomal delivery system.
Ha, DH; Han, HK; Shin, HJ, 2012
)
0.9
" The challenges facing ALS use include: very poor oral bioavailability (0."( Enteric-coated alendronate sodium nanoliposomes: a novel formula to overcome barriers for the treatment of osteoporosis.
Ahmed, OA; Al-Abdali, RT; Hosny, KM, 2013
)
0.74
" EuC-NLS with PC:CH:Lec:dicetyl phosphate (4:3:1:1) successfully resist the release of ALS in acidic environments and enhanced the bioavailability in rabbits 12-fold compared with the marketed tablets."( Enteric-coated alendronate sodium nanoliposomes: a novel formula to overcome barriers for the treatment of osteoporosis.
Ahmed, OA; Al-Abdali, RT; Hosny, KM, 2013
)
0.74
"EuC-NLS is a promising novel formula for ALS with higher bioavailability and a lower dose, avoiding the side effects of esophageal ulceration."( Enteric-coated alendronate sodium nanoliposomes: a novel formula to overcome barriers for the treatment of osteoporosis.
Ahmed, OA; Al-Abdali, RT; Hosny, KM, 2013
)
0.74
"The lung deposition and safety evaluation data observed from these studies suggested that aerosolized nanosized alendronate sodium by the inhalation route could be a new and promising route of administration as an antidote to radioactive substances through an increase in the bioavailability of the drug as well as a decrease in side effects on systemic delivery."( In vivo lung deposition and sub-acute inhalation toxicity studies of nano-sized alendronate sodium as an antidote for inhaled toxic substances in Sprague Dawley rats.
Ahmad, FJ; Ali, R; Bhatnagar, A; Mittal, G; Sultana, S; Talegaonkar, S, 2013
)
0.83
" The model, which included first-order absorption rate for oral dosing, showed good fit to alendronate data obtained from plasma and urine."( A simple pharmacokinetic model of alendronate developed using plasma concentration and urine excretion data from healthy men.
Baek, IH; Chae, JW; Kim, DH; Kwon, KI; Lee, BY; Mahat, B; Seo, JW; Yun, HY, 2014
)
0.9
" sodium alendronate (Aln) is characterized by extremely low bioavailability and high toxicity."( Injectable nanoparticle-loaded hydrogel system for local delivery of sodium alendronate.
Bacakova, L; Filova, E; Kamperman, M; Pamula, E; Parizek, M; Posadowska, U; Wlodarczyk-Biegun, M, 2015
)
1.08
"Alendronate sodium (ALD) is used orally but it is poorly absorbed from the gastrointestinal (GI) tract."( Tc-99m Radiolabeled Alendronate Sodium Microemulsion: Characterization and Permeability Studies Across Caco-2 Cells.
Asikoglu, M; Ekinci, M; Elitez, Y; Gundogdu, E; Ilem-Ozdemir, D, 2018
)
2.25
" This study suggests that the lower incidence of BP-ONJ in alendronate treatment is not originated by its potency, but might be due to the low bioavailability of alendronate, lower dosing on a daily basis, and having no additional therapies."( Effects of an oral bisphosphonate and three intravenous bisphosphonates on several cell types in vitro.
Al-Nawas, B; Jung, J; Kwon, YD; Pabst, AM; Park, JS; Righesso, L; Walter, C, 2018
)
0.72
" The present study was designed to conduct comparative bioavailability analysis of oral formulations of aledronate sodium through an open-label, randomized, 2-sequence, 2-period crossover study."( COMPARATIVE BIOAVAILABILITY ANALYSIS OF ORAL ALENDRONATE SODIUM FORMULATIONS IN PAKISTAN.
Bashir, S; Goodman, B; Hussain, S; Mahmood, S; Mahmood, W; Malik, F; Raza, SA; Riaz, H; Waseem, D, 2016
)
0.69
" However, systemic administration of AL is characterized by extremely low bioavailability and high toxicity."( Alendronate delivery on amino modified mesoporous bioactive glass scaffolds to enhance bone regeneration in osteoporosis rats.
Huang, Q; Jiang, X; Wang, X; Wen, J; Weng, W; Wu, J; Zeng, D; Zhang, X, 2018
)
1.92
" TDME achieved two fold increase in bioavailability as compared to oral administration in pharmacokinetic studies."( Positive effect of alendronate on bone turnover in ovariectomised rats' osteoporosis: comparison of transdermal lipid-based delivery with conventional oral administration.
Boche, M; Pokharkar, V, 2018
)
0.81
" Nearly six-time enhancement of bioavailability was observed when alendronate was used in the nanoparticulate form in transdermal patches used with sonophoresis."( Ultrasound-assisted transdermal delivery of alendronate for the treatment of osteoporosis.
Huang, G; Li, B; Ma, Z; Qin, S, 2020
)
1.06
"Capryol 90 is an effective absorption enhancer for improving the intestinal absorption of poorly absorbed drugs via both transcellular and paracellular pathways."( Absorption-Enhancing Mechanisms of Capryol 90, a Novel Absorption Enhancer, for Improving the Intestinal Absorption of Poorly Absorbed Drugs: Contributions to Trans- or Para-Cellular Pathways.
Imanishi, A; Kaneda, A; Katsumi, H; Kimura, E; Koyama, M; Morishita, M; Ukai, H; Yamamoto, A, 2020
)
0.56
" The disadvantages of this class are their poor bioavailability and side effects on oral and intravenous application such as stomach irritation and osteonecrosis in jaw."( Fabrication and characterization of bovine hydroxyapatite-gelatin-alendronate scaffold cross-linked by glutaraldehyde for bone regeneration.
Budiatin, AS; Khotib, J; Mahyudin, F, 2021
)
0.86
" However, the use of Alen has been limited due to its low bioavailability and gastrointestinal side effects."( Alendronate-Decorated Nanoparticles as Bone-Targeted Alendronate Carriers for Potential Osteoporosis Treatment.
Chen, S; Jing, C; Li, B; Liang, H; Liu, C; Na, H; Tan, H; Zhang, C; Zhao, L, 2021
)
2.06
"Low oral bioavailability of alendronate sodium (ALE) significantly limits its clinical application."( Preparation and evaluation of alendronate sodium solid lipid nanoparticles with high oral bioavailability in rats.
Geng, R; Huang, H; Sun, S; Wang, H; Wu, L; Xie, B; Xiong, Y, 2022
)
1.3
"Astragaloside (AS) has an anti-osteoporotic effect, but its poor water solubility and low bioavailability limit its application."( Alendronate modified mPEG-PLGA nano-micelle drug delivery system loaded with astragaloside has anti-osteoporotic effect in rats.
He, H; Ma, L; Pan, W; Shi, C; Wang, W; Xi, Y; Xu, G; Xu, N, 2022
)
2.16
" However, ALN is characterized by restricted oral absorption and bioavailability and simultaneously its administration has serious side-effects (jaw osteonecrosis, irritation of the gastrointestinal system, nausea, musculoskeletal pain, and cardiovascular risks)."( How Efficient are Alendronate-Nano/Biomaterial Combinations for Anti-Osteoporosis Therapy? An Evidence-Based Review of the Literature.
Klara, J; Lewandowska-Łańcucka, J, 2022
)
1.06

Dosage Studied

In order to determine whether osteoclastic bone resorption is restarted after withdrawn of bisphosphonates, we conducted histological examinations on murine osteoclasts, osteoblasts and osteocytes. Four groups of 5 rats each were included in the study; the first 2 groups were dosed with alendronate or a vehicle during concurrent orthodontic tooth movement. Etidronate was given cyclically (14-day courses in a dosage of 400 mg/d separated by 76-day intervals with calcium and vitamin D supplementation) and alendronsite was given daily in a dose of 10mg/d.

ExcerptRelevanceReference
"A method was developed and validated for the direct determination in pharmaceutical dosage formulations of alendronate, a non-chromophoric compound."( Determination of alendronate in pharmaceutical dosage formulations by ion chromatography with conductivity detection.
Brooks, MA; Ip, DP; Tsai, EW, 1992
)
0.84
" A practical dosing recommendation, derived from these findings and reflective of the long-term nature of therapy for a disease such as osteoporosis, is that patients take the drug with water after an overnight fast and at least 30 minutes before any other food or beverage."( Studies of the oral bioavailability of alendronate.
Freeman, A; Gertz, BJ; Holland, SD; Kline, WF; Lasseter, KC; Matuszewski, BK; Mucklow, JC; Porras, AG; Quan, H, 1995
)
0.56
"Application of ion chromatography (IC) to the analysis of non-chromophoric bisphosphonate drugs in pharmaceutical dosage formulations is described."( Determination of bisphosphonate drugs in pharmaceutical dosage formulations by ion chromatography with indirect UV detection.
Bell, C; Brooks, MA; Chamberlin, SD; Forsyth, RJ; Ip, DP; Tsai, EW, 1994
)
0.29
" Dosing up to at least 2 h after a meal dramatically reduces absorption (80%-90%)."( Clinical pharmacology of alendronate sodium.
Gertz, BJ; Holland, SD; Kline, WF; Matuszewski, BK; Porras, AG, 1993
)
0.59
"The short-term dose-response relationship between treatment with the bisphosphonate alendronate, biochemical markers of bone turnover, and changes in lumbar spine bone mineral density (BMD) over 9 months was assessed using a double-masked controlled study design in 65 postmenopausal women (mean age 51."( Short-term effect of alendronate on bone mass and bone remodeling in postmenopausal women.
Chesnut, CH; Harris, ST, 1993
)
0.83
" Fifty-nine patients were treated and 50 patients were assessable for the dose-response relationship."( Dose-response study of alendronate sodium for the treatment of cancer-associated hypercalcemia.
Averbuch, SD; Bilezikian, JP; Gertz, BJ; Glusman, J; Nussbaum, SR; Rude, R; Sacco, JF; Stepanavage, M; Stewart, AF; Warrell, RP, 1993
)
0.6
"While a statistically significant dose-response relationship was not clearly evident at doses greater than 5 mg, single doses of > or = 5 mg alendronate sodium effectively lowered serum calcium concentrations and were well tolerated in the treatment of cancer-associated hypercalcemia."( Dose-response study of alendronate sodium for the treatment of cancer-associated hypercalcemia.
Averbuch, SD; Bilezikian, JP; Gertz, BJ; Glusman, J; Nussbaum, SR; Rude, R; Sacco, JF; Stepanavage, M; Stewart, AF; Warrell, RP, 1993
)
0.8
" BMD continued to increase over the entire 3-year study duration in the ALN-treated groups and, compared with the other dosage groups, 10 mg ALN produced the largest gains in BMD during the 3rd year."( Oral alendronate induces progressive increases in bone mass of the spine, hip, and total body over 3 years in postmenopausal women with osteoporosis.
Broll, H; Correa-Rotter, R; Cumming, DC; De Deuxchaisnes, CN; Devogelaer, JP; Geusens, P; Hirsch, LJ; Hosking, D; Jaeger, P; Kaufman, JM; Leite, M; Leon, J; Liberman, U; Lombardi, A; Menkes, CJ; Meunier, PJ; Plezia, K; Reid, I; Rodriguez, J; Romanowicz, A; Santora, AC; Seeman, E; Vermeulen, A; Yates, AJ; Yuan, W, 1996
)
0.81
" The present study was carried out to determine dose-response relationships, particularly the effects of relatively low doses of ALN, on bone mineral density (BMD), biochemical indexes of bone and mineral metabolism, and bone histology, with particular attention to effects in elderly women."( Dose-response relationships for alendronate treatment in osteoporotic elderly women. Alendronate Elderly Osteoporosis Study Centers.
Bone, HG; Downs, RW; Gertz, BJ; Hale, E; Harris, ST; Kimmel, DB; Licata, AA; McClung, MR; Polvino, WJ; Tucci, JR; Weinstein, RS, 1997
)
0.58
" Rats were dosed concomitantly with indomethacin (40 mg/kg, subcutaneously) and an amino or pyridinyl bisphosphonate (orally at."( Nonclinical model for assessing gastric effects of bisphosphonates.
Berman, SK; Blank, MA; Ems, BL; Gibson, GW; Myers, WR; Phipps, RJ; Smith, PN, 1997
)
0.3
" Even when used according to manufacturer's dosing instructions alendronate should probably be used with caution."( Primary amino-bisphosphonates: a new class of gastrotoxic drugs--comparison of alendronate and aspirin.
Goodgame, R; Graham, DY; Malaty, HM, 1997
)
0.76
" These findings confirm that mineralization is normal, and trabecular bone turnover markedly decreased in patients receiving long-term dosing with alendronate."( Histomorphometric assessment of the long-term effects of alendronate on bone quality and remodeling in patients with osteoporosis.
Arlot, ME; Chavassieux, PM; Meunier, PJ; Reda, C; Wei, L; Yates, AJ, 1997
)
0.74
" Continuous daily dosing with alendronate (10 mg) was found to be well tolerated."( Alendronate for osteoporosis. Safe and efficacious nonhormonal therapy.
Adachi, JD, 1998
)
2.03
" The initial dose of alendronate sodium was 5 mg/d; the dosage was increased from 5 to 10 mg/d at 24 months."( Treatment with alendronate prevents fractures in women at highest risk: results from the Fracture Intervention Trial.
Barrett-Connor, E; Bauer, DC; Black, DM; Ensrud, KE; Karpf, DB; Palermo, L; Quandt, SA; Thompson, DE,
)
0.8
" This decrease was only statistically significant after 96 h of culture; however, a dose-response effect could not be documented."( Effect of alendronate on cultured normal human osteoblasts.
Aubía, J; Ballester, J; Carbonell, J; Díez, A; Farré, M; García-Moreno, C; Mariñoso, ML; Mellibovsky, L; Nacher, M; Nogués, X; Serrano, S, 1998
)
0.7
" The recommended dosage is 10 mg once daily, continuously."( [Drug clinics. The drug of the month. Alendronate (Fosamax)].
Scheen, AJ, 1998
)
0.57
" To examine the pharmacokinetics of this drug, several groups of postmenopausal women were dosed intravenously in several studies."( Pharmacokinetics of intravenous alendronate.
Cocquyt, V; De Grève, J; DeSmet, M; Gertz, BJ; Holland, SD; Kline, WF; Porras, AG; Quan, H; Van Belle, SJ; Vyas, KP; Zhang, KE, 1999
)
0.59
" Study 1 is a retrospective study of 20 patients with moderate to severe disease who were treated with intravenous (iv) pamidronate (221 +/- 18 mg [SEM]; range 60-360 mg), and after biochemical remission and relapse were retreated with generally larger iv dosage (293 +/- 28 mg; range 180-600 mg)."( Paget's disease: acquired resistance to one aminobisphosphonate with retained response to another.
Bhagat, CI; Criddle, A; Faulkner, DL; Gan, SK; Geelhoed, E; Gutteridge, DH; Kent, GN; Price, RI; Prince, RL; Retallack, RW; Stewart, GO; Stuckey, BG; Vasikaran, S; Ward, LC; Will, RK, 1999
)
0.3
"The aim of the study was to assess the long-term anabolic effect of the parathyroid hormone (PTH) analog SDZ PTS 893 in a dose-response manner, and to determine the ability of the antiresorptive agents estradiol and alendronate to maintain bone mass after withdrawal of SDZ PTS 893."( Long-term therapy of ovariectomy-induced osteopenia with parathyroid hormone analog SDZ PTS 893 and bone maintenance in retired breeder rats.
Gasser, JA; Mosekilde, LI; Thomsen, JS, 1999
)
0.49
" Oral dosing should not be substituted for intravenous administration in the treatment of malignant osteolysis."( Oral bisphosphonates: A review of clinical use in patients with bone metastases.
Berenson, J; Hortobagyi, G; Lipton, A; Major, PP, 2000
)
0.31
"This paper describes the rationale and supporting data for once-weekly dosing of alendronate."( Weekly administration of alendronate: rationale and plan for clinical assessment.
Adami, S; Bone, HG; Daifotis, A; Favus, M; Orloff, J; Prahalada, S; Rizzoli, R; Ross, PD; Santora, A; Yates, J, 2000
)
0.84
" Animal studies demonstrate that both weekly and daily parenteral administration of alendronate effectively increase bone mass and strength, but confirmation of efficacy is needed for weekly oral dosing in humans."( Weekly administration of alendronate: rationale and plan for clinical assessment.
Adami, S; Bone, HG; Daifotis, A; Favus, M; Orloff, J; Prahalada, S; Rizzoli, R; Ross, PD; Santora, A; Yates, J, 2000
)
0.83
"Current safety and efficacy data justify further investigation of once-weekly dosing of alendronate."( Weekly administration of alendronate: rationale and plan for clinical assessment.
Adami, S; Bone, HG; Daifotis, A; Favus, M; Orloff, J; Prahalada, S; Rizzoli, R; Ross, PD; Santora, A; Yates, J, 2000
)
0.83
" Less frequent dosing with any medication may enhance compliance, thereby maximizing the effectiveness of therapy."( Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group.
Adami, S; Bone, HG; Crepaldi, G; Emkey, R; Felsenberg, D; Foldes, AJ; Greenspan, SL; Kaur, A; Kiel, D; Levine, MA; McClung, M; Orloff, JJ; Pinchera, A; Recker, RR; Roux, C; Santora, AC; Schnitzer, T; Thompson, DE; Tonino, RP; Yates, J, 2000
)
0.6
" The study was designed as a dose-response study, and the site-specific effects of immobilization and of treatment are described."( Treatment with risedronate or alendronate prevents hind-limb immobilization-induced loss of bone density and strength in adult female rats.
Mackey, MS; Mosekilde, L; Phipps, RJ; Thomsen, JS, 2000
)
0.6
" The present study compared the potential for alendronate and risedronate to produce endoscopic upper GI mucosal irritation using the highest approved dosage regimens for the two agents."( An endoscopic comparison of the effects of alendronate and risedronate on upper gastrointestinal mucosae.
Graham, DY; Lanza, F; Malaty, HM; Musliner, T; Quan, H; Reyes, R; Sahba, B; Schwartz, H, 2000
)
0.83
" The bisphosphonate alendronate was recently approved for once-a-week dosing for the prevention and treatment of postmenopausal osteoporosis."( Osteoporosis. Efficacy and safety of a bisphosphonate dosed once weekly.
Baran, D, 2001
)
0.63
" A subsequent clinical trial reported that the once-weekly dosing regimen is therapeutically equivalent to the daily regimen."( Update on alendronate for osteoporosis: once-weekly dosing.
Schnitzer, TJ, 2001
)
0.71
" Alendronate was administered to 6-week-old mice during a period of active growth at a dosage of 73 microg alendronate/kg/day for the first 4 weeks and 26 microg alendronate/kg/day for the next 4 weeks."( A controlled study of the effects of alendronate in a growing mouse model of osteogenesis imperfecta.
Boskey, AL; Camacho, NP; Doty, SB; Ilg, WA; Raggio, CL; Root, L; Toledano, TR; Zraick, V, 2001
)
1.49
" Etidronate was given cyclically (14-day courses in a dosage of 400 mg/d separated by 76-day intervals with calcium and vitamin D supplementation) and alendronate was given daily in a dosage of 10 mg/d."( Comparative efficacy and safety study of etidronate and alendronate in postmenopausal osteoporosis. effect of adding hormone replacement therapy.
Béra-Louville, A; Cortet, B; Delcambre, B; Gauthier, A; Gauthier, P; Marchandise, X, 2001
)
0.76
" Alendronate, however, can be given as a once-weekly dose, whereas risedronate is not yet available in this dosage form."( Role of alendronate and risedronate in preventing and treating osteoporosis.
Leonard, M; Licata, AA; Peters, ML, 2001
)
1.66
"To review data describing use of intermittent dosing of alendronate."( Intermittent dosing of alendronate.
Heck, AM; Tsun, EC, 2001
)
0.87
"A comprehensive literature search was conducted using MEDLINE (1966-May 2001) and EMBASE (1974-May 2001) databases to identify all information regarding intermittent dosing of alendronate."( Intermittent dosing of alendronate.
Heck, AM; Tsun, EC, 2001
)
0.81
"A small number of clinical studies have evaluated the use of intermittent alendronate dosing in an attempt to improve patient compliance and adverse events."( Intermittent dosing of alendronate.
Heck, AM; Tsun, EC, 2001
)
0.85
" The definitive role of intermittent dosing in patients with postmenopausal osteoporosis remains to be determined."( Intermittent dosing of alendronate.
Heck, AM; Tsun, EC, 2001
)
0.62
" Future analyses with this method could be used to identify improved dosing regimens and to predict which osteoporosis treatments would best complement each other."( A theoretical analysis of the contributions of remodeling space, mineralization, and bone balance to changes in bone mineral density during alendronate treatment.
Beaupré, GS; Carter, DR; Hernandez, CJ; Marcus, R, 2001
)
0.51
" We found, in dose-response studies, that alendronate and risedronate inhibit bone resorption (in pit assays) at doses tenfold lower than those reducing osteoclast number."( Inhibition of bone resorption by alendronate and risedronate does not require osteoclast apoptosis.
Halasy-Nagy, JM; Reszka, AA; Rodan, GA, 2001
)
0.86
" A weekly dosing regimen of alendronate is preferred by both patients and physicians, as it has the potential to provide greater convenience and enhance compliance."( The upper GI safety and tolerability of oral alendronate at a dose of 70 milligrams once weekly: a placebo-controlled endoscopy study.
Daifotis, A; Lanza, F; Leung, A; Musliner, T; Quan, H; Reyes, R; Sahba, B; Schwartz, H; Torosis, J; Winograd, S, 2002
)
0.87
" A dosage of 20 mg/d is required initially with daily treatment lasting at least 10 weeks."( [Dose-dependent prevention of early periprosthetic bone loss by alendronate].
Arabmotlagh, M; Hennigs, T; Schwarz, A; Zichner, L,
)
0.37
" However, many patients find the daily dosing regimen inconvenient."( Once-weekly treatment for osteoporosis.
Stone, M, 2002
)
0.31
" The method was validated for the direct determination of alendronate in tablet dosage formulations."( Spectrophotometric determination of alendronate in pharmaceutical formulations via complex formation with Fe(III) ions.
Janković, I; Kuljanin, J; Marinković, V; Nedeljković, J; Prstojević, D, 2002
)
0.83
" Also, the risk of these adverse GI tract events can be decreased by following the dosing instructions (e."( Alendronate and risedronate: what you need to know about their upper gastrointestinal tract toxicity.
Baker, DE, 2002
)
1.76
" Clodronate treatment at our dosage is ineffective in this pathology in spite of the good compliance of patients."( Bisphosphonates in the treatment of thalassemia-induced osteoporosis.
Crisafulli, A; Di Pietro, C; Frisina, N; Gaudio, A; Lasco, A; Meo, A; Morabito, N, 2002
)
0.31
" A 70-mg once-weekly dosage form of alendronate has recently been approved and clinical experience with its gastrointestinal tolerability is ongoing."( What the gastroenterologist should know about the gastrointestinal safety profiles of bisphosphonates.
Graham, DY, 2002
)
0.59
"Less than daily alendronate dosing has been identified as an attractive alternative to daily dosing for patients and physicians."( Long-term predictions of the therapeutic equivalence of daily and less than daily alendronate dosing.
Beaupré, GS; Carter, DR; Hernandez, CJ; Marcus, R, 2002
)
0.89
"The aim of this study was to provide confirmation that once-weekly dosing with 70 mg of alendronate (seven times the daily oral dose) and twice-weekly dosing with 35 mg is equivalent to the 10-mg once-daily regimen and to gain more extensive safety experience with this new dosing regimen."( Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis.
Adami, S; Bone, G; Foldes, AJ; Greenspan, SL; Kaur, A; Levine, MA; Orloff, JJ; Peverly, CA; Rizzoli, R; Roux, C; Santora, AC; Schnitzer, TJ; Uebelhart, B; Watts, NB, 2002
)
0.79
"This study aimed to determine patient preference for once-weekly versus once-daily dosing with alendronate, and to determine which treatment regimen the patients believed was more convenient and would be easier to comply with for a long period."( Patient preference for once-weekly alendronate 70 mg versus once-daily alendronate 10 mg: a multicenter, randomized, open-label, crossover study.
Lewiecki, EM; Palmisano, JJ; Petruschke, RA; Simon, JA; Smith, ME; Wang, L, 2002
)
0.81
" Of the patients who completed the questionnaire, 235 patients preferred the 70-mg once-weekly dosing regimen compared with the 10-mg once-daily regimen (86."( Patient preference for once-weekly alendronate 70 mg versus once-daily alendronate 10 mg: a multicenter, randomized, open-label, crossover study.
Lewiecki, EM; Palmisano, JJ; Petruschke, RA; Simon, JA; Smith, ME; Wang, L, 2002
)
0.59
"When once-weekly alendronate 70 mg was compared with once-daily alendronate 10 mg in this study, 70-mg once-weekly alendronate was the preferred dosing regimen."( Patient preference for once-weekly alendronate 70 mg versus once-daily alendronate 10 mg: a multicenter, randomized, open-label, crossover study.
Lewiecki, EM; Palmisano, JJ; Petruschke, RA; Simon, JA; Smith, ME; Wang, L, 2002
)
0.93
" In histomorphometry with iliac bone biopsies, mineralization was normal, and trabecular bone turnover markedly decreased in patients receiving long-term dosing with alendronate."( [Clinical trials of alendronate].
Okano, T; Teshima, R, 2003
)
0.84
" The high dosage of alendronate increased overall growth plate height, particularly within the hypertrophic zone, which suggests a failure of vascular invasion-induced apoptosis in the hypertrophic cells."( Alendronate affects long bone length and growth plate morphology in the oim mouse model for Osteogenesis Imperfecta.
Evans, KD; Lau, ST; Martin, RB; Oberbauer, AM, 2003
)
2.09
" Drug not excreted within 24 hours after dosing is believed to be sequestered in the skeleton, from which it is liberated slowly into the circulation to be eliminated renally."( Pharmacokinetics of alendronate: an overview.
Gertz, B; Lin, JH; Russell, G, 1999
)
0.63
" Alendronate was revealed to be well tolerated, with a good safety profile; a dose of 10 mg daily offers the best risk:benefit ratio and appears to be the optimal dosage for the treatment of established postmenopausal osteoporosis."( Alendronate in the treatment of postmenopausal osteoporosis.
Favus, M; Hosking, DJ; Yates, AJ, 1999
)
2.66
" Bone mineral density increases at other skeletal sites and effects on bone turnover were also virtually identical for the two dosing regimens."( Therapeutic equivalence of alendronate 35 milligrams once weekly and 5 milligrams daily in the prevention of postmenopausal osteoporosis.
Bone, HG; Daifotis, AG; Davie, MW; de Villiers, TJ; Gilchrist, N; Luckey, MM; Orloff, JJ; Santora, AC; Wu, M, 2003
)
0.62
"Alendronate 35 mg once weekly is therapeutically equivalent to alendronate 5 mg daily and provides patients with greater dosing convenience, in addition to the proven efficacy of alendronate and good tolerability."( Therapeutic equivalence of alendronate 35 milligrams once weekly and 5 milligrams daily in the prevention of postmenopausal osteoporosis.
Bone, HG; Daifotis, AG; Davie, MW; de Villiers, TJ; Gilchrist, N; Luckey, MM; Orloff, JJ; Santora, AC; Wu, M, 2003
)
2.06
" The potent bisphosphonate zoledronate can be given at intervals of as long as 1 year and produces changes in bone density and in markers of bone turnover comparable with those seen with conventional daily oral dosing with alendronate or risedronate."( Bisphosphonates: new indications and methods of administration.
Reid, IR, 2003
)
0.5
"Alendronate, a bisphosphonate that potently inhibits bone resorption, has been shown in long-term clinical trials to be an effective treatment for osteoporosis, increasing bone mineral density and substantially reducing the incidence of both vertebral and nonvertebral fractures, including hip fractures, mostly using a daily dosage regimen."( Once weekly alendronate.
Sambrook, P, 2003
)
2.14
"To compare the effects of alendronate (ALN) 70 mg once weekly (OW) and risedronate (RIS) 5 mg daily between-meal dosing on biochemical markers of bone turnover and bone mineral density (BMD) in postmenopausal women with osteoporosis."( Comparison of change in bone resorption and bone mineral density with once-weekly alendronate and daily risedronate: a randomised, placebo-controlled study.
Adami, S; Andia, JC; Benhamou, L; Felsenberg, D; Hosking, D; Petruschke, RA; Reginster, JY; Rybak-Feglin, A; Santora, AC; Välimäki, M; Yacik, C; Zaru, L, 2003
)
0.84
" After 1 month of Alendronate, an aminobisphosphonate, given at a dosage of 10 mg once a week intravenously for the first 6 weeks and then once a month thereafter, the arthritis and skin nodules improved, and the remission has continued for more than 2 years."( Successful treatment of multicentric reticulohistiocytosis with alendronate: evidence for a direct effect of bisphosphonate on histiocytes.
Goto, H; Imanishi, Y; Inaba, M; Inui, K; Kobayashi, K; Kumeda, Y; Nishizawa, Y; Okada, F, 2003
)
0.89
" At least 12 (n = 12) dosage units were tested for each product (except Fosmin, n = 10)."( Disintegration/dissolution profiles of copies of Fosamax (alendronate).
Chow, J; Cryer, B; Epstein, S; Johnson, MA; Leyes, AE; Ragi, S; Walliser, J; Zanchetta, JR, 2003
)
0.56
" Neobon is a softgel capsule, so special consideration was given to this different dosage form."( Disintegration/dissolution profiles of copies of Fosamax (alendronate).
Chow, J; Cryer, B; Epstein, S; Johnson, MA; Leyes, AE; Ragi, S; Walliser, J; Zanchetta, JR, 2003
)
0.56
" However, a constraining requirement for dosing limited its general acceptance in treatment."( Efficacy of intermittent low dose alendronate in Thai postmenopausal osteoporosis.
Aunphongpuwanart, S; Chailurkit, LO; Jongjaroenprasert, W; Ongphiphadhanakul, B; Rajatanavin, R; Sae-tung, S, 2004
)
0.6
"Once weekly dosing of alendronate has been shown to provide equivalent efficacy to once daily dosing for treatment of osteoporosis in postmenopausal women."( Patients with osteoporosis prefer once weekly to once daily dosing with alendronate.
Fuleihan, Gel-H; Gaines, KA; González González, JG; Kendler, D; Kung, AW; Melton, ME; Verbruggen, N, 2004
)
0.87
" The main outcome was the responses of the participants to the Dosing Regimen Questionnaire administered at the end of the study."( Patients with osteoporosis prefer once weekly to once daily dosing with alendronate.
Fuleihan, Gel-H; Gaines, KA; González González, JG; Kendler, D; Kung, AW; Melton, ME; Verbruggen, N, 2004
)
0.56
"Of the participants expressing a preference, 84% preferred the once weekly dosing regimen with alendronate to the once daily dosing regimen."( Patients with osteoporosis prefer once weekly to once daily dosing with alendronate.
Fuleihan, Gel-H; Gaines, KA; González González, JG; Kendler, D; Kung, AW; Melton, ME; Verbruggen, N, 2004
)
0.77
"The majority of postmenopausal women with osteoporosis preferred the once weekly to the once daily dosing regimen of alendronate."( Patients with osteoporosis prefer once weekly to once daily dosing with alendronate.
Fuleihan, Gel-H; Gaines, KA; González González, JG; Kendler, D; Kung, AW; Melton, ME; Verbruggen, N, 2004
)
0.77
"The objective of this review is to present the clinical profiles of the once-weekly and once-daily dosing formulations of alendronate and risedronate, the 2 bisphosphonates currently available in the United States for the prevention and treatment of postmenopausal osteoporosis."( Alendronate and risedronate for the treatment of postmenopausal osteoporosis: clinical profiles of the once-weekly and once-daily dosing formulations.
Emkey, R, 2004
)
1.97
"To evaluate pharmacists' knowledge of approved dosing information for cyclic etidronate, alendronate and risedronate in the treatment of postmenopausal osteoporosis; and to assess its relationship to demographic and pharmaceutical care factors."( Pharmaceutical care and community pharmacists' understanding of bisphosphonate dosing information.
Kendler, DL; Li, WW, 2004
)
0.55
"Fax-back questionnaire to evaluate pharmacists' knowledge of approved bisphosphonate dosing information and their involvement in pharmaceutical/patient care activities through independent indices."( Pharmaceutical care and community pharmacists' understanding of bisphosphonate dosing information.
Kendler, DL; Li, WW, 2004
)
0.32
"Mean bisphosphonate dosing knowledge score was 76 +/- 11% (mean +/- SD)."( Pharmaceutical care and community pharmacists' understanding of bisphosphonate dosing information.
Kendler, DL; Li, WW, 2004
)
0.32
"There is a wide range of knowledge of bisphosphonate dosing and delivery of pharmaceutical care amongst community pharmacists surveyed."( Pharmaceutical care and community pharmacists' understanding of bisphosphonate dosing information.
Kendler, DL; Li, WW, 2004
)
0.32
" Alternative dosing schedules and routes of administration have become available and may improve fracture protection, compliance, and tolerability for the long term treatment of a chronic condition such as osteoporosis."( Oral antiresorptive therapy.
Hosking, DJ; Pande, I, 2005
)
0.33
" Patient-reported compliance with dosing instructions was over 98%."( Treatment preference and tolerability with alendronate once weekly over a 3-month period: an Israeli multi-center study.
Cohen, YC; Foldes, AJ; Ish-Shalom, S; Shamir-Elron, Y; Vered, I; Weiss, M, 2005
)
0.59
"The majority of post-menopausal women with osteoporosis, including those who were previously intolerant to alendronate OD, preferred alendronate OW to the once-daily dosing regimen."( Treatment preference and tolerability with alendronate once weekly over a 3-month period: an Israeli multi-center study.
Cohen, YC; Foldes, AJ; Ish-Shalom, S; Shamir-Elron, Y; Vered, I; Weiss, M, 2005
)
0.8
" Alternative dosing schedules and routes of administration have become available and may improve fracture protection, compliance, and tolerability for the long term treatment of a chronic condition such as osteoporosis."( Oral antiresorptive therapy.
Hosking, DJ; Pande, I, 2004
)
0.32
" Dosing frequency will likely affect tolerability and adherence to treatment."( Efficacy and tolerability of alendronate once weekly in Asian postmenopausal osteoporotic women.
Ho, AY; Kung, AW, 2005
)
0.62
" The weak affinity of clodronate translated into a requirement for 10-fold higher dosing in in vitro bone resorption assays when bone was pretreated with BP and subsequently washed prior to adding osteoclasts."( Relative binding affinities of bisphosphonates for human bone and relationship to antiresorptive efficacy.
Freedman, LP; Leu, CT; Luegmayr, E; Reszka, AA; Rodan, GA, 2006
)
0.33
" Reducing oral bisphosphonate dosing frequency is one measure available to increase therapy convenience and practicality, with the hope of improving compliance and persistence."( Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis.
Altman, R; Amonkar, MM; Cramer, JA; Hebborn, A, 2005
)
0.33
" However, compliance and persistence rates for both regimens were suboptimal, suggesting that less frequent dosing intervals may provide an opportunity to further improve the consistent use of bisphosphonate therapy."( Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis.
Altman, R; Amonkar, MM; Cramer, JA; Hebborn, A, 2005
)
0.33
"Sixty patients were randomly assigned to receive either oral alendronate at a dosage of 10 mg/day for six months or no alendronate."( Three-year changes in bone mineral density around the knee after a six-month course of oral alendronate following total knee arthroplasty. A prospective, randomized study.
Huang, CC; Ko, JY; Wang, CJ; Wang, JW; Weng, LH, 2006
)
0.8
"The groups were comparable at baseline in age, gender, daily dosage of prednisone, BMD at the spine and the hip and markers of bone turnover, while the number of patients with prevalent vertebral deformities was slightly higher in the alendronate-treated patients (54% versus 39%, not significant)."( Positive effect of alendronate on bone mineral density and markers of bone turnover in patients with rheumatoid arthritis on chronic treatment with low-dose prednisone: a randomized, double-blind, placebo-controlled trial.
Bijlsma, JW; Dijkmans, BA; Geusens, P; Lems, WF; Lips, P; Lodder, MC; Schrameijer, N; van de Ven, CM, 2006
)
0.85
" Nevertheless, the need to follow inconvenient dosing instructions every week could still hinder long-term compliance and therapeutic outcome."( Oral ibandronate in the management of postmenopausal osteoporosis: review of upper gastrointestinal safety.
Delmas, PD; Emkey, R; Epstein, S; Hiltbrunner, V; Schimmer, RC; Wilson, KM, 2006
)
0.33
" Urine samples were collected up to +36 h post dosing and the concentrations of alendronic acid were assessed using a high-performance liquid chromatographic method with pre-derivatization and fluorescence detection (HPLC/FL) method."( In vitro disintegration and dissolution and in vivo bioequivalence of two alendronate once-weekly formulations.
Almeida, A; Almeida, S; Filipe, A; Lainesse, A; Penedo, C; Rocha, A; Vallée, F, 2006
)
0.56
" ALN NP exhibited a significant cytotoxic effect, in a dose-response relationship, on macrophage-like RAW264 cells in cell culture."( Alendronate-loaded nanoparticles deplete monocytes and attenuate restenosis.
Cohen-Sela, E; Danenberg, HD; Epstein, H; Gao, J; Gati, I; Golomb, G; Reich, R; Rosenzweig, O, 2006
)
1.78
" One week before implant placement, 10 rabbits were given doses of alendronate and continued on weekly dosing for 5 weeks until euthanized."( Effect of alendronate on endosseous implant integration: an in vivo study in rabbits.
Beck, FM; Chacon, GE; Larsen, PE; McGlumphy, EA; Stine, EA, 2006
)
0.97
"In summary, orally dosed alendronate administration in rabbits had no significant effect on dental implant torque-removal values 6 weeks after endosseous placement in femur and tibia."( Effect of alendronate on endosseous implant integration: an in vivo study in rabbits.
Beck, FM; Chacon, GE; Larsen, PE; McGlumphy, EA; Stine, EA, 2006
)
1.04
" Drug dosage can be modulated through amine modification of the material surface, leading to a bisphosphonate adsorption in the ordered mesoporous matrices 3 times larger than that for unmodified materials."( Confinement and controlled release of bisphosphonates on ordered mesoporous silica-based materials.
Balas, F; Horcajada, P; Manzano, M; Vallet-Regí, M, 2006
)
0.33
"Chronic oral-dosed osteoporosis therapies are associated with poor adherence and persistence, regardless of age or dosing regimen."( Adherence and persistence associated with the pharmacologic treatment of osteoporosis in a managed care setting.
Boccuzzi, SJ; Downey, TW; Foltz, SH; Kahler, KH; Omar, MA, 2006
)
0.33
"To compare medication persistence among patients receiving daily orally administered bisphosphonates with persistence among patients receiving weekly orally administered bisphosphonates to ascertain whether less frequent dosing is associated with better long-term treatment persistence."( Medication persistence with weekly versus daily doses of orally administered bisphosphonates.
Ettinger, MP; Gallagher, R; MacCosbe, PE,
)
0.13
"The inconvenience and complexity of required dosing procedures with oral bisphosphonate therapy for the prevention and treatment of osteoporosis are thought to be major factors that hinder medication persistence, and poor persistence is associated with suboptimal health-care outcomes."( Medication persistence with weekly versus daily doses of orally administered bisphosphonates.
Ettinger, MP; Gallagher, R; MacCosbe, PE,
)
0.13
"This study demonstrates that weekly dosing of orally administered bisphosphonates is associated with higher medication persistence than is daily dosing."( Medication persistence with weekly versus daily doses of orally administered bisphosphonates.
Ettinger, MP; Gallagher, R; MacCosbe, PE,
)
0.13
" The aim of this observational study was to observe, in clinical practice, the incidence of hip and nonvertebral fractures among women in the year following initiation of once-a-week dosing of either risedronate or alendronate."( Effectiveness of bisphosphonates on nonvertebral and hip fractures in the first year of therapy: the risedronate and alendronate (REAL) cohort study.
Delmas, PD; Lange, JL; Lindsay, R; Silverman, SL; Watts, NB, 2007
)
0.73
" The variety of bisphosphonates currently available to us provides a wide range of tolerability and dosing profiles thus necessitating a thorough comparison of the most recent oral and intravenous bisphosphonates to differentiate the clinical context in which they should be used."( Tolerability of different dosing regimens of bisphosphonates for the treatment of osteoporosis and malignant bone disease.
Adachi, JD; Beattie, K; Bobba, RS; Kumbhare, D; Parkinson, B, 2006
)
0.33
" Twelve patients who presented with exposed bone associated with bisphosphonates were reviewed to determine the type, dosage and duration of their bisphosphonate therapy, presenting findings, comorbidities and the event that incited the bone exposure."( Bisphosphonate-associated osteonecrosis of the jaw in patients with multiple myeloma and breast cancer.
Alati, C; Allegra, A; Alonci, A; Cicciù, M; De Ponte, FS; Musolino, C; Nastro, E; Oteri, G; Quartarone, E, 2007
)
0.34
" We hypothesized that a self-suspendable nanoparticulate dosage form, with a minimum amount of expients, could be formulated by complexing the negatively charged alendronate with gallium or gadolinium."( Nanosuspensions of alendronate with gallium or gadolinium attenuate neointimal hyperplasia in rats.
Berger, V; Eisenberg, G; Epstein, H; Gao, J; Golomb, G; Koroukhov, N; Levi, I, 2007
)
0.86
" Inconvenient dosing was reported as a primary reason for discontinuation due to stopping or changing treatment in 19 (6."( Comparison of raloxifene and bisphosphonates based on adherence and treatment satisfaction in postmenopausal Asian women.
Chen, SH; Chen, YJ; Hall, BJ; Khan, MA; Kung, AW; Mirasol, R; Pasion, EG; Shah, GA; Sivananthan, SK; Tam, F; Tay, BK; Thiebaud, D, 2007
)
0.34
" Alendronate treatment, at a dosage previously shown to improve bone strength in ovariectomized rats, neither blunted nor enhanced these training adaptations and had no independent effect on muscle contractility."( Relative effects of exercise training and alendronate treatment on skeletal muscle function of ovariectomized rats.
Fuchs, R; Maddalozzo, GF; Marley, K; Snow, C; Widrick, JJ,
)
1.31
"To examine in a major cohort of patients whether or not musculoskeletal adverse effects (MAEs), similar to those seen in intravenous bisphosphonates (BP), might occur also in high dosage oral treatment regimens with alendronate (ALN) and risedronate (RSN)."( Common musculoskeletal adverse effects of oral treatment with once weekly alendronate and risedronate in patients with osteoporosis and ways for their prevention.
Bock, O; Boerst, H; Degner, C; Felsenberg, D; Stephan-Oelkers, M; Thomasius, FE; Valentine, SM,
)
0.55
" They are observed exclusively in patients starting ALN or RSN treatment with once weekly dosage regimens."( Common musculoskeletal adverse effects of oral treatment with once weekly alendronate and risedronate in patients with osteoporosis and ways for their prevention.
Bock, O; Boerst, H; Degner, C; Felsenberg, D; Stephan-Oelkers, M; Thomasius, FE; Valentine, SM,
)
0.36
" 10 years), dosing frequency (monthly vs."( Osteoporosis medication profile preference: results from the PREFER-US study.
McHorney, CA; Weiss, TW, 2007
)
0.34
" Effectiveness was ranked as the most important determinant of preference (79% ranked it #1) compared with time on market (14%), dosing procedure (4%) and dosing frequency (3%)."( Osteoporosis medication profile preference: results from the PREFER-US study.
McHorney, CA; Weiss, TW, 2007
)
0.34
" Drug effectiveness was the most important determinant of preference, while dosing frequency was the least important determinant."( Osteoporosis medication profile preference: results from the PREFER-US study.
McHorney, CA; Weiss, TW, 2007
)
0.34
"Particulated dosage forms of bisphosphonates, such as polymeric nanoparticles and liposomes, deplete circulating monocytes and attenuate inflammation."( Additive-free albumin nanoparticles of alendronate for attenuating inflammation through monocyte inhibition.
Golomb, G; Koroukhov, N; Markovsky, E, 2007
)
0.61
" Alendronate is a well-tolerated and comparatively safe drug with an attractive once-a-week dosing regimen."( Alendronate for the treatment of osteoporosis in men.
Davison, KS; Olszynski, WP, 2008
)
2.7
" In order to improve the efficacy of antiresorptive drugs, fewer demands on patients and better adherence were obtained with less frequent dosing schedule."( [Alendronate and vitamin D (Fosavance): persistence, adherence and importance of vitamin D].
Grazio, S; Morović-Vergles, J, 2007
)
1.25
" The effect of patient age, prescriber, initial dosing regimen, gastrointestinal adverse events, co-medication and fractures on non-compliance was investigated."( Determinants of non-compliance with bisphosphonates in women with postmenopausal osteoporosis.
Erkens, JA; Herings, RM; Olson, M; Penning-van Beest, FJ, 2008
)
0.35
" Daily dosing at start, increased number of co-medications and new use of intestinal agents in the year after starting bisphosphonates were independently associated with an increased odds of non-compliance."( Determinants of non-compliance with bisphosphonates in women with postmenopausal osteoporosis.
Erkens, JA; Herings, RM; Olson, M; Penning-van Beest, FJ, 2008
)
0.35
"This study revealed several determinants of non-compliance with bisphosphonates, the best controllable being the type of initial bisphosphonate, with daily dosing leading to more non-compliance than weekly dosing."( Determinants of non-compliance with bisphosphonates in women with postmenopausal osteoporosis.
Erkens, JA; Herings, RM; Olson, M; Penning-van Beest, FJ, 2008
)
0.35
"Although daily doses of oral bisphosphonates are a generally safe and effective treatment for Paget's disease of bone (PDB), some patients may experience upper gastrointestinal adverse events (UGI AEs) or find the dosing requirements inconvenient and become noncompliant."( Randomized, active-controlled study of once-weekly alendronate 280 mg high dose oral buffered solution for treatment of Paget's disease.
Faustino, A; Gilchrist, NL; Hooper, M; Hosking, D; Leung, A; Reid, IR; Salzmann, G; Selby, P; West, J; Wu, M, 2009
)
0.6
" Although the products are labeled to be taken in the erect position, the semisupine position was included to simulate dosing in bedridden patients."( Esophageal transit and in vivo disintegration of branded risedronate sodium tablets and two generic formulations of alendronic acid tablets: a single-center, single-blind, six-period crossover study in healthy female subjects.
Atherton, CT; Blackshaw, PE; Dansereau, RJ; Hay, PD; Lawes, SC; Perkins, AC; Schnell, DJ; Spiller, RC; Wagner, LK, 2008
)
0.35
" Strategies to improve adherence to osteoporosis therapy include reducing dosing frequency, changing the route of administration, educating the patient about optimum bisphosphonate administration, and sending patient reminders."( Maximizing effectiveness of bisphosphonate therapy for osteoporosis.
Martens, MG; Shaw, H, 2008
)
0.35
" Six BPs are currently approved by the US Food and Drug Administration (FDA) for the treatment of Paget disease, and each has unique characteristics, such as response rates and requirements for dosage and administration, relevant to clinical outcome."( Paget disease of bone: therapeutic options.
Silverman, SL, 2008
)
0.35
" The clear dose-response effect may be viewed as a confirmation of the validity of the concept and encourages further study."( Peritoneal macrophage depletion by liposomal bisphosphonate attenuates endometriosis in the rat model.
Danenberg, HD; Golomb, G; Haber, E; Koroukhov, N; Ron-El, R; Schachter, M, 2009
)
0.35
" A once-weekly regimen of alendronate administration provides better patient compliance and persistence with the treatment than the once-daily dosing regimen, leading to greater efficacy against hip fractures."( Hip fracture protection by alendronate treatment in postmenopausal women with osteoporosis: a review of the literature.
Iwamoto, J; Matsumoto, H; Sato, Y; Takeda, T, 2008
)
0.94
" We also sought evidence of a dose-response relationship, where high adherence to or long-term use of aln led to more atypical femur fractures."( Subtrochanteric and diaphyseal femur fractures in patients treated with alendronate: a register-based national cohort study.
Abrahamsen, B; Eastell, R; Eiken, P, 2009
)
0.59
"Despite widely accepted efficacy of bisphophonates for osteoporotic fracture, patients treatment compliance has been low, especially, with daily regimen, in part because of the inconvenience associated with special dosing requirements of oral bisphophonates."( [New development in bisphosphonate treatment. Characteristics and effectiveness of intermittent bisphophonates].
Okazaki, R, 2009
)
0.35
" Also reviewed are results of "bridging" studies designed to demonstrate the comparable efficacy of less frequent dosing regimens to increase bone mineral density and to reduce bone turnover."( Efficacy of bisphosphonates in reducing fracture risk in postmenopausal osteoporosis.
Bilezikian, JP, 2009
)
0.35
" However, the use of daily regimen of alendronate in women at risk for osteoporosis has been relatively low in China because of its dosing inconvenience."( The efficacy and tolerability of once-weekly alendronate 70 mg on bone mineral density and bone turnover markers in postmenopausal Chinese women with osteoporosis.
Li, F; Li, M; Liu, J; Luo, B; Wang, W; Xie, H; Yan, Y; Zhang, G; Zhu, H, 2009
)
0.88
" We evaluated the effect of daily oral dosing of an inhibitor of human cathepsin K (SB-462795 [relacatib]) for 9 months on bone turnover, mass, and architecture in estrogen-deficient cynomolgus monkeys."( Treatment with a potent cathepsin K inhibitor preserves cortical and trabecular bone mass in ovariectomized monkeys.
Jerome, CP; Kumar, S; Stroup, GB, 2009
)
0.35
" After 4 days, the rabbits of group A2 received the subcutaneous injection of ALN at a dosage of 10 microg/(kg x d) for 8 weeks."( [In vitro effect of alendronate on chondrocytes and articular cartilage and subchondral bone in rabbit anterior cruciate ligament transection model].
Cheng, T; Hu, H; Li, B; Liu, X; Tian, F; Wang, Z; Zhang, L; Zhang, Y, 2009
)
0.68
" This new method can be utilized for routine analysis of FOS, CLO and ALN in dosage forms because of its efficiency, reliability, speed and simplicity."( Rapid analysis of alkylphosphonate drugs by capillary zone electrophoresis using indirect ultraviolet detection.
Prutthiwanasan, B; Suntornsuk, L, 2010
)
0.36
" No dose-response relationship was present."( Stroke in relation to use of raloxifene and other drugs against osteoporosis.
Mosekilde, L; Pinholt, EM; Rejnmark, L; Schwartz, K; Vestergaard, P, 2011
)
0.37
" The increase seen for alendronate did not seem to be causal as no classical dose-response relationship was present."( Stroke in relation to use of raloxifene and other drugs against osteoporosis.
Mosekilde, L; Pinholt, EM; Rejnmark, L; Schwartz, K; Vestergaard, P, 2011
)
0.68
"We evaluated the efficacy of oral alendronate with different dosing regimens for non-nociceptive symptoms and osteoporosis in a sciatic nerve chronic constriction injury (CCI) model."( Effective dosage and administration schedule of oral alendronate for non-nociceptive symptoms in rats with chronic constriction injury.
Hong, BY; Im, S; Ko, YJ; Lee, JI; Lim, SH; Park, GY; Park, JH, 2010
)
0.89
" Although less frequent dosing is preferred, other factors such as perceived efficacy, side effects, medication cost, availability of patient support programmes and route of delivery are equally important."( Efficacy, side effects and route of administration are more important than frequency of dosing of anti-osteoporosis treatments in determining patient adherence: a critical review of published articles from 1970 to 2009.
Glendenning, P; Inderjeeth, CA; Lee, S, 2011
)
0.37
" A potent CatKI, L-006235 (L-235), dosed at 10 mg/kg per day for 27 weeks, significantly decreased LV BMD loss (p < ."( Cathepsin K inhibitors prevent bone loss in estrogen-deficient rabbits.
Black, WC; Cusick, TE; Duong, LT; Gauthier, JY; Gentile, MA; Kimmel, DB; Masarachia, PJ; Pennypacker, BL; Samadfam, R; Scott, BB; Smith, SY, 2011
)
0.37
" We found that, LA treatment resulted in a dose-response modified biodistribution following both IV and IP administrations."( Route of administration-dependent anti-inflammatory effect of liposomal alendronate.
Afergan, E; Ben-David, M; Epstein, H; Golomb, G; Gutman, D; Haber, E; Koroukhov, N; Schachter, M, 2010
)
0.59
" This is an observational study, so a formal proof of causality cannot be made, but the dose-response relationship and the lack of impact of prior PPI use provides reasonable grounds for discouraging the use of PPIs to control upper gastrointestinal tract complaints in patients treated with oral bisphosphonates."( Proton pump inhibitor use and the antifracture efficacy of alendronate.
Abrahamsen, B; Eastell, R; Eiken, P, 2011
)
0.61
" Among patients with osteoporosis in Taiwan who had experienced a fracture and had started alendronate therapy, compliance with the dosage regimen was suboptimal."( Alendronate adherence and its impact on hip-fracture risk in patients with established osteoporosis in Taiwan.
Lin, SJ; Lin, TC; Yang, CY; Yang, YH, 2011
)
2.03
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
" Effective treatment was withdrawal of the drug or revision of the dosing and administration instructions."( Oral ulcers, a little known adverse effect of alendronate: review of the literature.
Kharazmi, M; Sjöqvist, K; Warfvinge, G, 2012
)
0.64
" We also focused our analysis on the impact of different dosing regimens of alendronate."( Alendronate and raloxifene use related to cardiovascular diseases: differentiation by different dosing regimens of alendronate.
Hsieh, CF; Huang, WF; Lu, PY; Tsai, YW, 2011
)
2.04
" However, an inverse dose-response relationship was seen, with an increased risk in those with low adherence (≤0."( Acute myocardial infarction and atherosclerosis of the coronary arteries in patients treated with drugs against osteoporosis: calcium in the vessels and not the bones?
Vestergaard, P, 2012
)
0.38
" sinensis dosage (300 and 500 mg/kg/day) or alendronate had a positive effect on body weights, mechanical strength, BMD, and BMC compared to the other HLS groups."( Prevention of disuse osteoporosis in rats by Cordyceps sinensis extract.
Cao, PC; Lei, W; Liu, D; Liu, N; Qi, W; Shi, L; Wu, ZX; Yan, YB; Zhang, Y, 2012
)
0.64
" As a preliminary study, the influences of applied AS dosage to CDHA coatings were evaluated using XRD and SEM."( Biomimetic coating of bisphosphonate incorporated CDHA on Ti6Al4V.
Bhaduri, SB; Lawrence, JG; Touny, AH; Zhou, H, 2012
)
0.38
"A dose-response relationship for local application of alendronate has been shown in this study."( Impregnation of bone chips with alendronate and cefazolin, combined with demineralized bone matrix: a bone chamber study in goats.
Bloem, RM; Buma, P; Hannink, G; Mathijssen, NM; Pilot, P; Schreurs, BW, 2012
)
0.91
" Intravenous ibandronate suppressed serum CTX levels to a significantly greater degree at 7 days after the second dosing (0."( Efficacy of intravenously administered ibandronate in postmenopausal Korean women with insufficient response to orally administered bisphosphonates.
Bae, SJ; Kim, BJ; Kim, GS; Kim, HK; Koh, JM; Lee, SH; Lim, KH, 2012
)
0.38
"A meta-analysis of spine BMD dose-response relationships for alendronate, risedronate, and ibandronate was performed."( A meta-analysis characterizing the dose-response relationships for three oral nitrogen-containing bisphosphonates in postmenopausal women.
Yates, J, 2013
)
0.63
"Animal data suggesting differences in potency and differences in approved oral dosage strengths for alendronate, risedronate, and ibandronate in the treatment of osteoporosis raise questions about their dose-response relationships and relative potencies in humans."( A meta-analysis characterizing the dose-response relationships for three oral nitrogen-containing bisphosphonates in postmenopausal women.
Yates, J, 2013
)
0.61
"A meta-analysis of dose-response relationships for spine BMD increases for these three bisphosphonates was performed using data from 21 placebo-controlled trials that collectively included over 13,000 patients on active treatment and over 8,000 on placebo."( A meta-analysis characterizing the dose-response relationships for three oral nitrogen-containing bisphosphonates in postmenopausal women.
Yates, J, 2013
)
0.39
" However, PTX is water-insoluble and toxic, even if administered at anti-angiogenic dosing schedule."( Poly(ethylene glycol)-paclitaxel-alendronate self-assembled micelles for the targeted treatment of breast cancer bone metastases.
Barshack, I; Benayoun, L; Clementi, C; Eldar-Boock, A; Miller, K; Pasut, G; Polyak, D; Satchi-Fainaro, R; Shaked, Y, 2013
)
0.67
"We observed three cohorts of women aged 65 years and older who initiated once-a-week dosing of bisphosphonate therapy; (1) patients adherent to alendronate (n = 21,615), (2) patients adherent to risedronate (n = 12,215), or (3) patients filling only a single bisphosphonate prescription (n = 5,390) as a referent population."( Effectiveness of risedronate and alendronate on nonvertebral fractures: an observational study through 2 years of therapy.
Delmas, PD; Lange, JL; Lindsay, R; Silverman, SL; Watts, NB, 2013
)
0.87
" This new formulation provides an alternative so that patients may select a method of dosing tailored to their preferences."( Alendronate sodium hydrate (oral jelly) for the treatment of osteoporosis: review of a novel, easy to swallow formulation.
Imai, K, 2013
)
1.83
" Treatment effects were evaluated using several determinants of bone strength, density and quality, including volumetric bone mineral density (vBMD), three-dimensional structure, finite element analysis (FEA) estimated peak force and biomechanical properties at the ultradistal (UD) radius at baseline, 3, 6, 9, 12, and 18 months of dosing in three treatment groups: vehicle (VEH), low ODN (2 mg/kg/day, L-ODN), and ALN (30 μg/kg/week)."( High-resolution peripheral quantitative computed tomography and finite element analysis of bone strength at the distal radius in ovariectomized adult rhesus monkey demonstrate efficacy of odanacatib and differentiation from alendronate.
Cabal, A; Cook, L; Dardzinski, BJ; Duong, LT; Evelhoch, JL; Hangartner, TN; Hargreaves, R; Jayakar, RY; Mathers, PD; McCracken, PJ; Motzel, S; Phillips, EA; Posavec, DJ; Sardesai, S; Savitz, AT; Scott, BB; Szumiloski, J; Williams, DS; Winkelmann, CT, 2013
)
0.57
" Four groups of 5 rats each were included in the study; the first 2 groups were dosed with alendronate or a vehicle during concurrent orthodontic tooth movement."( Impact of bisphosphonate drug burden in alveolar bone during orthodontic tooth movement in a rat model: a pilot study.
Adeeb, S; Doschak, MR; Kaipatur, NR; Major, PW; Stevenson, TR; Wu, Y, 2013
)
0.61
" Concurrent dosing of the bisphosphonate drug resulted in 56% and 65% reductions in tooth protraction at the 4-week and 8-week times, respectively."( Impact of bisphosphonate drug burden in alveolar bone during orthodontic tooth movement in a rat model: a pilot study.
Adeeb, S; Doschak, MR; Kaipatur, NR; Major, PW; Stevenson, TR; Wu, Y, 2013
)
0.39
" They differed markedly in study type, pharmacological agent used, dosing regimen, disease, aetiology/stage/location, concurrent off-loading regimen, outcomes and, follow-up."( A Surgeon's guide to advances in the pharmacological management of acute Charcot neuroarthropathy.
Afsie, S; Al-Nammari, SS; Timothy, T, 2013
)
0.39
"In this study, alendronate, the most commonly used biphosphonate for treating osteoporosis, was formulated as gastroretentive dosage form (GRDF) tablets to enhance its oral bioavailability."( Development and characterization of a gastroretentive dosage form composed of chitosan and hydroxyethyl cellulose for alendronate.
Chen, YC; Chiu, CC; Ho, HO; Sheu, MT, 2014
)
0.96
" Repeated SRT dosing did not significantly affect PK, although C 24h increased slightly."( Bone turnover markers and pharmacokinetics of a new sustained-release formulation of the cathepsin K inhibitor, ONO-5334, in healthy post-menopausal women.
Deacon, S; Hashimoto, Y; Kuwayama, T; Manako, J; Nagase, S; Ohyama, M; Sharpe, J; Small, M, 2015
)
0.42
" Intriguingly, ATP had a biphasic effect on breast cancer cells-lower dosage inhibited but higher dosage promoted its migration."( Differential impact of adenosine nucleotides released by osteocytes on breast cancer growth and bone metastasis.
Ellies, LG; Gao, X; Jiang, JX; Riquelme, MA; Sun, LZ; Zhou, JZ, 2015
)
0.42
"To review the product information (PI) for various brands of the same generic drugs and investigate the extent to which information is currently available on dosing in renal impairment and the concordance between the dosing recommendations for the same generic drug."( Renal drug dosing recommendations: evaluation of product information for brands of the same drug.
Castelino, RL; Jose, MD; Khanal, A; Peterson, GM, 2014
)
0.4
" For each generic drug all available brands listed as having solid oral dosage form were recorded."( Renal drug dosing recommendations: evaluation of product information for brands of the same drug.
Castelino, RL; Jose, MD; Khanal, A; Peterson, GM, 2014
)
0.4
" The majority of PI documents (88 of 155 PI; 57%) provided quantitative dosage recommendations, but this was often not detailed enough to help users to make an informed decision."( Renal drug dosing recommendations: evaluation of product information for brands of the same drug.
Castelino, RL; Jose, MD; Khanal, A; Peterson, GM, 2014
)
0.4
"The reporting of renal function quantification methods, and associated dosage recommendations, in PI requires standardisation to ensure optimal drug dosing."( Renal drug dosing recommendations: evaluation of product information for brands of the same drug.
Castelino, RL; Jose, MD; Khanal, A; Peterson, GM, 2014
)
0.4
" Alendronate dosing was stratified: 40 mg daily for subjects >50 kg, 20 mg for 30-50 kg, 10 mg for 20-30 kg."( A randomized, double blind, placebo-controlled trial of alendronate treatment for fibrous dysplasia of bone.
Bianco, P; Boyce, AM; Brillante, BA; Collins, MT; Kelly, MH; Kushner, H; Riminucci, M; Robey, PG; Wientroub, S, 2014
)
1.56
" These results have suggested that a low dosage of prednisolone can be used with little concern for development of osteopenia in dogs."( Quantitative computed tomographic assessment of bone mineral density changes associated with administration of prednisolone or prednisolone and alendronate sodium in dogs.
Cho, KO; Choi, J; Oh, J; Park, S; Son, KY, 2015
)
0.62
" Alendronate dosage was adjusted according to iCa."( Treatment of ionized hypercalcemia in 12 cats (2006-2008) using PO-administered alendronate.
Braudaway, SR; Chew, DJ; de Brito Galvao, JF; DiBartola, SP; Green, TA; Hardy, BT; Lord, L, 2015
)
1.55
"Minodronate is a potent nitrogen-containing bisphosphonate that can be administered according to a monthly (every 4 weeks) dosing regimen."( Patient preference for monthly bisphosphonate versus weekly bisphosphonate in a cluster-randomized, open-label, crossover trial: Minodroate Alendronate/Risedronate Trial in Osteoporosis (MARTO).
Furuya, T; Hasegawa, M; Hirabayashi, H; Iwamoto, J; Kumakubo, T; Makita, K; Okano, H; Urano, T, 2016
)
0.64
" Also, we estimated the optimal dosage of zoledronate in root treatment of the rat model for a maximum effect of zoledronate."( Could zoledronic acid prevent root resorption in replanted rat molar?
Choi, SC; Kim, EC; Kim, KC; Kim, MS; Kwon, YD; Yoo, JE, 2015
)
0.42
" In particular, 20 μM dosage of zoledronate solution showed the most effective dose in long-term follow up and might be suitable for inhibition of root resorption in delayed tooth replantation."( Could zoledronic acid prevent root resorption in replanted rat molar?
Choi, SC; Kim, EC; Kim, KC; Kim, MS; Kwon, YD; Yoo, JE, 2015
)
0.42
" These results led us to hypothesize a mode of action by which presence of a linker is crucial in facilitating the anabolic effects of EP4a when dosed as a prodrug with ALN."( In vivo effects of two novel ALN-EP4a conjugate drugs on bone in the ovariectomized rat model for reversing postmenopausal bone loss.
Chen, G; Grynpas, MD; Hu, S; Liu, CC; Willett, T; Young, RN, 2016
)
0.43
"In order to determine whether osteoclastic bone resorption is restarted after withdrawn of bisphosphonates, we conducted histological examinations on murine osteoclasts, osteoblasts and osteocytes after discontinuation of a daily regimen of alendronate (ALN) with a dosage of 1 mg/kg/day for 10 days."( Effects of drug discontinuation after short-term daily alendronate administration on osteoblasts and osteocytes in mice.
Amizuka, N; de Freitas, PH; Hasegawa, T; Hongo, H; Kitagawa, Y; Li, M; Michigami, T; Oda, K; Sasaki, M; Shimizu, T; Takahata, M; Tsuboi, K; Yamamoto, T, 2016
)
0.86
"This study showed that ESWT could efficiently improve the local BMD; relatively, the high dosage was effective."( Short-term effects of extracorporeal shock wave therapy on bone mineral density in postmenopausal osteoporotic patients.
Cheng, L; Gao, F; Guo, W; Li, Z; Shi, L; Sun, W; Wang, B; Wang, W, 2017
)
0.46
"Drug half-life has important implications for dosing regimen and peak-to-trough ratio at the steady state."( Relevance of Half-Life in Drug Design.
Beaumont, K; Di, L; Maurer, TS; Smith, DA, 2018
)
0.48
" This study suggests that the lower incidence of BP-ONJ in alendronate treatment is not originated by its potency, but might be due to the low bioavailability of alendronate, lower dosing on a daily basis, and having no additional therapies."( Effects of an oral bisphosphonate and three intravenous bisphosphonates on several cell types in vitro.
Al-Nawas, B; Jung, J; Kwon, YD; Pabst, AM; Park, JS; Righesso, L; Walter, C, 2018
)
0.72
" These conjugate drugs can be dosed infrequently (weekly or bimonthly) whereas the free drugs must be dosed daily."( Targeting therapeutics to bone by conjugation with bisphosphonates.
Grynpas, MD; Young, RN, 2018
)
0.48
" Whenever the initial dose failed to produce remission, the dosage was increased to twice a week the respective dose."( Long-term control of Paget's disease of bone with low-dose, once-weekly, oral bisphosphonate preparations, in a "real world" setting.
Abu Tailakh, M; Liel, Y, 2019
)
0.51
"The use of gastro-resistant risedronate, a convenient dosing regimen for oral bisphosphonate therapy, seems a cost-effective strategy compared with weekly alendronate, generic risedronate, and no treatment for the treatment of postmenopausal women with osteoporosis in France."( Cost-effectiveness of gastro-resistant risedronate tablets for the treatment of postmenopausal women with osteoporosis in France.
Hiligsmann, M; Reginster, JY, 2019
)
0.71
"033 which is congruent with the label claim of the dosage form."( A simple innovative spectrofluorometric method for the determination of alendronate in bulk and in pharmaceutical tablets.
Elmalla, SF; Mansour, FR, 2019
)
0.75
" This, together with the need for less frequent administration of zoledronate, supports its wider use in clinical practice, particularly if longer dosing intervals than those currently recommended are shown to be effective."( Practical guidance for the use of bisphosphonates in osteoporosis.
Compston, J, 2020
)
0.56
"The efficacy and renal safety of low-dose/high-frequency (LDHF) dosing and high-dose/low-frequency (HDLF) dosing of bisphosphonates (BPs) are comparable in patients with normal kidney function but might be different in patients with late-stage chronic kidney disease (CKD)."( Comparison of the Efficacy and Renal Safety of Bisphosphonate Between Low-Dose/High-Frequency and High-Dose/Low-Frequency Regimens in a Late-Stage Chronic Kidney Disease Rat Model.
Fujita, R; Iwasaki, N; Kimura-Suda, H; Kobayashi, H; Nakamura, F; Nakazawa, D; Ota, M; Sato, D; Shimizu, T; Takahata, M, 2020
)
0.56
" Glucocorticoid (GC) dosage (P = ."( Meta-regression analysis of the efficacy of alendronate for prevention of glucocorticoid-induced fractures.
Ding, L; Huang, H; Li, K; Lin, J; Qiu, M; Zhang, M, 2020
)
0.82
"The use of buffered soluble alendronate 70 mg effervescent tablet, a convenient dosing regimen for bisphosphonate therapy, seems a cost-effective strategy compared with relevant alternative treatments for postmenopausal women with osteoporosis aged 60 years and over in Italy."( Cost-effectiveness of buffered soluble alendronate 70 mg effervescent tablet for the treatment of postmenopausal women with osteoporosis in Italy.
Hiligsmann, M; Maggi, S; Reginster, JY; Sartori, L; Veronese, N, 2021
)
1.18
" Administration of risedronate gastric-resistant does not require fasting, and this more convenient dosing administration may explain its improved efficacy."( Fracture rates and economic outcomes in patients with osteoporosis prescribed risedronate gastro-resistant versus other oral bisphosphonates: a claims data analysis.
Alam, A; Boolell, M; Gauthier, G; Palacios, S; Thomasius, F; Vekeman, F, 2022
)
0.72
"Up to half of patients do not follow complex dosing instructions of immediate-release bisphosphonates used for the prevention of osteoporotic fractures, which can result in suboptimal effectiveness."( Fracture rates and economic outcomes in patients with osteoporosis prescribed risedronate gastro-resistant versus other oral bisphosphonates: a claims data analysis.
Alam, A; Boolell, M; Gauthier, G; Palacios, S; Thomasius, F; Vekeman, F, 2022
)
0.72
"This study aimed to compare alveolar healing after tooth extraction in two experimental rat models using continuous or discontinuous dosing of sodium alendronate (ALN)."( Effect of continuous and intermittent sodium alendronate oral dosing on post-extraction alveoli healing in rats.
Alves, APNN; do Nascimento, IV; Isaias, PHC; Moreira, MDS; Mota, MRL; Pereira, KMA; Silva, PGB; Sousa, FB; Verde, MEQL, 2021
)
1.08
" ORs were calculated by conditional logistic regression analysis with adjustment for several confounders and test for trend for dose-response relationship."( Alendronate Use and Risk of Type 2 Diabetes: A Nationwide Danish Nested Case-Control Study.
Al-Mashhadi, Z; Starup-Linde, J; Vestergaard, P; Viggers, R, 2021
)
2.06
" A test for trend suggested a dose-response relationship between longer effective use of alendronate and lower risk of type 2 diabetes."( Alendronate Use and Risk of Type 2 Diabetes: A Nationwide Danish Nested Case-Control Study.
Al-Mashhadi, Z; Starup-Linde, J; Vestergaard, P; Viggers, R, 2021
)
2.29
"Postmenopausal women compliance to alendronate therapy is suboptimal due to the complex dosing requirements."( Knowledge and compliance towards alendronate therapy among postmenopausal women with osteoporosis in Palestine.
Elaraj, J; Fatayer, D; Hamad, A; Jarar, B; Johar, A; Radwan, A; Shraim, N; Zriqah, A, 2022
)
1.28
" The median compliance score to alendronate dosing instructions was 5 out of a possible maximum 7, and the median knowledge score about alendronate interactions was 7 out of a possible maximum 14."( Knowledge and compliance towards alendronate therapy among postmenopausal women with osteoporosis in Palestine.
Elaraj, J; Fatayer, D; Hamad, A; Jarar, B; Johar, A; Radwan, A; Shraim, N; Zriqah, A, 2022
)
1.29
" Therefore, appropriate knowledge about the importance of proper compliance to dosing instructions and avoidance of interactions is of a great benefit for maximizing clinical effectiveness, lowering fracture risk and prevention of adverse effects of alendronate among patients treated with alendronate in Palestine."( Knowledge and compliance towards alendronate therapy among postmenopausal women with osteoporosis in Palestine.
Elaraj, J; Fatayer, D; Hamad, A; Jarar, B; Johar, A; Radwan, A; Shraim, N; Zriqah, A, 2022
)
1.18
" 100 µM alendronate reduced proliferation dramatically, and this dosage was excluded from further experiments."( Targeting a therapeutically relevant concentration of alendronate for in vitro studies on osteoblasts.
Herlofson, BB; Krüger, TB; Lian, AM; Reseland, JE; Syversen, U, 2022
)
1.4
" Their use is supported by over 3 decades of evidence; however, patient adherence to oral bisphosphonates remains poor in part due to complex dosing instructions and adverse events, including upper gastrointestinal symptoms."( Novel formulations of oral bisphosphonates in the treatment of osteoporosis.
Al-Daghri, N; Bock, O; Branco, J; Bruyère, O; Casado, E; Cavalier, E; Cooper, C; Cortet, B; de Wit, M; Fuggle, N; Giusti, A; Halbout, P; Harvey, NC; Hiligsmann, M; Kanis, JA; Kaufman, JM; Kurth, A; Maggi, S; Matijevic, R; Minisola, S; Palacios, S; Radermecker, RP; Reginster, JY; Rizzoli, R; Thomasius, F; Tuzun, S; Veronese, N, 2022
)
0.72
"The OMPR in the first year improved if the patients used AOMs with longer dosing intervals."( The real-world adherence of the first-line anti-osteoporosis medications in Taiwan: Visualize the gap between reality and expectations.
Chen, HM; Fu, SH; Hsu, CC; Hwang, JS; Lee, CC; Lin, JW; Lin, SC; Wang, CY; Wu, CH; Yang, RS, 2023
)
0.91
" To develop a combinatorial dosage regimen of alendronate and estradiol and enhance skin permeation through iontophoresis for the treatment of osteoporosis."( Novel iontophoretic drug delivery of estradiol with alendronate for osteoporosis treatment.
Chang, J; Li, S, 2023
)
1.42
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
EC 2.5.1.1 (dimethylallyltranstransferase) inhibitorAn EC 2.5.1.* (non-methyl-alkyl or aryl transferase) inhibitor that interferes with the action of dimethylallyltranstransferase (EC 2.5.1.1).
bone density conservation agentAn agent that inhibits bone resorption and/or favor bone mineralization and bone regeneration. Used to heal bone fractures and to treat bone diseases such as osteopenia and osteoporosis.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (2)

ClassDescription
1,1-bis(phosphonic acid)Any member of the class of phosphonic acids in which a carbon atom is directly attached to two phosphonic acid groups. They are analogues of pyrophosphates (with the central oxygen atom replaced by a carbon atom) and like pyrophosphates they tend to have a strong affinity for bone, so are frequently used for their antiresorptive and hypocalcaemic properties.
primary amino compoundA compound formally derived from ammonia by replacing one hydrogen atom by an organyl group.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
Alendronate Action Pathway2143

Protein Targets (7)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, farnesyl pyrophosphate synthaseTrypanosoma cruziIC50 (µMol)147.0000147.0000147.0000147.0000AID977608
Geranylgeranyl pyrophosphate synthaseHomo sapiens (human)IC50 (µMol)427.78670.00401.02764.5000AID1798541; AID391371; AID74507
Farnesyl pyrophosphate synthaseHomo sapiens (human)IC50 (µMol)0.75230.00020.71099.3600AID318593; AID318594; AID689987; AID72181; AID72667; AID72669
Farnesyl pyrophosphate synthaseHomo sapiens (human)Ki0.17610.00010.21651.9000AID318593; AID318594; AID72668
AcetylcholinesteraseHomo sapiens (human)IC50 (µMol)27,450.00000.00000.933210.0000AID1802945
Farnesyl pyrophosphate synthase Leishmania donovaniKi0.09500.01100.07820.1900AID238531
Farnesyl pyrophosphate synthase Leishmania majorKi0.09100.01000.03900.0910AID1697964
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (20)

Processvia Protein(s)Taxonomy
isoprenoid metabolic processGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
geranyl diphosphate biosynthetic processGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
geranylgeranyl diphosphate biosynthetic processGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
farnesyl diphosphate biosynthetic processGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
isoprenoid biosynthetic processGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
cholesterol biosynthetic processFarnesyl pyrophosphate synthaseHomo sapiens (human)
geranyl diphosphate biosynthetic processFarnesyl pyrophosphate synthaseHomo sapiens (human)
farnesyl diphosphate biosynthetic processFarnesyl pyrophosphate synthaseHomo sapiens (human)
acetylcholine catabolic process in synaptic cleftAcetylcholinesteraseHomo sapiens (human)
regulation of receptor recyclingAcetylcholinesteraseHomo sapiens (human)
osteoblast developmentAcetylcholinesteraseHomo sapiens (human)
acetylcholine catabolic processAcetylcholinesteraseHomo sapiens (human)
cell adhesionAcetylcholinesteraseHomo sapiens (human)
nervous system developmentAcetylcholinesteraseHomo sapiens (human)
synapse assemblyAcetylcholinesteraseHomo sapiens (human)
receptor internalizationAcetylcholinesteraseHomo sapiens (human)
negative regulation of synaptic transmission, cholinergicAcetylcholinesteraseHomo sapiens (human)
amyloid precursor protein metabolic processAcetylcholinesteraseHomo sapiens (human)
positive regulation of protein secretionAcetylcholinesteraseHomo sapiens (human)
retina development in camera-type eyeAcetylcholinesteraseHomo sapiens (human)
acetylcholine receptor signaling pathwayAcetylcholinesteraseHomo sapiens (human)
positive regulation of cold-induced thermogenesisAcetylcholinesteraseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (17)

Processvia Protein(s)Taxonomy
dimethylallyltranstransferase activityGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
farnesyltranstransferase activityGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
geranyltranstransferase activityGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
protein bindingGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
identical protein bindingGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
metal ion bindingGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
prenyltransferase activityGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
RNA bindingFarnesyl pyrophosphate synthaseHomo sapiens (human)
protein bindingFarnesyl pyrophosphate synthaseHomo sapiens (human)
metal ion bindingFarnesyl pyrophosphate synthaseHomo sapiens (human)
dimethylallyltranstransferase activityFarnesyl pyrophosphate synthaseHomo sapiens (human)
geranyltranstransferase activityFarnesyl pyrophosphate synthaseHomo sapiens (human)
amyloid-beta bindingAcetylcholinesteraseHomo sapiens (human)
acetylcholinesterase activityAcetylcholinesteraseHomo sapiens (human)
cholinesterase activityAcetylcholinesteraseHomo sapiens (human)
protein bindingAcetylcholinesteraseHomo sapiens (human)
collagen bindingAcetylcholinesteraseHomo sapiens (human)
hydrolase activityAcetylcholinesteraseHomo sapiens (human)
serine hydrolase activityAcetylcholinesteraseHomo sapiens (human)
acetylcholine bindingAcetylcholinesteraseHomo sapiens (human)
protein homodimerization activityAcetylcholinesteraseHomo sapiens (human)
laminin bindingAcetylcholinesteraseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (17)

Processvia Protein(s)Taxonomy
nucleoplasmGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
cytoplasmGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
cytosolGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
Z discGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
perinuclear region of cytoplasmGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
nucleoplasmFarnesyl pyrophosphate synthaseHomo sapiens (human)
cytosolFarnesyl pyrophosphate synthaseHomo sapiens (human)
cytoplasmFarnesyl pyrophosphate synthaseHomo sapiens (human)
extracellular regionAcetylcholinesteraseHomo sapiens (human)
basement membraneAcetylcholinesteraseHomo sapiens (human)
extracellular spaceAcetylcholinesteraseHomo sapiens (human)
nucleusAcetylcholinesteraseHomo sapiens (human)
Golgi apparatusAcetylcholinesteraseHomo sapiens (human)
plasma membraneAcetylcholinesteraseHomo sapiens (human)
cell surfaceAcetylcholinesteraseHomo sapiens (human)
membraneAcetylcholinesteraseHomo sapiens (human)
neuromuscular junctionAcetylcholinesteraseHomo sapiens (human)
synaptic cleftAcetylcholinesteraseHomo sapiens (human)
synapseAcetylcholinesteraseHomo sapiens (human)
perinuclear region of cytoplasmAcetylcholinesteraseHomo sapiens (human)
side of membraneAcetylcholinesteraseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (160)

Assay IDTitleYearJournalArticle
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1699996Cytotoxicity against human MCF7 cells assessed as cell growth inhibition measured after 24 to 48 hrs by SRB assay2020Bioorganic & medicinal chemistry letters, 12-01, Volume: 30, Issue:23
Synthesis and biological evaluation of indolylglyoxylamide bisphosphonates, antimitotic microtubule-targeting derivatives of indibulin with improved aqueous solubility.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID132682Inhibition of bone mineralization in the calvaria assay of mouse2002Journal of medicinal chemistry, Aug-15, Volume: 45, Issue:17
Highly potent geminal bisphosphonates. From pamidronate disodium (Aredia) to zoledronic acid (Zometa).
AID689988Inhibition of bone resorption in rat2011Journal of medicinal chemistry, Sep-08, Volume: 54, Issue:17
Remarkable potential of the α-aminophosphonate/phosphinate structural motif in medicinal chemistry.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1272979Binding affinity to hound bone powder assessed as reduction in bound compound level at 50 uM after 16 hrs by NMR spectroscopic analysis relative to control2016Bioorganic & medicinal chemistry, 02-15, Volume: 24, Issue:4
Structural features underlying raloxifene's biophysical interaction with bone matrix.
AID1697964Inhibition of recombinant Leishmania major FPPS expressed in Escherichia coli BL21(DE3) using GPP and [14C]IPP as substrate incubated for 15 mins by scintillation counting method2020Bioorganic & medicinal chemistry letters, 11-15, Volume: 30, Issue:22
A guanidinium-based inhibitor of a type I isopentenyl diphosphate isomerase.
AID340706Inhibition of farnesyl diphosphate synthase at 100 nM2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Determination of the microscopic equilibrium dissociation constants for risedronate and its analogues reveals two distinct roles for the nitrogen atom in nitrogen-containing bisphosphonate drugs.
AID28404Apical to basolateral fluxes across Caco-2 cell monolayers at 37 degree celsius was studied.2000Journal of medicinal chemistry, Oct-05, Volume: 43, Issue:20
A peptide prodrug approach for improving bisphosphonate oral absorption.
AID1744122Inhibition of human ACMSD assessed as picolinic acid level at 1 mM by HPLC analysis (Rvb = 83.6 +/- 3.1%)2021Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1
Diflunisal Derivatives as Modulators of ACMS Decarboxylase Targeting the Tryptophan-Kynurenine Pathway.
AID246048Effective concentration against human Gamma delta T cells2005Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8
Pyridinium-1-yl bisphosphonates are potent inhibitors of farnesyl diphosphate synthase and bone resorption.
AID96034Toxicity evaluated against human nasopharyngeal carcinoma KB cell line2004Journal of medicinal chemistry, Jan-01, Volume: 47, Issue:1
Effects of bisphosphonates on the growth of Entamoeba histolytica and Plasmodium species in vitro and in vivo.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID318593Inhibition of human recombinant FPPS expressed in Escherichia coli BL212008Journal of medicinal chemistry, Apr-10, Volume: 51, Issue:7
Structure-activity relationships among the nitrogen containing bisphosphonates in clinical use and other analogues: time-dependent inhibition of human farnesyl pyrophosphate synthase.
AID210617Inhibition of Toxoplasma gondii tachyzoites in human foreskin fibroblast monolayer(DMEM with 10%fetal calf serum)2001Journal of medicinal chemistry, Mar-15, Volume: 44, Issue:6
Bisphosphonates inhibit the growth of Trypanosoma brucei, Trypanosoma cruzi, Leishmania donovani, Toxoplasma gondii, and Plasmodium falciparum: a potential route to chemotherapy.
AID689987Inhibition of recombinant human FPPS expressed in Escherichia coli by scintillation counting2011Journal of medicinal chemistry, Sep-08, Volume: 54, Issue:17
Remarkable potential of the α-aminophosphonate/phosphinate structural motif in medicinal chemistry.
AID1421091Antiproliferative activity against mouse RAW264.7 cells assessed as reduction in cell viability at 100 uM after 72 hrs by WST8 assay2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID187201Periosteal mineralizing surface measured Histomorphometrically after a does of 3 ug/kg in Tibial Diaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID387286Induction of apoptosis in mouse osteoclast cells assessed as nucleosomal DNA fragmentation at 100 uM after 48 hrs by Hoechst 33258 staining2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis and biological evaluation of indolyl bisphosphonates as anti-bone resorptive and anti-leishmanial agents.
AID1367799Plasma clearance in human2018Journal of medicinal chemistry, 05-24, Volume: 61, Issue:10
Relevance of Half-Life in Drug Design.
AID231757Ratio of calvaria mineralization to calvaria bone resorption2002Journal of medicinal chemistry, Aug-15, Volume: 45, Issue:17
Highly potent geminal bisphosphonates. From pamidronate disodium (Aredia) to zoledronic acid (Zometa).
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID318594Inhibition of human recombinant FPPS expressed in Escherichia coli BL21 after 10 mins2008Journal of medicinal chemistry, Apr-10, Volume: 51, Issue:7
Structure-activity relationships among the nitrogen containing bisphosphonates in clinical use and other analogues: time-dependent inhibition of human farnesyl pyrophosphate synthase.
AID625278FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of no concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID72667Inhibitory activity against farnesyl Pyrophosphate Synthase was determined2003Journal of medicinal chemistry, Nov-20, Volume: 46, Issue:24
3-D QSAR investigations of the inhibition of Leishmania major farnesyl pyrophosphate synthase by bisphosphonates.
AID318595Inhibition of bone resorption in rat assessed as phosphate2008Journal of medicinal chemistry, Apr-10, Volume: 51, Issue:7
Structure-activity relationships among the nitrogen containing bisphosphonates in clinical use and other analogues: time-dependent inhibition of human farnesyl pyrophosphate synthase.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID151353Inhibition of Plasmodium falciparum 3D7 in erythrocytes2001Journal of medicinal chemistry, Mar-15, Volume: 44, Issue:6
Bisphosphonates inhibit the growth of Trypanosoma brucei, Trypanosoma cruzi, Leishmania donovani, Toxoplasma gondii, and Plasmodium falciparum: a potential route to chemotherapy.
AID28056Distribution in rat feces following intravenous administration of 1 mg/kg alendronate2000Journal of medicinal chemistry, Oct-05, Volume: 43, Issue:20
A peptide prodrug approach for improving bisphosphonate oral absorption.
AID169148Bone Formation rate/bone measured Histomorphometrically after a dose of 3 ug/kg in proximal tibial metaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1421093Antiproliferative activity against human PC3 cells assessed as reduction in cell viability at 100 uM after 72 hrs by WST8 assay2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID248139In vitro inhibitory concentration against bone resorption in 17 day old fetal mouse metatarsals2005Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8
Pyridinium-1-yl bisphosphonates are potent inhibitors of farnesyl diphosphate synthase and bone resorption.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID164862Inhibitory activity against Protein-tyrosine phosphatase activity; active2004Bioorganic & medicinal chemistry letters, Feb-23, Volume: 14, Issue:4
Mechanism of action of pyridazine analogues on protein tyrosine phosphatase 1B (PTP1B).
AID28406Basolateral to apical fluxes across Caco-2 cell monolayers at 37 degree celsius was studied.2000Journal of medicinal chemistry, Oct-05, Volume: 43, Issue:20
A peptide prodrug approach for improving bisphosphonate oral absorption.
AID1421106Induction of mineralization in C57BL mouse bone marrow cells at 50 nM supplemented with fresh medium containing compound every 3 days for 10 to 15 days by alizarin red dye based assay2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID1421112Induction of mineralization in mouse MC3T3-E1 cells at >500 nM after 10 to 15 days by alizarin red dye based assay2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID235770Therapeutic ratio comparing nephrotoxic potential versus bone antiresorptive potency ( reciprocal of ED50 (TPTX assay) / the total urinary malate dehydrogenase excretion)2002Journal of medicinal chemistry, Aug-15, Volume: 45, Issue:17
Highly potent geminal bisphosphonates. From pamidronate disodium (Aredia) to zoledronic acid (Zometa).
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID391371Inhibition of human recombinant geranylgeranyl diphosphate synthase2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Inhibition of geranylgeranyl diphosphate synthase by bisphosphonates: a crystallographic and computational investigation.
AID180049Endosteal mineralizing surface measured Histomorphometrically after a does of 3 ug/kg in Tibial Diaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID1894079Anti-osteoclast activity rat assessed as inhibition of bone resorption relative to control2021Journal of medicinal chemistry, 02-11, Volume: 64, Issue:3
Bisphosphonates, Old Friends of Bones and New Trends in Clinics.
AID72668Binding affinity towards farnesyl Pyrophosphate Synthase using [14C]- isopentenyl pyrophosphate as radioligand2003Journal of medicinal chemistry, Nov-20, Volume: 46, Issue:24
3-D QSAR investigations of the inhibition of Leishmania major farnesyl pyrophosphate synthase by bisphosphonates.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID214469Inhibition of Trypanosoma cruzi Amastigotes was determined in Vero cells culture and fetal calf serum2001Journal of medicinal chemistry, Mar-15, Volume: 44, Issue:6
Bisphosphonates inhibit the growth of Trypanosoma brucei, Trypanosoma cruzi, Leishmania donovani, Toxoplasma gondii, and Plasmodium falciparum: a potential route to chemotherapy.
AID29612Bioavailability by the ratios of 14C p.o. /14C i.v. accumulated in urine at 24 hr (dose 10 mg/kg p.o.)2000Journal of medicinal chemistry, Oct-05, Volume: 43, Issue:20
A peptide prodrug approach for improving bisphosphonate oral absorption.
AID1272974Binding affinity to synthetic ceramic hydroxyapatite type 1 assessed as reduction in bound compound level at 50 uM after 1 hr by NMR spectroscopic analysis relative to control2016Bioorganic & medicinal chemistry, 02-15, Volume: 24, Issue:4
Structural features underlying raloxifene's biophysical interaction with bone matrix.
AID1421113Induction of mineralization in C57BL mouse bone marrow cells at >50 nM supplemented with fresh medium containing compound every 3 days for 10 to 15 days by alizarin red dye based assay2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID249161Lethal dose required to inhibit the growth of human KB (nasopharyngeal carcinoma) cell line2005Journal of medicinal chemistry, May-05, Volume: 48, Issue:9
Bisphosphonate inhibitors of Toxoplasma gondi growth: in vitro, QSAR, and in vivo investigations.
AID175264Directly measured thickness measured using micro Computed Tomography(CT) after a dose of 3 ug/kg in Vertebral Bone2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID169292Bone Volume /Tissue Volume (%)measured using micro Computed Tomography(CT) after a dose of 3 ug/kg in Vertebral Bone2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID169157Bone Volume /Tissue Volume (%)measured Histomorphometrically after a dose of 3 ug/kg in proximal tibial metaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID28057Distribution in rat femur following intravenous administration of 1 mg/kg alendronate2000Journal of medicinal chemistry, Oct-05, Volume: 43, Issue:20
A peptide prodrug approach for improving bisphosphonate oral absorption.
AID1421092Antiproliferative activity against human MG63 cells assessed as reduction in cell viability at 100 uM after 72 hrs by WST8 assay2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID174910Derived trabecular no measured using micro Computed Tomography(CT) after a dose of 3 ug/kg in Vertebral Bone2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID1226174Binding affinity to hydroxyapatite at 3.2 to 3.7 mM after 1 hr by NMR analysis relative to control2015ACS medicinal chemistry letters, Apr-09, Volume: 6, Issue:4
Structural requirements for bisphosphonate binding on hydroxyapatite: NMR study of bisphosphonate partial esters.
AID191809Trabecular no measured Histomorphometrically after a dose of 3 ug/kg in proximal tibial metaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID132683Inhibition of bone resorption in the calvaria assay of mouse2002Journal of medicinal chemistry, Aug-15, Volume: 45, Issue:17
Highly potent geminal bisphosphonates. From pamidronate disodium (Aredia) to zoledronic acid (Zometa).
AID1636357Drug activation in human Hep3B cells assessed as human CYP3A4-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID1421108Cytotoxicity against C57BL mouse bone marrow cells assessed as effect on cell proliferation at 0.03 to 500 uM after 72 hrs by crystal violet staining based assay2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1636356Drug activation in human Hep3B cells assessed as human CYP2C9-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID55429Ability to inhibit growth of Dictostelium discoideum.2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
An investigation of bone resorption and Dictyostelium discoideum growth inhibition by bisphosphonate drugs.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID71581pIC50 value for stimulation of TNF-alpha release in gamma-delta T cells, using individual observed maximum TNF-alpha release2004Journal of medicinal chemistry, Jan-15, Volume: 47, Issue:2
Quantitative structure-activity relationships for gammadelta T cell activation by bisphosphonates.
AID387284Antibone resorptive activity in mouse bone marrow cells assessed as inhibition of osteoclastogenesis at 100 nM after 7 days by TRAP assay in presence of MCSF and RANKL2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis and biological evaluation of indolyl bisphosphonates as anti-bone resorptive and anti-leishmanial agents.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID190806Tissue area measured Histomorphometrically after a dose of 3 ug/kg in Tibial Diaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID28059Distribution in rat liver following intravenous administration of 1 mg/kg alendronate2000Journal of medicinal chemistry, Oct-05, Volume: 43, Issue:20
A peptide prodrug approach for improving bisphosphonate oral absorption.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID773413Inhibition of recombinant full length PTP1B (unknown origin) assessed as p-nitrophenyl phosphate conversion to p-nitrophenol at 50 uM after 10 mins by spectrophotometric analysis2013Bioorganic & medicinal chemistry letters, Oct-15, Volume: 23, Issue:20
Calix[4]arene methylenebisphosphonic acids as inhibitors of protein tyrosine phosphatase 1B.
AID247940Inhibitory concentration against Dictyostelium discoideum cell growth2005Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8
Pyridinium-1-yl bisphosphonates are potent inhibitors of farnesyl diphosphate synthase and bone resorption.
AID1458040Oral bioavailability in rat2017Journal of medicinal chemistry, 08-24, Volume: 60, Issue:16
Design, Synthesis, and Pharmacokinetics of a Bone-Targeting Dual-Action Prodrug for the Treatment of Osteoporosis.
AID28058Distribution in rat kidney following intravenous administration of 1 mg/kg alendronate2000Journal of medicinal chemistry, Oct-05, Volume: 43, Issue:20
A peptide prodrug approach for improving bisphosphonate oral absorption.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1636440Drug activation in human Hep3B cells assessed as human CYP2D6-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID1367803Volume of distribution in human2018Journal of medicinal chemistry, 05-24, Volume: 61, Issue:10
Relevance of Half-Life in Drug Design.
AID187084Mineral apposition measured Histomorphometrically after a dose of 3 ug/kg in proximal tibial metaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID238531Binding affinity towards Farnesyl diphosphate synthase from leishmania major2005Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8
Pyridinium-1-yl bisphosphonates are potent inhibitors of farnesyl diphosphate synthase and bone resorption.
AID169151Bone Formation rate/tissue vol measured Histomorphometrically after a does of 3 ug/kg in proximal tibial metaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID184509Mineralizing apposition measured Histomorphometrically after a dose of 3 ug/kg in Tibial Diaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID67525In vitro growth inhibition against Entamoeba histolytica2004Journal of medicinal chemistry, Jan-01, Volume: 47, Issue:1
Effects of bisphosphonates on the growth of Entamoeba histolytica and Plasmodium species in vitro and in vivo.
AID615463In-vitro antibone resorptive activity Sprague-Dawley rat pup long bone osteoclasts assessed as compound concentration causing inhibition of bone resorption after 72 hrs by MTT assay2011European journal of medicinal chemistry, May, Volume: 46, Issue:5
Synthesis and bio-activity evaluation of tetraphenyl(phenylamino) methylene bisphosphonates as antioxidant agents and as potent inhibitors of osteoclasts in vitro.
AID210170Effective dose after subcutaneous administration to TPTX rats for 50% reduction of hypercalcemia2002Journal of medicinal chemistry, Aug-15, Volume: 45, Issue:17
Highly potent geminal bisphosphonates. From pamidronate disodium (Aredia) to zoledronic acid (Zometa).
AID615461In-vitro antibone resorptive activity Sprague-Dawley rat pup long bone osteoclasts assessed as compound concentration causing inhibition of bone resorption after 24 hrs by MTT assay2011European journal of medicinal chemistry, May, Volume: 46, Issue:5
Synthesis and bio-activity evaluation of tetraphenyl(phenylamino) methylene bisphosphonates as antioxidant agents and as potent inhibitors of osteoclasts in vitro.
AID1700468Inhibition of resorption activity of mouse peripheral blood cell-derived osteoclasts at 1-20 uM incubated for 48 hrs by Kossa-staining based assay2020Journal of medicinal chemistry, 11-25, Volume: 63, Issue:22
Novel 2,7-Diazaspiro[4,4]nonane Derivatives to Inhibit Mouse and Human Osteoclast Activities and Prevent Bone Loss in Ovariectomized Mice without Affecting Bone Formation.
AID29611Bioavailability by the ratios of 14C p.o. /14C i.v. accumulated in bone at 24 hr (dose 10 mg/kg p.o.)2000Journal of medicinal chemistry, Oct-05, Volume: 43, Issue:20
A peptide prodrug approach for improving bisphosphonate oral absorption.
AID71579Inhibitory activity, for stimulation of TNF-alpha release in gamma-delta T cells, using individual observed maximum TNF-alpha release2004Journal of medicinal chemistry, Jan-15, Volume: 47, Issue:2
Quantitative structure-activity relationships for gammadelta T cell activation by bisphosphonates.
AID340434Antimicrobial activity against Dictyostelium discoideum2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Determination of the microscopic equilibrium dissociation constants for risedronate and its analogues reveals two distinct roles for the nitrogen atom in nitrogen-containing bisphosphonate drugs.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1421107Induction of mineralization in C57BL mouse bone marrow cells co-cultured with human PC3 cells at 50 to 100 nM supplemented with fresh medium containing compound every 3 days for 10 to 15 days by alizarin red dye based assay2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID72669Inhibitory activity against farnesyl Pyrophosphate Synthase expressed as #NAME? (M)2003Journal of medicinal chemistry, Nov-20, Volume: 46, Issue:24
3-D QSAR investigations of the inhibition of Leishmania major farnesyl pyrophosphate synthase by bisphosphonates.
AID1421090Antiproliferative activity against mouse J774A.1 cells assessed as reduction in cell viability at 100 uM after 72 hrs by WST8 assay2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID1367798Volume of distribution (excluding bone) in human2018Journal of medicinal chemistry, 05-24, Volume: 61, Issue:10
Relevance of Half-Life in Drug Design.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID71578Inhibitory activity, for stimulation of TNF-alpha release in gamma-delta T cells, using a constrained maximum TNF-alpha release of 2700 pg/mL2004Journal of medicinal chemistry, Jan-15, Volume: 47, Issue:2
Quantitative structure-activity relationships for gammadelta T cell activation by bisphosphonates.
AID187192Periosteal mineral apposition rate measured Histomorphometrically after a dose of 3 ug/kg in Tibial Diaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID174913Derived trabecular thickness measured using micro Computed Tomography(CT) after a dose of 3 ug/kg in Vertebral Bone2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID1421097Inhibition of RANKL-induced osteoclastogenesis in mouse RAW264.7 cells after 72 hrs by TRAP staining based microscopic analysis2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID169542Mineral surface/bone surface measured Histomorphometrically after a dose of 3 ug/kg in proximal tibial metaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID72181Inhibitory activity against the human recombinant FPPSase (Farnesyl diphosphate) enzyme2002Journal of medicinal chemistry, May-23, Volume: 45, Issue:11
Inhibition of geranylgeranyl diphosphate synthase by bisphosphonates and diphosphates: a potential route to new bone antiresorption and antiparasitic agents.
AID208225Inhibition of Trypanosoma rhodesiense (strain STIB900) was determined using blood stream from trypomastigotes2001Journal of medicinal chemistry, Mar-15, Volume: 44, Issue:6
Bisphosphonates inhibit the growth of Trypanosoma brucei, Trypanosoma cruzi, Leishmania donovani, Toxoplasma gondii, and Plasmodium falciparum: a potential route to chemotherapy.
AID213660In vitro antiparasitic activity against Trypanosoma cruzi (amastigotes)2001Bioorganic & medicinal chemistry letters, Mar-26, Volume: 11, Issue:6
Bisphosphonates derived from fatty acids are potent growth inhibitors of Trypanosoma cruzi.
AID158550In vitro growth inhibition against Plasmodium falciparum2004Journal of medicinal chemistry, Jan-01, Volume: 47, Issue:1
Effects of bisphosphonates on the growth of Entamoeba histolytica and Plasmodium species in vitro and in vivo.
AID244679Therapeutic index (TI) value as ratio of lethal dose (LD50) to the inhibitory concentration (IC50)2005Journal of medicinal chemistry, May-05, Volume: 48, Issue:9
Bisphosphonate inhibitors of Toxoplasma gondi growth: in vitro, QSAR, and in vivo investigations.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID95764Inhibition of L. donovani (Amastigotes) strain MHOM/ET/67/L82 maintained in female golden hamsters2001Journal of medicinal chemistry, Mar-15, Volume: 44, Issue:6
Bisphosphonates inhibit the growth of Trypanosoma brucei, Trypanosoma cruzi, Leishmania donovani, Toxoplasma gondii, and Plasmodium falciparum: a potential route to chemotherapy.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1744121Inhibition of human ACMSD assessed as QUIN level at 1 mM by HPLC analysis (Rvb = 16.4 +/- 2.9%)2021Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1
Diflunisal Derivatives as Modulators of ACMS Decarboxylase Targeting the Tryptophan-Kynurenine Pathway.
AID615462In-vitro antibone resorptive activity Sprague-Dawley rat pup long bone osteoclasts assessed as compound concentration causing inhibition of bone resorption after 48 hrs by MTT assay2011European journal of medicinal chemistry, May, Volume: 46, Issue:5
Synthesis and bio-activity evaluation of tetraphenyl(phenylamino) methylene bisphosphonates as antioxidant agents and as potent inhibitors of osteoclasts in vitro.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID24120Distribution in rat urine following intravenous administration of 1 mg/kg alendronate2000Journal of medicinal chemistry, Oct-05, Volume: 43, Issue:20
A peptide prodrug approach for improving bisphosphonate oral absorption.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID28060Distribution in rat tibia following intravenous administration of 1 mg/kg alendronate2000Journal of medicinal chemistry, Oct-05, Volume: 43, Issue:20
A peptide prodrug approach for improving bisphosphonate oral absorption.
AID1367797Drug excretion in human kidney2018Journal of medicinal chemistry, 05-24, Volume: 61, Issue:10
Relevance of Half-Life in Drug Design.
AID1272975Binding affinity to synthetic ceramic hydroxyapatite type 1 assessed as reduction in bound compound level at 50 uM after 16 hrs by NMR spectroscopic analysis relative to control2016Bioorganic & medicinal chemistry, 02-15, Volume: 24, Issue:4
Structural features underlying raloxifene's biophysical interaction with bone matrix.
AID180034Endosteal eroded surface measured Histomorphometrically after a dose of 3 ug/kg in Tibial Diaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID221770Effective concentration to activate gammadelta T cells2002Journal of medicinal chemistry, Oct-24, Volume: 45, Issue:22
Quantitative structure--activity relations for gammadelta T cell activation by phosphoantigens.
AID248772In vitro inhibitory concentration against the growth of Toxoplasma gondii in human foreskin fibroblast monolayer cells (HFF cells)2005Journal of medicinal chemistry, May-05, Volume: 48, Issue:9
Bisphosphonate inhibitors of Toxoplasma gondi growth: in vitro, QSAR, and in vivo investigations.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID184809Bone resorption activity in rats.2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
An investigation of bone resorption and Dictyostelium discoideum growth inhibition by bisphosphonate drugs.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1458039Oral bioavailability in human2017Journal of medicinal chemistry, 08-24, Volume: 60, Issue:16
Design, Synthesis, and Pharmacokinetics of a Bone-Targeting Dual-Action Prodrug for the Treatment of Osteoporosis.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID71580pIC50 value for stimulation of TNF-alpha release in gamma-delta T cells, using a constrained maximum TNF-alpha release of 2700 pg/mL2004Journal of medicinal chemistry, Jan-15, Volume: 47, Issue:2
Quantitative structure-activity relationships for gammadelta T cell activation by bisphosphonates.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID238395Inhibition of hypoxanthine-guanine phosphoribosyltransferase (TcHPRT)2004Bioorganic & medicinal chemistry letters, Sep-06, Volume: 14, Issue:17
The purine transferase from Trypanosoma cruzi as a potential target for bisphosphonate-based chemotherapeutic compounds.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID191812Trabecular thickness measured Histomorphometrically after a dose of 3 ug/kg in proximal tibial metaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID74507Inhibitory activity against the human recombinant geranylgeranyl diphosphate synthase (GGPPSase).2002Journal of medicinal chemistry, May-23, Volume: 45, Issue:11
Inhibition of geranylgeranyl diphosphate synthase by bisphosphonates and diphosphates: a potential route to new bone antiresorption and antiparasitic agents.
AID1421094Antiproliferative activity against RANKL-differentiated mouse RAW264.7 cells assessed as reduction in cell viability at 100 uM after 72 hrs by CCK8 assay2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID174811Connectivity density measured using micro Computed Tomography(CT) after a dose of 3 ug/kg in Vertebral Bone2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID1272978Binding affinity to hound bone powder assessed as reduction in bound compound level at 50 uM after 1 hr by NMR spectroscopic analysis relative to control2016Bioorganic & medicinal chemistry, 02-15, Volume: 24, Issue:4
Structural features underlying raloxifene's biophysical interaction with bone matrix.
AID1409747Half life in human2018ACS medicinal chemistry letters, Mar-08, Volume: 9, Issue:3
Data Sets Representative of the Structures and Experimental Properties of FDA-Approved Drugs.
AID1421114Induction of mineralization in C57BL mouse bone marrow cells co-cultured with human PC3 cells at >100 nM supplemented with fresh medium containing compound every 3 days for 10 to 15 days by alizarin red dye based assay2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID185551Marrow area measured Histomorphometrically after a dose of 3 ug/kg in Tibial Diaphysis2001Journal of medicinal chemistry, Nov-22, Volume: 44, Issue:24
Synthesis and biological evaluation of prostaglandin-F alkylphosphinic acid derivatives as bone anabolic agents for the treatment of osteoporosis.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1802945AChE Inhibition Assay from Article 10.3109/14756361003691860: \\Design, synthesis and anticholinesterase activity of some new a-aminobisphosphonates.\\2010Journal of enzyme inhibition and medicinal chemistry, Dec, Volume: 25, Issue:6
Design, synthesis and anticholinesterase activity of some new α-aminobisphosphonates.
AID1798541GGPP Synthase Inhibition Assay from Article 10.1021/jm800325y: \\Inhibition of geranylgeranyl diphosphate synthase by bisphosphonates: a crystallographic and computational investigation.\\2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Inhibition of geranylgeranyl diphosphate synthase by bisphosphonates: a crystallographic and computational investigation.
AID1811Experimentally measured binding affinity data derived from PDB2006Proteins, Jan-01, Volume: 62, Issue:1
Structure and mechanism of the farnesyl diphosphate synthase from Trypanosoma cruzi: implications for drug design.
AID977608Experimentally measured binding affinity data (IC50) for protein-ligand complexes derived from PDB2006Proteins, Jan-01, Volume: 62, Issue:1
Structure and mechanism of the farnesyl diphosphate synthase from Trypanosoma cruzi: implications for drug design.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (3,873)

TimeframeStudies, This Drug (%)All Drugs %
pre-19906 (0.15)18.7374
1990's415 (10.72)18.2507
2000's1559 (40.25)29.6817
2010's1495 (38.60)24.3611
2020's398 (10.28)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 112.25

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index112.25 (24.57)
Research Supply Index8.48 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index206.72 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (112.25)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials731 (17.85%)5.53%
Reviews488 (11.91%)6.00%
Case Studies435 (10.62%)4.05%
Observational25 (0.61%)0.25%
Other2,417 (59.01%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (164)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis [NCT00051558]Phase 3428 participants (Actual)Interventional2002-11-30Completed
Open Label, Balanced, Randomized, Two-way, Single-dose, Crossover Bioequivalence Study of Alendronate Sodium 70 mg Tablets of Dr Reddy's, India and Fosamax® Tablets of Merck & Co., Inc., USA, in Healthy Subjects Under Fasting Conditions [NCT01133496]Phase 180 participants (Actual)Interventional2006-12-31Completed
A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis [NCT01631214]Phase 34,093 participants (Actual)Interventional2012-05-04Completed
A 6-Month, Randomized, Open-Label, Active-Comparator Controlled, Parallel-Group Study With a 6-Month Extension to Evaluate the Safety and Efficacy of Alendronate Sodium 70 mg/Vitamin D3 5600 I.U. Combination Tablets Versus Calcitriol in the Treatment of O [NCT01350934]Phase 4219 participants (Actual)Interventional2011-06-19Completed
A 12-Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Once Weekly Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis [NCT00092014]Phase 31,053 participants (Actual)Interventional2002-09-01Completed
Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS), an Open Label Prospective Trial [NCT01104987]16 participants (Actual)Observational2009-10-31Completed
A 6-Month, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Alendronate 280-mg Oral Buffered Solution Once Weekly in Patients With Paget's Disease of Bone [NCT00480662]Phase 360 participants (Actual)Interventional2001-10-31Completed
A Triple-Blind, Randomized, Active-Controlled, Parallel-Group, Multicenter Study to Evaluate and Compare the Efficacy and Tolerability of Alendronate Sodium With Calcium Supplementation in the Treatment of Osteoporosis in Postmenopausal Women [NCT00398606]Phase 3650 participants Interventional1995-04-30Completed
A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporo [NCT00092066]Phase 3717 participants (Actual)Interventional2003-09-24Completed
A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70-mg Alendronate/5600 IU Vitamin D3 Final Market Combination Tablet to a 70-mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3 [NCT00803790]Phase 1318 participants (Actual)Interventional2006-05-31Completed
A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis; A 12 Month Extension to: A Randomized, Double [NCT00092040]Phase 3936 participants (Actual)Interventional2003-03-18Completed
SALTIRE II: Bisphosphonates and RANKL Inhibition in Aortic Stenosis [NCT02132026]Phase 2152 participants (Actual)Interventional2014-11-12Completed
A 5-year, Double-blind, Randomized, Placebo-controlled Extension Study to Examine the Long-term Safety and Efficacy of Oral Alendronate in Postmenopausal Women Who Previously Received Alendronate in Conjunction With the Fracture Intervention Trial [NCT00398931]Phase 31,099 participants (Actual)Interventional1998-02-28Completed
Secondary Prevention of Osteoporosis: A Window of Opportunity in the Acute Rehabilitation Setting [NCT00421343]Phase 329 participants (Actual)Interventional2007-02-28Completed
Effect of Alendronate With β - TCP Bone Substitute in Surgical Therapy of Periodontal Intra-osseous Defects: A Randomized, Controlled Clinical Trial. [NCT02795546]Phase 432 participants (Actual)Interventional2015-01-31Completed
A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density [NCT00377819]Phase 3504 participants (Actual)Interventional2006-09-30Completed
A Double-Blind, Randomized, Placebo-Controlled, Multicenter 4-Week Study to Assess the Effect of Alendronate 70 mg and Vitamin D3 2800 IU Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women [NCT00641771]Phase 156 participants (Actual)Interventional2004-05-31Completed
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Compare the Safety and Tolerability of an Oral Buffered Solution of Alendronate Sodium 70 mg Once-Weekly Versus Placebo for the Treatment of Osteoporosis in Postmenopausal Women [NCT00092027]Phase 3454 participants (Actual)Interventional2003-03-19Completed
An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003 [NCT01657162]Phase 31,139 participants (Actual)Interventional2012-11-20Completed
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of FOSAMAX PLUS and FOSAMAX PLUS D in Usual Practice [NCT01065779]880 participants (Actual)Observational2006-03-31Completed
Randomized, 2-Way Crossover, Bioequivalence Study of Teva Pharmaceuticals USA and Merck Sharp & Dohme (USA) (Fosamax®) Alendronate Sodium Tablets Administered as a 1 x 70 mg in Healthy Adult Males Under Fasting Conditions [NCT00835406]Phase 1140 participants (Actual)Interventional2000-06-30Completed
Evaluation of the Efficacy and Tolerability of Alendronate Versus Denosumab in Kidney Transplant Patients With Reduced Bone Mineral Density [NCT04169698]Phase 2/Phase 390 participants (Actual)Interventional2019-10-17Completed
Effects of Denosumab on Bone Mineral Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study [NCT03292146]Phase 330 participants (Actual)Interventional2017-10-25Completed
The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women [NCT01077817]684,815 participants (Actual)Observational2010-02-26Completed
Effect and Cost Comparation of Different Treatment Strategies for Osteoporotic Vertebral Fractures (OVF): Teriparatide Injection and Percutaneous Vertebroplasty (PVP) [NCT03692143]90 participants (Anticipated)Observational2017-01-01Active, not recruiting
A Randomized, Double-blind, Double-dummy, Positive-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis [NCT05397938]Phase 2231 participants (Anticipated)Interventional2022-06-15Not yet recruiting
Denosumab vs Alendronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial [NCT05662358]90 participants (Anticipated)Interventional2021-01-03Recruiting
A Phase IIb, Randomized, Double-Blind, Placebo- and Active-Controlled, Dose-Range-Finding Study to Evaluate the Effects of MK-5442 on Bone Mineral Density (BMD) in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisph [NCT00996801]Phase 2526 participants (Actual)Interventional2009-11-30Completed
The Effect of Oral Administration of Alendronate on Knee Functions Following Anterior Cruciate Ligament Reconstruction - A Pilot Study of Single-Blind Randomized Controlled Trial [NCT05527548]Phase 464 participants (Anticipated)Interventional2022-12-22Recruiting
A Comparison of Alendronate vs. Alfacalcidol Medication for the Preservation of Bone Mineral Density Around the Femoral Implant and in the Lumbar Spine After a Total Hip Arthroplasty [NCT01020253]60 participants (Actual)Interventional2006-01-31Active, not recruiting
Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics [NCT01128257]6,054 participants (Actual)Observational2010-04-30Completed
A Multi Center, Randomized, Open-label, Parallel, Phase IV Clinical Trial to Evaluate Efficacy and Safety of MASI BONE S (Alendronate Sodium Trihydrate) in Postmenopausal Women With Osteoporosis [NCT05387200]Phase 4170 participants (Anticipated)Interventional2021-07-02Recruiting
A Non-interventional Two-arm Two-centre, Retrospective/Prospective Study to Compare the Effect of Alendronate 70mg Formulation (Tablet vs Effervescent Tablet) on Bone Turnover Markers and Patient Reported Outcomes [NCT03435094]80 participants (Anticipated)Observational2018-02-25Recruiting
Predictive Value of Bone Turnover Markers During Discontinuation With Alendronate [NCT03051620]142 participants (Actual)Observational2017-02-01Completed
Effects of Romosozumab on Bone Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study [NCT04779216]Phase 330 participants (Actual)Interventional2021-09-20Active, not recruiting
A Randomised, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density [NCT00896532]Phase 2419 participants (Actual)Interventional2009-06-03Completed
Bisphosphonates for Prevention of Post-Denosumab Bone Loss in Premenopausal Women With Idiopathic Osteoporosis [NCT03396315]Phase 227 participants (Actual)Interventional2018-01-29Active, not recruiting
Clinical Efficacy of Subgingivally Delivered 1% Alendronate in the Treatment of Smokers With Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial. [NCT02168543]Phase 246 participants (Actual)Interventional2009-03-31Completed
Effects of 1% Sodium Alendronate in Non Surgical Periodontal Therapy on Clinical and Tomographical Parameters: a Randomized Placebo Controlled 6-month Clinical Trial [NCT02470611]Phase 432 participants (Actual)Interventional2012-11-30Completed
The Effect of Alendronate on the Immune Response to Hepatitis B Vaccine in Healthy Adults - a Randomized Placebo-controlled Pilot Study [NCT02057263]Phase 128 participants (Actual)Interventional2014-04-30Completed
Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial [NCT02455869]Phase 2/Phase 3104 participants (Actual)Interventional2014-07-31Completed
Osteoporosis Treatment Protocol in Patients With Fragility Fractures: Application and Efficacy [NCT04861142]350 participants (Anticipated)Observational2021-04-23Recruiting
Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis [NCT00727493]Phase 445 participants (Anticipated)Interventional2004-01-31Recruiting
Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis [NCT00936260]228 participants (Actual)Interventional1998-01-31Completed
Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (10 mg; Mylan) and Fosamax Tablets (10 mg; Merck) in Healthy Volunteers [NCT00983996]Phase 1112 participants (Actual)Interventional2002-06-30Completed
Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy [NCT00822029]Phase 32 participants (Actual)Interventional2009-02-28Terminated(stopped due to only 2 patients inclued and Study Principal Investigator has left the hospital)
Changes in Bone Density, Radiographic Texture Analysis and Bone Turnover During Two Years of Antiresorptive Therapy for Postmenopausal Osteoporosis [NCT00145977]36 participants (Actual)Interventional2001-07-31Completed
A Randomized, Double-Blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Postmenopausal Women With Low Bone Mineral Density [NCT00043186]Phase 2412 participants (Actual)Interventional2002-05-31Completed
12 Month Open-Label Extension Study of the Effect of Alendronate on Bone in People With Chronic SCI Previously Treated With Teriparatide [NCT02195895]Phase 217 participants (Actual)Interventional2014-04-30Completed
The Effect of Alendronate Sodium Vitamin D3 Tablets on Knee Joint Structure and Knee Osteoarthritis Pain: A Multi-center, Randomized, Double-blind, Controlled Study. [NCT04739592]Phase 460 participants (Anticipated)Interventional2021-07-07Recruiting
A Six Month Double-Blind, Placebo-Controlled Trial Followed by Six Month Open-Label Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture. [NCT00346190]Phase 310 participants Interventional2003-01-31Recruiting
Impact of Oral Alendronate Therapy on Bone Mineral Density in HIV-infected Children and Adolescents With Low Bone Mineral Density [NCT00921557]Phase 252 participants (Actual)Interventional2009-11-30Completed
A Randomized, Placebo-Controlled Trial of Alendronate in the Treatment of Polyostotic Fibrous Dysplasia and the McCune-Albright Syndrome [NCT00001728]Phase 240 participants (Actual)Interventional1998-08-24Completed
A 2-year Randomised Parallel Group Trial of Alendronate, Ibandronate and Risedronate for Postmenopausal Osteoporosis in Secondary Care. [NCT00666627]Phase 2410 participants (Anticipated)Interventional2007-04-30Completed
Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (70 mg; Mylan) and Fosamax Tablets (70 mg; Merck) in Healthy Volunteers [NCT01012934]Phase 1110 participants (Actual)Interventional2002-07-31Completed
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Denisty [NCT00330460]Phase 31,189 participants (Actual)Interventional2006-05-31Completed
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density [NCT00293813]Phase 2247 participants (Actual)Interventional2006-05-31Completed
Platelet Rich Fibrin Combined With 1% Alendronate Gel in Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial [NCT02609061]Phase 2/Phase 372 participants (Actual)Interventional2015-01-31Completed
Prevention of Postmenopausal Bone Loss in Osteopenic Women With Alendronate Given on a 70 mg Once-every Two Week Regimen: a 2-year, Double-blind, Placebo-controlled Clinical Trial. [NCT00463268]Phase 383 participants (Actual)Interventional2007-09-30Completed
A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women [NCT00729651]Phase 4343 participants (Actual)Interventional2008-03-20Completed
A Randomized, Open-Label, Muti-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A Six Month, Two-Sequence, and Two-Period Crossover Study [NCT02598440]Phase 4341 participants (Actual)Interventional2004-03-31Completed
A Phase III (Phase V Program), Open-Label, Randomized, Referred-Care-Controlled, Clinical Trial to Evaluate the Efficacy and Safety of MK -0217A/Alendronate Sodium-70 mg/Vitamin D3 5600 I.U. Combination Tablet on Vitamin D Inadequacy in the Treatment of O [NCT00692913]Phase 3515 participants (Actual)Interventional2008-06-30Completed
Intravenous Liposomal Alendronate Infusion in Subjects Undergoing Bare Metal Coronary Stent Implantation [NCT00739466]Phase 2226 participants (Actual)Interventional2008-09-30Completed
Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis - Indication and Duration: A Randomized, Double-blind, Placebocontrolled Study to Evaluate the Effects of Discontinuation of Alendronate in Patients With Both Rheumatoid Arthritis and Low Bone [NCT02944799]Phase 269 participants (Actual)Interventional2015-12-31Completed
A 24-week, International, Multi Centre, Randomised, Double-blind, Double-dummy, Parallel Group, Phase IV Clinical Trial Investigating Changes in Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) Treated With Either 100 µ [NCT00713258]Phase 475 participants (Actual)Interventional2008-04-30Terminated(stopped due to Slow enrolment)
Cyclic Versus Daily Teriparatide on Bone Mass [NCT00668941]Phase 2140 participants (Anticipated)Interventional2005-09-30Active, not recruiting
The Use of Buffered Soluble Alendronate 70 mg (Steovess/Binosto) After Denosumab Discontinuation to Prevent Increase in Bone Turnover [NCT04403698]Phase 230 participants (Actual)Interventional2019-11-13Completed
Effects of Romosozumab on Bone Health in Women With Spinal Cord Injury and Osteoporosis [NCT04708886]Phase 212 participants (Anticipated)Interventional2021-03-01Active, not recruiting
A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70 mg Alendronate/2800 IU Vitamin D3 Final Market Combination Tablet to a 70 mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3 [NCT00806416]Phase 1244 participants (Actual)Interventional2003-05-31Completed
Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis [NCT00265252]Phase 460 participants Interventional2005-06-30Active, not recruiting
The P.O.W.E.R. STUDY (Premenopause, Osteopenia/Osteoporosis, Women, Alendronate, Depression) [NCT00006180]Phase 4220 participants Interventional2000-08-10Completed
Anabolic Actions of Parathyroid Hormone in Osteoporotic Men [NCT00000427]Phase 381 participants Interventional1999-09-30Completed
Alendronate Versus Placebo for Idiopathic Juvenile Osteoporosis [NCT00001720]Phase 250 participants Interventional1998-03-31Completed
A Multi-center, Randomized, Open-label, Controlled, One-year Trial to Measure the Effect of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteopenia and Osteoporosis [NCT00404820]Phase 3604 participants (Actual)Interventional2006-10-31Completed
Teh Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in Teh Preservation of Teh Tooth Socket [NCT03980847]Phase 220 participants (Actual)Interventional2018-02-23Completed
A Randomized, Double-Blind, Placebo-Controlled, Prospective, Cross-Over Phase II Clinical Trial to Determine the Safety and Efficacy of Alendronate (Fosamax) in Juvenile Osteoporosis (IND#60,017) [NCT00259857]Phase 222 participants (Actual)Interventional2003-10-31Completed
A Multicenter, Randomized, Cross-Over, Open-label Study to Evaluate the Adherence, Preference, and Satisfaction of Denosumab and Alendronate in Postmenopausal Women With Low Bone Mineral Density [NCT00518531]Phase 3250 participants (Actual)Interventional2007-09-01Completed
Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation [NCT00297830]Phase 2/Phase 3111 participants (Actual)Interventional2005-11-30Completed
Évaluation Multidimensionnelle de la réponse au Traitement de l'ostéoporose spontanée et Induite Par Les corticostéroïdes à l'Aide d'un Bisphosphonate à Administration Orale Chez Des Malades Porteurs d'Une Dystrophie Musculaire sévère. [NCT01882400]Phase 411 participants (Actual)Interventional2001-05-31Completed
Osteoprotegerin/sRANKL Ratio and Bone Mineral Density in Patients With Primary Hyperparathyroidism Treated With Parathyroidectomy or Alendronate [NCT01889134]112 participants (Actual)Interventional2009-01-31Completed
The Optimal Sequential Therapy After Long Term Denosumab Treatment [NCT05091099]Phase 444 participants (Anticipated)Interventional2021-11-20Recruiting
Alendronate to Prevent Perimenopausal Transition Bone Loss [NCT00221312]48 participants (Actual)Observational2002-05-31Completed
Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial [NCT01968850]Phase 230 participants (Actual)Interventional2014-04-23Completed
Glucocorticoids Promote Osteoclast Survival [NCT00572299]3 participants (Actual)Observational2004-01-31Terminated(stopped due to Terminated due to recruitment problems)
Study CR9108963: A 12-month, Randomized, Double-blind, Parallel-group, Placebo and Active-controlled Dose-range Finding Study of the Efficacy and Safety of SB-751689 in Post-menopausal Women With Osteoporosis [NCT00471237]Phase 2564 participants (Actual)Interventional2007-05-14Terminated(stopped due to Terminated for futility by sponsor after a pre-planned interim review of data)
Study to Determine the Pharmacokinetics of a Single 14C-labeled Intravenous Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose to Postmenopausal Women With Osteopenia or Osteoporosis [NCT00577850]Phase 132 participants (Actual)Interventional2002-11-30Completed
Testosterone and Alendronate in Hypogonadal Men [NCT01460654]Phase 244 participants (Actual)Interventional2011-10-31Terminated
The Impact of Bisphosphonates on Bone Loss in Patients Undergoing Surgery and Postoperative Chemotherapy for Gynecologic Malignancies. [NCT00593580]Phase 260 participants (Anticipated)Interventional2008-02-29Completed
Efficacy and Safety of Minodronate in the Treatment of Postmenopausal Osteoporosis With Low Back Pain: a Single-centre and Randomized Controlled Trial [NCT05645289]Phase 472 participants (Anticipated)Interventional2023-01-01Not yet recruiting
Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal [NCT00504166]Phase 453 participants (Actual)Interventional2006-02-28Completed
A Feasibility Study of Alendronate as Treatment for Femoral Head Osteonecrosis in Adults With Sickle Cell Disease [NCT06016634]Phase 224 participants (Anticipated)Interventional2024-01-31Not yet recruiting
The Effectiveness of Single or Repeat Zoledronate Infusion Versus Oral Alendronate in Consolidating the Bone Accrual Achieved With Denosumab: a Study Organised by the European Calcified Tissue Society [NCT05575167]125 participants (Anticipated)Observational2023-11-28Recruiting
Pilot Clinical Trial of Short-Term Bisphosphonate Administration as Chemoprevention for Breast Cancer Via Engagement of γδ T Cells [NCT02781805]Phase 16 participants (Actual)Interventional2016-08-05Terminated
Double Blind Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid-Associated Osteopenia and Osteoporosis [NCT00209469]Phase 2/Phase 390 participants Interventional2002-07-31Active, not recruiting
Effect of Anti-osteoporotic Medications on Hepatic Steatosis and Fibrosis of Women With Postmenopausal Osteoporosis and Nonalcoholic Fatty Liver Disease [NCT05493761]Phase 470 participants (Anticipated)Interventional2022-12-23Recruiting
[NCT00004488]Phase 282 participants (Anticipated)Interventional1998-10-31Completed
The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer [NCT00354302]Phase 3497 participants (Actual)Interventional2006-04-24Completed
Clinical Study Evaluating Selective or Nonselective Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis [NCT04704947]Phase 350 participants (Anticipated)Interventional2017-10-01Recruiting
Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients? [NCT00299572]Phase 450 participants Interventional2006-03-31Not yet recruiting
A Multi Centre, Randomised, Open Label, Cross-over Study to Evaluate the Percentage of False Negative Osteoporosis Diagnosis's Using the Standard Case-finding Procedure as Described by the Dutch Institute for Healthcare (CBO) and to Determine the Preferen [NCT00327990]Phase 4300 participants (Actual)Interventional2005-04-30Completed
A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets [NCT00400530]Phase 325 participants Interventional2005-12-31Completed
A Phase III, Double-blind, Randomized, Parallel Group, Placebo-controlled Study of Oral Fosamax, 70 mg Once a Week, for the Prevention of Androgen Deprivation Bone Loss in Non-metastatic Prostate Cancer [NCT00236002]Phase 3182 participants (Actual)Interventional2005-07-31Terminated(stopped due to Slow accrual than anticipated.)
Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients? [NCT00261625]Phase 450 participants (Anticipated)Interventional2005-08-31Completed
A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporo [NCT00092079]Phase 3652 participants (Actual)Interventional2004-01-31Completed
The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women [NCT00460057]Phase 463 participants (Actual)Interventional2006-03-31Completed
Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients [NCT00136058]Phase 3250 participants Interventional2002-01-31Completed
Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol. [NCT00138983]Phase 3200 participants Interventional2000-05-31Completed
Pharmacokinetics of a Single Oral Dose of Maxmarvil® in Healthy Postmenopausal Women Without a Previous History of Fractures [NCT01526278]Phase 118 participants (Actual)Interventional2011-10-31Completed
Phase IV Study Teriparatide and Antiresorptive Combination Treatment Subsequent to 9 Months of Teriparatide Monotherapy [NCT01535027]Phase 4125 participants (Actual)Interventional2006-03-31Completed
A Phase III Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density, Tolerability, and Safety in the Treatment of Postmenopausal Women With Osteoporosis Previously Treated With A [NCT01552122]Phase 30 participants (Actual)Interventional2012-05-31Withdrawn
Renal Osteodystrophy: A Fresh Approach [NCT02440581]141 participants (Actual)Interventional2015-07-01Completed
Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir [NCT00120757]Phase 3140 participants Interventional2004-10-31Completed
Maintaining Skeletal Health in Postmenopausal Women With Surgically Resected Stage I-IIIa Hormone-receptor Positive Breast Cancer Who Are Receiving Anastrozole, Through the Use of Alendronate as Determined by the Osteoporosis Australia Bone Maintenance Al [NCT00122356]Phase 3303 participants (Actual)Interventional2005-09-30Completed
Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors [NCT00391404]Phase 3100 participants (Anticipated)Interventional2006-05-31Recruiting
[NCT00035971]Phase 40 participants InterventionalCompleted
Prevention of Osteoporosis in Men With Prostate Cancer [NCT00048841]Phase 3112 participants Interventional2002-05-31Completed
Phase II Randomized Study of High-Dose Ketoconazole With or Without Alendronate Sodium in Patients With Androgen-Independent Metastastic Adenocarinoma of the Prostate [NCT00019695]Phase 20 participants Interventional1999-03-31Terminated
Randomised Controlled Trial of the Effect of Alendronate on Vascular Calcification and Arterial Stiffness in Chronic Kidney Disease: A Pilot Study [NCT00395382]Phase 450 participants (Anticipated)Interventional2007-01-31Completed
Assessment of Bone Quality After Defective Socket Preservation Using Sodium Alendronate Gel Compared to Sticky Bone : A Histomorphometric Randomized Clinical Controlled Trial [NCT05771038]Early Phase 132 participants (Anticipated)Interventional2023-04-30Recruiting
A Multicentre, Double-Blind, Randomized Placebo-Controlled Study of 70mg Alendronate Once Weekly for the Prevention and Treatment of Osteoporosis in Canadian Adult Cystic Fibrosis Patients [NCT00157690]Phase 456 participants (Actual)Interventional2003-12-31Completed
Prevention of Osteoporosis in Men With Prostate Cancer [NCT00177619]Phase 3120 participants Interventional2002-05-31Completed
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Once-Weekly Alendronate in HIV-Infected Subjects With Decreased Bone Mineral Density Receiving Calcium and Vitamin D [NCT00061256]Phase 280 participants InterventionalCompleted
A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease. [NCT00503113]Phase 4801 participants (Actual)Interventional2007-07-31Completed
A Randomized, Double-Blind, Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of Denosumab in Japanese Osteoporotic Subjects With Prevalent Fragility Vertebral Fracture(s) [NCT00680953]Phase 31,262 participants (Actual)Interventional2008-05-31Completed
Stem Cell Recruitment in Osteoporosis Therapy [NCT01656629]55 participants (Actual)Interventional2012-08-31Terminated(stopped due to Inability to analyze collected samples due to no funds.)
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption [NCT01750086]Phase 427 participants (Actual)Interventional2013-01-31Completed
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study [NCT02139007]Phase 427 participants (Actual)Interventional2014-06-30Completed
Double-Blinded Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid- Associated Osteopenia and Osteoporosis [NCT00277251]Phase 2/Phase 320 participants Interventional2003-03-31Completed
Comparison of the Effect of Denosumab and Alendronate on Bone Density and Microarchitecture in Rheumatoid Arthritis Females With Low Bone Mass: A Randomized Controlled Trial [NCT01770106]Phase 440 participants (Actual)Interventional2012-12-31Completed
Osteoporosis in Cystic Fibrosis: Study of Bone Mass and Bone Metabolism, and Prospective Randomized Therapeutic Trial. [NCT01812551]Phase 3171 participants (Actual)Interventional2002-10-31Completed
Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy [NCT01512446]Phase 3436 participants (Actual)Interventional2012-02-29Terminated(stopped due to low recruitment rate)
Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial [NCT03005678]Phase 4140 participants (Actual)Interventional2017-04-01Completed
The Effect of Effervescent and Buffered Alendronate on Bone Turnover Compared to Conventional Alendronate: A Randomized Non-inferiority Study [NCT05325515]Phase 464 participants (Actual)Interventional2021-10-01Completed
Efficacy of a Calcimimetic (Cinacalcet) in the Long Term Control of Patients With Primary Hyperparathyroidism [NCT02417389]Phase 422 participants (Actual)Interventional2008-05-31Completed
The Effects of Alendronate After Cure of Primary Hyperparathyroidism [NCT00359385]Phase 40 participants (Actual)Interventional2006-07-31Withdrawn(stopped due to incomplete enrollment)
Bone Formation-Resorption Coupling and Osteoporosis [NCT00000400]Phase 2176 participants (Actual)Interventional1999-08-31Completed
Prevention of Osteoporosis After Cardiac Transplantation [NCT00000412]Phase 3149 participants (Actual)Interventional1997-09-30Completed
Clinical Trial of Continuous Low-Dose Hormone Replacement Therapy Combined With Alendronate in Postmenopausal Women With Low Bone Density [NCT00000430]Phase 3240 participants Interventional1999-10-31Terminated
The Assessment of Osteoporosis Treatment in Post-menopausal Women [NCT03006003]Phase 4500 participants (Anticipated)Interventional2017-01-01Recruiting
A Non-Randomized, Open-Label, Prospective, Non-Controlled, 12-Month Clinical Trial to Determine the Effects of Alendronate 35 or 70 mg/Week Depending Upon Body Weight, in Children and Adolescent With IJO [NCT00010439]Phase 210 participants (Actual)Interventional2000-09-30Completed
Bisphosphonate Therapy for Osteogenesis Imperfecta [NCT00159419]Phase 418 participants (Actual)Interventional1999-08-31Completed
Metabolic, Endocrine, and Central Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis [NCT03040531]Phase 2/Phase 3200 participants (Anticipated)Interventional2017-01-19Recruiting
Phase II Study of Alendronate Sodium in Juvenile Osteoporosis (IND# 60,017)-Post Study Evaluation of Participants From Phase IIa and Phase IIb Clinical Study. [NCT00920075]11 participants (Actual)Observational2009-07-31Completed
Cyclical vs Daily Continuous PTH in Combination With Alendronate vs Alendronate Alone [NCT00005006]Phase 2140 participants (Actual)Interventional1987-09-30Completed
Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of Osteoporosis [NCT00005005]Phase 2238 participants (Actual)Interventional1999-10-31Completed
[NCT00004489]60 participants (Anticipated)Interventional1998-10-31Completed
Prospective Trial of 99Tc-MDP and Fosamax in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis Treated With Supraphysiological Doses of Thyroid Hormone [NCT02304757]142 participants (Actual)Interventional2015-01-31Completed
Proof of Concept Study of Alendronate for Asthma [NCT02230332]Phase 2/Phase 378 participants (Actual)Interventional2015-01-31Completed
Double Blind Placebo Controlled Trial to Evaluate Preservation of Bone Mineral Density of the Hip and Distal Femur by Biphosphate Therapy (Fosamax) Following Spinal Cord Injury [NCT01131884]1 participants (Actual)Interventional2010-06-30Terminated(stopped due to Only 1 participant enrolled since the beginning of this study)
Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant [NCT00580047]59 participants (Actual)Interventional2003-12-01Completed
1% Alendronate and Aloevera Gel Local Host Modulating Agents in Chronic Periodontitis Subjects With Class II Furcation Defects: A Randomized Controlled Clinical Trial [NCT03204097]Phase 2/Phase 390 participants (Actual)Interventional2016-03-31Completed
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women With Osteopenia Secondary to Glucocorticoids [NCT03197623]Phase 158 participants (Actual)Interventional2016-10-14Completed
Comparative Evaluation of Subgingivally Delivered 1% Metformin and 1% Alendronate Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial [NCT02461667]Phase 2/Phase 3108 participants (Actual)Interventional2014-07-31Completed
Teriparatide Compared With Alendronate on Spine Bone Mineral Density in Postmenopausal Women With Osteoporosis [NCT02416271]Phase 4203 participants (Actual)Interventional2001-04-30Completed
Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover [NCT05151484]Phase 460 participants (Anticipated)Interventional2022-03-21Recruiting
Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications [NCT03542695]Early Phase 11 participants (Actual)Interventional2021-11-03Active, not recruiting
Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab [NCT03623633]Phase 451 participants (Actual)Interventional2018-11-30Active, not recruiting
A Phase III (Phase IV Program) Open-Label, Multicenter Clinical Trial in Thailand to Study the Effect of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) for 6 Months on 25-Hydroxyvitamin D Levels in the Treatm [NCT01437111]Phase 3200 participants (Actual)Interventional2011-10-26Completed
A Randomized, Double-blinded, Active-controlled, Multicentered Phase III Trial to Assess the Efficacy and Safety of Minodronate Tablets in Postmenopausal Women With Osteoporosis [NCT05305183]Phase 3330 participants (Anticipated)Interventional2022-05-31Not yet recruiting
Evaluation of Topical Application of Alendronate Sodium In-situ Gel and Recombinant Human Bone Morphogenic Protein 2 on Dental Implant Stability and Crestal Bone Level: A Randomized Controlled Clinical Study [NCT04140006]Phase 1/Phase 220 participants (Anticipated)Interventional2019-07-01Enrolling by invitation
Efficacy Of Platelet Rich Fibrin With 1% Alendronate For Treatment Of Intrabony Defects In Chronic Periodontitis: A Randomized Controlled Clinical Trial [NCT02518152]Phase 2/Phase 390 participants (Actual)Interventional2014-10-31Completed
A Multi-centre, Prospective, Randomised Trial of Short Course Alendronate Therapy or Placebo Combined With Vitamin D and Calcium to Prevent Loss of Bone Mineral Density in Antiretroviral-naïve, HIV-1 Infected Subjects Initiating Antiretroviral Therapy [NCT02322099]Phase 453 participants (Actual)Interventional2016-05-31Terminated(stopped due to Due to the COVID-19 pandemic the study was terminated prematurely)
Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study [NCT02303873]Phase 499 participants (Actual)Interventional2007-03-31Completed
Randomized Trial Comparing Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment [NCT02371252]Phase 4140 participants (Actual)Interventional2014-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00010439 (2) [back to overview]Number of Participants With Increased Bone Mineral Density
NCT00010439 (2) [back to overview]Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy.
NCT00043186 (36) [back to overview]Total Body Bone Mineral Density Percent Change From Baseline at Month 12
NCT00043186 (36) [back to overview]Total Hip Bone Mineral Density Percent Change From Baseline at Month 42
NCT00043186 (36) [back to overview]Total Hip Bone Mineral Density Percent Change From Baseline at Month 48
NCT00043186 (36) [back to overview]Urine NTX/Creatinine Percent Change From Baseline at Month 12
NCT00043186 (36) [back to overview]Urine NTX/Creatinine Percent Change From Baseline at Month 24
NCT00043186 (36) [back to overview]Urine NTX/Creatinine Percent Change From Baseline at Month 36
NCT00043186 (36) [back to overview]Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm
NCT00043186 (36) [back to overview]Urine NTX/Creatinine Percent Change From Baseline at Month 42
NCT00043186 (36) [back to overview]Serum CTX Percent Change From Baseline at Month 24
NCT00043186 (36) [back to overview]Serum CTX Percent Change From Baseline at Month 12
NCT00043186 (36) [back to overview]Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48
NCT00043186 (36) [back to overview]Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42
NCT00043186 (36) [back to overview]Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36
NCT00043186 (36) [back to overview]Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
NCT00043186 (36) [back to overview]Serum CTX Percent Change From Baseline at Month 36
NCT00043186 (36) [back to overview]Serum CTX Percent Change From Baseline at Month 42
NCT00043186 (36) [back to overview]Serum CTX Percent Change From Baseline at Month 48
NCT00043186 (36) [back to overview]Total Body Bone Mineral Density Percent Change From Baseline at Month 24
NCT00043186 (36) [back to overview]Total Body Bone Mineral Density Percent Change From Baseline at Month 36
NCT00043186 (36) [back to overview]Total Body Bone Mineral Density Percent Change From Baseline at Month 42
NCT00043186 (36) [back to overview]Total Body Bone Mineral Density Percent Change From Baseline at Month 48
NCT00043186 (36) [back to overview]Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
NCT00043186 (36) [back to overview]Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
NCT00043186 (36) [back to overview]Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms
NCT00043186 (36) [back to overview]Urine NTX/Creatinine Percent Change From Baseline at Month 48
NCT00043186 (36) [back to overview]Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48
NCT00043186 (36) [back to overview]Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42
NCT00043186 (36) [back to overview]Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36
NCT00043186 (36) [back to overview]Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
NCT00043186 (36) [back to overview]Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12
NCT00043186 (36) [back to overview]Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48
NCT00043186 (36) [back to overview]Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42
NCT00043186 (36) [back to overview]Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36
NCT00043186 (36) [back to overview]Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24
NCT00043186 (36) [back to overview]Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12
NCT00043186 (36) [back to overview]Total Hip Bone Mineral Density Percent Change From Baseline at Month 36
NCT00051558 (15) [back to overview]Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
NCT00051558 (15) [back to overview]Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
NCT00051558 (15) [back to overview]Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
NCT00051558 (15) [back to overview]Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
NCT00051558 (15) [back to overview]Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
NCT00051558 (15) [back to overview]Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
NCT00051558 (15) [back to overview]Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
NCT00051558 (15) [back to overview]Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
NCT00051558 (15) [back to overview]Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
NCT00051558 (15) [back to overview]Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
NCT00051558 (15) [back to overview]Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
NCT00051558 (15) [back to overview]Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
NCT00051558 (15) [back to overview]Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
NCT00051558 (15) [back to overview]Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
NCT00051558 (15) [back to overview]Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
NCT00145977 (10) [back to overview]Changes in Radiographic Texture Analysis (RTA) Spectral Density Coefficient Beta (BETA) From Baseline to Month 24
NCT00145977 (10) [back to overview]Changes in Total Hip BMD +/- Treatment With Alendronate
NCT00145977 (10) [back to overview]Changes in Femoral Neck BMD +/- Treatment With Alendronate
NCT00145977 (10) [back to overview]Changes in Lumbar Spine BMD +/- Treatment With Alendronate
NCT00145977 (10) [back to overview]Changes in Peripheral Heel BMD +/- Treatment With Alendronate
NCT00145977 (10) [back to overview]Changes in Radiographic Texture Analysis (RTA) Feature Integrated First Moment of the Power Spectrum (iFMP) From Baseline to Month 24
NCT00145977 (10) [back to overview]Changes in Radiographic Texture Analysis (RTA) Feature Standard Deviation of Root Mean Square (sdRMS) From Baseline to Month 24
NCT00145977 (10) [back to overview]Changes in Radiographic Texture Analysis (RTA) Integrated Root Mean Square (iRMS) From Baseline to Month 24
NCT00145977 (10) [back to overview]Changes in Radiographic Texture Analysis (RTA) Minimum First Moment of the Power Spectrum (minFMP) From Baseline to Month 24
NCT00145977 (10) [back to overview]Changes in Radiographic Texture Analysis (RTA) Minkowski Fractal Dimension (MINK) From Baseline to Month 24
NCT00159419 (1) [back to overview]Bone Mineral Density
NCT00259857 (6) [back to overview]Participants With Atraumatic Fractures
NCT00259857 (6) [back to overview]Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy
NCT00259857 (6) [back to overview]Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy
NCT00259857 (6) [back to overview]Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy
NCT00259857 (6) [back to overview]Number of Participants With Improvement in BMD of Hip
NCT00259857 (6) [back to overview]Participants With Atraumatic Fractures
NCT00293813 (2) [back to overview]Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
NCT00293813 (2) [back to overview]Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12
NCT00297830 (3) [back to overview]Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months
NCT00297830 (3) [back to overview]Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
NCT00297830 (3) [back to overview]Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 12 Months
NCT00330460 (5) [back to overview]Trochanter Bone Mineral Density Percent Change From Baseline at Month 12
NCT00330460 (5) [back to overview]Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12
NCT00330460 (5) [back to overview]Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
NCT00330460 (5) [back to overview]Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
NCT00330460 (5) [back to overview]Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
NCT00377819 (3) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density
NCT00377819 (3) [back to overview]Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)
NCT00377819 (3) [back to overview]Percent Change From Baseline in Total Hip Bone Mineral Density
NCT00404820 (7) [back to overview]Therapy Preference at End of Study (Month 12)
NCT00404820 (7) [back to overview]Number of Patients With a Clinical Fracture From Baseline to Month 12
NCT00404820 (7) [back to overview]Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12
NCT00404820 (7) [back to overview]Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population
NCT00404820 (7) [back to overview]Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population
NCT00404820 (7) [back to overview]Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12
NCT00404820 (7) [back to overview]Change in Body Height From Baseline to Month 12
NCT00421343 (1) [back to overview]Number Adherent With the Intervention
NCT00471237 (25) [back to overview]Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)
NCT00471237 (25) [back to overview]Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)
NCT00471237 (25) [back to overview]Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)
NCT00471237 (25) [back to overview]Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)
NCT00471237 (25) [back to overview]Maximum Blood Concentration (Cmax) of Ronacaleret
NCT00471237 (25) [back to overview]Mean Change From Baseline in Height
NCT00471237 (25) [back to overview]Mean Change From Baseline in Weight
NCT00471237 (25) [back to overview]Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit
NCT00471237 (25) [back to overview]Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit
NCT00471237 (25) [back to overview]Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)
NCT00471237 (25) [back to overview]Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).
NCT00471237 (25) [back to overview]Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans
NCT00471237 (25) [back to overview]Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans
NCT00471237 (25) [back to overview]Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans
NCT00471237 (25) [back to overview]Blood Concentrations of Ronacaleret
NCT00471237 (25) [back to overview]Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event
NCT00471237 (25) [back to overview]Number of Participants With Hypercalcemia
NCT00471237 (25) [back to overview]Number of Participants Withdrew Due to Hypercalcemia
NCT00471237 (25) [back to overview]Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)
NCT00471237 (25) [back to overview]Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans
NCT00471237 (25) [back to overview]Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)
NCT00471237 (25) [back to overview]Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret
NCT00471237 (25) [back to overview]Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)
NCT00471237 (25) [back to overview]Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)
NCT00471237 (25) [back to overview]Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)
NCT00503113 (8) [back to overview]Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
NCT00503113 (8) [back to overview]Relative Change From Baseline in Mean Serum Creatinine.
NCT00503113 (8) [back to overview]Relative Change From Baseline in Actual GFR (Using CG Formula)
NCT00503113 (8) [back to overview]Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
NCT00503113 (8) [back to overview]Absolute Change From Baseline in Mean Serum Creatinine.
NCT00503113 (8) [back to overview]Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
NCT00503113 (8) [back to overview]Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
NCT00503113 (8) [back to overview]Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
NCT00504166 (1) [back to overview]Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT
NCT00518531 (18) [back to overview]Compliance With Treatment in the Second Treatment Period
NCT00518531 (18) [back to overview]Compliance With Treatment in the First Treatment Period
NCT00518531 (18) [back to overview]Beliefs About Medicines Questionnaire (BMQ): Necessity Score
NCT00518531 (18) [back to overview]Adherence With Treatment in the Second Treatment Period
NCT00518531 (18) [back to overview]Beliefs About Medicines Questionnaire (BMQ) Concern Score
NCT00518531 (18) [back to overview]Time to Non-persistence to Alendronate Treatment in the Second Treatment Period
NCT00518531 (18) [back to overview]Adherence With Treatment in the First Treatment Period
NCT00518531 (18) [back to overview]Persistence With Treatment in the Second Treatment Period
NCT00518531 (18) [back to overview]Time to Non-adherence to Alendronate Treatment in the First Treatment Period
NCT00518531 (18) [back to overview]Time to Non-adherence to Alendronate Treatment in the Second Treatment Period
NCT00518531 (18) [back to overview]Time to Non-compliance to Alendronate Treatment in the First Treatment Period
NCT00518531 (18) [back to overview]Time to Non-compliance to Alendronate Treatment in the Second Treatment Period
NCT00518531 (18) [back to overview]Time to Non-persistence to Alendronate Treatment in the First Treatment Period
NCT00518531 (18) [back to overview]Persistence With Treatment in the First Treatment Period
NCT00518531 (18) [back to overview]Overall Satisfaction to Study Treatment
NCT00518531 (18) [back to overview]Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period
NCT00518531 (18) [back to overview]Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period
NCT00518531 (18) [back to overview]Beliefs About Medicines Questionnaire (BMQ) Preference Score
NCT00580047 (2) [back to overview]Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation
NCT00580047 (2) [back to overview]Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant
NCT00680953 (3) [back to overview]The Percentage of Non-vertebral Fractures
NCT00680953 (3) [back to overview]Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.
NCT00680953 (3) [back to overview]Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo
NCT00692913 (8) [back to overview]Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52
NCT00692913 (8) [back to overview]Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density
NCT00692913 (8) [back to overview]Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
NCT00692913 (8) [back to overview]Falls Per Participant
NCT00692913 (8) [back to overview]Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase
NCT00692913 (8) [back to overview]Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase
NCT00692913 (8) [back to overview]Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
NCT00692913 (8) [back to overview]Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26
NCT00729651 (4) [back to overview]Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment
NCT00729651 (4) [back to overview]Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment
NCT00729651 (4) [back to overview]Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment
NCT00729651 (4) [back to overview]Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment
NCT00803790 (3) [back to overview]Part 1: Urinary Excretion of Alendronate
NCT00803790 (3) [back to overview]Part II : Maximum Concentration (Cmax) of Vitamin D
NCT00803790 (3) [back to overview]Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D
NCT00806416 (3) [back to overview]Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet
NCT00806416 (3) [back to overview]Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
NCT00806416 (3) [back to overview]Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
NCT00835406 (2) [back to overview]Bioequivalence Based on Rmax
NCT00835406 (2) [back to overview]Bioequivalence Based on Ae0-36
NCT00896532 (15) [back to overview]Percent Change From Baseline in Osteocalcin
NCT00896532 (15) [back to overview]Percent Change From Baseline in Osteocalcin
NCT00896532 (15) [back to overview]Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
NCT00896532 (15) [back to overview]Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
NCT00896532 (15) [back to overview]Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine
NCT00896532 (15) [back to overview]Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
NCT00896532 (15) [back to overview]Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
NCT00896532 (15) [back to overview]Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
NCT00896532 (15) [back to overview]Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
NCT00896532 (15) [back to overview]Percent Change From Baseline at Month 12 in BMD of the Femoral Neck
NCT00896532 (15) [back to overview]Percent Change From Baseline at Month 6 in BMD of the Total Hip
NCT00896532 (15) [back to overview]Percent Change From Baseline at Month 6 in BMD of the Femoral Neck
NCT00896532 (15) [back to overview]Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine
NCT00896532 (15) [back to overview]Percent Change From Baseline at Month 12 in BMD of the Total Hip
NCT00896532 (15) [back to overview]Percent Change From Baseline at Month 12 in BMD of the Distal Radius
NCT00920075 (3) [back to overview]Number of Participants With Fracture
NCT00920075 (3) [back to overview]Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).
NCT00920075 (3) [back to overview]Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).
NCT00921557 (13) [back to overview]Percent Change From Baseline to Week 96 in Lumbar Spine BMD
NCT00921557 (13) [back to overview]Percent Change From Baseline to Weeks 24 and 48 in Whole Body (With Head) BMD
NCT00921557 (13) [back to overview]Change in CD4 Percent From Baseline
NCT00921557 (13) [back to overview]Percent of Participants With HIV-1 RNA <= 400 Copies/ml
NCT00921557 (13) [back to overview]Safety as Measured by the Incidence of New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures
NCT00921557 (13) [back to overview]Percentage of Participants Developing New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures
NCT00921557 (13) [back to overview]Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Whole Body (With Head) BMD
NCT00921557 (13) [back to overview]Change in Centers for Disease Control (CDC) HIV Disease Category
NCT00921557 (13) [back to overview]Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Lumbar Spine BMD
NCT00921557 (13) [back to overview]Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Lumbar Spine BMD
NCT00921557 (13) [back to overview]Percent Change From Baseline to Week 96 in Whole Body (With Head) BMD
NCT00921557 (13) [back to overview]Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Whole Body (With Head) BMD.
NCT00921557 (13) [back to overview]Percent Change From Baseline to Weeks 24 and 48 in Lumbar Spine BMD
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Hip
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in 1/3 Distal Forearm Areal BMD
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD of the Hip
NCT00996801 (17) [back to overview]Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once
NCT00996801 (17) [back to overview]Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once
NCT00996801 (17) [back to overview]Number of Participants With Predefined Tier 1 Adverse Events
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Urinary-N Telopeptides of Type 1 Collagen (u-NTx)
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Trochanter Areal BMD
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD (vBMD) of the Lumbar Spine
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Total Hip Areal BMD
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Total Body Areal BMD
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Serum N-Terminal Propeptide (s-P1NP)
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Serum C-Terminal Propeptide of Type 1 Collagen (s-CTx)
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD)
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Femoral Neck Areal BMD
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Lumbar Spine
NCT01065779 (8) [back to overview]Change From Baseline in Serum Osteocalcin at End of Treatment
NCT01065779 (8) [back to overview]Change From Baseline in Urine Deoxypyridinoline at End of Treatment
NCT01065779 (8) [back to overview]Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment
NCT01065779 (8) [back to overview]Change From Baseline in Alkaline Phosphatase at End of Treatment
NCT01065779 (8) [back to overview]Number of Participants With Improved, Unchanged, or Worsened Disease
NCT01065779 (8) [back to overview]Number of Participants With Unexpected Adverse Events
NCT01065779 (8) [back to overview]Number of Participants With Serious Adverse Events
NCT01065779 (8) [back to overview]Number of Participants With Non-Serious AEs
NCT01077817 (2) [back to overview]Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)
NCT01077817 (2) [back to overview]Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)
NCT01350934 (7) [back to overview]Extension Study: Percentage Change From Baseline in s-P1NP at Month 12
NCT01350934 (7) [back to overview]Extension Study: Percentage Change From Baseline in s-CTx at Month 12
NCT01350934 (7) [back to overview]Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12
NCT01350934 (7) [back to overview]Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at Month 6
NCT01350934 (7) [back to overview]Base Study: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 6
NCT01350934 (7) [back to overview]Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6
NCT01350934 (7) [back to overview]Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12
NCT01437111 (2) [back to overview]Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
NCT01437111 (2) [back to overview]Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26
NCT01460654 (1) [back to overview]Percent Change in Spine Bone Density From Baseline to 12 Months
NCT01512446 (3) [back to overview]Number of New Osteoporotic Fractures
NCT01512446 (3) [back to overview]Mortality
NCT01512446 (3) [back to overview]Combination of New Osteoporotic Fractures and Deaths
NCT01631214 (28) [back to overview]Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24
NCT01631214 (28) [back to overview]Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12
NCT01631214 (28) [back to overview]Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24
NCT01631214 (28) [back to overview]Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36
NCT01631214 (28) [back to overview]Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36
NCT01631214 (28) [back to overview]Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24
NCT01631214 (28) [back to overview]Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36
NCT01631214 (28) [back to overview]Percentage of Participants With a Clinical Fracture at the Primary Analysis
NCT01631214 (28) [back to overview]Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24
NCT01631214 (28) [back to overview]Percentage of Participants With Any Fracture at the Primary Analysis
NCT01631214 (28) [back to overview]Percentage of Participants With a Nonvertebral Fracture Through Month 24
NCT01631214 (28) [back to overview]Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
NCT01631214 (28) [back to overview]Percentage of Participants With a Nonvertebral Fracture Through Month 12
NCT01631214 (28) [back to overview]Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12
NCT01631214 (28) [back to overview]Percentage of Participants With Any Fracture Through Month 12
NCT01631214 (28) [back to overview]Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis
NCT01631214 (28) [back to overview]Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24
NCT01631214 (28) [back to overview]Percentage of Participants With a Major Osteoporotic Fracture Through Month 12
NCT01631214 (28) [back to overview]Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis
NCT01631214 (28) [back to overview]Percentage of Participants With a Hip Fracture Through Month 24
NCT01631214 (28) [back to overview]Percentage of Participants With a Hip Fracture Through Month 12
NCT01631214 (28) [back to overview]Percentage of Participants With a Hip Fracture at the Primary Analysis
NCT01631214 (28) [back to overview]Percentage of Participants With a Clinical Vertebral Fracture Through Month 24
NCT01631214 (28) [back to overview]Percentage of Participants With a Clinical Vertebral Fracture Through Month 12
NCT01631214 (28) [back to overview]Percentage of Participants With a Clinical Fracture Through Month 24
NCT01631214 (28) [back to overview]Percentage of Participants With a Clinical Fracture Through Month 12
NCT01631214 (28) [back to overview]Percentage of Participants With New Vertebral Fractures Through Month 24
NCT01631214 (28) [back to overview]Percentage of Participants With New Vertebral Fractures Through Month 12
NCT01656629 (1) [back to overview]The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN).
NCT01657162 (11) [back to overview]Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)
NCT01657162 (11) [back to overview]Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only)
NCT01657162 (11) [back to overview]Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline
NCT01657162 (11) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)
NCT01657162 (11) [back to overview]Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only)
NCT01657162 (11) [back to overview]Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)
NCT01657162 (11) [back to overview]Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)
NCT01657162 (11) [back to overview]Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
NCT01657162 (11) [back to overview]Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
NCT01657162 (11) [back to overview]Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)
NCT01657162 (11) [back to overview]Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)
NCT01750086 (1) [back to overview]Bone Turnover Marker (Blood Sample)
NCT02139007 (6) [back to overview]All Study Sites--Length of Contracting Procedures
NCT02139007 (6) [back to overview]All Study Sites--Length of Time to Site IRB Approval
NCT02139007 (6) [back to overview]All Study Sites-Length of Time to 1st Participant Enrolled
NCT02139007 (6) [back to overview]Atypical Femoral Fracture
NCT02139007 (6) [back to overview]Clinical Fracture Rate
NCT02139007 (6) [back to overview]Osteonecrosis of the Jaw
NCT02195895 (5) [back to overview]BMD by DXA at the Lumbar Spine
NCT02195895 (5) [back to overview]BMD of Total Hip by DXA
NCT02195895 (5) [back to overview]C-terminal Telopeptide (CTX)
NCT02195895 (5) [back to overview]Amino-terminal Propeptide of Type 1 Collagen (P1NP)
NCT02195895 (5) [back to overview]Bone-specific Alkaline Phosphatase (BSAP)
NCT02230332 (6) [back to overview]Asthma Control Test (ACT)
NCT02230332 (6) [back to overview]Salmeterol Protected Methacholine Challenge PC20
NCT02230332 (6) [back to overview]Beta-2 Adrenergic Receptor Agonist-induced cAMP Production
NCT02230332 (6) [back to overview]Fractional Exhaled Nitrix Oxide
NCT02230332 (6) [back to overview]Peripheral Blood Mononuclear Cell ADRB2 Cell Surface Density
NCT02230332 (6) [back to overview]Salivary Alpha Amylase Ratio (Post-Salmeterol / Pre-Salmeterol)
NCT02304757 (4) [back to overview]Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100)
NCT02304757 (4) [back to overview]Percent Change of Bone Mineral Density in Lumbar and Hip
NCT02304757 (4) [back to overview]Side Effects
NCT02304757 (4) [back to overview]Bone Turnover Markers
NCT02371252 (2) [back to overview]Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
NCT02371252 (2) [back to overview]Bone Mineral Density (BMD) at Total Hip
NCT02440581 (5) [back to overview]Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip
NCT02440581 (5) [back to overview]Change in Serum Biochemical Bone Markers of Bone Activity - Bone-specific Alkaline Phosphatase (BSAP)
NCT02440581 (5) [back to overview]Change in Serum Biochemical Bone Markers of Bone Activity - Fibroblast Growth Factor 23 (FGF23)
NCT02440581 (5) [back to overview]Change in Serum Biochemical Bone Markers of Bone Activity - Parathyroid Hormone (PTH)
NCT02440581 (5) [back to overview]Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT)
NCT03051620 (5) [back to overview]Number of Participants in Which CTX Increased Above the Least Significant Change
NCT03051620 (5) [back to overview]Percent Change in Bone Turnover Markers Measured Three and Six Months After Stopping Alendronate Treatment and BMD After One and Two Years
NCT03051620 (5) [back to overview]The Number of Participants Who Lost BMD Beyond the Least Significant Change (LSC) at the Lumbar Spine and Total Hip.
NCT03051620 (5) [back to overview]If Baseline Bone Turnover Markers at the Time of Alendronate Discontinuation Predict Changes in BMD After One and Two Years.
NCT03051620 (5) [back to overview]If Carboxy-terminal Collagen Crosslinks (CTX) Three and Six Months After Stopping Alendronate Predicted TH BMD (Total Hip BMD) Loss Above the Least Significant Change at Month 12 at the Individual Level.
NCT03292146 (3) [back to overview]Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA
NCT03292146 (3) [back to overview]Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)
NCT03292146 (3) [back to overview]Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA

Number of Participants With Increased Bone Mineral Density

Number of participants with increase in bone mineral density at Lumbar Spine and/or Hip at 12 months as compared to the bone mineral density at Lumbar Spine and/or Hip obtained before therapy (baseline values) (NCT00010439)
Timeframe: at 12 months

Interventionparticipants (Number)
Alendronate10

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Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy.

Participants (pts) with fractures bef.and aft.therapy; pts analysed for average changes in mineral apposition rate (MAR) (high (1.9um/day) to near normal (1.2 um/day)as revealed in bone biopsies. MAR is the distance between the two tetracycline labels (um/day). The data represent the average of 10-17 measurements of the disltance obtained by reading 2-7 individual slides of bone biopsy and pts analysed for average insignificant biochemical markers (serum bone specific alkaline phosphatase for bone formation and urinary N-telopeptide for resorption)to determine the effect of therapy. (NCT00010439)
Timeframe: Before and 12 months after treatment with alendronate

Interventionparticipants (Number)
Participants with fractures before therapy.Participants with fractures after therapy.Pts average MAR near normal after therapyPts av biomarker change insignificant aft. therapy
Alendronate9199

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Total Body Bone Mineral Density Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 12 months

InterventionPercent change (Least Squares Mean)
Placebo-0.21
Denosumab 6 mg Q3M1.82
Denosumab 14 mg Q3M1.80
Denosumab 30 mg Q3M2.74
Denosumab 14 mg Q6M0.55
Denosumab 60 mg Q6M2.51
Denosumab 100 mg Q6M1.78
Denosumab 210 mg Q6M2.08
Alendronate 70 mg1.51

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Total Hip Bone Mineral Density Percent Change From Baseline at Month 42

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 42 months

InterventionPercent change (Least Squares Mean)
Placebo-1.96
Denosumab 6 mg Q3M5.01
Denosumab 14 mg Q3M3.98
Denosumab 30 mg Q3M2.37
Denosumab 14 mg Q6M4.54
Denosumab 60 mg Q6M6.34
Denosumab 100 mg Q6M4.70
Denosumab 210 mg Q6M-2.67
Alendronate 70 mg2.98

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Total Hip Bone Mineral Density Percent Change From Baseline at Month 48

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 48 months

InterventionPercent change (Least Squares Mean)
Placebo-3.52
Denosumab 6 mg Q3M5.45
Denosumab 14 mg Q3M4.03
Denosumab 30 mg Q3M3.86
Denosumab 14 mg Q6M4.82
Denosumab 60 mg Q6M6.06
Denosumab 100 mg Q6M4.99
Denosumab 210 mg Q6M-1.37
Alendronate 70 mg1.17

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Urine NTX/Creatinine Percent Change From Baseline at Month 12

Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and Month 12

InterventionPercent change (Median)
Placebo24.300
Denosumab 6 mg Q3M-40.018
Denosumab 14 mg Q3M-54.688
Denosumab 30 mg Q3M-60.652
Denosumab 14 mg Q6M-2.027
Denosumab 60 mg Q6M-36.523
Denosumab 100 mg Q6M-51.256
Denosumab 210 mg Q6M-58.502
Alendronate 70 mg-45.409

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Urine NTX/Creatinine Percent Change From Baseline at Month 24

Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 24 months

InterventionPercent change (Median)
Placebo14.422
Denosumab 6 mg Q3M-19.699
Denosumab 14 mg Q3M-37.691
Denosumab 30 mg Q3M-49.907
Denosumab 14 mg Q6M2.134
Denosumab 60 mg Q6M-32.303
Denosumab 100 mg Q6M-37.001
Denosumab 210 mg Q6M-47.105
Alendronate 70 mg-44.482

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Urine NTX/Creatinine Percent Change From Baseline at Month 36

Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 36 months

InterventionPercent change (Median)
Placebo0.508
Denosumab 6 mg Q3M-33.294
Denosumab 14 mg Q3M-47.752
Denosumab 30 mg Q3M82.910
Denosumab 14 mg Q6M-44.301
Denosumab 60 mg Q6M-36.874
Denosumab 100 mg Q6M-27.174
Denosumab 210 mg Q6M70.997
Alendronate 70 mg-15.627

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Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Alendronate 70 mg4.59

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Urine NTX/Creatinine Percent Change From Baseline at Month 42

Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 42 months

InterventionPercent change (Median)
Placebo-18.102
Denosumab 6 mg Q3M-40.741
Denosumab 14 mg Q3M-40.043
Denosumab 30 mg Q3M-58.893
Denosumab 14 mg Q6M-47.188
Denosumab 60 mg Q6M-39.269
Denosumab 100 mg Q6M-46.674
Denosumab 210 mg Q6M26.277
Alendronate 70 mg-33.102

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Serum CTX Percent Change From Baseline at Month 24

Serum C-Telopeptide (CTX). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 24 months

InterventionPercent change (Median)
Placebo-5.940
Denosumab 6 mg Q3M-50.687
Denosumab 14 mg Q3M-74.078
Denosumab 30 mg Q3M-83.985
Denosumab 14 mg Q6M-8.467
Denosumab 60 mg Q6M-68.437
Denosumab 100 mg Q6M-80.460
Denosumab 210 mg Q6M-85.680
Alendronate 70 mg-69.386

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Serum CTX Percent Change From Baseline at Month 12

Serum C-Telopeptide (CTX). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and Month 12

InterventionPercent change (Median)
Placebo-4.699
Denosumab 6 mg Q3M-61.366
Denosumab 14 mg Q3M-77.989
Denosumab 30 mg Q3M-87.238
Denosumab 14 mg Q6M-12.054
Denosumab 60 mg Q6M-70.757
Denosumab 100 mg Q6M-78.617
Denosumab 210 mg Q6M-84.107
Alendronate 70 mg-72.603

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Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 48 months

InterventionPercent change (Least Squares Mean)
Placebo-2.39
Denosumab 6 mg Q3M9.35
Denosumab 14 mg Q3M9.93
Denosumab 30 mg Q3M9.03
Denosumab 14 mg Q6M10.10
Denosumab 60 mg Q6M10.34
Denosumab 100 mg Q6M11.76
Denosumab 210 mg Q6M2.50
Alendronate 70 mg4.54

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Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 42 months

InterventionPercent change (Least Squares Mean)
Placebo1.09
Denosumab 6 mg Q3M7.21
Denosumab 14 mg Q3M10.04
Denosumab 30 mg Q3M5.06
Denosumab 14 mg Q6M9.46
Denosumab 60 mg Q6M9.59
Denosumab 100 mg Q6M9.99
Denosumab 210 mg Q6M1.06
Alendronate 70 mg6.51

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Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 36 months

InterventionPercent change (Least Squares Mean)
Placebo-1.80
Denosumab 6 mg Q3M8.57
Denosumab 14 mg Q3M9.17
Denosumab 30 mg Q3M1.94
Denosumab 14 mg Q6M7.99
Denosumab 60 mg Q6M9.04
Denosumab 100 mg Q6M10.63
Denosumab 210 mg Q6M0.85
Alendronate 70 mg4.70

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Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 24 months

InterventionPercent change (Least Squares Mean)
Placebo-1.25
Denosumab 6 mg Q3M7.42
Denosumab 14 mg Q3M7.21
Denosumab 30 mg Q3M8.83
Denosumab 14 mg Q6M3.94
Denosumab 60 mg Q6M7.19
Denosumab 100 mg Q6M7.31
Denosumab 210 mg Q6M7.86
Alendronate 70 mg6.09

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Serum CTX Percent Change From Baseline at Month 36

Serum C-Telopeptide (CTX). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 36 months

InterventionPercent change (Median)
Placebo-16.577
Denosumab 6 mg Q3M-62.298
Denosumab 14 mg Q3M-53.643
Denosumab 30 mg Q3M56.286
Denosumab 14 mg Q6M-57.500
Denosumab 60 mg Q6M-54.418
Denosumab 100 mg Q6M-45.057
Denosumab 210 mg Q6M72.135
Alendronate 70 mg-33.982

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Serum CTX Percent Change From Baseline at Month 42

Serum C-Telopeptide (CTX). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 42 months

InterventionPercent change (Median)
Placebo-16.279
Denosumab 6 mg Q3M-63.543
Denosumab 14 mg Q3M-40.827
Denosumab 30 mg Q3M-62.334
Denosumab 14 mg Q6M-46.408
Denosumab 60 mg Q6M-57.255
Denosumab 100 mg Q6M-56.377
Denosumab 210 mg Q6M33.999
Alendronate 70 mg-46.743

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Serum CTX Percent Change From Baseline at Month 48

Serum C-Telopeptide (CTX). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 48 months

InterventionPercent change (Median)
Placebo-14.561
Denosumab 6 mg Q3M-40.016
Denosumab 14 mg Q3M-34.999
Denosumab 30 mg Q3M-52.656
Denosumab 14 mg Q6M-39.899
Denosumab 60 mg Q6M-51.494
Denosumab 100 mg Q6M-36.480
Denosumab 210 mg Q6M7.067
Alendronate 70 mg-43.724

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Total Body Bone Mineral Density Percent Change From Baseline at Month 24

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 24 months

InterventionPercent change (Least Squares Mean)
Placebo-1.64
Denosumab 6 mg Q3M2.59
Denosumab 14 mg Q3M2.91
Denosumab 30 mg Q3M4.44
Denosumab 14 mg Q6M0.89
Denosumab 60 mg Q6M2.57
Denosumab 100 mg Q6M3.00
Denosumab 210 mg Q6M2.75
Alendronate 70 mg1.50

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Total Body Bone Mineral Density Percent Change From Baseline at Month 36

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 36 months

InterventionPercent change (Least Squares Mean)
Placebo-1.61
Denosumab 6 mg Q3M3.14
Denosumab 14 mg Q3M3.04
Denosumab 30 mg Q3M2.34
Denosumab 14 mg Q6M2.04
Denosumab 60 mg Q6M2.80
Denosumab 100 mg Q6M2.59
Denosumab 210 mg Q6M-0.29
Alendronate 70 mg4.55

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Total Body Bone Mineral Density Percent Change From Baseline at Month 42

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 42 months

InterventionPercent change (Least Squares Mean)
Placebo1.61
Denosumab 6 mg Q3M1.90
Denosumab 14 mg Q3M4.05
Denosumab 30 mg Q3M8.85
Denosumab 14 mg Q6M3.72
Denosumab 60 mg Q6M4.92
Denosumab 100 mg Q6M3.79
Denosumab 210 mg Q6M-0.75
Alendronate 70 mg2.85

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Total Body Bone Mineral Density Percent Change From Baseline at Month 48

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 48 months

InterventionPercent change (Least Squares Mean)
Placebo-2.54
Denosumab 6 mg Q3M3.68
Denosumab 14 mg Q3M3.38
Denosumab 30 mg Q3M3.76
Denosumab 14 mg Q6M3.42
Denosumab 60 mg Q6M3.43
Denosumab 100 mg Q6M3.68
Denosumab 210 mg Q6M-0.29
Alendronate 70 mg4.49

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Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 12 months

InterventionPercent change (Least Squares Mean)
Placebo-0.56
Denosumab 6 mg Q3M2.89
Denosumab 14 mg Q3M2.45
Denosumab 30 mg Q3M3.32
Denosumab 14 mg Q6M1.94
Denosumab 60 mg Q6M3.56
Denosumab 100 mg Q6M2.53
Denosumab 210 mg Q6M2.33
Alendronate 70 mg2.11

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Total Hip Bone Mineral Density Percent Change From Baseline at Month 24

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 24 months

InterventionPercent change (Least Squares Mean)
Placebo-1.92
Denosumab 6 mg Q3M4.04
Denosumab 14 mg Q3M3.55
Denosumab 30 mg Q3M5.03
Denosumab 14 mg Q6M2.62
Denosumab 60 mg Q6M4.96
Denosumab 100 mg Q6M3.67
Denosumab 210 mg Q6M4.18
Alendronate 70 mg3.27

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Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Placebo-0.81
Denosumab 6 mg Q3M4.41
Denosumab 14 mg Q3M4.71
Denosumab 30 mg Q3M6.69
Denosumab 14 mg Q6M3.03
Denosumab 60 mg Q6M4.55
Denosumab 100 mg Q6M5.52
Denosumab 210 mg Q6M5.07

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Urine NTX/Creatinine Percent Change From Baseline at Month 48

Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 48 months

InterventionPercent change (Median)
Placebo-21.064
Denosumab 6 mg Q3M-23.311
Denosumab 14 mg Q3M-38.002
Denosumab 30 mg Q3M-50.864
Denosumab 14 mg Q6M-46.128
Denosumab 60 mg Q6M-40.375
Denosumab 100 mg Q6M-41.998
Denosumab 210 mg Q6M7.884
Alendronate 70 mg-32.198

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Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 48 months

InterventionPercent change (Least Squares Mean)
Placebo-4.67
Denosumab 6 mg Q3M1.04
Denosumab 14 mg Q3M1.42
Denosumab 30 mg Q3M1.77
Denosumab 14 mg Q6M1.74
Denosumab 60 mg Q6M1.71
Denosumab 100 mg Q6M1.37
Denosumab 210 mg Q6M-0.94
Alendronate 70 mg-2.67

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Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 42 months

InterventionPercent change (Least Squares Mean)
Placebo-6.59
Denosumab 6 mg Q3M1.00
Denosumab 14 mg Q3M0.82
Denosumab 30 mg Q3M-3.91
Denosumab 14 mg Q6M1.29
Denosumab 60 mg Q6M-0.87
Denosumab 100 mg Q6M0.02
Denosumab 210 mg Q6M0.59
Alendronate 70 mg-3.32

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Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 36 months

InterventionPercent change (Least Squares Mean)
Placebo-3.64
Denosumab 6 mg Q3M1.99
Denosumab 14 mg Q3M1.06
Denosumab 30 mg Q3M1.05
Denosumab 14 mg Q6M2.08
Denosumab 60 mg Q6M2.69
Denosumab 100 mg Q6M1.92
Denosumab 210 mg Q6M0.12
Alendronate 70 mg-0.95

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Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 24 months

InterventionPercent change (Least Squares Mean)
Placebo-2.78
Denosumab 6 mg Q3M1.31
Denosumab 14 mg Q3M0.62
Denosumab 30 mg Q3M1.30
Denosumab 14 mg Q6M2.48
Denosumab 60 mg Q6M1.89
Denosumab 100 mg Q6M1.48
Denosumab 210 mg Q6M0.81
Alendronate 70 mg-0.78

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Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 12 months

InterventionPercent change (Least Squares Mean)
Placebo-1.97
Denosumab 6 mg Q3M0.89
Denosumab 14 mg Q3M0.40
Denosumab 30 mg Q3M1.10
Denosumab 14 mg Q6M0.94
Denosumab 60 mg Q6M1.29
Denosumab 100 mg Q6M1.07
Denosumab 210 mg Q6M1.09
Alendronate 70 mg-0.53

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Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48

Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 48 months

InterventionPercent change (Median)
Placebo18.122
Denosumab 6 mg Q3M-34.727
Denosumab 14 mg Q3M-45.779
Denosumab 30 mg Q3M-47.770
Denosumab 14 mg Q6M-46.286
Denosumab 60 mg Q6M-34.361
Denosumab 100 mg Q6M-42.653
Denosumab 210 mg Q6M21.053
Alendronate 70 mg-17.891

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Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42

Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 42 months

InterventionPercent change (Median)
Placebo1.288
Denosumab 6 mg Q3M-40.182
Denosumab 14 mg Q3M-40.819
Denosumab 30 mg Q3M-52.684
Denosumab 14 mg Q6M-53.763
Denosumab 60 mg Q6M-44.892
Denosumab 100 mg Q6M-48.303
Denosumab 210 mg Q6M17.841
Alendronate 70 mg-22.069

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Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36

Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 36 months

InterventionPercent change (Median)
Placebo1.955
Denosumab 6 mg Q3M-39.012
Denosumab 14 mg Q3M-56.021
Denosumab 30 mg Q3M22.343
Denosumab 14 mg Q6M-47.500
Denosumab 60 mg Q6M-42.541
Denosumab 100 mg Q6M-47.418
Denosumab 210 mg Q6M61.747
Alendronate 70 mg-8.209

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Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24

Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 24 months

InterventionPercent change (Median)
Placebo16.464
Denosumab 6 mg Q3M-41.225
Denosumab 14 mg Q3M-47.597
Denosumab 30 mg Q3M-57.905
Denosumab 14 mg Q6M-22.350
Denosumab 60 mg Q6M-43.448
Denosumab 100 mg Q6M-50.176
Denosumab 210 mg Q6M-48.833
Alendronate 70 mg-48.778

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Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12

Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 12 months

InterventionPercent change (Median)
Placebo-4.609
Denosumab 6 mg Q3M-62.716
Denosumab 14 mg Q3M-60.098
Denosumab 30 mg Q3M-70.256
Denosumab 14 mg Q6M-39.474
Denosumab 60 mg Q6M-65.215
Denosumab 100 mg Q6M-61.979
Denosumab 210 mg Q6M-67.634
Alendronate 70 mg-61.059

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Total Hip Bone Mineral Density Percent Change From Baseline at Month 36

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100. (NCT00043186)
Timeframe: Baseline and 36 months

InterventionPercent change (Least Squares Mean)
Placebo-2.84
Denosumab 6 mg Q3M4.79
Denosumab 14 mg Q3M4.41
Denosumab 30 mg Q3M-1.23
Denosumab 14 mg Q6M4.31
Denosumab 60 mg Q6M5.83
Denosumab 100 mg Q6M4.33
Denosumab 210 mg Q6M-1.43
Alendronate 70 mg0.93

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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset

change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) (NCT00051558)
Timeframe: 18 month endpoint

Interventiongrams per square centimeters (Least Squares Mean)
Teriparatide0.056
Alendronate0.023

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Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures

Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain. (NCT00051558)
Timeframe: 36 months

,
Interventionparticipants (Number)
Any FractureNonvertebral FractureVertebral FractureClinical Vertebral FractureNonvertebral Fragility FractureSeverity-Radiographic Vertebral Fracture: MildSeverity-Radiographic Vertebral Fracture: ModerateSeverity-Radiographic Vertebral Fracture: Severe
Alendronate27151345724
Teriparatide1916309120

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Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA) (NCT00051558)
Timeframe: 18, 24, 36 months, and 18 and 36 month endpoints

,
Interventiongrams per square centimeters (Least Squares Mean)
Change, baseline to 36 month endpoint(N=185,N=177)Change from baseline at 36 months(N=120,N=113)Change from baseline at 24 months(N=135,N=131)Change, baseline to 18 month endpoint(N=185,N=176)Change from baseline at 18 months (N=156,N=145)
Alendronate0.0170.0210.0150.0140.017
Teriparatide0.0330.0410.0300.0240.028

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Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) (NCT00051558)
Timeframe: 24 and 36 months and Endpoint at 36 months

,
Interventiongrams per square centimeters (Least Squares Mean)
Change, baseline to 36 month endpoint(N=198,N=195)Change from baseline at 36 months (N=123, N=112)Change from baseline at 24 months (N=136, N=131)
Alendronate0.0340.0440.043
Teriparatide0.0730.0900.081

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Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA) (NCT00051558)
Timeframe: 18, 24, 36 months, and 18 and 36 month endpoints

,
Interventiongrams per square centimeters (Least Squares Mean)
Change, baseline to 36 month endpoint(N=185,N=177)Change from baseline at 36 months(N=120,N=113)Change from baseline at 24 months(N=135,N=131)Change, baseline to 18 month endpoint(N=185,N=176)Change from baseline at 18 months (N=156,N=144)
Alendronate0.0170.0200.0180.0170.018
Teriparatide0.0320.0370.0340.0260.027

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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin

(NCT00051558)
Timeframe: 1, 6, 18, and 36 months

,
Interventionpercent (Mean)
Percent change from baseline at Month1(N=94,N=100)Percent change from baseline at Month 6(N=84,N=88)Percent change from baseline at Month18(N=77,N=77)Percent change from baseline at Month36(N=56,N=58)
Alendronate-5.2-33.6-25.0-19.6
Teriparatide147.1120.0108.962.1

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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen

(NCT00051558)
Timeframe: 1, 6, 18, and 36 months

,
Interventionpercent (Mean)
Percent change from baseline at Month 1(N=66,N=78)Percent change from baseline at Month 6(N=67,N=76)Percent change from baseline at Month18(N=55,N=65)Percent change from baseline at Month36(N=45,N=49)
Alendronate-8.8-22.3-21.3-15.4
Teriparatide48.210.55.1-1.3

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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen

(NCT00051558)
Timeframe: 1, 6, 18, and 36 months

,
Interventionpercent (Mean)
Percent change from baseline at Month 1(N=98,N=99)Percent change from baseline at Month 6(N=86,N=85)Percent change from baseline at Month18(N=77,N=76)Percent change from baseline at Month36(N=59,N=57)
Alendronate-14.8-43.2-35.8-20.2
Teriparatide107.0130.886.361.7

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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments

(NCT00051558)
Timeframe: 1, 6, 18, and 36 months

,
Interventionpercent (Mean)
Percent change from baseline at Month 1(N=70,N=79)Percent change from baseline at Month 6(N=66,N=75)Percent change from baseline at Month18(N=64,N=71)Percent change from baseline at Month36(N=49,N=48)
Alendronate-38.6-42.4-47.5-16.2
Teriparatide29.066.829.130.7

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Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA) (NCT00051558)
Timeframe: 12, 18, 24, and 36 months

,
Interventiongrams per square centimeters (Least Squares Mean)
Change from baseline at Month 36 (N=120,N=113)Change from baseline at Month 24 (N=135,N=131)Change from baseline at Month 18 (N=156,N=145)Change from baseline at Month 12 (N=167,N=158)
Alendronate0.0210.0150.0170.012
Teriparatide0.0410.0300.0280.026

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Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset

change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) (NCT00051558)
Timeframe: 3, 6, 12, and 18 months

,
Interventiongrams per square centimeters (Least Squares Mean)
Change from baseline at Month 18 (N=127,N=119)Change from baseline at Month 12 (N=139,N=129)Change from baseline at Month 6 (N=147,N=139)Change from baseline at Month 3 (N=149,N=150)
Alendronate0.0270.0240.0150.012
Teriparatide0.0620.0520.0310.017

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Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) (NCT00051558)
Timeframe: 3, 6, 12, 18, 24, 36 months

,
Interventiongrams per square centimeters (Least Squares Mean)
Change from baseline at Month 36 (N=123,N=112)Change from baseline at Month 24 (N=136,N=131)Change from baseline at Month 18 (N=156,N=148)Change from baseline at Month 12 (N=170,N=159)Change from baseline at Month 6 (N=178,N=173)Change from baseline at Month 3 (N=183,N=184)
Alendronate0.0440.0430.0310.0280.0180.012
Teriparatide0.0900.0810.0660.0540.0340.019

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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)

change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) (NCT00051558)
Timeframe: 18 month endpoint

Interventiongrams per square centimeters (Least Squares Mean)
Teriparatide0.059
Alendronate0.028

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Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined

change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA) (NCT00051558)
Timeframe: 12, 18, 24, and 36 months

,
Interventiongrams per square centimeters (Least Squares Mean)
Change from baseline at 36 Months (N=120, N=113)Change from baseline at 24 Months (N=135, N=131)Change from baseline at 18 Months (N=156, N=145)Change from baseline at 12 Months (N=167, N=158)
Alendronate0.0200.0180.0180.014
Teriparatide0.0370.0340.0270.022

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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase

(NCT00051558)
Timeframe: 1, 6, 18, and 36 months

,
Interventionpercent (Mean)
Percent change from baseline at Month 1(N=65,N=78)Percent change from baseline at Month 6(N=66,N=76)Percent change from baseline at Month18(N=54,N=65)Percent change from baseline at Month36(N=44,N=49)
Alendronate0.5-7.2-4.120.6
Teriparatide35.052.334.444.7

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Changes in Radiographic Texture Analysis (RTA) Spectral Density Coefficient Beta (BETA) From Baseline to Month 24

The Percent Change in Radiographic Texture Analysis (RTA) spectral density coefficient beta (BETA) from Baseline to Month 24 is an analysis of spectral density vs. the spacial frequency on a log-log plot. BETA is the coefficient (slope) of this plot. Higher values of beta correspond to rougher (strong bone) and lower values to smoother, higher-frequency texture pattern (washed out bone). (NCT00145977)
Timeframe: Baseline to Month 24

InterventionPercent Change (Mean)
Alendronate3.09
Control6.53

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Changes in Total Hip BMD +/- Treatment With Alendronate

Percent Change in total hip BMD from Baseline to Month 24 (NCT00145977)
Timeframe: Baseline to Month 24

InterventionPercent Change (Mean)
Alendronate-3.68
Control-0.77

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Changes in Femoral Neck BMD +/- Treatment With Alendronate

Percent Change in femoral neck BMD from Baseline to Month 24 (NCT00145977)
Timeframe: Baseline to Month 24

InterventionPercent Change (Mean)
Alendronate-4.21
Control0.04

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Changes in Lumbar Spine BMD +/- Treatment With Alendronate

Percent Change in lumbar spine BMD from Baseline to Month 24 (NCT00145977)
Timeframe: Baseline to Month 24

InterventionPercent Change (Mean)
Alendronate5.28
Control-1.48

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Changes in Peripheral Heel BMD +/- Treatment With Alendronate

Percent Change in peripheral heel BMD from Baseline to Month 24 (NCT00145977)
Timeframe: Baseline to Month 24

InterventionPercent Change (Mean)
Alendronate1.02
Control-1.99

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Changes in Radiographic Texture Analysis (RTA) Feature Integrated First Moment of the Power Spectrum (iFMP) From Baseline to Month 24

To derive a measure of variability and directionality in the first moment of the power spectrum (FMP) in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and FMP is calculated for each segment. We use iFMP (integrated FMP) as a measure of overall special frequency of the radiographic pattern. FMP characterizes spatial frequency in the radiographic pattern and the underlying trabecular structure. This corresponds to the coarseness or fineness of the radiographic texture pattern. A high level of FMP indicates thin and closely spaced trabecular structure. Low FMP indicates widely spaced dark areas usually corresponding to a strong, thick trabecular structure. (NCT00145977)
Timeframe: Baseline to Month 24

InterventionPercent Change (Mean)
Alendronate0.09
Control1.04

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Changes in Radiographic Texture Analysis (RTA) Feature Standard Deviation of Root Mean Square (sdRMS) From Baseline to Month 24

"Root Mean Square (RMS) is a measure of the variability in the radiographic texture pattern, the relative difference in the contrast between light and dark areas is expressed in a grayscale level. In practical terms, a bone image with a washed-out appearance due to loss of trabecular structure such as that seen in osteoporosis, will have a low value for RMS because there will be relatively little contrast between lighter and darker areas of the image. An image of a bone with strong trabecular structure will have a high RMS value because the contrast between the lighter and darker areas of the image will be greater.~To derive a measure of variability in the RMS in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and RMS is calculated for each segment. We use sdRMS (standard deviation of the RMS across the segments) as a measure of the direction dependence (anisotropy) of the trabeculae in the bone image." (NCT00145977)
Timeframe: Baseline to Month 24

InterventionPercent Change (Mean)
Alendronate6.85
Control1.08

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Changes in Radiographic Texture Analysis (RTA) Integrated Root Mean Square (iRMS) From Baseline to Month 24

"Root Mean Square (RMS) is a measure of the variability in the radiographic texture pattern, the relative difference in the contrast between light and dark areas is expressed in a grayscale level. In practical terms, a bone image with a washed-out appearance due to loss of trabecular structure such as that seen in osteoporosis, will have a low value for RMS because there will be relatively little contrast between lighter and darker areas of the image. An image of a bone with strong trabecular structure will have a high RMS value because the contrast between the lighter and darker areas of the image will be greater.~To derive a measure of variability in the RMS in the region of interest in the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and RMS is calculated for each segment. The iRMS (integrated RMS) roughly corresponds to RMS averaged across all 24 angular sectors" (NCT00145977)
Timeframe: Baseline to Month 24

InterventionPercent Change (Mean)
Alendronate-3.70
Control-0.53

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Changes in Radiographic Texture Analysis (RTA) Minimum First Moment of the Power Spectrum (minFMP) From Baseline to Month 24

To derive a measure of variability and directionality in the first moment of the power spectrum (FMP) in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals and FMP is calculated for each segment. We use minFMP (minimum FMP) to represent the lowest value of FMP across the 24 angular sectors corresponding to the special frequency in the most washed-out direction. FMP characterizes spatial frequency in the radiographic pattern and the underlying trabecular structure. This corresponds to the coarseness or fineness of the radiographic texture pattern. A high level of FMP indicates thin and closely spaced trabecular structure. Low FMP indicates widely spaced dark areas usually corresponding to a strong, thick trabecular structure. (NCT00145977)
Timeframe: Baseline to Month 24

InterventionPercent Change (Mean)
Alendronate-3.61
Control-0.18

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Changes in Radiographic Texture Analysis (RTA) Minkowski Fractal Dimension (MINK) From Baseline to Month 24

The Percent Change in Radiographic Texture Analysis (RTA) Minkowski Fractal Dimension (MINK) from Baseline to Month 24 is a description of the similarity of texture of the images at different magnifications. The Minkowski fractal dimension is calculated from the slope of the least -square fitted line relating log volume and log magnification. (NCT00145977)
Timeframe: Baseline to Month 24

InterventionPercent Change (Mean)
Alendronate-0.06
Control0.12

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Bone Mineral Density

"By Dual-energy x-ray absorptiometry. Results were reported as z-scores as well as as absolute values. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome, or similar, as accurate and appropriate." (NCT00159419)
Timeframe: 2 years

Interventionz-score (Mean)
Pamidronate Treatment-1.3
Alendronate-1.1

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Participants With Atraumatic Fractures

Number of Participants with Atraumatic fractures before therapy. (NCT00259857)
Timeframe: 0 months

Interventionparticipants (Number)
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D11
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D11

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Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy

Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment. (NCT00259857)
Timeframe: 12 months therapy

Interventionparticipants (Number)
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D10
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D9

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Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy

BMD of lumbar spine was measured using DXA scan at visit 24 months (Year-2)after alendronate or placebo treatment. (NCT00259857)
Timeframe: 24 months therapy

Interventionparticipants (Number)
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D10
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D6

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Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy

(NCT00259857)
Timeframe: 12 months of therapy

Interventionparticipants (Number)
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D10
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D9

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Number of Participants With Improvement in BMD of Hip

Analysis was done per protocol and intention to treat. (NCT00259857)
Timeframe: 24 months of therapy

Interventionparticipants (Number)
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D10
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D6

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Participants With Atraumatic Fractures

Number of participants with fractures at the completion of therapy. (NCT00259857)
Timeframe: 24 months

Interventionparticipants (Number)
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D0
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D0

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Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12

Cortical Thickness measured by XtremeCT. (NCT00293813)
Timeframe: 12 months

InterventionPercent Change from Baseline (Least Squares Mean)
Alendronate 70 mg QW2.4
Denosumab 60 mg Q6M3.4
Placebo-.8

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Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12

Cortical Thickness measured by XtremeCT. (NCT00293813)
Timeframe: 12 months

InterventionPercent Change from Baseline (Least Squares Mean)
Alendronate 70 mg QW4.9
Denosumab 60 mg Q6M5.8
Placebo1.4

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Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months

BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer. (NCT00297830)
Timeframe: Baseline, 12 months

Interventionpercent change (Mean)
Active Zoledronic Acid and Placebo Alendronate0.39
Placebo Zoledronic Acid and Active Alendronate-0.21
Reference Group-2.2

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Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months

BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer. (NCT00297830)
Timeframe: Baseline, 12 months

Interventionpercent change (Mean)
Active Zoledronic Acid and Placebo Alendronate1.98
Placebo Zoledronic Acid and Active Alendronate-0.45
Reference Group-2.6

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Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 12 Months

BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer. (NCT00297830)
Timeframe: Baseline, 12 months

Interventionpercent change (Mean)
Active Zoledronic Acid and Placebo Alendronate0.28
Placebo Zoledronic Acid and Active Alendronate-0.57
Reference Group-3.3

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Trochanter Bone Mineral Density Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. (NCT00330460)
Timeframe: 12 months

InterventionPercent Change from Baseline (Least Squares Mean)
Alendronate 70 mg QW3.4
Denosumab 60 mg Q6M4.5

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Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. (NCT00330460)
Timeframe: 12 months

InterventionPercent Change from Baseline (Least Squares Mean)
Alendronate 70 mg QW0.6
Denosumab 60 mg Q6M1.1

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Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. (NCT00330460)
Timeframe: 12 months

InterventionPercent Change from Baseline (Least Squares Mean)
Alendronate 70 mg QW1.8
Denosumab 60 mg Q6M2.4

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Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. (NCT00330460)
Timeframe: 12 months

InterventionPercent Change from Baseline (Least Squares Mean)
Alendronate 70 mg QW4.2
Denosumab 60 mg Q6M5.3

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Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. (NCT00330460)
Timeframe: 12 months

InterventionPercent Change from Baseline (Least Squares Mean)
Alendronate 70 mg QW2.6
Denosumab 60 mg Q6M3.5

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100. (NCT00377819)
Timeframe: Baseline, 12 months

InterventionPercent Change (Least Squares Mean)
Alendronate 70 mg QW1.85
Denosumab 60 mg Q6M3.03

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Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)

Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100. (NCT00377819)
Timeframe: Baseline, 3 months

InterventionPercent Change (Median)
Alendronate 70 mg QW-4.2
Denosumab 60 mg Q6M-63.3

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Percent Change From Baseline in Total Hip Bone Mineral Density

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100. (NCT00377819)
Timeframe: Baseline, 12 months

InterventionPercent Change (Least Squares Mean)
Alendronate 70 mg QW1.05
Denosumab 60 mg Q6M1.9

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Therapy Preference at End of Study (Month 12)

Patients were administered a questionnaire at the end of the study in which they were asked which type of therapy, weekly oral or yearly iv, they preferred. (NCT00404820)
Timeframe: Month 12

,
InterventionParticipants (Number)
No data availableYearly ivWeekly oral
Alendronate 70 mg168293
Zoledronic Acid 5 mg3033048

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Number of Patients With a Clinical Fracture From Baseline to Month 12

A diagnosis of clinical fracture was based on physical examination findings, ie, swelling, tenderness, limited movement, pain. (NCT00404820)
Timeframe: Baseline to end of study (Month 12)

InterventionParticipants (Number)
Zoledronic Acid 5 mg10
Alendronate 70 mg4

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Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12

The level of bone activity as measured by P1NP over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study. (NCT00404820)
Timeframe: Screening to end of study (Month 12)

Interventionng/ml (Mean)
Zoledronic Acid 5 mg28.2
Alendronate 70 mg25.5

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Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population

The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study. (NCT00404820)
Timeframe: Screening to end of study (Month 12)

Interventionng/ml (Mean)
Zoledronic Acid 5 mg0.293
Alendronate 70 mg0.294

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Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population

The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study. (NCT00404820)
Timeframe: Screening to end of study (Month 12)

Interventionng/ml (Mean)
Zoledronic Acid 5 mg0.282
Alendronate 70 mg0.270

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Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12

The Qualeffo-41 QoL questionnaire was completed by the patient at Baseline and at Month 12. The questionnaire includes 41 questions covering 7 domains (pain, physical function and activities of daily living, physical function and jobs around the house, physical function and mobility, leisure and social activities, general health perception, mental function). Scores on each question range from 1 to 3, 4, or 5. The total score summed over all questions ranges from 41-205 points; the lower the score the higher the quality of life. A negative change score indicates improvement. (NCT00404820)
Timeframe: Baseline to end of study (Month 12)

InterventionUnits on a scale (Mean)
Zoledronic Acid 5 mg-1.2
Alendronate 70 mg-0.6

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Change in Body Height From Baseline to Month 12

Body height was measured at Baseline and at the end of the study (Month 12) and the change in height calculated. (NCT00404820)
Timeframe: Baseline to end of study (Month 12)

Interventioncm (Mean)
Zoledronic Acid 5 mg-0.1
Alendronate 70 mg0.0

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Number Adherent With the Intervention

(NCT00421343)
Timeframe: 6 months

Interventionparticipants (Number)
Osteoporosis Medication29

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Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)

Responder rate of participants who remained the same or had any improvement as compared to baseline in DXA BMD of vertebra, femur and vertebra plus femur were reported. Baseline values were assessed on Day 0. Percent change (improvement) from Baseline was computed as (change from baseline / baseline value) * 100%. (NCT00471237)
Timeframe: Baseline (Day 0), Month 5, 6 and 12

,,,,,,
InterventionParticipants (Count of Participants)
Month 5, Vertebra, BMD % change >=0Month 5, Femur, BMD % change >=0Month 5, Vertebra + Femur, BMD % change >=0Month 6, Vertebra, BMD % change >=0Month 6, Femur, BMD % change >=0Month 6, Vertebra + Femur, BMD % change >=0Month 12, Vertebra, BMD % change >=0Month 12, Femur, BMD % change >=0Month 12, Vertebra + Femur, BMD % change >=0Early Withdrawal, Vertebra, BMD % change >=0Early Withdrawal, Femur, BMD % change >=0Early Withdrawal, Vertebra + Femur, BMD %change>=0
Alendronate, 70 mg, Capsule, OW000111444035000
Placebo000000162010111
Ronacaleret, 100 mg Tablet, OD000000292319111
Ronacaleret, 200 mg Tablet, OD111000321412100
Ronacaleret, 300 mg Tablet, OD000000351917211
Ronacaleret, 400 mg Tablet, OD100000311616111
Teriparatide, 20 mcg, SC Injection, OD000000342524111

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Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)

Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of CTX1. (NCT00471237)
Timeframe: Baseline (Day 0), Week 4, Month 3, 6, and 12

Interventionnanogram per litre (ng/L) (Least Squares Mean)
BaselineWeek 4Month 3Month 6Month 12
Placebo625.2530.7523.5517.6525.1

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Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)

Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of P1NP. (NCT00471237)
Timeframe: Baseline (Day 0), Week 4, Month 3, 6, and 12

,,,,,
InterventionMicrogram per Litre (mcg/L) (Least Squares Mean)
BaselineBaseline, Placebo contrastWeek 4Week 4, Placebo contrastMonth 3Month 3, Placebo contrastMonth 6Month 6, Placebo contrastMonth 12Month 12, Placebo contrast
Alendronate, 70 mg, Capsule, OW47.711.0043.660.9620.150.5116.410.4316.980.42
Teriparatide, 20 mcg, SC Injection, OD48.571.0292.742.0599.742.52117.83.07119.02.92
Ronacaleret, 100 mg Tablet, OD45.590.9649.671.1049.991.2656.371.4761.431.51
Ronacaleret, 200 mg Tablet, OD47.701.0057.361.2765.211.6575.731.9782.692.03
Ronacaleret, 300 mg Tablet, OD46.620.9860.271.3373.681.8690.552.3698.042.41
Ronacaleret, 400 mg Tablet, OD46.190.9763.461.4086.842.20104.62.72112.62.76

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Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)

Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of P1NP. (NCT00471237)
Timeframe: Baseline (Day 0), Week 4, Month 3, 6, and 12

InterventionMicrogram per Litre (mcg/L) (Least Squares Mean)
BaselineWeek 4Month 3Month 6Month 12
Placebo47.6645.3239.5338.4140.74

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Maximum Blood Concentration (Cmax) of Ronacaleret

Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, Cmax of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects. (NCT00471237)
Timeframe: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12

,,,
Interventionng/mL (Geometric Mean)
Cmax. Month 6Cmax. Month 12
Ronacaleret, 100 mg Tablet, OD572.10661.70
Ronacaleret, 200 mg Tablet, OD1050.42999.91
Ronacaleret, 300 mg Tablet, OD1756.452254.26
Ronacaleret, 400 mg Tablet, OD1556.581506.45

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Mean Change From Baseline in Height

Assessments performed on Day 0 were considered as Baseline. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in height at Month 6 and 12 and early withdrawal were reported. (NCT00471237)
Timeframe: Baseline (Day 0), Month 6, 12 and early withdrawal

,,,,,,
InterventionCentimeter (Mean)
Month 6Month 12Early withdrawal
Alendronate, 70 mg, Capsule, OW-0.07-0.08-0.37
Placebo-0.04-0.140.03
Ronacaleret, 100 mg Tablet, OD0.170.040.17
Ronacaleret, 200 mg Tablet, OD0.720.02-0.13
Ronacaleret, 300 mg Tablet, OD0.05-0.09-0.16
Ronacaleret, 400 mg Tablet, OD-0.04-0.17-0.16
Teriparatide, 20 mcg, SC Injection, OD0.110.110

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Mean Change From Baseline in Weight

Baseline values were assessed on Day 0. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in weight at Month 6, 12 and early withdrawal were reported. (NCT00471237)
Timeframe: Baseline (Day 0), Month 6, 12 and early withdrawal

,,,,,,
InterventionKilogram (Mean)
Month 6Month 12Early withdrawal
Alendronate, 70 mg, Capsule, OW0.290.57-0.12
Placebo-0.020.32-0.45
Ronacaleret, 100 mg Tablet, OD0.27-0.720.40
Ronacaleret, 200 mg Tablet, OD0.451.18-0.34
Ronacaleret, 300 mg Tablet, OD-0.24-0.220.37
Ronacaleret, 400 mg Tablet, OD0.11-0.480.00
Teriparatide, 20 mcg, SC Injection, OD0.510.09-2.15

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Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit

The hematology parameters analyzed were white blood cells (WBC) count with differential WBC count, red blood cells, haemoglobin, haematocrit, mean corpuscular volume and platelet count. The clinical chemistry parameters analyzed were sodium, potassium, calcium, calcium (albumin adjusted), phosphate, bicarbonate, creatinine, bilirubin (total), alanine amino transferase, aspartate amino transferase, glucose, albumin, alkaline phosphatase, creatine phosphokinase, urea, uric acid, total protein, 25-OH vitamin D, 1,25-2(OH) vitamin D, whole parathyroid hormone (PTH 1-84)) and intact PTH (1-84 and 7-84). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important laboratory findings at any visit were reported. (NCT00471237)
Timeframe: Up to Month 12

,,,,,,
InterventionParticipants (Count of Participants)
Monocytes- highTotal neutrophils- highTotal neutrophils- lowEosinophils- highGlucose- highGlucose- lowBasophils- highHematocrit- lowHemoglobin- highHemoglobin- lowPlatelets- highWhite Blood Cell- highWhite Blood Cell- lowCalcium- highPhosphorus- highAlkaline Phosphatase- highTotal bilirubin- high
Alendronate, 70 mg, Capsule, OW28613115010001000010
Placebo179161210322122110100
Ronacaleret, 100 mg Tablet, OD1411586000000010011
Ronacaleret, 200 mg Tablet, OD19108119410101201002
Ronacaleret, 300 mg Tablet, OD17108185002020021131
Ronacaleret, 400 mg Tablet, OD18414194310110101031
Teriparatide, 20 mcg, SC Injection, OD64463001110100100

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Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit

The potential clinical importance ranges (low and high) of the vital sign parameters-systolic blood pressure (> 30 millimeter of mercury [mmHg] decrease from Baseline, > 30 mmHg increase from Baseline), diastolic blood pressure (> 20 mmHg decrease from Baseline and > 20 mmHg increase from Baseline) and heart rate (<45 and >120 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported. (NCT00471237)
Timeframe: Up to 12 Months

,,,,,,
InterventionParticipants (Count of Participants)
Systolic Blood Pressure, HighSystolic Blood Pressure, LowDiastolic Blood Pressure, HighDiastolic Blood Pressure, LowHeart Rate, Low
Alendronate, 70 mg, Capsule, OW883100
Placebo56282
Ronacaleret, 100 mg Tablet, OD108690
Ronacaleret, 200 mg Tablet, OD810541
Ronacaleret, 300 mg Tablet, OD961121
Ronacaleret, 400 mg Tablet, OD1146101
Teriparatide, 20 mcg, SC Injection, OD13120

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Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)

Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. (NCT00471237)
Timeframe: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12

,,,
Interventionh (Median)
Tmax, Month 6Tmax, Month 12
Ronacaleret, 100 mg Tablet, OD1.4831.000
Ronacaleret, 200 mg Tablet, OD1.2501.500
Ronacaleret, 300 mg Tablet, OD1.7001.500
Ronacaleret, 400 mg Tablet, OD1.5001.500

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Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).

DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from baseline to month 6 and 12 in aBMD of hip (total hip, femoral neck and trochanter) were reported. (NCT00471237)
Timeframe: Baseline (Day 0), Month 6 and Month 12

,,,,,
InterventionPercent change in BMD (Least Squares Mean)
Total Hip aBMD, Month 6Total Hip aBMD, Month 12
Alendronate, 70 mg, Capsule, OW1.842.70
Placebo0.420.27
Ronacaleret, 100 mg Tablet, OD-0.26-0.62
Ronacaleret, 200 mg Tablet, OD-0.37-0.75
Ronacaleret, 300 mg Tablet, OD-0.86-1.07
Ronacaleret, 400 mg Tablet, OD-0.88-1.31

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Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans

QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in mg/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. (NCT00471237)
Timeframe: Baseline (Day 0) and Month 12

,,,,,,
InterventionPercent change in BMD (Mean)
Femur integral VOI BMDFemur trabecular VOI BMDFemur cortical VOI BMDNeck integral VOI BMDNeck trabecular VOI BMDNeck cortical VOI BMDTrochanter integral VOI BMDTrochanter trabecular VOI BMDTrochanter cortical VOI BMD
Alendronate, 70 mg, Capsule, OW2.703.052.441.652.771.103.153.553.33
Placebo0.02-0.361.11-0.10-0.951.23-0.58-1.620.56
Ronacaleret, 100 mg Tablet, OD-0.05-0.40-0.320.16-2.190.44-0.16-1.34-0.70
Ronacaleret, 200 mg Tablet, OD-0.81-2.16-1.46-0.94-2.68-1.67-1.53-2.54-1.53
Ronacaleret, 300 mg Tablet, OD-0.531.16-1.06-1.201.35-1.85-1.162.12-1.48
Ronacaleret, 400 mg Tablet, OD-0.152.81-1.79-1.453.05-2.80-0.982.10-2.59
Teriparatide, 20 mcg, SC Injection, OD3.9213.190.222.0611.27-0.694.9614.121.99

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Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans

QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular volume of interest (VOI) are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from Baseline to month 12 in the volumetric integral, cortical, and trabecular density (BMD) at the hip and lumbar spine measured by QCT were reported. (NCT00471237)
Timeframe: Baseline (Day 0) and Month 12

,,,,,,
InterventionPercent change in BMD (Mean)
Total vertebra integral VOI BMDMid vertebra integral VOI BMDMid Cylinder trabecular VOI BMDMid Osteo trabecular VOI BMDTotal vertebra trabecular VOI BMDMid Osteo cortical VOI BMD
Alendronate, 70 mg, Capsule, OW5.044.854.885.154.974.98
Placebo-0.98-1.31-2.45-2.21-2.46-0.30
Ronacaleret, 100 mg Tablet, OD1.091.201.751.811.670.63
Ronacaleret, 200 mg Tablet, OD3.004.656.177.065.812.37
Ronacaleret, 300 mg Tablet, OD3.916.068.999.548.522.57
Ronacaleret, 400 mg Tablet, OD4.837.3313.2913.2111.401.22
Teriparatide, 20 mcg, SC Injection, OD14.8017.9724.3724.2123.829.25

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Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans

Percent change in thickness of femur neck cortical VOI thickness and trochanter cortical VOI thickness were at Month 12 measured by QCT were reported. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. (NCT00471237)
Timeframe: Baseline (Day 0) and Month 12

,,,,,,
InterventionPercent change in cortical thickness (Mean)
Neck cortical VOI ThicknessTrochanter cortical VOI Thickness
Alendronate, 70 mg, Capsule, OW-0.130.81
Placebo-0.85-1.00
Ronacaleret, 100 mg Tablet, OD-0.130.76
Ronacaleret, 200 mg Tablet, OD1.121.01
Ronacaleret, 300 mg Tablet, OD-0.88-0.82
Ronacaleret, 400 mg Tablet, OD0.321.60
Teriparatide, 20 mcg, SC Injection, OD0.390.76

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Blood Concentrations of Ronacaleret

Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Blood concentrations of ronacaleret were reported. (NCT00471237)
Timeframe: Pre-dose (0.0 hour [h]) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12

,,,
Interventionnanograms per millilitre (ng/mL) (Mean)
Week 4, Pre-doseWeek 4, 8-12 h post doseMonth 6, Pre-doseMonth 6, 1-4 h post doseMonth 6, 8-12 h post doseMonth 6, 24 h post doseMonth 12, Pre-doseMonth 12, 1-4 h post doseMonth 12, 8-12 h post doseMonth 12, 24 h post dose
Ronacaleret, 100 mg Tablet, OD41.22204.8221.37644.90186.69186.2120.68779.92203.39187.23
Ronacaleret, 200 mg Tablet, OD37.24328.3365.941308.35385.03290.7433.47999.63262.20297.20
Ronacaleret, 300 mg Tablet, OD85.44581.0874.121610.74576.35578.63147.631819.53651.95626.72
Ronacaleret, 400 mg Tablet, OD79.40685.14117.942054.71796.99473.41114.832128.24740.18512.65

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Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event

Full 12-lead ECGs pre-dose at screening and visits 6, 8, 11, 12 and 14 were recorded. Participants rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. The central reviewer measured the following parameters and provide a clinical interpretation: heart rate, RR interval, PR interval, QRS interval, QT (uncorrected) interval, QTcB (Bazett's correction) interval, QTcF (Fridericia's correction) interval. The central reviewer was provided the investigator or designated qualified site physician with a central ECG report or confirmatory report to assist them in identifying any clinically significant abnormalities that would preclude the participant from further participation in the study. (NCT00471237)
Timeframe: Up to 12 months

InterventionParticipants (Count of Participants)
Placebo1
Ronacaleret, 100 mg Tablet, OD5
Ronacaleret, 200 mg Tablet, OD4
Ronacaleret, 300 mg Tablet, OD3
Ronacaleret, 400 mg Tablet, OD3
Alendronate, 70 mg, Capsule, OW5
Teriparatide, 20 mcg, SC Injection, OD0

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Number of Participants With Hypercalcemia

Participants with albumin-adjusted serum calcium pre-dose values of >11.0 mg/ deciliter (dL) or post-dose values of >12.0 mg/dL were recorded as participants with hypercalcemia. Number of participant with hypercalcemia were reported. (NCT00471237)
Timeframe: Up to Month 12

InterventionParticipants (Count of Participants)
Placebo0
Ronacaleret, 100 mg Tablet, OD1
Ronacaleret, 200 mg Tablet, OD1
Ronacaleret, 300 mg Tablet, OD4
Ronacaleret, 400 mg Tablet, OD11
Alendronate, 70 mg, Capsule, OW0
Teriparatide, 20 mcg, SC Injection, OD1

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Number of Participants Withdrew Due to Hypercalcemia

A confirmed albumin-adjusted serum calcium pre-dose value of >11.0 mg/dL or post-dose value of >12.0 mg/dL was set as a withdrawal criteria for the study. Number of participants who met this pre-defined stopping criteria were reported. (NCT00471237)
Timeframe: Up to Month 12

InterventionParticipants (Count of Participants)
Placebo0
Ronacaleret, 100 mg Tablet, OD0
Ronacaleret, 200 mg Tablet, OD0
Ronacaleret, 300 mg Tablet, OD0
Ronacaleret, 400 mg Tablet, OD0
Alendronate, 70 mg, Capsule, OW0
Teriparatide, 20 mcg, SC Injection, OD0

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Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)

DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from Baseline in areal bone mineral density (aBMD) was reported. (NCT00471237)
Timeframe: Baseline (Day 0) and 12 Months

InterventionPercent change in BMD (Least Squares Mean)
Placebo0.03
Ronacaleret, 100 mg Tablet, OD0.32
Ronacaleret, 200 mg Tablet, OD1.39
Ronacaleret, 300 mg Tablet, OD1.61
Ronacaleret, 400 mg Tablet, OD1.62
Alendronate, 70 mg, Capsule, OW4.54

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Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans

QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. (NCT00471237)
Timeframe: Baseline (Day 0) and Month 12

InterventionPercent change in VOI (Mean)
Placebo0.04
Ronacaleret, 100 mg Tablet, OD0.85
Ronacaleret, 200 mg Tablet, OD3.01
Ronacaleret, 300 mg Tablet, OD3.58
Ronacaleret, 400 mg Tablet, OD3.54
Alendronate, 70 mg, Capsule, OW5.39
Teriparatide, 20 mcg, SC Injection, OD12.23

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Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)

DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from baseline to month 6 in aBMD was reported. (NCT00471237)
Timeframe: Baseline (Day 0) and Month 6

Interventionpercent change in BMD (Least Squares Mean)
Placebo0.66
Ronacaleret, 100 mg Tablet, OD0.21
Ronacaleret, 200 mg Tablet, OD1.61
Ronacaleret, 300 mg Tablet, OD0.47
Ronacaleret, 400 mg Tablet, OD1.01
Alendronate, 70 mg, Capsule, OW3.42

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Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret

Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, AUC(0-t) and AUC(0-τ) of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects. (NCT00471237)
Timeframe: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12

,,,
Interventionnanogram*hour per millilitre (ng*hr/mL) (Geometric Mean)
AUC 0-t, Month 6AUC 0-t, Month 12AUC 0-tau, Month 6AUC 0-tau, Month 12
Ronacaleret, 100 mg Tablet, OD2495.87512766.68223628.09013922.9369
Ronacaleret, 200 mg Tablet, OD4575.87464548.64906428.55406455.1756
Ronacaleret, 300 mg Tablet, OD7545.33029259.312710825.908314827.6940
Ronacaleret, 400 mg Tablet, OD6712.05376798.42199810.461410079.2847

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Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)

Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of BALP. (NCT00471237)
Timeframe: Baseline (Day 0), Week 4, Month 3, 6, and 12

,,,,,
Interventionmcg/L (Least Squares Mean)
BaselineBaseline, Placebo contrastWeek 4Week 4, Placebo contrastMonth 3Month 3, Placebo contrastMonth 6Month 6, Placebo contrastMonth 12Month 12, Placebo contrast
Alendronate, 70 mg, Capsule, OW14.310.9913.680.989.440.758.360.658.420.64
Ronacaleret, 100 mg Tablet, OD14.961.0314.721.0515.231.2016.311.2716.641.26
Ronacaleret, 200 mg Tablet, OD14.240.9814.511.0315.441.2217.431.3618.801.42
Ronacaleret, 300 mg Tablet, OD15.061.0415.971.1418.771.4822.181.7323.361.76
Ronacaleret, 400 mg Tablet, OD14.120.9815.721.1217.851.4121.471.6823.281.76
Teriparatide, 20 mcg, SC Injection, OD14.501.0016.191.1516.531.3117.631.3819.081.44

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Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)

Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of BALP. (NCT00471237)
Timeframe: Baseline (Day 0), Week 4, Month 3, 6, and 12

Interventionmcg/L (Least Squares Mean)
BaselineWeek 4Month 3Month 6Month 12
Placebo14.4614.0212.6612.8113.25

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Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)

Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of CTX1. (NCT00471237)
Timeframe: Baseline (Day 0), Week 4, Month 3, 6, and 12

,,,,,
Interventionnanogram per litre (ng/L) (Least Squares Mean)
BaselineBaseline, Placebo contrastWeek 4Week 4, Placebo contrastMonth 3Month 3, Placebo contrastMonth 6Month 6, Placebo contrastMonth 12Month 12, Placebo contrast
Alendronate, 70 mg, Capsule, OW630.41.01288.00.54257.10.49235.90.46158.30.30
Ronacaleret, 100 mg Tablet, OD635.31.02515.20.97598.51.14648.21.25695.21.32
Ronacaleret, 200 mg Tablet, OD632.01.01525.40.99688.91.32777.11.50806.11.54
Ronacaleret, 300 mg Tablet, OD587.90.94506.10.95723.21.38859.61.66852.81.62
Ronacaleret, 400 mg Tablet, OD645.51.03529.21.00818.91.56964.31.86991.91.89
Teriparatide, 20 mcg, SC Injection, OD564.00.90576.11.09864.11.6511122.1510712.04

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Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.

The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values. (NCT00503113)
Timeframe: Baseline and 9 months

,,
Interventionmg/g (Mean)
BaselineRelative Change at 9 month (n=233,232,225)
Alendronate 70 mg Oral16.128.3
Ibandronate 3 mg Infusion14.115.6
Ibandronate 3 mg Injection16.021.6

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Relative Change From Baseline in Mean Serum Creatinine.

(NCT00503113)
Timeframe: Baseline and 9 months

,,
Interventionmg/dL (Mean)
BaselineRelative Change at 9 months (n=233,232,225)
Alendronate 70 mg Oral0.82.2
Ibandronate 3 mg Infusion0.80.8
Ibandronate 3 mg Injection0.81.7

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Relative Change From Baseline in Actual GFR (Using CG Formula)

Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment. (NCT00503113)
Timeframe: Baseline and 9 months

,,
InterventionmL/min (Mean)
BaselineRelative Change at 9 month (n=233,232,225)
Alendronate 70 mg Oral62.0-2.8
Ibandronate 3 mg Infusion62.9-1.3
Ibandronate 3 mg Injection65.0-2.3

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Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.

(NCT00503113)
Timeframe: Baseline and 9 months

,,
Interventionmg/g (Mean)
BaselineChange from Baseline at 9 months (n=233,232,225)
Alendronate 70 mg Oral16.11.4
Ibandronate 3 mg Infusion14.10.5
Ibandronate 3 mg Injection16.0-0.8

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Absolute Change From Baseline in Mean Serum Creatinine.

(NCT00503113)
Timeframe: Baseline and 9 months

,,
Interventionmg/dL (Mean)
BaselineChange from Baseline at 9 months (n=233,232,225)
Alendronate 70 mg Oral0.80.0
Ibandronate 3 mg Infusion0.80.0
Ibandronate 3 mg Injection0.80.0

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Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)

Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment. (NCT00503113)
Timeframe: Baseline and 9 months

,,
InterventionmL/min (Mean)
BaselineChange from Baseline at 9 months (N=233,232,225)
Alendronate 70 mg Oral62.0-1.9
Ibandronate 3 mg Infusion62.9-1.0
Ibandronate 3 mg Injection65.0-1.6

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Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)

Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment. (NCT00503113)
Timeframe: Baseline and 9 months

,,
InterventionmL/min (Mean)
BaselineRelative Change at 9 month (n= 233, 232, 225)
Alendronate 70 mg Oral70.5-2.1
Ibandronate 3 mg Infusion71.5-0.2
Ibandronate 3 mg Injection72.5-1.4

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Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)

The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment. (NCT00503113)
Timeframe: Baseline and 9 months

,,
InterventionmL/min (Mean)
BaselineChange from baseline at 9 months (n=233,232,225)
Alendronate 70 mg Oral70.5-1.6
Ibandronate 3 mg Infusion71.5-0.5
Ibandronate 3 mg Injection72.5-1.3

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Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT

Trabecular number is a three-dimensional measure of the mean inter-trabecular distance; the primary micro-architectural feature measured by high-resolution CT imaging. The parameter was calculated from scans of the distal radius and distal tibia at baseline, 12, and 24 months. The percent change from baseline over these time periods was calculated as the primary outcome measure indicating the micro-architectural status of trabecular bone. (NCT00504166)
Timeframe: Baseline, 24 months

,
InterventionPercent change (Mean)
Distal RadiusDistal Tibia
Alendronate Treatment2.10.9
Placebo Treatment-0.64.1

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Compliance With Treatment in the Second Treatment Period

Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance). (NCT00518531)
Timeframe: Treatment period 2 (Month 13 to Month 24)

,
InterventionParticipants (Number)
YesNo
Alendronate7837
Denosumab997

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Compliance With Treatment in the First Treatment Period

Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance). (NCT00518531)
Timeframe: Treatment period 1 (Month 1 to Month 12)

,
InterventionParticipants (Number)
YesNo
Alendronate9727
Denosumab11412

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Beliefs About Medicines Questionnaire (BMQ): Necessity Score

"The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other.~Participants' beliefs about the necessity of the prescribed medication to treat osteoporosis were based on the average of 5 items from the BMQ that form the necessity score. The necessity score ranges from 1 to 5, with higher scores indicating stronger beliefs about the necessity of the prescribed medication for controlling osteoporosis." (NCT00518531)
Timeframe: Baseline, Month 6, Month 12, Month 18 and Month 24

,
Interventionscores on a scale (Mean)
Baseline (n=104, 117)Month 6 (n=106, 114)Month 12 (n=103, 95)Month 18 (n=98, 98)Month 24 (n=91, 100)
Alendronate3.323.143.213.203.21
Denosumab3.263.313.173.283.22

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Adherence With Treatment in the Second Treatment Period

A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed nonadherent to treatment. (NCT00518531)
Timeframe: Treatment period 2 (Months 13 to 24)

,
InterventionParticipants (Number)
YesNo
Alendronate7342
Denosumab988

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Beliefs About Medicines Questionnaire (BMQ) Concern Score

The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. Participants' concern about the adverse consequences of taking the medication for controlling osteoporosis was based on the average of 10 items from the BMQ that form the concern score. The concern score ranges from 1 to 5, with higher scores indicating stronger concerns about the adverse consequences of taking the prescribed medication for controlling osteoporosis. (NCT00518531)
Timeframe: Baseline and Month 6, Month 12, Month 18, and Month 24

,
Interventionscores on a scale (Mean)
Baseline (n=104, 117)Month 6 (n=106, 114)Month 12 (n=103, 95)Month 18 (n=98, 98)Month 24 (n=91, 100)
Alendronate2.332.222.572.432.39
Denosumab2.432.122.512.242.18

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Time to Non-persistence to Alendronate Treatment in the Second Treatment Period

Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System. (NCT00518531)
Timeframe: Treatment period 2 (Month 13 to Month 24)

Interventionweeks (Mean)
Alendronate42.76

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Adherence With Treatment in the First Treatment Period

A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed non-adherent to treatment. (NCT00518531)
Timeframe: Treatment period 1 (Month 1 to Month 12)

,
InterventionParticipants (Number)
YesNo
Alendronate9529
Denosumab11115

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Persistence With Treatment in the Second Treatment Period

Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period. (NCT00518531)
Timeframe: Treatment period 2 (Month 13 to Month 24)

,
InterventionParticipants (Number)
YesNo
Alendronate8233
Denosumab1033

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Time to Non-adherence to Alendronate Treatment in the First Treatment Period

Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit. (NCT00518531)
Timeframe: Treatment Period 1 (Month 1 to Month 12)

Interventionweeks (Mean)
Alendronate43.29

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Time to Non-adherence to Alendronate Treatment in the Second Treatment Period

Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit. (NCT00518531)
Timeframe: Treatment Period 2 (Month 13 to Month 24)

Interventionweeks (Mean)
Alendronate39.45

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Time to Non-compliance to Alendronate Treatment in the First Treatment Period

Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period. (NCT00518531)
Timeframe: Treatment period 1 (Month 1 to Month 12)

Interventionweeks (Mean)
Alendronate43.75

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Time to Non-compliance to Alendronate Treatment in the Second Treatment Period

Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period. (NCT00518531)
Timeframe: Treatment period 2 (Month 13 to Month 24)

Interventionweeks (Mean)
Alendronate39.97

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Time to Non-persistence to Alendronate Treatment in the First Treatment Period

Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System. (NCT00518531)
Timeframe: Treatment period 1 (Month 1 to Month 12)

Interventionweeks (Mean)
Alendronate44.59

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Persistence With Treatment in the First Treatment Period

Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period. (NCT00518531)
Timeframe: Treatment period 1 (Month 1 to Month 12)

,
InterventionParticipants (Number)
YesNo
Alendronate9925
Denosumab11412

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Overall Satisfaction to Study Treatment

"Participant satisfaction with their treatment was assessed using question 7 (ie, Please rate your satisfaction with the weekly pill on the following: frequency of administration; mode of administration [taking a pill]; convenience; overall satisfaction) and question 8 (ie, Please rate your satisfaction with the six month injection on the following: frequency of administration; mode of administration [receiving an injection]; convenience; overall satisfaction) from the Preference Satisfaction Questionnaire (PSQ) at the end of each treatment period. The PSQ is a 34 item, self-report questionnaire of participants' preference and satisfaction for each of the two study treatments. Possible answers include: Not at all Satisfied, A Little Satisfied, Moderately Satisfied, Quite Satisfied, and Very Satisfied." (NCT00518531)
Timeframe: End of treatment period 1 (Month 12)

,
InterventionParticipants (Number)
Not at all satisfiedA little satisfiedModerately satisfiedQuite satisfiedVery satisfied
Alendronate31173459
Denosumab3321895

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Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period

The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period. (NCT00518531)
Timeframe: Month 18, Month 24 (treatment period 2)

Interventionscores on a scale (Mean)
Treatment period 2 Month 6 (n=98)Treatment period 2 Month 12 (n= 90)
Alendronate23.423.8

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Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period

The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period. (NCT00518531)
Timeframe: Month 6, Month 12 (treatment period 1)

Interventionscores on a scale (Mean)
Month 6 (n=109)Month 12 (n= 100)
Alendronate24.324.4

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Beliefs About Medicines Questionnaire (BMQ) Preference Score

The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. The BMQ preference score, which measures a participant's overall evaluation of a medication, is based on the average of 7 items in the BMQ. The preference score ranges from 1 to 5, with higher scores indicating stronger preference for one medication over the other. (NCT00518531)
Timeframe: Baseline and Month 6, Month 12, Month 18, and Month 24

,
Interventionscores on a scale (Mean)
Baseline (n=104, 117)Month 6 (n=106, 114)Month 12 (n=103, 95)Month 18 (n=98, 98)Month 24 (n=91, 100)
Alendronate2.973.012.622.552.57
Denosumab3.473.723.433.773.80

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Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation

Compare compliance where a study coordinator interviewed patients as to how often they missed the once a week oral alendronate, missed taking calcium and vitamin D supplementation, or missed the once a year IV Reclast. (NCT00580047)
Timeframe: 24 months

Interventionpercentage of compliance (Number)
Intravenous Bisphosphonate Post Transplantation100
Oral Bisphosphonate Post Transplantation80
Placebo Group Post Transplantation80

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Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant

Posterior Anterior (PA) spine bone density was measured by dual energy x-ray absorptiometry (DXA) at baseline and 24 months post transplant. The percentage change in the PA spine bone density was then compared from baseline to 24 months post transplant. (NCT00580047)
Timeframe: 24 months

Interventionpercentage of change of bone density (Number)
Intravenous Bisphosphonate Post Transplantation8.1
Oral Bisphosphonate Post Transplantation6.6
Placebo Group Post Transplantation6.5

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The Percentage of Non-vertebral Fractures

The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures (NCT00680953)
Timeframe: Baseline to 24 Months

Interventionpercentage of participants (Number)
Denosumab4.1
Placebo4.1
Alendronate2.7

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Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.

The results are expressed as a percentage by Kaplan-Meier estimate. (NCT00680953)
Timeframe: Baseline to 24 Months

Interventionpercentage of participants (Number)
Denosumab0.0
Placebo0.5
Alendronate0.0

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Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo

(NCT00680953)
Timeframe: Baseline to 24 months

InterventionVertebral fractures (Mean)
Denosumab3.6
Placebo10.3
Alendronate7.2

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Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52

"Percentage of participants with serum levels of 25-hydroxyvitamin D below~20 ng/mL after 52 weeks of treatment (6 month extension study) with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls." (NCT00692913)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
FOSAVANCE 560011.3
Referred-Care36.9

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Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density

Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DEXA) and measured in g/cm^2 was obtained at baseline (visit 1) and Week 52 (visit 13) or at early study discontinuation visit. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent change from baseline, the greater the response to therapy. (NCT00692913)
Timeframe: Baseline and Week 52

,
InterventionPercent Change (Least Squares Mean)
Lumbar Spine (n= 226/ n=219)Total Hip (n=227/ n=218)
FOSAVANCE 56004.922.22
Referred-Care3.911.40

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Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio

N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (NTx) is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. (NCT00692913)
Timeframe: Baseline and Week 26

InterventionPercent Change (Least Squares Mean)
FOSAVANCE 5600-57.06
Referred-Care-47.36

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Falls Per Participant

"Number of falls per participant was measured.~The fall event rate during the study period was defined as the number of adjudicated falls during the study period divided by the total patient-years in the study. Each participant was to be in the study for approximately one year.~In order to guide and standardize all procedures during the fall adjudication process, a Standard Operating Procedure for Fall Adjudication was created by the~SPONSOR and served as a guideline to standardize operational procedures for fall adjudication." (NCT00692913)
Timeframe: Up to Week 52

InterventionNumber of Falls (Mean)
FOSAVANCE 56000.51
Referred-Care0.45

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Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase

Bone-Specific Alkaline Phosphatase (BSAP) is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. (NCT00692913)
Timeframe: Baseline and Week 26

InterventionPercent Change (Least Squares Mean)
FOSAVANCE 5600-46.67
Referred-Care-39.60

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Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase

BSAP is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. (NCT00692913)
Timeframe: Baseline and Week 52

InterventionPercent Change (Least Squares Mean)
FOSAVANCE 5600-51.21
Referred-Care-43.13

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Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio

NTx is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. (NCT00692913)
Timeframe: Baseline and Week 52

InterventionPercent Change (Least Squares Mean)
FOSAVANCE 5600-58.42
Referred-Care-50.07

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Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26

"Percentage of participants with serum levels of 25-hydroxyvitamin D below~20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls." (NCT00692913)
Timeframe: Week 26

InterventionPercentage of Participants (Number)
FOSAVANCE 56008.6
Referred-Care31.0

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Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment

(NCT00729651)
Timeframe: 16 weeks

,
Interventionparticipants (Number)
With Vitamin D DeficiencyWithout Vitamin D Deficiency
Fosamax5577
Fosamax Plus D2134

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Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment

(NCT00729651)
Timeframe: 16 weeks

,
Interventionparticipants (Number)
With 25 OHD < 20ng/ml at 16 weeks of treatmentWith 25 OHD >= 20ng/ml at 16 weeks of treatment
Fosamax9339
Fosamax Plus D7129

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Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment

(NCT00729651)
Timeframe: Baseline and 16 weeks

InterventionPercentage Change Serum PTH (Least Squares Mean)
Fosamax Plus D8.17
Fosamax29.98

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Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment

(NCT00729651)
Timeframe: 16 weeks

Interventionng/ml (Mean)
Fosamax Plus D30.08
Fosamax17.14

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Part 1: Urinary Excretion of Alendronate

Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose on Days 1 and 2. (NCT00803790)
Timeframe: Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)

Interventionμg (Least Squares Mean)
Alendronate+Vitamin D Combo133.6
Alendronate132.2

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Part II : Maximum Concentration (Cmax) of Vitamin D

Serum vitamin D pharmacokinetic parameter was calculated for the following: maximum concentration of drug observed in serum (Cmax). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period. (NCT00803790)
Timeframe: Day 1 across the 80-hour plasma collection period (Periods 1 and 2)

Interventionng/ml (Least Squares Mean)
Alendronate+Vitamin D Combo12.2
Vitamin D13.0

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Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D

The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period. (NCT00803790)
Timeframe: Day 1 across the 80-hour plasma collection period (Period 1 and 2)

Interventionng*hr/mL (Least Squares Mean)
Alendronate+Vitamin D Combo490.2
Vitamin D518.7

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Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet

Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose. (NCT00806416)
Timeframe: On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).

Interventionmicrograms (μg) (Least Squares Mean)
Alendronate/Vitamin D Combination197.5
Alendronate191.9

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Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet

"Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet.~Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose." (NCT00806416)
Timeframe: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).

Interventionng*hr/mL (Least Squares Mean)
Alendronate/Vitamin D Combination296.4
Vitamin D337.9

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Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet

Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose. (NCT00806416)
Timeframe: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).

Interventionng/mL (Least Squares Mean)
Alendronate/Vitamin D Combination5.9
Vitamin D6.6

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Bioequivalence Based on Rmax

Rmax = maximum rate of urinary excretion (NCT00835406)
Timeframe: Urine collected over 36 hour period

Interventionng/mL (Geometric Mean)
Alendronate Sodium73.96
Fosamax®73.99

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Bioequivalence Based on Ae0-36

Ae0-36 = cumulative urine excretion (NCT00835406)
Timeframe: Urine collected over 36 hour period

Interventionng/mL (Geometric Mean)
Alendronate Sodium219.28
Fosamax®213.44

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Percent Change From Baseline in Osteocalcin

Percent change from baseline in the bone turnover marker (BTM) osteocalcin was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline. (NCT00896532)
Timeframe: Baseline and months 1, 3, 6, 9, and 12

,,,,,
Interventionpercent change (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12
Placebo-1.64.1-7.1-6.0-14.1
Romosozumab 140 mg Q3M60.1-5.6-16.5-29.0-24.7
Romosozumab 140 mg QM53.115.6-7.4-27.7-31.1
Romosozumab 210 mg Q3M77.9-3.7-23.2-30.7-26.2
Romosozumab 210 mg QM78.641.610.0-4.0-12.5
Romosozumab 70 mg QM28.1-0.3-11.8-26.9-27.3

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Percent Change From Baseline in Osteocalcin

Percent change from baseline in the bone turnover marker (BTM) osteocalcin was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline. (NCT00896532)
Timeframe: Baseline and months 1, 3, 6, 9, and 12

,
Interventionpercent change (Least Squares Mean)
Month 3Month 6Month 9Month 12
Alendronate-28.7-40.6-50.9-50.3
Teriparatide104.7106.799.991.6

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Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)

Percent change from baseline in the bone turnover marker (BTM) BSAP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline. (NCT00896532)
Timeframe: Baseline and months 1, 3, 6, 9, and 12

,,,,,
Interventionpercent change (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12
Placebo-1.1-7.6-4.13.59.2
Romosozumab 140 mg Q3M35.1-18.0-18.2-12.5-10.8
Romosozumab 140 mg QM29.31.3-6.6-5.5-5.0
Romosozumab 210 mg Q3M47.5-17.3-20.0-17.7-12.4
Romosozumab 210 mg QM60.927.413.110.49.2
Romosozumab 70 mg QM11.7-8.5-8.7-4.9-2.6

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Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)

Percent change from baseline in the bone turnover marker (BTM) BSAP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline. (NCT00896532)
Timeframe: Baseline and months 1, 3, 6, 9, and 12

,
Interventionpercent change (Least Squares Mean)
Month 3Month 6Month 9Month 12
Alendronate-30.5-35.4-32.5-31.2
Teriparatide21.829.841.845.7

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Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine

Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. (NCT00896532)
Timeframe: Baseline to 12 months

Interventionpercent change (Least Squares Mean)
Placebo-0.1
Alendronate4.1
Teriparatide7.1
Romosozumab 70 mg QM5.4
Romosozumab 140 mg Q3M5.4
Romosozumab 140 mg QM9.1
Romosozumab 210 mg Q3M5.5
Romosozumab 210 mg QM11.3
Romosozumab Monthly8.6
Romosozumab Every 3 Months5.5
Romosozumab 140 mg7.3
Romosozumab 210 mg8.4

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Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)

Percent change from baseline in the bone turnover marker (BTM) CTX was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline. (NCT00896532)
Timeframe: Baseline and months 1, 3, 6, 9, and 12

,
Interventionpercent change (Least Squares Mean)
Month 3Month 6Month 9Month 12
Alendronate-65.0-64.2-64.4-66.7
Teriparatide69.493.581.377.0

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Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)

Percent change from baseline in the bone turnover marker (BTM) P1NP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline. (NCT00896532)
Timeframe: Baseline and months 1, 3, 6, 9, and 12

,,,,,
Interventionpercent change (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12
Placebo-0.7-5.4-5.9-10.6-8.7
Romosozumab 140 mg Q3M61.4-15.5-22.8-23.8-23.3
Romosozumab 140 mg QM55.03.8-18.6-26.1-31.2
Romosozumab 210 mg Q3M75.8-19.5-25.5-30.1-29.7
Romosozumab 210 mg QM92.225.66.9-5.8-17.2
Romosozumab 70 mg QM24.2-9.1-20.0-26.9-23.0

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Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)

Percent change from baseline in the bone turnover marker (BTM) CTX was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline. (NCT00896532)
Timeframe: Baseline and months 1, 3, 6, 9, and 12

,,,,,
Interventionpercent change (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12
Romosozumab 140 mg Q3M-19.2-6.2-8.41.312.2
Romosozumab 140 mg QM-35.4-26.5-24.6-27.7-33.0
Romosozumab 210 mg Q3M-33.0-12.6-10.5-11.7-6.6
Romosozumab 210 mg QM-28.5-3.7-8.7-17.2-22.5
Romosozumab 70 mg QM-22.1-21.5-18.1-15.1-20.3
Placebo-3.9-2.42.71.09.8

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Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)

Percent change from baseline in the bone turnover marker (BTM) P1NP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline. (NCT00896532)
Timeframe: Baseline and months 1, 3, 6, 9, and 12

,
Interventionpercent change (Least Squares Mean)
Month 3Month 6Month 9Month 12
Alendronate-50.8-57.0-60.8-60.8
Teriparatide97.1138.0116.898.3

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Percent Change From Baseline at Month 12 in BMD of the Femoral Neck

"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables." (NCT00896532)
Timeframe: Baseline to 12 months

Interventionpercent change (Least Squares Mean)
Placebo-1.1
Alendronate1.2
Teriparatide1.1
Romosozumab 70 mg QM0.6
Romosozumab 140 mg Q3M1.8
Romosozumab 140 mg QM4.2
Romosozumab 210 mg Q3M1.4
Romosozumab 210 mg QM3.7

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Percent Change From Baseline at Month 6 in BMD of the Total Hip

"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables." (NCT00896532)
Timeframe: Baseline to 6 months

Interventionpercent change (Least Squares Mean)
Placebo-0.6
Alendronate0.9
Teriparatide0.5
Romosozumab 70 mg QM0.5
Romosozumab 140 mg Q3M0.9
Romosozumab 140 mg QM2.2
Romosozumab 210 mg Q3M1.1
Romosozumab 210 mg QM2.9

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Percent Change From Baseline at Month 6 in BMD of the Femoral Neck

"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables." (NCT00896532)
Timeframe: Baseline to 6 months

Interventionpercent change (Least Squares Mean)
Placebo-0.4
Alendronate0.5
Teriparatide0.5
Romosozumab 70 mg QM0.2
Romosozumab 140 mg Q3M0.4
Romosozumab 140 mg QM2.1
Romosozumab 210 mg Q3M0.9
Romosozumab 210 mg QM1.9

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Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine

"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables." (NCT00896532)
Timeframe: Baseline to 6 months

Interventionpercent change (Least Squares Mean)
Placebo0.3
Alendronate2.6
Teriparatide4.8
Romosozumab 70 mg QM4.1
Romosozumab 140 mg Q3M4.2
Romosozumab 140 mg QM7.1
Romosozumab 210 mg Q3M4.4
Romosozumab 210 mg QM8.2

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Percent Change From Baseline at Month 12 in BMD of the Total Hip

"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables." (NCT00896532)
Timeframe: Baseline to 12 months

Interventionpercent change (Least Squares Mean)
Placebo-0.7
Alendronate1.9
Teriparatide1.3
Romosozumab 70 mg QM1.3
Romosozumab 140 mg Q3M1.3
Romosozumab 140 mg QM3.4
Romosozumab 210 mg Q3M1.9
Romosozumab 210 mg QM4.1

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Percent Change From Baseline at Month 12 in BMD of the Distal Radius

"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline in distal radius BMD was analyzed using an analysis of covariance (ANCOVA) model with the percent change from baseline to Month 12 in DXA BMD as dependent variable, baseline BMD value, machine type, interaction of baseline BMD and machine type, treatment (categorical) and geographic region as the independent class variables." (NCT00896532)
Timeframe: Baseline to 12 months

Interventionpercent change (Least Squares Mean)
Placebo-0.9
Alendronate-0.3
Teriparatide-1.7
Romosozumab 70 mg QM-1.8
Romosozumab 140 mg Q3M-1.1
Romosozumab 140 mg QM-1.0
Romosozumab 210 mg Q3M-0.4
Romosozumab 210 mg QM-1.2

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Number of Participants With Fracture

Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained. (NCT00920075)
Timeframe: Post study (1-6 years), one clinical visit

Interventionparticipants (Number)
1 Alendronate for 12 Months, Post Study0

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Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).

Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan. (NCT00920075)
Timeframe: Post study (1-6 yrs), one clinical visit

Interventionparticipants (Number)
1 Alendronate for 12 Months, Post Study11

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Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).

Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of hip was measured by DXA scan. (NCT00920075)
Timeframe: Post study (1-6 years), one clincial visit

Interventionparticipants (Number)
1 Alendronate for 12 Months, Post Study10

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Percent Change From Baseline to Week 96 in Lumbar Spine BMD

Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only. (NCT00921557)
Timeframe: Weeks 0 and 96

InterventionPercent change from baseline (Median)
1A: Alendronate/Alendronate24.9
1B: Alendronate/Placebo14.8

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Percent Change From Baseline to Weeks 24 and 48 in Whole Body (With Head) BMD

Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

,
InterventionPercent change from baseline (Median)
Week 24Week 48
1: Alendronate5.510.7
2: Placebo0.35.2

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Change in CD4 Percent From Baseline

Change in percentage of lymphocytes that are CD4 cells calculated as measurement at each time point minus baseline measurement (NCT00921557)
Timeframe: Weeks 0, 48, 96 and 144

,,
Interventionpercent of lymphocytes that are CD4 cell (Median)
Week 48 - Week 0Week 96 - Week 0Week 144 - Week 0
1A: Alendronate/Alendronate001
1B: Alendronate/Placebo1-1-1
2: Placebo/Alendronate12-4

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Percent of Participants With HIV-1 RNA <= 400 Copies/ml

Percent calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point. (NCT00921557)
Timeframe: Weeks 0, 48, 96 and 144

,,
InterventionParticipants (Count of Participants)
Week 0Week 48Week 96Week 144
1A: Alendronate/Alendronate10101210
1B: Alendronate/Placebo16161210
2: Placebo/Alendronate15141310

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Safety as Measured by the Incidence of New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures

Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004). (NCT00921557)
Timeframe: Weeks 0 to 144

,,
InterventionParticipants (Count of Participants)
Week 0 to 48Week 48 to 96Week 96 to 144
1A: Alendronate/Alendronate213
1B: Alendronate/Placebo334
2: Placebo/Alendronate223

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Percentage of Participants Developing New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures

Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004). Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Week 0 to 48

InterventionParticipants (Count of Participants)
1: Alendronate5
2: Placebo2

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Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Whole Body (With Head) BMD

Percent change was calculated as (measurement at time T2 - measurement at time T2)/measurement at time T1 * 100%. (NCT00921557)
Timeframe: Weeks 48, 96 and 144

InterventionPercent change (Median)
1B: Alendronate/Placebo (48 Week Change)0.8
2: Placebo/Alendronate (48 Week Change)0.5
1B: Alendronate/Placebo (96 Week Change)0.9

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Change in Centers for Disease Control (CDC) HIV Disease Category

Percentage of participants advancing in CDC HIV disease category from baseline throughout study follow-up (NCT00921557)
Timeframe: Weeks 144

,,
InterventionParticipants (Count of Participants)
Week 0 to 48Week 48 to 96Week 96 to 144
1A: Alendronate/Alendronate100
1B: Alendronate/Placebo010
2: Placebo/Alendronate000

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Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Lumbar Spine BMD

Percent change was calculated as (measurement at time T2 - measurement at time T1)/measurement at Time T1 * 100%. (NCT00921557)
Timeframe: Weeks 48, 96 and 144

InterventionPercent change (Median)
1B: Alendronate/Placebo (48 Week Change)0.9
2: Placebo/Alendronate (48 Week Change)2.0
1B: Alendronate/Placebo (96 Week Change)1.7

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Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Lumbar Spine BMD

A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in lumbar spine BMD from baseline. Results represent average changes in lumbar spine BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

,
Interventionpercentage of baseline (Mean)
MaleFemaleNon-hispanicHispanic11 - < 15 years15 - < 19 years>= 19 yearsOn TenofovirNot on Tenofovir25-OH Vit D<30 ng/ml25-0H Vit D>=30 ng/mlBone age < 15 yearsBone age>=15 yearsTanner stage <= 3Tanner stage >= 4
1: Alendronate20.325.419.423.637.116.58.124.819.922.022.136.011.333.015.4
2: Placebo6.89.44.87.810.68.01.96.88.26.87.810.05.010.65.9

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Percent Change From Baseline to Week 96 in Whole Body (With Head) BMD

Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only. (NCT00921557)
Timeframe: Weeks 0 and 96

InterventionPercent change from baseline (Median)
1A: Alendronate/Alendronate19.6
1B: Alendronate/Placebo10.3

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Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Whole Body (With Head) BMD.

A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in whole body (with head) BMD from baseline. Results represent average changes in whole body (with head) BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

,
Interventionpercentage of baseline (Mean)
MaleFemaleNon-HispanicHispanic11 - < 15 years15 - < 19 years>= 19 yearsOn tenofovirNot on tenofovir25-0H Vit D<30 ng/ml25-0H Vit D>=30 ng/mlBone age < 15 yearsBone age >=15 yearsTanner stage <= 3Tanner stage >= 4
1: Alendronate11.414.09.813.919.210.54.713.211.610.615.119.07.718.09.4
2: Placebo4.18.20.36.18.06.5-0.35.05.85.85.28.42.38.03.8

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Percent Change From Baseline to Weeks 24 and 48 in Lumbar Spine BMD

Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B combined as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

,
InterventionPercent change from baseline (Median)
Week 24Week 48
1: Alendronate14.415.9
2: Placebo5.57.1

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Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Hip

vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo0.10
MK-5442 5 mg-0.49
MK-5442 7.5 mg-0.15
MK-5442 10 mg-0.16
Alendronate 70 mg0.99

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Least Squares Mean Percent Change From Baseline to Month 12 in 1/3 Distal Forearm Areal BMD

"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.54
MK-5442 5 mg-1.38
MK-5442 7.5 mg-0.92
MK-5442 10 mg-2.01
Alendronate 70 mg-0.91

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Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD of the Hip

vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.02
MK-5442 5 mg0.76
MK-5442 7.5 mg0.81
MK-5442 10 mg0.27
Alendronate 70 mg1.23

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Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once

"Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).~Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least a one calcium level value ≥10.6 mg/dL were considered as having a Tier 1 adverse event (AE). A Tier 1 AE was an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons." (NCT00996801)
Timeframe: Baseline through Month 12

,,,,,
InterventionParticipants (Number)
≥10.6 ng/mL≥11.1 ng/mL≥12.1 ng/mL
Alendronate 70 mg710
MK-5442 10 mg2771
MK-5442 15 mg39191
MK-5442 5 mg1610
MK-5442 7.5 mg1940
Placebo310

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Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once

"Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).~≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least one albumin-corrected calcium level value ≥10.6 mg/dL were considered as having a Tier 1 AE (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons)." (NCT00996801)
Timeframe: Baseline through Month 12

,,,,,
InterventionParticipants (Number)
≥10.6 ng/mL≥11.1 ng/mL≥12.1 ng/mL
Alendronate 70 mg200
MK-5442 10 mg1331
MK-5442 15 mg2890
MK-5442 5 mg300
MK-5442 7.5 mg710
Placebo110

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Number of Participants With Predefined Tier 1 Adverse Events

Osteonecrosis of the jaw (ONJ), kidney stones, and bone neoplasms were predefined Tier-1 AEs in the study (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons). (NCT00996801)
Timeframe: Baseline through Month 12

,,,,,
InterventionParticipants (Number)
Osteonecrosis of the jawKidney stonesBone neoplasms
Alendronate 70 mg010
MK-5442 10 mg000
MK-5442 15 mg000
MK-5442 5 mg000
MK-5442 7.5 mg000
Placebo030

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Least Squares Mean Percent Change From Baseline to Month 12 in Urinary-N Telopeptides of Type 1 Collagen (u-NTx)

"Urinary, type I collagen, crosslinked N-telopeptide (uNTx) is a biomarker used to measure the rate of bone turnover found in urine.~uNTx was expressed in units of nanomoles (nM) per bone collagen equivalents (BCE) per millimoles of creatinine (Cr) or nM/BCE/mM Cr" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo63.64
MK-5442 5 mg86.51
MK-5442 7.5 mg83.32
MK-5442 10 mg107.44
Alendronate 70 mg0.18

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Least Squares Mean Percent Change From Baseline to Month 12 in Trochanter Areal BMD

"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.30
MK-5442 5 mg-1.56
MK-5442 7.5 mg-1.50
MK-5442 10 mg-1.52
Alendronate 70 mg1.68

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Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD (vBMD) of the Lumbar Spine

vBMD was measured using quantitative computed tomography (QCT) in order to assess bone strength. Quantitative computed tomography is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo0.18
MK-5442 5 mg-0.25
MK-5442 7.5 mg0.08
MK-5442 10 mg0.16
Alendronate 70 mg1.74

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Least Squares Mean Percent Change From Baseline to Month 12 in Total Hip Areal BMD

"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-1.44
MK-5442 5 mg-2.18
MK-5442 7.5 mg-2.16
MK-5442 10 mg-1.66
Alendronate 70 mg0.46

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Least Squares Mean Percent Change From Baseline to Month 12 in Total Body Areal BMD

"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.17
MK-5442 5 mg-0.54
MK-5442 7.5 mg-0.69
MK-5442 10 mg-1.10
Alendronate 70 mg0.82

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Least Squares Mean Percent Change From Baseline to Month 12 in Serum N-Terminal Propeptide (s-P1NP)

s-P1NP is a sensitive marker of bone formation rate in the assessment of osteoporosis and is measured in units of ng/ml. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo68.61
MK-5442 5 mg127.18
MK-5442 7.5 mg125.69
MK-5442 10 mg163.96
Alendronate 70 mg-5.85

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Least Squares Mean Percent Change From Baseline to Month 12 in Serum C-Terminal Propeptide of Type 1 Collagen (s-CTx)

C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis and in measured in units of nanograms (n)/milliliter (ml). (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo165.80
MK-5442 5 mg214.09
MK-5442 7.5 mg227.07
MK-5442 10 mg251.08
Alendronate 70 mg26.78

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Least Squares Mean Percent Change From Baseline to Month 12 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)

Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of μg/L. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo29.51
MK-5442 5 mg50.04
MK-5442 7.5 mg49.98
MK-5442 10 mg51.64
Alendronate 70 mg-3.83

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Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD)

"Areal bone mineral density (BMD) was measured using dual-energy X-ray absorptiometry (DXA) scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.36
MK-5442 5 mg-0.67
MK-5442 7.5mg-0.52
MK-5442 10 mg-0.53
Alendronate 70 mg1.29

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Least Squares Mean Percent Change From Baseline to Month 12 in Femoral Neck Areal BMD

"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-1.26
MK-5442 5 mg-2.12
MK-5442 7.5 mg-1.37
MK-5442 10 mg-1.84
Alendronate 70 mg-0.08

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Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Lumbar Spine

vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.67
MK-5442 5 mg-3.41
MK-5442 7.5 mg14.66
MK-5442 10 mg-0.34
Alendronate 70 mg12.80

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Change From Baseline in Serum Osteocalcin at End of Treatment

For efficacy evaluation, changes in Serum Osteocalcin were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. (NCT01065779)
Timeframe: Baseline and End of Treatment (Up to ~ 16 weeks)

Interventionng/mL (Mean)
FOSAMAX PLUS/ FOSAMAX PLUS D0.69

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Change From Baseline in Urine Deoxypyridinoline at End of Treatment

For efficacy evaluation, changes in Serum Deoxypyridinoline were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. (NCT01065779)
Timeframe: Baseline and End of Treatment (Up to ~ 16 weeks)

Interventionnmol/mmol (Mean)
FOSAMAX PLUS/ FOSAMAX PLUS D1.03

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Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment

For efficacy evaluation, changes in Serum 25-hydroxyvitamin D were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. (NCT01065779)
Timeframe: Baseline and End of Treatment (Up to ~ 16 weeks)

Interventionng/mL (Mean)
FOSAMAX PLUS/ FOSAMAX PLUS D1.73

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Change From Baseline in Alkaline Phosphatase at End of Treatment

For efficacy evaluation, changes in Serum Alkaline Phosphatase were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study. (NCT01065779)
Timeframe: Baseline and End of Treatment (Up to ~ 16 weeks)

Interventionmg/dL (Mean)
FOSAMAX PLUS/ FOSAMAX PLUS D-16.36

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Number of Participants With Improved, Unchanged, or Worsened Disease

"Evaluation of disease improvement was conducted in 3 categories of improved, unchanged, or worsened. Changes in biochemical markers and vitamin D levels were reviewed before (baseline) and after treatment using statistical analyses to determine disease status, which was reported as either improved, unchanged, or worsened." (NCT01065779)
Timeframe: Baseline and end of Treatment (Up to ~ 16 weeks)

InterventionParticipants (Number)
ImprovedUnchangedWorsened
FOSAMAX PLUS/ FOSAMAX PLUS D5492391

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Number of Participants With Unexpected Adverse Events

Number of participants that experienced unexpected Adverse Events (AEs) regardless of whether or not the AE was considered related to the use of the product. There was no required routine visit scheduled for AE assessment. An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE. (NCT01065779)
Timeframe: Up to ~ 16 weeks and 14 days after treatment discontinuation

InterventionParticipants (Number)
FOSAMAX PLUS/ FOSAMAX PLUS D2

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Number of Participants With Serious Adverse Events

"Number of participants that experienced Serious Adverse events (SAE). There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators.~SAEs were considered serious if the event resulted in:~death or was life-threatening~prolonged an existing inpatient hospitalization~a persistent or significant disability/ incapacity~a congenital anomaly/ birth defect~a significant medical situation, other important medical event based upon appropriate medical judgment of the investigator" (NCT01065779)
Timeframe: Up to ~ 16 weeks and 14 days after treatment discontinuation

InterventionParticipants (Number)
FOSAMAX PLUS/ FOSAMAX PLUS D0

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Number of Participants With Non-Serious AEs

An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE. There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators. (NCT01065779)
Timeframe: Up to ~ 16 weeks and 14 days after treatment discontinuation

InterventionParticipants (Number)
FOSAMAX PLUS/ FOSAMAX PLUS D42

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Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)

To assess the relative risk of esophageal cancer associated with osteoporosis study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene), initiators of osteoporosis drugs and non-initiators (comparators, women sharing match criteria with the initiator) entered an inception cohort for every three-month period, beginning in the first quarter of 1996. Assignment to study drug exposure group remained fixed from the start of follow-up, analogous to an intent-to-treat analysis. The risk of esophageal cancer among initiators of study drug compared to non-initiators of study drug was estimated through calculation of a hazard ratio. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug were used. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug were used. (NCT01077817)
Timeframe: Up to approximately 7.3 years of follow-up

InterventionNumber of cases per 100,0000 woman-years (Number)
Comparators32
Alendronate32
Etidronate42
Ibandronate46
Risendronate47
Raloxifene29

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Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)

To determine the use of study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene) among female participants with esophageal cancer (cases) and a comparison subcohort, a case-cohort analysis was performed using women meeting criteria from the General Practice Research Database (GPRD, United Kingdom). Exposure to osteoporosis drugs administered 720 days before cancer onset was determined in cases and compared to contemporaneous assessments in a comparison subcohort matched by year of birth and membership in the GPRD on the case's onset date. Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review. (NCT01077817)
Timeframe: Exposure to study drug at least 720 days before disease onset

,
InterventionPercentage of participants (Number)
AlendronateEtidronateIbandronateRisedronateRaloxifene
Comparison Sample (Case Cohort)2.72.10.030.90.4
Esophageal Cancer Cohort4.63.70.32.60.3

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Extension Study: Percentage Change From Baseline in s-P1NP at Month 12

s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 12. (NCT01350934)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Fosamax Plus-68.07
Calcitriol-17.00

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Extension Study: Percentage Change From Baseline in s-CTx at Month 12

s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 12. (NCT01350934)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Fosamax Plus-76.15
Calcitriol-24.19

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Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12

BMD at the lumbar spine was assessed by DXA at baseline and Month 12. (NCT01350934)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Fosamax Plus5.17
Calcitriol2.26

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Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at Month 6

s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 6. (NCT01350934)
Timeframe: Baseline and Month 6

InterventionPercent change (Least Squares Mean)
Fosamax Plus-59.12
Calcitriol-16.75

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Base Study: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 6

s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 6. (NCT01350934)
Timeframe: Baseline and Month 6

InterventionPercent change (Least Squares Mean)
Fosamax Plus-79.23
Calcitriol-27.20

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Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6

BMD at the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) at baseline and Month 6. (NCT01350934)
Timeframe: Baseline and Month 6

InterventionPercent change (Least Squares Mean)
Fosamax Plus3.54
Calcitriol1.59

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Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12

"The term vitamin D insufficiency is used to describe vitamin D levels that are low enough to cause secondary hyperparathyroidism, bone loss, and increased risk of skeletal fracture. In this study, a threshold for vitamin D insufficiency was a level of serum 25(OH) D <20 ng/mL." (NCT01350934)
Timeframe: Baseline and Month 12

InterventionPercentage of Participants (Number)
Fosamax Plus4.1
Calcitriol47.1

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Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26

Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study. (NCT01437111)
Timeframe: Week 26

InterventionParticipants (Number)
Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline1
Fosamax Plus: Other Osteoporosis Therapy at Baseline3
Fosamax Plus: Treatment Naive at Baseline1
Fosamax Plus: All Treated Participants5

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Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26

Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study. (NCT01437111)
Timeframe: Baseline and Week 26

InterventionPercent change (Mean)
Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline-12.65
Fosamax Plus: Other Osteoporosis Therapy at Baseline-49.82
Fosamax Plus: Treatment Naive at Baseline-76.81
Fosamax Plus: All Treated Participants-57.74

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Percent Change in Spine Bone Density From Baseline to 12 Months

Percent Change in Spine Bone Density from Baseline (month 0) to Month 12 (NCT01460654)
Timeframe: Baseline and 12 months

Interventionpercent change of bone mineral density (Mean)
Testosterone and Placebo Alendronate2.52
Alendronate and Placebo Testosterone0.61
Testosterone and Alendronate3.16

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Number of New Osteoporotic Fractures

Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes. (NCT01512446)
Timeframe: From baseline to study termination (mean duration 5.6 months)

Interventionosteoporotic fractures (Number)
Placebo5
Alendronate5

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Mortality

Number of deaths (NCT01512446)
Timeframe: From baseline to study termination (mean duration 5.6 months)

InterventionParticipants (Count of Participants)
Placebo2
Alendronate0

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Combination of New Osteoporotic Fractures and Deaths

Number of participants with a new osteoporotic fracture or death (NCT01512446)
Timeframe: From baseline to study termination (mean duration 5.6 months)

InterventionParticipants (Count of Participants)
Placebo7
Alendronate5

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Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 24

Interventionpercent change (Least Squares Mean)
Alendronate/Alendronate7.2
Romosozumab/Alendronate15.3

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Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 12

Interventionpercent change (Least Squares Mean)
Alendronate/Alendronate2.8
Romosozumab/Alendronate6.2

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Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 24

Interventionpercent change (Least Squares Mean)
Alendronate/Alendronate2.3
Romosozumab/Alendronate6.0

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Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 36

Interventionpercent change (Least Squares Mean)
Alendronate/Alendronate2.4
Romosozumab/Alendronate6.0

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Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 36

Interventionpercent change (Least Squares Mean)
Alendronate/Alendronate7.8
Romosozumab/Alendronate15.2

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Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 24

Interventionpercent change (Least Squares Mean)
Alendronate/Alendronate3.5
Romosozumab/Alendronate7.2

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Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 36

Interventionpercent change (Least Squares Mean)
Alendronate/Alendronate3.5
Romosozumab/Alendronate7.2

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Percentage of Participants With a Clinical Fracture at the Primary Analysis

All fracture assessments were performed by blinded central imaging readers. Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Interventionpercentage of participants (Number)
Alendronate/Alendronate13.0
Romosozumab/Alendronate9.7

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Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24

A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit. Incident vertebral fractures were confirmed by a second independent reader. (NCT01631214)
Timeframe: 24 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate2.5
Romosozumab/Alendronate1.3

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Percentage of Participants With Any Fracture at the Primary Analysis

All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures. (NCT01631214)
Timeframe: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Interventionpercentage of participants (Number)
Alendronate/Alendronate19.1
Romosozumab/Alendronate13.0

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Percentage of Participants With a Nonvertebral Fracture Through Month 24

A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: 24 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate7.8
Romosozumab/Alendronate6.3

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Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 12

Interventionpercent change (Least Squares Mean)
Alendronate/Alendronate5.0
Romosozumab/Alendronate13.7

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Percentage of Participants With a Nonvertebral Fracture Through Month 12

A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate4.6
Romosozumab/Alendronate3.4

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Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 12

Interventionpercent change (Least Squares Mean)
Alendronate/Alendronate1.7
Romosozumab/Alendronate4.9

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Percentage of Participants With Any Fracture Through Month 12

All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures. (NCT01631214)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate9.2
Romosozumab/Alendronate6.5

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Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis

A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Interventionpercentage of participants (Number)
Alendronate/Alendronate10.6
Romosozumab/Alendronate8.7

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Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24

"A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:~Grade 0 (Normal) = no fracture;~Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);~Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;~Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.~Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method." (NCT01631214)
Timeframe: 24 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate9.2
Romosozumab/Alendronate4.8

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Percentage of Participants With a Major Osteoporotic Fracture Through Month 12

Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate4.2
Romosozumab/Alendronate3.0

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Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis

Major nonvertebral fractures included a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip. (NCT01631214)
Timeframe: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Interventionpercentage of participants (Number)
Alendronate/Alendronate9.6
Romosozumab/Alendronate7.1

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Percentage of Participants With a Hip Fracture Through Month 24

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter. (NCT01631214)
Timeframe: 24 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate2.1
Romosozumab/Alendronate1.5

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Percentage of Participants With a Hip Fracture Through Month 12

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter. (NCT01631214)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate1.1
Romosozumab/Alendronate0.7

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Percentage of Participants With a Hip Fracture at the Primary Analysis

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter. (NCT01631214)
Timeframe: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Interventionpercentage of participants (Number)
Alendronate/Alendronate3.2
Romosozumab/Alendronate2.0

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Percentage of Participants With a Clinical Vertebral Fracture Through Month 24

A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic. (NCT01631214)
Timeframe: 24 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate2.1
Romosozumab/Alendronate0.9

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Percentage of Participants With a Clinical Vertebral Fracture Through Month 12

A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic. (NCT01631214)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate0.9
Romosozumab/Alendronate0.5

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Percentage of Participants With a Clinical Fracture Through Month 24

Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: 24 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate9.6
Romosozumab/Alendronate7.1

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Percentage of Participants With a Clinical Fracture Through Month 12

Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate5.4
Romosozumab/Alendronate3.9

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Percentage of Participants With New Vertebral Fractures Through Month 24

"All fracture assessments were performed by blinded central imaging readers.~New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:~Grade 0 (Normal) = no fracture;~Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);~Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;~Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.~Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method." (NCT01631214)
Timeframe: 24 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate8.0
Romosozumab/Alendronate4.1

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Percentage of Participants With New Vertebral Fractures Through Month 12

"New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:~Grade 0 (Normal) = no fracture;~Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);~Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;~Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.~Incident vertebral fractures were confirmed by a second independent reader." (NCT01631214)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Alendronate/Alendronate5.0
Romosozumab/Alendronate3.2

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The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN).

(NCT01656629)
Timeframe: up to 3 months

Interventionpercent change in osteoprogenitor cells (Mean)
Teriparatide0.0000242
Alendronate0.0000104
Calcium and Vitamin D-0.0000068

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Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)

Serum Chemistry laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: sodium (Low: ≤129; High: ≥148 milliequivalent per liter [mEq/L]), potassium (Low: ≤3.2; High: ≥5.5 mEq/L), albumin (<2.5 grams [g]/deciliter [dL]), total protein (<5 g/dL), glucose (Low: ≤54; High: >125 mg/dL [fasting] or >200 milligrams [mg]/dL [random]), creatinine (≥2.1 mg/dL), aspartate aminotransferase (AST) (≥5.1*upper limit of normal [ULN]), alanine aminotransferase (ALT) (≥5.1*ULN), alkaline phosphatase (AP) (≥3.1*ULN), total bilirubin (≥1.51*ULN [with any increase in liver function tests] ≥2.0*ULN [with normal liver function tests]), creatine kinase (≥3.1*ULN), total cholesterol (>226 mg/dL), and total calcium (Low: ≤7.4; High: ≥11.6 mg/dL). Only the serum chemistry parameters with at least 1 participant with a notable laboratory value are presented. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

,
InterventionParticipants (Count of Participants)
Alkaline PhosphataseCholesterol TotalCreatine KinaseGlucose (Fasting; High)Glucose (Random)Potassium (Low)Potassium (High)Sodium (Low)Sodium (High)
Abaloparatide-SC/Alendronate17522211416
Placebo/Alendronate07311823312

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Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only)

Coagulation laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Activated Partial Thromboplastin Time (≥1.41*ULN), Prothrombin Time (≥1.21*ULN). Because the Activated Partial Thromboplastin Time was the only coagulation laboratory parameter with at least 1 participant with a notable laboratory value, this is the only parameter presented below. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

InterventionParticipants (Count of Participants)
Abaloparatide-SC/Alendronate9
Placebo/Alendronate4

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Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline

Vertebral fractures were determined clinically and via protocol directed radiograph evaluation. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

InterventionParticipants (Count of Participants)
Abaloparatide-SC/Alendronate3
Placebo/Alendronate25

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Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)

A TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. A serious adverse event (SAE) was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), congenital anomaly/birth defect, or persistent or significant disability/incapacity. Intensity for each AE was defined as mild, moderate, or severe. AEs included both SAEs and non-serious AEs. AEs whose causal relation was characterized as Possible or Probable were considered as related to study drug. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

,
InterventionParticipants (Count of Participants)
TEAEsTEAEs Related to Study TreatmentSevere TEAEsSerious TEAEsTEAEs Leading to DeathTEAEs Leading to Discontinuation
Abaloparatide-SC/Alendronate452853865030
Placebo/Alendronate466804058236

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Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only)

Urine laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Glucose (2+), Protein (2+), Blood (>50 red blood cells per high-power field [rbc/hpf]). (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

,
InterventionParticipants (Count of Participants)
GlucoseProteinBlood
Abaloparatide-SC/Alendronate4677
Placebo/Alendronate3650

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Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)

Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Interventionpercentage of events (Number)
Abaloparatide-SC/Alendronate2.7
Placebo/Alendronate5.6

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Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)

Hematology laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Absolute Eosinophils (>5000 cells/mm^3), Absolute Lymphocytes (≤499 cells/mm^3), Absolute Neutrophils (≤999 cells/mm^3), % Eosinophils (>50%), % Lymphocytes (≤5%), % Neutrophils (≤10%), Hemoglobin (Low: ≤9.4 g/dL; High: change from baseline ≥2.1 g/dL), Platelets (≤99000 cells/mm^3), and White Blood Cells (Low: ≤1499 cells/mm^3; High: ≥20001 cells/mm^3). Only the hematology parameters with at least 1 participant with a notable laboratory value are presented. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

,
InterventionParticipants (Count of Participants)
Absolute LymphocytesLymphocytes (Absolute Count or Percentage)Absolute NeutrophilsNeutrophils (Absolute Count or Percentage)Hemoglobin (Low)Hemoglobin (High)Platelets
Abaloparatide-SC/Alendronate1515007191
Placebo/Alendronate1111222170

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Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Total hip BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Interventionpercent change (Mean)
Abaloparatide-SC/Alendronate5.4737
Placebo/Alendronate1.3698

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Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Lumbar spine BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Interventionpercent change (Mean)
Abaloparatide-SC/Alendronate12.7921
Placebo/Alendronate3.5133

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Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)

Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

InterventionParticipants (Count of Participants)
Abaloparatide-SC/Alendronate15
Placebo/Alendronate32

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Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Femoral neck BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Interventionpercent change (Mean)
Abaloparatide-SC/Alendronate4.5113
Placebo/Alendronate0.4649

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Bone Turnover Marker (Blood Sample)

The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8. (NCT01750086)
Timeframe: 8 weeks

Interventionpercentage of change in CTX (Mean)
Denosumab 60mg Subcutaneous Injection-7
Alendronate 70mg Weekly x 8 Weeks43

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All Study Sites--Length of Contracting Procedures

Mean time Between Clinical Site Recruitment and Contract Execution (NCT02139007)
Timeframe: Length of time Between Clinical Site Recruitment and Contract Execution

InterventionMonths (Mean)
All Study Sites -- Contracting Procedures3.4

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All Study Sites--Length of Time to Site IRB Approval

Mean time to gain site IRB approval (NCT02139007)
Timeframe: Length of time to site IRB approval

InterventionDays (Mean)
All Study Sites --IRB Approval13.9

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All Study Sites-Length of Time to 1st Participant Enrolled

Mean time from study initiation to 1st participant enrolled. (NCT02139007)
Timeframe: Length of time t for sites to recruit/enroll 1st participant

InterventionMonths (Mean)
All Study Sites-Initiation to the First Participant Recruited5.0

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Atypical Femoral Fracture

Patient reported fracture rate at 6 months after enrollment via follow-up survey (NCT02139007)
Timeframe: Baseline to 6 months following enrollment

InterventionParticipants (Count of Participants)
Continuation Arm0
Discontinuation Arm0

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Clinical Fracture Rate

Patient reported fracture rate at 6 months following enrollment via survey. (NCT02139007)
Timeframe: Baseline to 6 months following enrollment

InterventionParticipants (Count of Participants)
Continuation Arm0
Discontinuation Arm0

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Osteonecrosis of the Jaw

Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey . (NCT02139007)
Timeframe: Baseline to 6 months following enrollment

InterventionParticipants (Count of Participants)
Continuation Arm0
Discontinuation Arm0

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BMD by DXA at the Lumbar Spine

The mean percent change in bone mineral density (BMD) in the lumbar spine after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams. (NCT02195895)
Timeframe: 12 months

InterventionPercent change (Mean)
Alendronate, Calcium, Vitamin D2.54

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BMD of Total Hip by DXA

The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams. (NCT02195895)
Timeframe: 12 months

InterventionPercent change (Mean)
Alendronate, Calcium, Vitamin D1.32

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C-terminal Telopeptide (CTX)

The mean percent change in C-terminal telopeptide (CTX) from baseline after 12 months of treatment. CTX is a bone marker found in blood serum and measures the rate of bone breakdown. (NCT02195895)
Timeframe: 12 months

InterventionPercent change (Mean)
Alendronate, Calcium, Vitamin D-61.8

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Amino-terminal Propeptide of Type 1 Collagen (P1NP)

The mean percent change in amino-terminal of type 1 collagen (P1NP) from baseline after 12 months of treatment. P1NP is a bone marker found in blood serum and provides information about how fast the body is making new bone. (NCT02195895)
Timeframe: 12 months

InterventionPercent change (Mean)
Alendronate, Calcium, Vitamin D-51.5

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Bone-specific Alkaline Phosphatase (BSAP)

The mean percent change in bone-specific alkaline phosphatase (BSAP) after 12 months of treatment. BSAP is a bone marker found in blood serum and measures the rate of bone breakdown. (NCT02195895)
Timeframe: 12 months

InterventionPercent change (Mean)
Alendronate, Calcium, Vitamin D-15.5

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Asthma Control Test (ACT)

Asthma Control Test : Score calculated as the sum total of a 5-item questionnaire. Each item ranges from 1 (poor control) to 5 (good control) so that the range of the total score is 5 to 25. Scores below 20 indicate that asthma is not well controlled. (NCT02230332)
Timeframe: 8 weeks after randomization

Interventionunits on a scale (Mean)
Alendronate22.2
Placebo22.2

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Salmeterol Protected Methacholine Challenge PC20

Following administration of Salmeterol, the concentration of Methacholine required to produce a 20% drop in FEV1 - measured in mg/ml and reported on log base 2 scale. (NCT02230332)
Timeframe: 8 weeks after randomization

Interventionmg/ml on log base 2 scale (Mean)
Alendronate1.8
Placebo1.7

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Beta-2 Adrenergic Receptor Agonist-induced cAMP Production

Peripheral blood mononuclear cells cAMP concentrations measured using isoproterenol (ISO) as a beta-2 adrenergic receptor agonist, and using phosphate buffered saline (PBS) as a positive control. The outcome is expressed as the ratio of cAMP concentration using ISO relative to cAMP concentration using PBS. (NCT02230332)
Timeframe: 8 weeks after randomization

Interventionratio (Geometric Mean)
Alendronate5.9
Placebo5.9

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Fractional Exhaled Nitrix Oxide

(NCT02230332)
Timeframe: 8 weeks after randomization

Interventionparts per billion (Geometric Mean)
Alendronate16.8
Placebo15.4

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Peripheral Blood Mononuclear Cell ADRB2 Cell Surface Density

(NCT02230332)
Timeframe: 8 weeks after randomization

Interventionnumber of receptors per cell (Geometric Mean)
Alendronate1680
Placebo1863

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Salivary Alpha Amylase Ratio (Post-Salmeterol / Pre-Salmeterol)

Salivary Alpha Amylase (sAA) levels from saliva samples obtained through passive drooling, before and 1 hour after Salmeterol administration. The outcome is expressed as the ratio of the Post-Salmeterol to the Pre-Salmeterol sAA levels. (NCT02230332)
Timeframe: 8 weeks after randomization

Interventionratio (Mean)
Alendronate1.6
Placebo1.6

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Percent Change of Bone Mineral Density in Lumbar and Hip

Percent change of bone mineral density in lumbar and hip by dual energy x-ray absorptiometry (NCT02304757)
Timeframe: baseline, 6 months, and 12 months

,
Interventionpercentage change (Mean)
Percentage change of lumbar spine at month 6Percentage change of lumbar spine month 12Percentage change of total hip at month 6Percentage change of total hip at month 12
99Tc-MDP3.03.80.95.1
Fosamax3.25.14.94.6

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Side Effects

A transient rash and phlebitis, gastrointestinal reaction. (NCT02304757)
Timeframe: 6 months, and 12 months

,
Interventionside effects (Number)
abdominal paindyspepsia
99Tc-MDP00
Fosamax24

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Bone Turnover Markers

bone turnover markers including C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide(PINP) (NCT02304757)
Timeframe: baseline and 12 months

,
Interventionng/ml (Mean)
PINP before treatmentPINP at 12monthsCTX before treatmentCTX at 12months
99Tc-MDP43.772552.64220.46570.3707
Fosamax29.25520.561230.15260.1771

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Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)

Percent changes of bone mineral density at lumbar spine (L1-L4) from baseline to 1-year after treatment will be compared and analysed between 2 groups. (NCT02371252)
Timeframe: 1 year after treatment

Interventionpercent (Mean)
Original Alendronate (Fosamax)5.54
Generic Alendronate (Bonmax)5.39

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Bone Mineral Density (BMD) at Total Hip

Percent changes of bone mineral density at total hip from baseline to 1-year after treatment will be compared and analysed between 2 groups. (NCT02371252)
Timeframe: 1 year after treatment

Interventionpercent (Mean)
Original Alendronate (Fosamax)2.48
Generic Alendronate (Bonmax)2.52

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Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip

At one year the investigators will asses bone mass using QCT of the total hip and compare one year changes in bone mass between the treatment and control groups. (NCT02440581)
Timeframe: One Year (at baseline and one year)

Interventiong/cm^3 (Mean)
Control, Low Turnover-10.71
Treatment, Low Turnover5.72
Control, High Turnover-3.52
Treatment, High Turnover.2

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Change in Serum Biochemical Bone Markers of Bone Activity - Bone-specific Alkaline Phosphatase (BSAP)

Bone markers of bone activity tracked over time for changes.1 Yr. Change in BSAP (NCT02440581)
Timeframe: 1 year (at baseline and one year)

Interventionpg/ml (Mean)
Control, Low Turnover.61
Treatment, Low Turnover-1.01
Control, High Turnover-8.92
Treatment, High Turnover-10.36

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Change in Serum Biochemical Bone Markers of Bone Activity - Fibroblast Growth Factor 23 (FGF23)

Bone markers of bone activity tracked over time for changes. 1 Yr. Change in FGF-23 (NCT02440581)
Timeframe: 1 Year (at baseline and 1 year)

Interventionpg/ml (Mean)
Control, Low Turnover985
Treatment, Low Turnover326
Control, High Turnover3337
Treatment, High Turnover607

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Change in Serum Biochemical Bone Markers of Bone Activity - Parathyroid Hormone (PTH)

Bone markers of bone activity tracked over time for changes.1 Yr. Change in PTH (NCT02440581)
Timeframe: 1 Year (at baseline and one year)

Interventionpg/ml (Mean)
Control, Low Turnover89
Treatment, Low Turnover379
Control, High Turnover-125
Treatment, High Turnover-240

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Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT)

At one year the investigators will asses differences between the treatment and control groups in changes in Coronary Artery Calcifications by MDCT. 1 Yr. Change in Sqrt CAC Vol. (NCT02440581)
Timeframe: One year (at baseline and one year)

InterventionHounsfield Unit (Mean)
Control, Low Turnover2.78
Treatment, Low Turnover4.48
Control, High Turnover4.97
Treatment, High Turnover3.47

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Number of Participants in Which CTX Increased Above the Least Significant Change

"Number of participants in which CTX increased above the least significant change.~The Department of Clinical Biochemistry, Rigshospitalet, Glostrup, Denmark provided the the least significant change for p-CTX > 30%." (NCT03051620)
Timeframe: From baseline to month 24

Interventionparticipants (Number)
Study Population85

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Percent Change in Bone Turnover Markers Measured Three and Six Months After Stopping Alendronate Treatment and BMD After One and Two Years

We constructed receiver operating characteristic (ROC) curves to evaluate if changes in p-CTX or p-PINP measured three and six months after stopping alendronate predicted TH BMD loss above the least significant change at month 12 and/or month 24 at the individual level. (NCT03051620)
Timeframe: one and two years after baseline

Interventionpercentage change (Mean)
Mean change in PINP from baseline to month 3Mean change in PINP from baseline to month 6Mean change in TH BMD from baseline to month 12Mean change in TH BMD from baseline to month 24
Study Population3654-1.14-2.65

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The Number of Participants Who Lost BMD Beyond the Least Significant Change (LSC) at the Lumbar Spine and Total Hip.

the number of patients who lost BMD beyond the LSC at the lumbar spine (>3%) and total hip (>5%) (NCT03051620)
Timeframe: from baseline to month 24

Interventionparticipants (Number)
SpineTotal hip
Study Population2126

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If Baseline Bone Turnover Markers at the Time of Alendronate Discontinuation Predict Changes in BMD After One and Two Years.

We constructed receiver operating characteristic (ROC) curves to evaluate if baseline p-CTX or baseline p-PINP at the time of alendronate discontinuation predicted TH BMD loss above the least significant change at month 12 and/or month 24 at the individual level. (NCT03051620)
Timeframe: Changes in TH BMD after one and two years.

Interventionpercentage change (Mean)
Mean change in TH BMD after one yearMean change in TH BMD after two years
Study Population-1.14-2.65

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Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA

(NCT03292146)
Timeframe: Baseline to 24 months

Intervention% change (Mean)
Denosumab (0-12 Months) Followed by Alendronate (12-24 Months)3.9
Placebo (0-12 Months) Followed by Alendronate (12-24 Months)5.8

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Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)

Postero-anterior (PA) lumbar spine bone mineral density was assessed by dual-energy x-ray absorptiometry (DXA). The DXA scanner used was a Hologic Horizon A (Hologic, Inc., Waltham, MA). (NCT03292146)
Timeframe: 12 months (Period 1)

Interventiong/cm^2 (Least Squares Mean)
Denosumab (0-12 Months) Followed by Alendronate (12-24 Months)0.90
Placebo (0-12 Months) Followed by Alendronate (12-24 Months)0.87

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Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA

(NCT03292146)
Timeframe: 12 months to 24 months (Period 2)

Intervention% change (Mean)
Denosumab (0-12 Months) Followed by Alendronate (12-24 Months)-2.0
Placebo (0-12 Months) Followed by Alendronate (12-24 Months)4.6

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