Page last updated: 2024-11-04

risedronic acid

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Description

Risedronic acid is a bisphosphonate medication used to treat and prevent osteoporosis, Paget's disease of bone, and hypercalcemia. It is also used to treat bone metastases from cancers such as breast cancer, prostate cancer, and multiple myeloma. Risedronic acid works by inhibiting the activity of osteoclasts, which are cells that break down bone. This results in increased bone density and a reduced risk of fractures. Risedronic acid is synthesized through a multi-step process involving the reaction of a phosphorus-containing compound with a diphosphonic acid. It is typically administered orally, but it can also be given intravenously. Risedronic acid is a potent inhibitor of bone resorption and has been shown to be effective in reducing fracture risk in patients with osteoporosis. It is also effective in treating Paget's disease of bone and hypercalcemia. However, risedronic acid can cause side effects such as gastrointestinal upset, esophagitis, and osteonecrosis of the jaw. It is important to note that risedronic acid should be taken on an empty stomach and with a full glass of water. Patients should also avoid lying down for at least 30 minutes after taking risedronic acid.'

Risedronic Acid: A pyridine and diphosphonic acid derivative that acts as a CALCIUM CHANNEL BLOCKER and inhibits BONE RESORPTION. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID5245
CHEMBL ID923
CHEBI ID8869
SCHEMBL ID18378
MeSH IDM000603388

Synonyms (85)

Synonym
AC-1295
BIDD:GT0010
AB01275490-01
gtpl3176
ne-58095
[1-hydroxy-1-phosphono-2-(3-pyridyl)ethyl]phosphonic acid
phosphonic acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-
(1-hydroxy-2-pyridin-3-ylethane-1,1-diyl)bis(phosphonic acid)
risedronate ,
risedronic acid
C08233
105462-24-6
DB00884
acide risedronique [inn-french]
(1-hydroxy-2-(3-pyridyl)ethylidene)diphosphonic acid
ne 58019
acidum risedronicum [inn-latin]
risedronic acid [inn:ban]
acido risedronico [inn-spanish]
hsdb 7326
1-hydroxy-2-(3-pyridinyl)ethylidene bis-phosphonic acid
RIS ,
bisphosphonate 1
risdronate
[1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonic acid
bdbm12576
jmc515594 compound 64
chembl923 ,
(1-hydroxy-1-phosphono-2-pyridin-3-yl-ethyl)phosphonic acid
HMS2090C21
ridron
m05ba07
chebi:8869 ,
risedronic acid (inn)
ridron (tn)
D08484
(1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphonic acid
A801245
1-hydroxy-2-(3-pyridinyl)ethylidenebisphosphonicacidmonohydrate;risedronic acid monohydrate
unii-km2z91756z
km2z91756z ,
acido risedronico
acidum risedronicum
acide risedronique
FT-0642593
risedronic acid [hsdb]
2-(3-pyridinyl)-1-hydroxyethane diphosphonic acid
risedronic acid [inn]
risedronic acid [mi]
risedronic acid [who-dd]
risedronic acid [mart.]
risedronate [vandf]
S1874
AKOS015892564
CS-1964
HY-B0148
SCHEMBL18378
IIDJRNMFWXDHID-UHFFFAOYSA-N
2-(3-pyridyl)-1-hydroxyethane-1,1-bisphosphonic acid
AB01275490_02
DTXSID2023563 ,
phosphonic acid, [1-hydroxy-2-(3-pyridinyl)ethylidene]bis-
sr-05000001495
(1-hydroxy-2-(pyridin-3-yl)ethane-1,1-diyl)bis(phosphonic acid)
SR-05000001495-1
NCGC00386377-01
Q408724
risedronic acid (actonel)
mfcd00867080
1-hydroxy-2-(pyridin-3-yl)ethane-1,1-diyldiphosphonic acid
AS-13584
BCP13805
AMY3524
(1-hydroxy-2-(pyridin-3-yl)ethane-1,1-diyl)diphosphonic acid
HMS3741A17
EN300-117266
phosphonic acid, p,p'-[1-hydroxy-2-(3-pyridinyl)ethylidene]bis-
Z1501485357
acide risedronique (inn-french)
risedronsaure
acidum risedronicum (inn-latin)
acido risedronico (inn-spanish)
acide risedroniqe
dtxcid303563
risedronic acid (mart.)

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Risedronate was well tolerated, had a good safety profile, and was not associated with gastrointestinal adverse events."( Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trial. European Corticosteroid-Induced Osteoporosis Treatment Study.
Adami, S; Devogelaer, JP; Eusebio, RA; Hughes, RA; Laan, RF; Reid, DM; Sacco-Gibson, NA; Wenderoth, DH, 2000
)
0.31
" Some bisphosphonates have been associated with upper gastrointestinal (GI) tract adverse effects."( Upper gastrointestinal tract safety of risedronate: a pooled analysis of 9 clinical trials.
Adami, S; Bolognese, MA; Ernst, TF; Ettinger, MP; Josse, RG; Lindsay, R; Mulder, H; Roberts, A; Stevens, KP; Taggart, H; Zippel, H, 2002
)
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
)
0.31
"To evaluate the frequency of upper gastrointestinal (GI) tract adverse events associated with risedronate during two (2-year) randomized, double-blind, parallel-group, placebo-controlled studies."( Upper gastrointestinal tract safety of daily oral risedronate in patients taking NSAIDs: a randomized, double-blind, placebo-controlled trial.
Adami, S; Barton, IP; Bensen, WG; Cline, GA; Cohen, SB; Hosterman, MA; Pavelka, K, 2005
)
0.33
" The number of upper GI tract adverse events was similar between treatment groups, with no dose-related response: 161 for placebo, 176 for rlsedronate at 5 mg/d, and 150 for risedronate at 15 mg/d."( Upper gastrointestinal tract safety of daily oral risedronate in patients taking NSAIDs: a randomized, double-blind, placebo-controlled trial.
Adami, S; Barton, IP; Bensen, WG; Cline, GA; Cohen, SB; Hosterman, MA; Pavelka, K, 2005
)
0.33
"The results of this study show that risedronate regimens at 5 mg/d or 15 mg/d as well as once weekly at 35 mg or 50 mg are not associated with an increased frequency of upper GI tract adverse events, even in patients who have an increased risk for such events."( Upper gastrointestinal tract safety of daily oral risedronate in patients taking NSAIDs: a randomized, double-blind, placebo-controlled trial.
Adami, S; Barton, IP; Bensen, WG; Cline, GA; Cohen, SB; Hosterman, MA; Pavelka, K, 2005
)
0.33
" Risedronate was safe and effective in osteoporotic women with mild, moderate, or severe age-related renal impairment."( Safety and efficacy of risedronate in patients with age-related reduced renal function as estimated by the Cockcroft and Gault method: a pooled analysis of nine clinical trials.
Barton, IP; Boonen, S; Burgio, DE; Dunlap, LE; Miller, PD; Roux, C, 2005
)
0.33
" Risedronate is a pyridinyl bisphosphonate well established as safe and effective in the treatment and prevention of osteoporosis."( Safety and efficacy of risedronate in patients with age-related reduced renal function as estimated by the Cockcroft and Gault method: a pooled analysis of nine clinical trials.
Barton, IP; Boonen, S; Burgio, DE; Dunlap, LE; Miller, PD; Roux, C, 2005
)
0.33
" The incidences of overall adverse events and of renal function-related adverse events were similar in the placebo and risedronate 5 mg groups regardless of renal function."( Safety and efficacy of risedronate in patients with age-related reduced renal function as estimated by the Cockcroft and Gault method: a pooled analysis of nine clinical trials.
Barton, IP; Boonen, S; Burgio, DE; Dunlap, LE; Miller, PD; Roux, C, 2005
)
0.33
"These findings show that risedronate is safe and effective in osteoporotic women with age-related mild, moderate, or severe renal impairment."( Safety and efficacy of risedronate in patients with age-related reduced renal function as estimated by the Cockcroft and Gault method: a pooled analysis of nine clinical trials.
Barton, IP; Boonen, S; Burgio, DE; Dunlap, LE; Miller, PD; Roux, C, 2005
)
0.33
" The changes were compared in bone mineral density (BMD), bone metabolism markers and adverse events after 12 months oral administration of risedronate sodium."( Efficacy and safety of risedronate sodium in treatment of postmenopausal osteoporosis.
Chen, L; Deng, X; Li, Y; Zhang, Z, 2005
)
0.33
"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
)
0.33
"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,
)
0.13
" Risedronate administration in the dose which is considered to be comparable to a dose of risedronate used for treatment of osteoporosis in women seems to be safe in terms of effects on mouse haematopoiesis."( Risedronate has no adverse effects on mouse haematopoiesis.
Broulík, P; Necas, E; Pelichovská, T; Sefc, L, 2007
)
0.34
" 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,
)
0.13
" Bone mineral density, bone turnover markers, fractures, and adverse events were evaluated."( Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis.
Beary, JF; Benhamou, CL; Boonen, S; Burgio, DE; Delmas, PD; Eusebio, RA; Man, Z; Matzkin, E; McClung, MR; Racewicz, A; Roux, C; Zanchetta, JR, 2008
)
0.35
" The incidence of adverse events, adverse events leading to withdrawal, and upper gastrointestinal tract adverse events were similar in the 2 treatment groups."( Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis.
Beary, JF; Benhamou, CL; Boonen, S; Burgio, DE; Delmas, PD; Eusebio, RA; Man, Z; Matzkin, E; McClung, MR; Racewicz, A; Roux, C; Zanchetta, JR, 2008
)
0.35
" In placebo controlled trials it has been shown to be safe and effective in preventing fractures."( Review of the safety and efficacy of risedronate for the treatment of male osteoporosis.
Adachi, JD; Bobba, R, 2007
)
0.34
" Risedronate 75 mg twice monthly was effective and safe suggesting a new, convenient dosing schedule."( Monthly dosing of 75 mg risedronate on 2 consecutive days a month: efficacy and safety results.
Benhamou, CL; Delmas, PD; Eusebio, R; Man, Z; Matzkin, E; McClung, MR; Olszynski, WP; Recker, RR; Tlustochowicz, W; Zanchetta, J, 2008
)
0.35
" 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
)
0.35
" Bone mineral density (BMD), bone turnover markers (BTMs), fractures, and adverse events were evaluated."( Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet.
Balske, A; Benhamou, CL; Bolognese, MA; Brown, JP; Burgio, DE; McClung, MR; McCullough, LK; Miller, PD; Recker, RR; Sarley, J; Zanchetta, J, 2012
)
0.38
" The incidence of adverse events leading to withdrawal and serious adverse events were similar across treatment groups."( Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet.
Balske, A; Benhamou, CL; Bolognese, MA; Brown, JP; Burgio, DE; McClung, MR; McCullough, LK; Miller, PD; Recker, RR; Sarley, J; Zanchetta, J, 2012
)
0.38
" 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
)
0.38
" The safety of risedronate was evaluated based on adverse events, laboratory data, vital signs, and physical examination results."( Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study.
Boonen, S; Eusebio, R; Lorenc, RS; Orwoll, ES; Stoner, KJ; Wenderoth, D, 2012
)
0.38
" Bone mineral density (BMD), bone turnover markers, new vertebral fractures, and adverse events were evaluated."( Efficacy and safety of risedronate 150-mg once a month in the treatment of postmenopausal osteoporosis: 2-year data.
Beary, JF; Benhamou, CL; Boonen, S; Burgio, DE; Delmas, P; Eusebio, RA; Man, Z; Matzkin, E; McClung, MR; Racewicz, A; Roux, C; Zanchetta, JR, 2013
)
0.39
" The incidence of adverse events, adverse events leading to withdrawal, and upper gastrointestinal tract adverse events were similar in the two treatment groups."( Efficacy and safety of risedronate 150-mg once a month in the treatment of postmenopausal osteoporosis: 2-year data.
Beary, JF; Benhamou, CL; Boonen, S; Burgio, DE; Delmas, P; Eusebio, RA; Man, Z; Matzkin, E; McClung, MR; Racewicz, A; Roux, C; Zanchetta, JR, 2013
)
0.39
" An investigation of the cytotoxicity of the RA-CSC systems upon osteoblast-like cells showed no toxic effects of concentrations up to 2%."( Preparation, characterization, release kinetics, and in vitro cytotoxicity of calcium silicate cement as a risedronate delivery system.
Gong, T; Häfeli, UO; Sun, C; Troczynski, T; Wang, Z; Yang, Q; Zhang, Y, 2014
)
0.4
" 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
)
0.4
" Bone mineral density (BMD), biochemical markers of bone metabolism, fractures, and adverse events (AEs) were evaluated."( Efficacy, tolerability and safety of once-monthly administration of 75mg risedronate in Japanese patients with involutional osteoporosis: a comparison with a 2.5mg once-daily dosage regimen.
Hagino, H; Horii, S; Kishimoto, H; Nakamura, T; Ohishi, H, 2014
)
0.4
" The subjects' bone mineral densities (BMDs), bone turnover markers (P1NP and β-CTX), new vertebral fractures, and adverse events were assessed at baseline and during the treatments."( The efficacy and safety of weekly 35-mg risedronate dosing regimen for Chinese postmenopausal women with osteoporosis or osteopenia: 1-year data.
Chen, DC; Fu, WZ; Gu, JM; He, JW; Hu, WW; Hu, YQ; Jin, XL; Lin, H; Liu, YJ; Tang, H; Wang, C; Wang, L; Xia, WB; Yue, H; Zhang, H; Zhang, ZL, 2015
)
0.42
" The incidences of clinical adverse events were 48."( The efficacy and safety of weekly 35-mg risedronate dosing regimen for Chinese postmenopausal women with osteoporosis or osteopenia: 1-year data.
Chen, DC; Fu, WZ; Gu, JM; He, JW; Hu, WW; Hu, YQ; Jin, XL; Lin, H; Liu, YJ; Tang, H; Wang, C; Wang, L; Xia, WB; Yue, H; Zhang, H; Zhang, ZL, 2015
)
0.42
" 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
" The groups had not only comparable Model for End-stage Liver Disease score and esophageal varices degree, but also similar incidence of digestive adverse effects."( Safety and efficacy of risedronate for patients with esophageal varices and liver cirrhosis: a non-randomized clinical trial.
Caramori, CA; Lima, TB; Nunes, HRC; Qi, X; Romeiro, FG; Santos, LAA; Silva, GF, 2019
)
0.51
" 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
" Incident of non-traumatic spine fractures and adverse events were tracked as safety endpoints."( Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial.
Amasaki, Y; Atsumi, T; Fujieda, Y; Fukaya, S; Furukawa, S; Furusaki, A; Horita, T; Iwasaki, N; Kasahara, H; Katayama, K; Kato, M; Katsumata, K; Kurita, T; Matsui, K; Nishimoto, N; Oku, K; Sagawa, A; Shane, P; Takahata, M; Takeda, T; Takeuchi, K; Tanimura, K; Tsutsumi, A; Yasuda, S, 2021
)
0.62
"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
)
0.91

Pharmacokinetics

ExcerptReferenceRelevance
" Pharmacokinetic parameters were estimated by simultaneous analysis of risedronate serum concentration and urinary excretion rate-time data."( The effect of dosing regimen on the pharmacokinetics of risedronate.
Clay, ME; Heise, MA; Melson, CW; Mitchell, DY; Nesbitt, JD; Pallone, KA; Russell, DA, 1999
)
0.3
" Mean Cmax (0."( Dose-proportional pharmacokinetics of risedronate on single-dose oral administration to healthy volunteers.
Brezovic, CP; Eusebio, RA; Kelly, SC; Mitchell, DY; Nesbitt, JD; Pallone, KA; Powell, JH; Sacco-Gibson, NA; Thompson, GA, 2000
)
0.31
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" Pharmacodynamic study was performed on Dexamethasone (DEX) induced osteoporotic model."( Design and Development of Bioceramic Based Functionalized PLGA Nanoparticles of Risedronate for Bone Targeting: In-vitro Characterization and Pharmacodynamic Evaluation.
Ahmad, FJ; Gupta, S; Kalam, A; Manglani, K; Rawat, P; Talegaonkar, S; Vohora, D, 2015
)
0.42
" Biochemical and in-vivo pharmacokinetic studies on osteoporotic rat model treated with different formulations were performed."( Revisiting bone targeting potential of novel hydroxyapatite based surface modified PLGA nanoparticles of risedronate: Pharmacokinetic and biochemical assessment.
Ahmad, FJ; Ahmad, I; Gupta, S; Pandey, S; Rawat, P; Talegaonkar, S; Thomas, SC; Vohora, D, 2016
)
0.43
"To develop a population pharmacokinetic model that describes the absorption and low plasma levels of risedronate in the body."( Osteoporosis treatment with risedronate: a population pharmacokinetic model for the description of its absorption and low plasma levels.
Cardozo, B; Karalis, V; Karatza, E, 2021
)
0.62

Compound-Compound Interactions

ExcerptReferenceRelevance
"Therapies utilizing intermittent human parathyroid hormone(1-34) (hPTH[1-34]) in combination with other agents have recently been proposed as possible anabolic regimens for the treatment of osteoporosis."( Effects of intermittent hPTH(1-34) alone and in combination with 1,25(OH)(2)D(3) or risedronate on endosteal bone remodeling in canine cancellous and cortical bone.
Boyce, RW; Eriksen, EF; Franks, AF; Jankowsky, ML; Paddock, CL, 1996
)
0.29
" The purpose was to determine the effects of the anti-resorptive agents alone and in combination with intermittent PTH on bone formation in the mandible and a long bone in the aged ovariectomized (Ovx) rat."( Mandibular bone formation rates in aged ovariectomized rats treated with anti-resorptive agents alone and in combination with intermittent parathyroid hormone.
Hunziker, J; Miller, SC; Wronski, TJ, 2000
)
0.31
"The relationship between bone turnover and bone tissue and material properties was examined in ovariectomized (OVX) rats treated with risedronate in combination with or without vitamin K2."( Regulation of mineral-to-matrix ratio of lumbar trabecular bone in ovariectomized rats treated with risedronate in combination with or without vitamin K2.
Ikeda, S; Ito, M; Nakamura, T; Otomo, H; Phipps, RJ; Sakai, A; Tanaka, S, 2004
)
0.32
"To investigate the effects of vitamin K2 (Vit K2) alone or in combination with etidronate and risedronate on bone loss, osteoclast induction, and inflammation in patients with rheumatoid arthritis (RA)."( Osteoclast inhibitory effects of vitamin K2 alone or in combination with etidronate or risedronate in patients with rheumatoid arthritis: 2-year results.
Morishita, M; Nagashima, M; Takahashi, H; Takenouchi, K; Wauke, K, 2008
)
0.35
"Vit K2 alone or in combination with bisphosphonates for treatment of osteoporosis in patients with RA may inhibit osteoclast induction via decreases in levels of RANKL."( Osteoclast inhibitory effects of vitamin K2 alone or in combination with etidronate or risedronate in patients with rheumatoid arthritis: 2-year results.
Morishita, M; Nagashima, M; Takahashi, H; Takenouchi, K; Wauke, K, 2008
)
0.35
" The anti-tumor activities of risedronate in combination with carboplatin, doxorubicin, vincristine or etoposide were assayed with CalcuSyn (Biosoft)."( Efficacy of the third-generation bisphosphonate risedronate alone and in combination with anticancer drugs against osteosarcoma cell lines.
Kawasoe, Y; Komiya, S; Minami, S; Murayama, T; Ueno, Y; Yamashita, Y; Yokouchi, M,
)
0.13
" These results suggested that ECT in combination with risedronate was more effective than risedronate alone for reducing back pain in postmenopausal women with osteoporosis."( Elcatonin in combination with risedronate is more effective than risedronate alone for relieving back pain in postmenopausal women with osteoporosis.
Iwamoto, J; Takakuwa, M, 2012
)
0.38
" A total of 180 women with low bone mineral density were randomly divided into four groups, one in which sodium risedronate was administered with sodium rabeprazole and one in which only risedronate was administered (BP + PPI and BP groups, respectively)."( The effects of risedronate administered in combination with a proton pump inhibitor for the treatment of osteoporosis.
Itoh, S; Sekino, Y; Shinomiya, K; Takeda, S, 2013
)
0.39
" We aimed to evaluate the effects of risedronate alone or combined with vitamin K2 on serum ucOC, OC, and incidence of vertebral fractures in elderly osteoporotic patients."( Effects of risedronate alone or combined with vitamin K2 on serum undercarboxylated osteocalcin and osteocalcin levels in postmenopausal osteoporosis.
Aizawa, T; Chida, S; Ebina, T; Hongo, M; Ishikawa, Y; Kasukawa, Y; Miyakoshi, N; Nozaka, K; Saito, H; Shimada, Y, 2014
)
0.4
" In the present study, to increase oral BA of the bisphosphonate, a novel enteric-coated tablet (ECT) dosage form of RS in combination with phytic acid (IP6), a natural chelating agent recognized as safe, was formulated."( Enteric-coated tablet of risedronate sodium in combination with phytic acid, a natural chelating agent, for improved oral bioavailability.
Jang, SW; Kang, MJ; Kim, BM; Kim, JS; Son, M, 2016
)
0.43

Bioavailability

ExcerptReferenceRelevance
" 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
"Food-drug interactions may reduce the bioavailability of drugs taken after meals (negative food effect)."( Effect of administration site in the gastrointestinal tract on bioavailability of poorly absorbed drugs taken after a meal.
Kamaguchi, R; Kataoka, M; Kokubo, H; Kozaki, T; Masaoka, Y; Sakuma, S; Tanno, FK; Yamashita, S, 2007
)
0.34
" 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
)
0.35
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
"Adducts based on a bisphosphonate drug (sodium risedronate) and titanium dioxide (TiO(2)) particles have been developed and characterized in order to improve the bioavailability of orally administrated bisphosphonates."( Particulate adducts based on sodium risedronate and titanium dioxide for the bioavailability enhancement of oral administered bisphosphonates.
Beggiato, S; Bignozzi, CA; Bozzi, P; Dalpiaz, A; Dissette, V; Ferraro, L; Leo, E; Pasti, L; Vighi, E, 2010
)
0.36
"This study was designed to develop a sensitive and rapid method for the quantitation of risedronate in human urine using ultra-performance liquid chromatography with ultra-violet detector (UPLC-UV) and to compare bioavailability parameter of 5, 35 and 150 mg risedronate."( UPLC-UV method for determination of risedronate in human urine.
Chung, YH; Jeong, JH; Lim, CH; Seo, YH, 2014
)
0.4
"The present study was performed to compare the bioavailability of 2 risedronate sodium 35 mg film-coated tablet formulations (test formulation and reference formulation)."( Bioequivalence study of two risedronate sodium film-coated tablet formulations in healthy volunteers.
Handayani, LR; Rosa, TA; Setiawati, A; Setiawati, E; Sholeh, AB; Simanjuntak, R; Utami, BS; Yunaidi, DA, 2014
)
0.4
" However, its oral efficacy is restricted due to its low bioavailability and severe gastrointestinal adverse effects."( Ionic complex of risedronate with positively charged deoxycholic acid derivative: evaluation of physicochemical properties and enhancement of intestinal absorption in rats.
Byun, Y; Park, JW, 2014
)
0.4
" Taken together, the results of this study suggest that chitosan-coated liposomes containing risedronate should be effective for improving the bioavailability of risedronate."( Effective mucoadhesive liposomal delivery system for risedronate: preparation and in vitro/in vivo characterization.
Han, HK; Jung, IW, 2014
)
0.4
" The results illustrated the potential use of SMEDDS for delivery of poorly absorbed RSD."( Comparative permeability studies with radioactive and nonradioactive risedronate sodium from self-microemulsifying drug delivery system and solution.
Asikoglu, M; Ekinci, M; Gundogdu, E; Ilem-Ozdemir, D; Ozgenc, E, 2015
)
0.42
" The low oral bioavailability and known dosing limitations due to food interactions of bisphosphonates have led to development of an oral delayed-release dose form of risedronate 35 mg to be taken weekly, before or after breakfast."( Bone safety with risedronate: histomorphometric studies at different dose levels and exposure.
Chavassieux, P; Lundy, MW; McClung, MR; Recker, RR; Ste-Marie, LG, 2015
)
0.42
"One approach for the enhancement of oral drug bioavailability is the technique of nanoparticle preparation."( Preparation of risedronate nanoparticles by solvent evaporation technique.
Dedkova, K; Devinsky, F; Jampilek, J; Peikertova, P; Pisarcik, M; Placha, D; Vaculikova, E, 2014
)
0.4
"The oral bioavailability (BA) of risedronate sodium (RS), an antiresorptive agent, is less than 1% due to its low membrane permeability as well as the formation of non-absorbable complexes with multivalent cations such as calcium ion (Ca(2+)) in the gastrointestinal tract."( Enteric-coated tablet of risedronate sodium in combination with phytic acid, a natural chelating agent, for improved oral bioavailability.
Jang, SW; Kang, MJ; Kim, BM; Kim, JS; Son, M, 2016
)
0.43
" Drug package inserts for bisphosphonate supplements indicate that their bioavailability is reduced by high levels of metal cations (Ca(2+), Mg(2+), etc."( Interaction between Bisphosphonates and Mineral Water: Study of Oral Risedronate Absorption in Rats.
Akagi, Y; Aoyama, T; Itoh, A; Shimomura, H, 2016
)
0.43
" Pharmacokinetic studies revealed 6-fold and 4-fold increase in the relative bioavailability after intravenous and oral administration of nanoparticles respectively as compared to marketed formulation confirming better effective drug transport."( Revisiting bone targeting potential of novel hydroxyapatite based surface modified PLGA nanoparticles of risedronate: Pharmacokinetic and biochemical assessment.
Ahmad, FJ; Ahmad, I; Gupta, S; Pandey, S; Rawat, P; Talegaonkar, S; Thomas, SC; Vohora, D, 2016
)
0.43
" The oral bioavailability of risedronate in rats was determined through its percentage excreted in urine after administration of complexed or free risedronate in fed and fasted conditions."( Reduced food interaction and enhanced gastrointestinal tolerability of a new system based on risedronate complexed with Eudragit E100: Mechanistic approaches from in vitro and in vivo studies.
Guzman, ML; Laino, C; Manzo, RH; Olivera, ME; Soria, EA, 2016
)
0.43
"In this study, sustained release superabsorbent copolymer particles have been prepared and analyzed to increase bioavailability of orally administered risedronate sodium."( RELATIVE BIOAVAILABILITY OF RISEDRONATE SODIUM ADMINISTERED IN SUPERABSORBENT COPOLYMER PARTICLES VERSUS ORAL SOLUTION TO NORMAL HEALTHY RABBITS.
Abbas, N; Bukhari, NI; Hussain, T; Karim, S; Shahzad, MK, 2016
)
0.43
"Risedronate sodium is a bisphosphonate derivative having very low bioavailability when administered through the oral route."( Improvement of bone microarchitecture in methylprednisolone induced rat model of osteoporosis by using thiolated chitosan-based risedronate mucoadhesive film.
Anbu, J; Azamthulla, M; Banala, VT; Mukherjee, D; Ramachandra, SG; Srinivasan, B, 2018
)
0.48
"Albeit its well known potency as a postmenopausal osteoporosis treatment, Risedronate suffers from poor oral bioavailability and high oral toxicity."( Anionic versus cationic bilosomes as oral nanocarriers for enhanced delivery of the hydrophilic drug risedronate.
Abdallah, OY; Elnaggar, YSR; Hazzah, HA; Omran, S, 2019
)
0.51
"Delivery of bisphosphonates-like risedronate has been a major challenge till date due to its poor bioavailability and gastrointestinal tract adverse effects."( Improved treatment efficacy of risedronate functionalized chitosan nanoparticles in osteoporosis: formulation development, in vivo, and molecular modelling studies.
Anbu, J; Mukherjee, D; Murahari, M; Santhosh, S; Teja, BV, 2019
)
0.51
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
"Risedronate sodium (RS) is a potent inhibitor of bone resorption, having an extreme poor permeability and limited oral bioavailability (0."( QbD Approach for Novel Crosslinker-Free Ionotropic Gelation of Risedronate Sodium-Chitosan Nebulizable Microspheres: Optimization and Characterization.
El-Laithy, HM; Elkady, OA; Tadros, MI, 2019
)
0.51
" To avoid the undesirable adverse effects of long-term usage of bisphosphonates and improve their bioavailability in the bone microenvironment, we initially encapsulated risedronate (RIS) molecules inside nanoscale zeolitic imidazolate framework-8 particles (nZIF-8) by a one-step synthesis method to generate RIS@ZIF-8 nanoparticles."( Zeolitic Imidazolate Framework-8 Encapsulating Risedronate Synergistically Enhances Osteogenic and Antiresorptive Properties for Bone Regeneration.
Cheng, X; Gao, X; Liu, Y; Pei, X; Wan, Q; Wang, J; Xue, Y; Zhu, Z, 2020
)
0.56
" It is a BCS class III drug having poor oral bioavailability (<0."( Investigation on Potential of Chitosan Nanoparticles for Oral Bioavailability Enhancement of Risedronate Sodium.
Desai, J; Suthar, N; Thakkar, HP, 2021
)
0.62
"High lung deposition and bioavailability of RIS was monitored with 88."( Nebulization of risedronate alleviates airway obstruction and inflammation of chronic obstructive pulmonary diseases via suppressing prenylation-dependent RAS/ERK/NF-κB and RhoA/ROCK1/MLCP signaling.
Cao, J; Chen, H; Chen, R; Liu, D; Su, B; Tang, Y; Wu, D; Xu, J; Xu, W, 2022
)
0.72

Dosage Studied

ExcerptRelevanceReference
" 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
" In these studies another formulation of the drug and other dosing instructions are used."( A 2-year phase II study with 1-year of follow-up of risedronate (NE-58095) in postmenopausal osteoporosis.
Christiansen, C; Clemmesen, B; Ravn, P; Reginster, JY; Taquet, AN; Zegels, B, 1997
)
0.3
" Serum and urine samples were obtained for 48 hours after dosing for risedronate analysis."( Risedronate gastrointestinal absorption is independent of site and rate of administration.
Bekker, PJ; Clay, ME; Dunlap, LE; Eusebio, RA; Mitchell, DY; Nesbitt, JD; Pallone, KA; Russell, DA, 1998
)
0.3
" Risedronate was well tolerated during the dosing phase of the study as evidenced by clinical observations, body weight gain and food consumption which were not significantly different from the vehicle controls."( Evaluation of the effects of risedronate on hepatic microsomal drug metabolizing enzyme activities following administration to rats for 14 days: lack of an induction response.
Hu, JK; Schwecke, WP; Smith, BJ, 1998
)
0.3
" The data show that there is a dose-response with risedronate: patients who received 30 mg oral risedronate for 28 days benefited most, with a mean percentage decrease in AP excess of 72."( Risedronate, a highly effective, short-term oral treatment for Paget's disease: a dose-response study.
Bekker, PJ; Brown, JP; Hosking, DJ; Johnson, TD; Johnston, CC; Reginster, J; Ryan, WG; Ste-Marie, L, 1999
)
0.3
"5-1 h before breakfast or 2 h after an evening meal support previous clinical studies where risedronate was found to have similar effectiveness using these dosing regimens."( The effect of dosing regimen on the pharmacokinetics of risedronate.
Clay, ME; Heise, MA; Melson, CW; Mitchell, DY; Nesbitt, JD; Pallone, KA; Russell, DA, 1999
)
0.3
" 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
" Serum samples were obtained for 72 h after dosing, and urine samples were collected for 72 h after dosing and then periodically for 6 weeks."( Effect of renal function on risedronate pharmacokinetics after a single oral dose.
Eusebio, RA; Kelly, SC; Mitchell, DY; Nesbitt, JD; Pallone, KA; Powell, JH; Russell, DA; St Peter, JV; Thompson, GA, 2000
)
0.31
" 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
)
0.31
" 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
)
0.31
" The oesophageal transit is rapid and given the rapid disintegration and gastric emptying, oesophageal contact occurring via reflux of risedronate was unlikely since most, if not all, of the dosage form exited from the stomach within 30 min."( Oesophageal transit, disintegration and gastric emptying of a film-coated risedronate placebo tablet in gastro-oesophageal reflux disease and normal control subjects.
Blackshaw, PE; Dansereau, RJ; Frier, M; Hathaway, S; Juan, D; Li, Z; Long, P; Perkins, AC; Spiller, RC; Wilson, CG, 2001
)
0.31
" The time course of changes in PTH levels following cessation of dosing was unaffected by calcium supplementation."( Effect of high doses of oral risedronate (20 mg/day) on serum parathyroid hormone levels and urinary collagen cross-link excretion in postmenopausal women with spinal osteoporosis.
Collette, J; Eastell, R; Ethgen, D; Reginster, JY; Roumagnac, I; Russell, RG; Zegels, B, 2001
)
0.31
" As a result of this concern, dosage forms are now being designed to exhibit minimal esophageal adhesion."( The in-vitro porcine adhesion model is not predictive of the esophageal transit of risedronate tablets in humans.
Crail, D; Dansereau, R; Lane, M; McCargar, L; Myers, W, 2001
)
0.31
"As our population ages, and the consumption of pharmaceutical products rises, the incidence of solid oral dosage forms lodging in the esophagus is likely to increase and may be formulation dependent."( The use of scintigraphy to demonstrate the rapid esophageal transit of the oval film-coated placebo risedronate tablet compared to a round uncoated placebo tablet when administered with minimal volumes of water.
Blackshaw, PE; Dansereau, RJ; Frier, M; Hathaway, S; Li, Z; Perkins, AC; Spiller, RC; Vincent, RM; Wenderoth, D; Wilson, CG, 2001
)
0.31
" 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
)
0.31
" 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
)
0.31
" 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
)
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
)
0.31
" This dosage was well tolerated with a low incidence of GI side effects."( Bone density changes with once weekly risedronate in postmenopausal women.
Delaney, MF; Hurwitz, S; LeBoff, MS; Shaw, J, 2003
)
0.32
"The purpose of this study was to determine compliance with dosing instructions, and the prevalence of possible adverse events, when risedronate is used in clinical practice."( Tolerability and compliance with risedronate in clinical practice.
Hamilton, B; McCoy, K; Taggart, H, 2003
)
0.32
" To assess the anti-fracture efficacy of this new regimen, we have analyzed the fracture data collected in an active controlled study of risedronate dosing regimens (the Once-a-Week study) using matched historical control data from previous placebo-controlled trials."( Use of matched historical controls to evaluate the anti-fracture efficacy of once-a-week risedronate.
Brown, J; Kasibhatla, C; Li, Z; Lindsay, R; Watts, NB, 2003
)
0.32
" 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
)
0.32
"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
)
0.32
" Therefore, the pharmacokinetic profile of risedronate was considered to show linearity in a dosage range of up to 20 mg."( Clinical trial of risedronate in Japanese volunteers: single and multiple oral dose studies.
Cyong, JC; Gonsho, A; Ogura, Y; Orimo, H, 2004
)
0.32
"The efficacy and tolerability of risedronate once-a-week dosing (35 and 50mg) were compared with risedronate daily dosing (5mg) in a 2-year study in women with osteoporosis."( Two-year efficacy and tolerability of risedronate once a week for the treatment of women with postmenopausal osteoporosis.
Brown, JP; Chines, AA; Hanley, DA; Harris, ST; Li, Z; Watts, NB, 2004
)
0.32
" Risedronate 35 mg once a week is considered the optimal dose want a once-a-week dosing regimen."( Two-year efficacy and tolerability of risedronate once a week for the treatment of women with postmenopausal osteoporosis.
Brown, JP; Chines, AA; Hanley, DA; Harris, ST; Li, Z; Watts, NB, 2004
)
0.32
" We conclude that prophylactic treatment with risedronate in a training population at high risk for stress fracture using a maintenance dosage for the treatment of osteoporosis does not lower stress fracture risk."( The effect of prophylactic treatment with risedronate on stress fracture incidence among infantry recruits.
Burr, D; Finestone, A; Goldich, Y; Kaufman, S; Kreiss, Y; Liebergall, M; Milgrom, C; Novack, V; Pereg, D; Zimlichman, E, 2004
)
0.32
"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
)
0.32
"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
)
0.32
"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
" 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
" 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
"Patients should be clearly warned that the prescribed dosing for fluticasone nasal spray should be carefully followed because overuse may cause serious side effects."( Systemic effects of fluticasone nasal spray: report of 2 cases.
Licata, AA,
)
0.13
" Although bisphosphonates are effective in treatment of osteoporosis, a strict instruction to patients on the dosage often results in their inadequate compliance with the therapy."( [Practical approaches to the osteoporosis treatment--instructions for drug use that draws the effect of the medicine].
Ijiri, S, 2005
)
0.33
" 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
"In this NH population, weekly risedronate administered using a between-meal dosing schedule reduced serum BSAP at 6 weeks of treatment; this effect was not observed at 12 weeks."( Between-meal risedronate does not alter bone turnover in nursing home residents.
Agrawal, S; Binkley, NC; Drinka, PJ; Engelke, JA; Krause, PF; Krueger, DC; Nest, LJ, 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
" The dosage regimen could be simplified by providing the two compounds in an integrated pack."( Importance of calcium co-medication in bisphosphonate therapy of osteoporosis: an approach to improving correct intake and drug adherence.
Möller, G; Ringe, JD; van der Geest, SA, 2006
)
0.33
"In this multicenter, randomized, double-blind controlled trial, the efficacy and safety of once-weekly dosing with 17."( Efficacy and tolerability of once-weekly administration of 17.5 mg risedronate in Japanese patients with involutional osteoporosis: a comparison with 2.5-mg once-daily dosage regimen.
Fukunaga, M; Itabashi, A; Kishimoto, H; Kushida, K; Nakamura, T; Nawata, H; Ohashi, Y; Ohta, H; Shiraki, M; Takaoka, K, 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 purposes of the present study were to differentiate the effects of pre-surgery treatment with risedronate and post-surgery treatment with a reduced dosing frequency of risedronate on trabecular bone loss in ovariectomized rats and to determine whether post-surgery treatment with a reduced dosing frequency of risedronate would have a beneficial effect on trabecular bone loss after pre-surgery treatment with risedronate by means of bone histomorphometric analysis."( Effect of pre- and post-surgery treatment with risedronate on trabecular bone loss in ovariectomized rats.
Iwamoto, J; Sato, Y; Shen, CL; Takeda, T; Yeh, JK, 2006
)
0.33
" 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
)
0.34
" 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
"The purpose of the present study was to examine the effect of pretreatment with risedronate and/or vitamin K2 and treatment continuation with reduced dosing frequency of the drugs on the early cancellous bone loss induced by ovariectomy (OVX) in rats."( Beneficial effect of pretreatment and treatment continuation with risedronate and vitamin K2 on cancellous bone loss after ovariectomy in rats: a bone histomorphometry study.
Iwamoto, J; Sato, Y; Shen, CL; Takeda, T; Yeh, JK, 2006
)
0.33
"Patients preferred a weekly dosing regimen with proven vertebral and non-vertebral fracture efficacy."( Patient preference and adherence: comparative US studies between two bisphosphonates, weekly risedronate and monthly ibandronate.
Gold, DT; Safi, W; Trinh, H, 2006
)
0.33
" 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
"A stability indicating, reversed-phase ion-pair high-performance liquid chromatographic method was developed and validated for the determination of risedronate in pharmaceutical dosage forms."( Development and validation of a reversed-phase ion-pair high-performance liquid chromatographic method for the determination of risedronate in pharmaceutical preparations.
Kyriakides, D; Panderi, I, 2007
)
0.34
" The dosing period was 4 weeks."( Additive effect of vitamin K2 and risedronate on long bone mass in hypophysectomized young rats.
Iwamoto, J; Sato, Y; Takeda, T; Yeh, JK, 2007
)
0.34
"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,
)
0.13
" 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,
)
0.13
"Risedronate 150 mg once a month is similar in efficacy and safety to daily dosing and may provide an alternative for patients who prefer once-a-month oral dosing."( Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis.
Beary, JF; Benhamou, CL; Boonen, S; Burgio, DE; Delmas, PD; Eusebio, RA; Man, Z; Matzkin, E; McClung, MR; Racewicz, A; Roux, C; Zanchetta, JR, 2008
)
0.35
" In two groups, anterior cruciate ligament transection was performed and half were left untreated, and the other half dosed with risedronate (0."( Preservation of periarticular cancellous morphology and mechanical stiffness in post-traumatic experimental osteoarthritis by antiresorptive therapy.
Boyd, SK; Doschak, MR; MacNeil, JA; Zernicke, RF, 2008
)
0.35
" Risedronate 75 mg twice monthly was effective and safe suggesting a new, convenient dosing schedule."( Monthly dosing of 75 mg risedronate on 2 consecutive days a month: efficacy and safety results.
Benhamou, CL; Delmas, PD; Eusebio, R; Man, Z; Matzkin, E; McClung, MR; Olszynski, WP; Recker, RR; Tlustochowicz, W; Zanchetta, J, 2008
)
0.35
"Patients perceive less frequent dosing as being more convenient."( Monthly dosing of 75 mg risedronate on 2 consecutive days a month: efficacy and safety results.
Benhamou, CL; Delmas, PD; Eusebio, R; Man, Z; Matzkin, E; McClung, MR; Olszynski, WP; Recker, RR; Tlustochowicz, W; Zanchetta, J, 2008
)
0.35
" Intravenous pamidronate is efficacious and has long been available, but its use is hindered by an impractical recommended dosing regimen of 30 mg IV over 4 h for three consecutive days."( A review of Paget's disease of bone with a focus on the efficacy and safety of zoledronic acid 5 mg.
Abelson, A, 2008
)
0.35
" Bisphosphonates restore normal bone turnover and relieve bone pain, but oral formulations may be limited by complicated dosing regimens and poor gastrointestinal absorption."( A review of Paget's disease of bone with a focus on the efficacy and safety of zoledronic acid 5 mg.
Abelson, A, 2008
)
0.35
" 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 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
" Current dosing schedules are often inconvenient or impractical for patients."( Risedronate once monthly: a potential new regimen for the treatment of postmenopausal osteoporosis.
Díaz-Curiel, M; Moro-Alvarez, MJ, 2008
)
0.35
"5 mg risedronate, and was well tolerated with favorable safety profiles compared with once-daily dosage regimen."( [Efficacy and tolerability of risedronate for the treatment of osteoporosis].
Kishimoto, H, 2008
)
0.35
"The present study was designed to evaluate the effects of risedronate, one of the most potent bisphosphonates, on alveolar bone resorption and angiogenesis in rats with experimental periodontitis to identify dose-response curves and treatment durations that can be therapeutic for periodontal therapy versus those associated with osteonecrosis of the jaws."( Effects of risedronate on alveolar bone loss and angiogenesis: a stereologic study in rats.
Ayas, B; Cetinkaya, BO; Gurgor, P; Keles, GC, 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
" We next showed that risedronate given at a low dosage in animals bearing human B02-GFP breast tumors reduced osteolysis by inhibiting bone resorption, whereas therapy with higher doses also inhibited skeletal tumor burden."( Lowering bone mineral affinity of bisphosphonates as a therapeutic strategy to optimize skeletal tumor growth inhibition in vivo.
Clézardin, P; Daubiné, F; Ebetino, FH; Fournier, PG; Lundy, MW; Rogers, MJ, 2008
)
0.35
" Patients remarkably preferred therapy with a proven antifracture efficacy over a dosage frequency."( [Differences among bisfosfonates--specificity of risedronate (Actonel)].
Giljević, Z, 2008
)
0.35
"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
"Two studies in postmenopausal women with osteoporosis provide information about the efficacy and safety of dosing oral risedronate 5 mg daily at a time other than before breakfast (i."( Risedronate dosing before breakfast compared with dosing later in the day in women with postmenopausal osteoporosis.
Delmas, PD; Kendler, DL; Ringe, JD; Ste-Marie, LG; Taylor, EB; Vrijens, B, 2009
)
0.35
"Two studies in postmenopausal women with osteoporosis provide additional information about the efficacy and safety of dosing oral risedronate 5 mg daily at a time other than before breakfast (i."( Risedronate dosing before breakfast compared with dosing later in the day in women with postmenopausal osteoporosis.
Delmas, PD; Kendler, DL; Ringe, JD; Ste-Marie, LG; Taylor, EB; Vrijens, B, 2009
)
0.35
"One study, flexible dosing, was a 6-month North American study in 730 patients randomized to before-breakfast dosing or flexible dosing later in the day."( Risedronate dosing before breakfast compared with dosing later in the day in women with postmenopausal osteoporosis.
Delmas, PD; Kendler, DL; Ringe, JD; Ste-Marie, LG; Taylor, EB; Vrijens, B, 2009
)
0.35
"Results of these two studies demonstrate that overall flexible dosing of risedronate leads to smaller BMD gains compared to before-breakfast dosing."( Risedronate dosing before breakfast compared with dosing later in the day in women with postmenopausal osteoporosis.
Delmas, PD; Kendler, DL; Ringe, JD; Ste-Marie, LG; Taylor, EB; Vrijens, B, 2009
)
0.35
" Once-monthly dosing options might increase treatment compliance and persistence."( Comparison of the effects of once-monthly versus once-daily risedronate in postmenopausal osteoporosis: a phase II, 6-month, multicenter, randomized, double-blind, active-controlled, dose-ranging study.
Beary, JF; Brown, JP; Burgio, DE; Darbie, LM; Matzkin, E; Racewicz, AJ; Ste-Marie, LG, 2009
)
0.35
"The aim of this study was to compare the tolerability and efficacy of 3 once-monthly risedronate dosing regimens with those of risedronate 5 mg/d."( Comparison of the effects of once-monthly versus once-daily risedronate in postmenopausal osteoporosis: a phase II, 6-month, multicenter, randomized, double-blind, active-controlled, dose-ranging study.
Beary, JF; Brown, JP; Burgio, DE; Darbie, LM; Matzkin, E; Racewicz, AJ; Ste-Marie, LG, 2009
)
0.35
" The mechanism, efficacy, dosing options, and tolerability of risedronate are reviewed."( Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis.
Rackoff, P, 2009
)
0.35
" Interpretations from this study are limited by assumptions of persistence based on initial drug dosing and selected refill gap length measured."( Weekly versus monthly drug regimens: 1-year compliance and persistence with bisphosphonate therapy.
Gold, DT; Safi, W; Trinh, H, 2009
)
0.35
" Fracture trials were initially performed with daily formulations, then bridging trials, in which the efficacy of intermittent dosing was assessed versus daily using validated surrogate endpoints for fracture."( Update on monthly oral bisphosphonate therapy for the treatment of osteoporosis: focus on ibandronate 150 mg and risedronate 150 mg.
Epstein, S; Jeglitsch, M; McCloskey, E, 2009
)
0.35
" Furthermore, ibandronate has demonstrated antifracture efficacy with intermittent dosing in two pooled analyses."( Update on monthly oral bisphosphonate therapy for the treatment of osteoporosis: focus on ibandronate 150 mg and risedronate 150 mg.
Epstein, S; Jeglitsch, M; McCloskey, E, 2009
)
0.35
" Based on these results, the effects of risedronate 35 mg once a week are similar in efficacy to daily dosing and may lead less adverse events than once-a-month dose."( Effects of risedronate on bone turnover markers in osteoporotic postmenopausal women: comparison of two protocols of treatment.
Abdelmoula, J; Bahlous, A; Bouzid, K; Sahli, H; Sallami, S, 2009
)
0.35
"5 mg once daily was well tolerated by patients with PDB, even though the dosage was seven times higher than that approved for the treatment of osteoporosis in Japan (2."( Efficacy, tolerability, and safety of risedronate in Japanese patients with Paget's disease of bone.
Hashimoto, J; Takata, S; Yoh, K; Yoshimura, N, 2010
)
0.36
" Based on these results, the effects of risedronate 35 mg once a week are similar in efficacy to daily dosing and may lead less adverse events than once-a-month dose."( Effects of risedronate on bone turnover markers in osteoporotic postmenopausal women: comparison of two protocols of treatment.
Abdelmoula, J; Bahlous, A; Bouzid, K; Sahli, H; Sallami, S, 2009
)
0.35
" The method was validated and shown to be precise, accurate, and specific for the assay of risedronate in both bulk material and dosage forms."( Analysis of risedronate and related substances by ion-pair reversed-phase high-performance liquid chromatography with evaporative light-scattering detection.
Zhang, L, 2010
)
0.36
" Anastrozole was given at a dosage of 1 mg/day while oral risedronate was given at 35 mg/week."( Management of anastrozole-induced bone loss in breast cancer patients with oral risedronate: results from the ARBI prospective clinical trial.
Antonopoulou, Z; Dafni, U; Gogas, H; Kalogerakos, K; Koukouras, D; Lazarou, S; Markopoulos, C; Misitzis, J; Papadiamantis, J; Polychronis, A; Sarantopoulou, A; Siasos, N; Tzoracoleftherakis, E; Venizelos, B; Xepapadakis, G; Zobolas, V, 2010
)
0.36
" 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
" 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
" This adds to the range of risedronate dosing options and provides an alternative for patients who prefer once-a-month dosing."( Efficacy and safety of risedronate 150-mg once a month in the treatment of postmenopausal osteoporosis: 2-year data.
Beary, JF; Benhamou, CL; Boonen, S; Burgio, DE; Delmas, P; Eusebio, RA; Man, Z; Matzkin, E; McClung, MR; Racewicz, A; Roux, C; Zanchetta, JR, 2013
)
0.39
"After 2 years, treatment with risedronate 150-mg once a month provided similar efficacy and tolerability to daily dosing and provides an alternative for patients who prefer once-a-month oral dosing."( Efficacy and safety of risedronate 150-mg once a month in the treatment of postmenopausal osteoporosis: 2-year data.
Beary, JF; Benhamou, CL; Boonen, S; Burgio, DE; Delmas, P; Eusebio, RA; Man, Z; Matzkin, E; McClung, MR; Racewicz, A; Roux, C; Zanchetta, JR, 2013
)
0.39
" Delayed-release risedronate is a convenient dosing regimen for oral bisphosphonate therapy that might avoid poor compliance."( Treatment of postmenopausal osteoporosis with delayed-release risedronate 35 mg weekly for 2 years.
Balske, A; Burgio, DE; McClung, MR; Recker, RR; Wenderoth, D, 2013
)
0.39
"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
)
0.39
"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
)
0.39
"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
" This monthly regimen may provide a more convenient dosing schedule to some patients with postmenopausal osteoporosis."( A novel monthly dosing regimen of risedronate for the treatment of postmenopausal osteoporosis: 2-year data.
Balske, AM; Benhamou, CL; Delmas, PD; Eusebio, R; Man, Z; Matzkin, E; McClung, MR; Olszynski, WP; Recker, R; Tlustochowicz, W; Zanchetta, JR, 2013
)
0.39
"Risedronate, an anti-osteoporotic drug, is associated with low patient compliance due to the upper gastrointestinal side-effects and stringent dosing regimes."( Risedronate-loaded Eudragit S100 microparticles formulated into tablets.
Cruz, L; Ferreira, LM; Mattiazzi, J; Pohlmann, L; Rolim, CM; Silva, CB; Velasquez, AA, 2014
)
0.4
"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
)
0.39
" There was no relation between dosage and age (p=0."( Analysis of docetaxel therapy in elderly (≥70 years) castration resistant prostate cancer patients enrolled in the Netherlands Prostate Study.
Blaisse, RJ; de Wit, R; Erjavec, Z; Gerritse, FL; Los, M; Meulenbeld, HJ; Roodhart, JM; Smilde, TJ; van der Velden, AM, 2013
)
0.39
"Fifty-three patients received university pharmacy blinded medication for three months: 5 mg risedronate or placebo one dosage and 1 g calcium carbonate and 800IE cholecalciferol per day."( Risedronate does not enhance fixation or BMD in revision cups: randomised study with three years follow-up.
Digas, G; Kärrholm, JN; Saari, TM,
)
0.13
"This report describes bone safety and histomorphometric data across different dose levels and dosing frequencies of risedronate."( Bone safety with risedronate: histomorphometric studies at different dose levels and exposure.
Chavassieux, P; Lundy, MW; McClung, MR; Recker, RR; Ste-Marie, LG, 2015
)
0.42
" The low oral bioavailability and known dosing limitations due to food interactions of bisphosphonates have led to development of an oral delayed-release dose form of risedronate 35 mg to be taken weekly, before or after breakfast."( Bone safety with risedronate: histomorphometric studies at different dose levels and exposure.
Chavassieux, P; Lundy, MW; McClung, MR; Recker, RR; Ste-Marie, LG, 2015
)
0.42
"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
)
0.43
"The aim of this study was to examine the level of compliance and persistence in patients with postmenopausal osteoporosis (OP) receiving daily risedronate (5 mg) with either fixed dosing of three different timing regimens (A: before breakfast; B: in-between meals; C: before bedtime) or with flexible dosing and the effect on urinary N-terminal telopeptide of Type 1 collagen (NTX-1)."( Compliance, persistence, and preference outcomes of postmenopausal osteoporotic women receiving a flexible or fixed regimen of daily risedronate: A multicenter, prospective, parallel group study.
Lorenc, R; Oral, A, 2015
)
0.42
"A flexible dosing with daily risedronate appears be a valuable option in terms of compliance and persistence for patients with postmenopausal OP."( Compliance, persistence, and preference outcomes of postmenopausal osteoporotic women receiving a flexible or fixed regimen of daily risedronate: A multicenter, prospective, parallel group study.
Lorenc, R; Oral, A, 2015
)
0.42
" In this 1-year, randomized, double-blind, multicenter study we compared the weekly 35-mg and daily 5-mg risedronate dosing regimens in the treatment of Chinese postmenopausal women with osteoporosis or osteopenia."( The efficacy and safety of weekly 35-mg risedronate dosing regimen for Chinese postmenopausal women with osteoporosis or osteopenia: 1-year data.
Chen, DC; Fu, WZ; Gu, JM; He, JW; Hu, WW; Hu, YQ; Jin, XL; Lin, H; Liu, YJ; Tang, H; Wang, C; Wang, L; Xia, WB; Yue, H; Zhang, H; Zhang, ZL, 2015
)
0.42
"The weekly 35-mg and daily 5-mg risedronate dosing regimens during 1 year of follow-up show similar efficacy in improving BMDs and biochemical markers of bone turnover in Chinese postmenopausal women with osteoporosis or osteopenia."( The efficacy and safety of weekly 35-mg risedronate dosing regimen for Chinese postmenopausal women with osteoporosis or osteopenia: 1-year data.
Chen, DC; Fu, WZ; Gu, JM; He, JW; Hu, WW; Hu, YQ; Jin, XL; Lin, H; Liu, YJ; Tang, H; Wang, C; Wang, L; Xia, WB; Yue, H; Zhang, H; Zhang, ZL, 2015
)
0.42
" In the present study, to increase oral BA of the bisphosphonate, a novel enteric-coated tablet (ECT) dosage form of RS in combination with phytic acid (IP6), a natural chelating agent recognized as safe, was formulated."( Enteric-coated tablet of risedronate sodium in combination with phytic acid, a natural chelating agent, for improved oral bioavailability.
Jang, SW; Kang, MJ; Kim, BM; Kim, JS; Son, M, 2016
)
0.43
"This retrospective, observational study assessed 2-year persistence and compliance by treatment, route of administration, and dosing frequency in postmenopausal women initiating a new osteoporosis therapy."( Two-year persistence and compliance with osteoporosis therapies among postmenopausal women in a commercially insured population in the United States.
Barron, R; Durden, E; Juneau, P; Lopez-Gonzalez, L; Pinto, L, 2017
)
0.46
" Multivariable logistic regression was used to compare the odds of persistence and compliance across treatment and dosing regimens."( Two-year persistence and compliance with osteoporosis therapies among postmenopausal women in a commercially insured population in the United States.
Barron, R; Durden, E; Juneau, P; Lopez-Gonzalez, L; Pinto, L, 2017
)
0.46
" Patients initiating an every-6-month injection had significantly higher persistence compared with those initiating more frequently dosed (e."( Two-year persistence and compliance with osteoporosis therapies among postmenopausal women in a commercially insured population in the United States.
Barron, R; Durden, E; Juneau, P; Lopez-Gonzalez, L; Pinto, L, 2017
)
0.46
" In the zoledronate group, mean PINP 6 months post-FRAME was 23 ± 4 µg/L and at 12 months it was 47 ± 8 µg/L, suggesting that repeat zoledronate dosing is needed at 1 year to maintain the BMD gains."( Bone Loss After Romosozumab/Denosumab: Effects of Bisphosphonates.
Horne, AM; Mihov, B; Reid, IR, 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
)
0.51
" Simulations revealed the high variability in the concentration levels after different dosage schemes."( Osteoporosis treatment with risedronate: a population pharmacokinetic model for the description of its absorption and low plasma levels.
Cardozo, B; Karalis, V; Karatza, E, 2021
)
0.62
" Simulations are used to compare the risedronate plasma levels after different dosage schemes and assess the need for dose adjustment in patients with impaired kidney functionality."( Osteoporosis treatment with risedronate: a population pharmacokinetic model for the description of its absorption and low plasma levels.
Cardozo, B; Karalis, V; Karatza, E, 2021
)
0.62
" Simulations revealed the high discrepancy in the concentration levels observed after different dosage regimens, implying the safety profile of risedronate."( Osteoporosis treatment with risedronate: a population pharmacokinetic model for the description of its absorption and low plasma levels.
Cardozo, B; Karalis, V; Karatza, E, 2021
)
0.62
" 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
" In addition, we looked at benefit and harm comparisons between different dosage regimens for risedronate and between risedronate and other anti-osteoporotic drugs."( Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women.
Hsieh, SC; Liu, W; Peterson, J; Tugwell, P; Wells, GA; Zheng, C, 2022
)
0.72
" 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
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
pyridinesAny organonitrogen heterocyclic compound based on a pyridine skeleton and its substituted derivatives.
[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 (2)

PathwayProteinsCompounds
geranyl diphosphate biosynthesis67
Mevalonate arm of cholesterol biosynthesis pathway with inhibitors214

Protein Targets (10)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Geranylgeranyl pyrophosphate synthaseHomo sapiens (human)IC50 (µMol)75,195.28250.00401.02764.5000AID1798541; AID576219; AID669079; AID74507
Geranylgeranyl pyrophosphate synthaseHomo sapiens (human)Ki8,300.00001.80002.25002.7000AID576219
Farnesyl pyrophosphate synthaseHomo sapiens (human)IC50 (µMol)0.11040.00020.71099.3600AID1054150; AID1054151; AID1197852; AID1204204; AID1205922; AID1205923; AID1224396; AID1421103; AID1519530; AID318593; AID318594; AID332041; AID516764; AID669074; AID669076; AID685336; AID689987; AID72181; AID72667; AID72669
Farnesyl pyrophosphate synthaseHomo sapiens (human)Ki0.03290.00010.21651.9000AID318593; AID318594; AID72668
Farnesyl pyrophosphate synthase Leishmania donovaniIC50 (µMol)0.16990.11000.15600.1700AID259378; AID72651
Farnesyl pyrophosphate synthase Leishmania donovaniKi0.01700.01100.07820.1900AID238531
Farnesyl diphosphate synthaseToxoplasma gondiiIC50 (µMol)0.07400.07400.07400.0740AID593263; AID726609
Farnesyl pyrophosphate synthase Leishmania majorKi0.01600.01000.03900.0910AID1697964
HTrypanosoma bruceiIC50 (µMol)656.70002.10002.10002.1000AID254970
Farnesyl diphosphate synthaseTrypanosoma cruziIC50 (µMol)0.02700.02700.02700.0270AID593262; AID726611
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Butyrophilin subfamily 3 member A1Homo sapiens (human)EC50 (µMol)0.08000.00010.47193.0600AID1676487
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (12)

Processvia Protein(s)Taxonomy
positive regulation of cytokine productionButyrophilin subfamily 3 member A1Homo sapiens (human)
adaptive immune responseButyrophilin subfamily 3 member A1Homo sapiens (human)
positive regulation of type II interferon productionButyrophilin subfamily 3 member A1Homo sapiens (human)
activated T cell proliferationButyrophilin subfamily 3 member A1Homo sapiens (human)
T cell receptor signaling pathwayButyrophilin subfamily 3 member A1Homo sapiens (human)
regulation of cytokine productionButyrophilin subfamily 3 member A1Homo sapiens (human)
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)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (9)

Processvia Protein(s)Taxonomy
protein bindingButyrophilin subfamily 3 member A1Homo sapiens (human)
signaling receptor bindingButyrophilin subfamily 3 member A1Homo sapiens (human)
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)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (7)

Processvia Protein(s)Taxonomy
plasma membraneButyrophilin subfamily 3 member A1Homo sapiens (human)
external side of plasma membraneButyrophilin subfamily 3 member A1Homo sapiens (human)
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)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (221)

Assay IDTitleYearJournalArticle
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347160Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1061018Inhibition of Toxoplasma gondii recombinant FPPS expressed in Escherichia coli using [4-14C]IPP/DMAPP/GPP as substrate after 30 mins by scintillation counting analysis2014Bioorganic & medicinal chemistry, Jan-01, Volume: 22, Issue:1
New insights into molecular recognition of 1,1-bisphosphonic acids by farnesyl diphosphate synthase.
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.
AID1421099Inhibition of recombinant human C-terminal His6-tagged GGPPS expressed in Escherichia coli BL21 at 100 uM using IPP and FPP as substrates pretreated for 15 mins followed by substrates addition and measured after 1 hr by colorimetric method relative to con2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID480318Inhibition of RGGT-mediated Rap1A prenylation in mouse J774 cells after 24 hrs by Western blot analysis2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
Synthesis, chiral high performance liquid chromatographic resolution and enantiospecific activity of a potent new geranylgeranyl transferase inhibitor, 2-hydroxy-3-imidazo[1,2-a]pyridin-3-yl-2-phosphonopropionic acid.
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.
AID348330Antiinflammatory activity in delayed type hypersensitivity rat model assessed as inhibition of granuloma dry weight at 100 mg/kg, sc2008European journal of medicinal chemistry, May, Volume: 43, Issue:5
Synthesis, properties, and perspectives of gem-diphosphono substituted-thiazoles.
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).
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.
AID1224404Cytotoxicity against human SH-SY5Y cells assessed as LDH release after 48 hrs (Rvb = 0%)2014Journal of medicinal chemistry, Jul-10, Volume: 57, Issue:13
Multistage screening reveals chameleon ligands of the human farnesyl pyrophosphate synthase: implications to drug discovery for neurodegenerative diseases.
AID1421104Binding affinity to hydroxyapatite at 100 uM using sodium salt form of compound after 5 mins by ESI/MS analysis2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID576218Inhibition of Plasmodium vivax FPPS2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
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.
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.
AID669076Inhibition of human recombinant N-terminal-His6 tagged FPPS expressed in Escherichia coli BL21 using [3H]IPP and GPP as substrate measured after 20 mins by liquid scintillation counting2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Design and synthesis of active site inhibitors of the human farnesyl pyrophosphate synthase: apoptosis and inhibition of ERK phosphorylation in multiple myeloma cells.
AID678713Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
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.
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.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
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.
AID1054147Binding affinity to bone mineral hydroxyapatite at 50 uM after 5 mins by NMR-spectroscopic analysis2013Journal of medicinal chemistry, Oct-24, Volume: 56, Issue:20
Thienopyrimidine bisphosphonate (ThPBP) inhibitors of the human farnesyl pyrophosphate synthase: optimization and characterization of the mode of inhibition.
AID303798Bone mineral affinity on hydroxyaptite assessed as retention time by chromatography2007Journal of medicinal chemistry, Nov-29, Volume: 50, Issue:24
Synthesis and biological evaluation of alpha-halogenated bisphosphonate and phosphonocarboxylate analogues of risedronate.
AID229223Percent infected vero cells was determined2001Journal 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.
AID669083Antiproliferative activity against human KMS-28PE after 72 hrs by MTT assay2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Design and synthesis of active site inhibitors of the human farnesyl pyrophosphate synthase: apoptosis and inhibition of ERK phosphorylation in multiple myeloma cells.
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.
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.
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.
AID1204204Inhibition of FDPS (unknown origin)2015Bioorganic & medicinal chemistry letters, Jun-01, Volume: 25, Issue:11
N-Oxide derivatives of 3-(3-pyridyl)-2-phosphonopropanoic acids as potential inhibitors of Rab geranylgeranylation.
AID593262Inhibition of Trypanosoma cruzi FPPS after 30 mins using [14C]IPP by scintillation counting2011Bioorganic & medicinal chemistry, Apr-01, Volume: 19, Issue:7
Synthesis and biological evaluation of new 2-alkylaminoethyl-1,1-bisphosphonic acids against Trypanosoma cruzi and Toxoplasma gondii targeting farnesyl diphosphate synthase.
AID259378Inhibitory activity against FPPS in Leishmania major2006Journal of medicinal chemistry, Jan-12, Volume: 49, Issue:1
Inhibition of Trypanosoma cruzi hexokinase by bisphosphonates.
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.
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.
AID576004Antiplasmodial activity against Plasmodium berghei NK65 infected in 12 wk old C57BL/6 mouse assessed as prepatent period at 20 mg/kg, ip administered once daily via a regimen of day 1 pre-infection, on the day of infection followed by day 1 postinfection 2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID348327Antiinflammatory activity in delayed type hypersensitivity rat model assessed as inhibition of granuloma wet weight at 100 mg/kg, sc2008European journal of medicinal chemistry, May, Volume: 43, Issue:5
Synthesis, properties, and perspectives of gem-diphosphono substituted-thiazoles.
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).
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.
AID1421102Inhibition of recombinant human C-terminal His6-tagged FPPS expressed in Escherichia coli BL21 at 1 uM using DMAPP and IPP as substrates pretreated for 15 mins followed by substrates addition and measured after 1 hr by colorimetric method relative to cont2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID20808150% inhibitory concentration against Trypanosoma brucei rhodesiense2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID576002Antiplasmodial activity against Plasmodium berghei NK65 infected in 8 wk old C57BL/6 mouse assessed as prepatent period at 20 mg/kg, ip administered once daily via a regimen of day 1 pre-infection, on the day of infection followed by day 1, 2 and 3 days p2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
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.
AID575995Cytotoxicity against human HepG2 cells after 22 hrs2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID332041Inhibition of human FPPS2008Bioorganic & medicinal chemistry letters, May-01, Volume: 18, Issue:9
Farnesyl pyrophosphate synthase enantiospecificity with a chiral risedronate analog, [6,7-dihydro-5H-cyclopenta[c]pyridin-7-yl(hydroxy)methylene]bis(phosphonic acid) (NE-10501): Synthetic, structural, and modeling studies.
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.
AID1224403Inhibition of FPPS in human SH-SY5Y cells assessed as blocking of tau metabolism by measuring ratio of tau phosphorylation to total tau level at 100 nM after 24 hrs by ELISA (Rvb = 0.012 no-unit)2014Journal of medicinal chemistry, Jul-10, Volume: 57, Issue:13
Multistage screening reveals chameleon ligands of the human farnesyl pyrophosphate synthase: implications to drug discovery for neurodegenerative diseases.
AID255448Ratio of ED50 against KB cell line to that of IC50 of TbVSP12005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Bisphosphonate inhibition of the exopolyphosphatase activity of the Trypanosoma brucei soluble vacuolar pyrophosphatase.
AID1061026Antimicrobial activity against Trypanosoma cruzi CL amastigotes infected in african green monkey Vero cells measured on day 3 by fluorescence assay2014Bioorganic & medicinal chemistry, Jan-01, Volume: 22, Issue:1
New insights into molecular recognition of 1,1-bisphosphonic acids by farnesyl diphosphate synthase.
AID254970Inhibition of recombinant Trypanosoma brucei soluble vacuolar pyrophosphatase expressed in Escherichia coli2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Bisphosphonate inhibition of the exopolyphosphatase activity of the Trypanosoma brucei soluble vacuolar pyrophosphatase.
AID1224397Binding affinity to human FPPS assessed as change in thermal unfolding by differential scanning fluorimetry2014Journal of medicinal chemistry, Jul-10, Volume: 57, Issue:13
Multistage screening reveals chameleon ligands of the human farnesyl pyrophosphate synthase: implications to drug discovery for neurodegenerative diseases.
AID1091882Inhibition of Aquifex aeolicus IspH expressed in Escherichia coli BL21 (DE3) using HMBPP substrate2010Journal of the American Chemical Society, May-19, Volume: 132, Issue:19
Inhibition of the Fe(4)S(4)-cluster-containing protein IspH (LytB): electron paramagnetic resonance, metallacycles, and mechanisms.
AID1205922Inhibition of human FPPS in absence of pre-incubation of compound with enzyme2015ACS medicinal chemistry letters, Mar-12, Volume: 6, Issue:3
Farnesyl diphosphate synthase inhibitors with unique ligand-binding geometries.
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).
AID678712Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1054151Inhibition of human recombinant FPPS using GPP/[3H]IPP as substrate incubated for 10 mins prior to substrate addition by scintillation counting analysis2013Journal of medicinal chemistry, Oct-24, Volume: 56, Issue:20
Thienopyrimidine bisphosphonate (ThPBP) inhibitors of the human farnesyl pyrophosphate synthase: optimization and characterization of the mode of inhibition.
AID576221Partition coefficient, log P of the compound2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID208203In vitro rescue of growth inhibition of Trypanosoma uM of compound2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
AID678714Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID576227Antiplasmodial activity against Plasmodium berghei NK65 infected in 12 wk old BALB/c mouse assessed as prepatent period assessed as complete suppression of parasitemia at 20 mg/kg, ip administered once daily via a regimen of day 2, 1 pre-infection, on the2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID208217Predicted pIC50 against Trypomastigotes Brucei rhodesiense.2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
AID576208Antiplasmodial activity against chloroquine-sensitive Plasmodium falciparum 3D7 assessed as suppression of parasitemia by microscopic analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID1197855Competitive inhibition of human HPPS at 100 uM by NMR analysis in presence of Mg2+2015Bioorganic & medicinal chemistry letters, Mar-01, Volume: 25, Issue:5
Probing the molecular and structural elements of ligands binding to the active site versus an allosteric pocket of the human farnesyl pyrophosphate synthase.
AID303800Reduction of viability of mouse J744 cells after 48 hrs2007Journal of medicinal chemistry, Nov-29, Volume: 50, Issue:24
Synthesis and biological evaluation of alpha-halogenated bisphosphonate and phosphonocarboxylate analogues of risedronate.
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).
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.
AID575996Therapeutic index, ratio of TC50 for human HepG2 cells to IC50 for Plasmodium berghei NK652010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID1774079Stabilization of TTR V3OM mutant (unknown origin) assessed as acid-mediated protein aggregation inhibition ratio at 10 uM incubated for 1 week by absorbance method2021Journal of medicinal chemistry, 10-14, Volume: 64, Issue:19
Repositioning of the Anthelmintic Drugs Bithionol and Triclabendazole as Transthyretin Amyloidogenesis Inhibitors.
AID678716Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
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.
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.
AID593263Inhibition of Toxoplasma gondii FPPS after 30 mins using [14C]IPP by scintillation counting2011Bioorganic & medicinal chemistry, Apr-01, Volume: 19, Issue:7
Synthesis and biological evaluation of new 2-alkylaminoethyl-1,1-bisphosphonic acids against Trypanosoma cruzi and Toxoplasma gondii targeting farnesyl diphosphate synthase.
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.
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID576006Antiplasmodial activity against Plasmodium berghei NK65 infected in 12 wk old C57BL/6 mouse assessed as prepatent period at 10 mg/kg, ip administered once daily via a regimen of day 1 pre-infection, on the day of infection followed by day 1 postinfection 2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID669079Inhibition of human recombinant N-terminal His6 tagged GGPPS expressed in Escherichia coli BL21 using FPP and [14C]IPP as substrate incubated for 10 mins prior to substrate addition by scintillation counting2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Design and synthesis of active site inhibitors of the human farnesyl pyrophosphate synthase: apoptosis and inhibition of ERK phosphorylation in multiple myeloma cells.
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).
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.
AID340427Inhibition of farnesyl diphosphate synthase at 2 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.
AID256540Dose to inhibit the growth of human KB carcinoma cell line2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Bisphosphonate inhibition of the exopolyphosphatase activity of the Trypanosoma brucei soluble vacuolar pyrophosphatase.
AID726609Inhibition of Toxoplasma gondii farnesyl diphosphate synthase assessed as incorporation of [4-14C]IPP measured at 37 degC2013European journal of medicinal chemistry, Feb, Volume: 60Design, synthesis and biological evaluation of sulfur-containing 1,1-bisphosphonic acids as antiparasitic agents.
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
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.
AID235248Therapeutic index was expressed as ratio of LD50 for KB cell line to IC50 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.
AID480321Inhibition of GGPPS after 10 mins using [14C]IPP as substrate by liquid scintillation counting2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
Synthesis, chiral high performance liquid chromatographic resolution and enantiospecific activity of a potent new geranylgeranyl transferase inhibitor, 2-hydroxy-3-imidazo[1,2-a]pyridin-3-yl-2-phosphonopropionic acid.
AID214470Effect on inhibition on proliferation of Trypanosoma cruzi Amastigotes in vero cells at a conc of 150 uM2001Journal 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.
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.
AID72651Inhibitory activity against Leishmania major Farnesyl diphosphate synthase2004Journal 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.
AID721279Inhibition of recombinant GGTase 2 (unknown origin) by scintillation counting in presence of [3H]GGPP2013Bioorganic & medicinal chemistry letters, Feb-01, Volume: 23, Issue:3
Triazole-based inhibitors of geranylgeranyltransferase II.
AID1054150Inhibition of human recombinant FPPS using GPP/[3H]IPP as substrate incubated for 10 mins prior to substrate addition measured after 8 mins by scintillation counting analysis2013Journal of medicinal chemistry, Oct-24, Volume: 56, Issue:20
Thienopyrimidine bisphosphonate (ThPBP) inhibitors of the human farnesyl pyrophosphate synthase: optimization and characterization of the mode of inhibition.
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.
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID259377Cytotoxicity to Dictyostelium discoideum2006Journal of medicinal chemistry, Jan-12, Volume: 49, Issue:1
Inhibition of Trypanosoma cruzi hexokinase by bisphosphonates.
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.
AID326145Inhibition of Escherichia coli UPPS2007Proceedings of the National Academy of Sciences of the United States of America, Jun-12, Volume: 104, Issue:24
Bisphosphonates target multiple sites in both cis- and trans-prenyltransferases.
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.
AID678717Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID576217Inhibition of Plasmodium vivax GGPPS2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID259374Inhibitory activity against Trypanosoma cruzi hexokinase2006Journal of medicinal chemistry, Jan-12, Volume: 49, Issue:1
Inhibition of Trypanosoma cruzi hexokinase by bisphosphonates.
AID1774075Inhibition of 8-anilinonaphthalene-l-sulfonic acid binding to TTR V3OM mutant (unknown origin) expressed in Escherichia coli assessed as ANS saturation ratio at 400 uM incubated for 1 hr in presence of 7.5 uM ANS by fluorescence method (Rvb = 56 +/- 2.3%)2021Journal of medicinal chemistry, 10-14, Volume: 64, Issue:19
Repositioning of the Anthelmintic Drugs Bithionol and Triclabendazole as Transthyretin Amyloidogenesis Inhibitors.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
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.
AID576003Antiplasmodial activity against Plasmodium berghei NK65 infected in 8 wk old C57BL/6 mouse assessed as prepatent period at 20 mg/kg, ip administered once daily via regimen of 2 and 1 day post infection, on the day of infection followed by day 1 postinfect2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
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.
AID669081Antiproliferative activity against human JJN-3 after 72 hrs by MTT assay2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Design and synthesis of active site inhibitors of the human farnesyl pyrophosphate synthase: apoptosis and inhibition of ERK phosphorylation in multiple myeloma cells.
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.
AID576222Antiplasmodial activity against 3000 Plasmodium berghei NK65 liver stage sporozoites infected in 12 wk old C57BL/6 mouse assessed as delay in prepatent period at 20 mg/kg, ip administered once daily via a regimen of day 2, 1 pre-infection, on the day of i2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
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).
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).
AID1421103Inhibition of recombinant human C-terminal His6-tagged FPPS expressed in Escherichia coli BL21 using DMAPP and IPP as substrates pretreated for 15 mins followed by substrates addition and measured after 1 hr by colorimetric method2018European journal of medicinal chemistry, Oct-05, Volume: 158Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.
AID726611Inhibition of Trypanosoma cruzi farnesyl diphosphate synthase assessed as incorporation of [4-14C]IPP measured at 37 degC2013European journal of medicinal chemistry, Feb, Volume: 60Design, synthesis and biological evaluation of sulfur-containing 1,1-bisphosphonic acids as antiparasitic agents.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
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).
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.
AID412957Inhibition of Plasmodium vivax FPPS expressed in Escherichia coli BL21 by spectrophotometric assay2008Journal of medicinal chemistry, Dec-25, Volume: 51, Issue:24
Bisphosphonate inhibition of a Plasmodium farnesyl diphosphate synthase and a general method for predicting cell-based activity from enzyme data.
AID303801Inhibition of RGGT mediated Rap1A prenylation in J744 cells2007Journal of medicinal chemistry, Nov-29, Volume: 50, Issue:24
Synthesis and biological evaluation of alpha-halogenated bisphosphonate and phosphonocarboxylate analogues of risedronate.
AID576209Antiplasmodial activity against chloroquine-resistant Plasmodium falciparum W2mef assessed as suppression of parasitemia by microscopic analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID480330Inhibition of human FPPS assessed as Ras farnesylation up to 400 uM after 10 mins using [14C]mevalonate as substrate2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
Synthesis, chiral high performance liquid chromatographic resolution and enantiospecific activity of a potent new geranylgeranyl transferase inhibitor, 2-hydroxy-3-imidazo[1,2-a]pyridin-3-yl-2-phosphonopropionic acid.
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.
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.
AID326146Inhibition of Sulfolobus solfataricus HPPS2007Proceedings of the National Academy of Sciences of the United States of America, Jun-12, Volume: 104, Issue:24
Bisphosphonates target multiple sites in both cis- and trans-prenyltransferases.
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.
AID235247Therapeutic index was expressed as ratio of LD50 for KB cell line to IC50 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.
AID575998Antiplasmodial activity against Plasmodium berghei NK65 infected in 12 wk old BALB/c mouse assessed as prepatent period at 20 mg/kg, ip administered once daily via regimen of 1 preinfection, on day of infection followed by regimen of 1 day post infection 2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID235219Therapeutic index measured as the ratio of LD50 (KB cells) to IC50 (T.b. rhodesiense)2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
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.
AID576220Inhibition of human FPPS2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID678721Metabolic stability in human liver microsomes assessed as GSH adduct formation at 100 uM after 90 mins by HPLC-MS analysis2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID726610Antiparasitic activity against Trypanosoma cruzi amastigotes infected in gamma-irradiated vero cells assessed as growth inhibition measured after 3 days by fluorescence assay2013European journal of medicinal chemistry, Feb, Volume: 60Design, synthesis and biological evaluation of sulfur-containing 1,1-bisphosphonic acids as antiparasitic agents.
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.
AID669075Inhibition of human recombinant N-terminal-His6 tagged FPPS expressed in Escherichia coli BL21 using [3H]IPP and GPP as substrate at 1 uM incubated for 10 mins prior to substrate addition measured after 20 mins by liquid scintillation counting2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Design and synthesis of active site inhibitors of the human farnesyl pyrophosphate synthase: apoptosis and inhibition of ERK phosphorylation in multiple myeloma cells.
AID576212Antiplasmodial activity against 5 X 10'6 blood stream Plasmodium berghei NK65 infected in 12 wk old C57BL/6 mouse assessed as delay in prepatent period at 20 mg/kg, ip administered once daily via a regimen of day 2, 1 pre-infection, on the day of infectio2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID270723Antiproliferative activity against human NCI-H460 cell line by MTT assay2006Journal of medicinal chemistry, Sep-21, Volume: 49, Issue:19
Activity of nitrogen-containing and non-nitrogen-containing bisphosphonates on tumor cell lines.
AID669094Ratio of IC50 for human recombinant FPPS without compound preincubation to IC50 for human recombinant FPPS with compound preincubation2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Design and synthesis of active site inhibitors of the human farnesyl pyrophosphate synthase: apoptosis and inhibition of ERK phosphorylation in multiple myeloma cells.
AID1245160Binding affinity to FPPS (unknown origin) in presence of isopentenyl pyrophosphate and in presence of Mg2+ ions by neutron protein crystallography2015Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18
Protonation State and Hydration of Bisphosphonate Bound to Farnesyl Pyrophosphate Synthase.
AID576005Antiplasmodial activity against Plasmodium berghei NK65 infected in 12 wk old C57BL/6 mouse assessed as prepatent period at 10 mg/kg, ip administered once daily via a regimen of day 2, 1 days pre-infection, on the day of infection followed by day 1 postin2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID726608Antiparasitic activity against Toxoplasma gondii tachyzoite expressing red fluorescence protein assessed as growth inhibition by fluorescence plate reader2013European journal of medicinal chemistry, Feb, Volume: 60Design, synthesis and biological evaluation of sulfur-containing 1,1-bisphosphonic acids as antiparasitic agents.
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.
AID259375Cytotoxicity in human nasopharyngeal carcinoma KB cell line2006Journal of medicinal chemistry, Jan-12, Volume: 49, Issue:1
Inhibition of Trypanosoma cruzi hexokinase by bisphosphonates.
AID208205In vitro rescue of growth inhibition of Trypanosoma uM of compound2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
AID516764Inhibition of N-terminal His-tagged human FPPS expressed in Escherichia coli2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
Novel bisphosphonate inhibitors of the human farnesyl pyrophosphate synthase.
AID1676487Binding affinity to BTN3A1 in human PBMC-derived Vgamma9/Vdelta2 T cells
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.
AID678715Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1224396Allosteric inhibition of human recombinant FPPS using GPP and [3H]IPP as substrate incubated with enzyme for 10 mins prior to substrate addition by liquid scintillation counting analysis2014Journal of medicinal chemistry, Jul-10, Volume: 57, Issue:13
Multistage screening reveals chameleon ligands of the human farnesyl pyrophosphate synthase: implications to drug discovery for neurodegenerative diseases.
AID208207In vitro rescue of growth inhibition of Trypanosoma uM of compound2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
AID1197852Inhibition of human FPPS2015Bioorganic & medicinal chemistry letters, Mar-01, Volume: 25, Issue:5
Probing the molecular and structural elements of ligands binding to the active site versus an allosteric pocket of the human farnesyl pyrophosphate synthase.
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.
AID1519530Inhibition of FDPS (unknown origin)2019Bioorganic & medicinal chemistry letters, 12-15, Volume: 29, Issue:24
Novel benzimidazole phosphonates as potential inhibitors of protein prenylation.
AID158476Inhibitory activity against Entamoeba histolytica pyrophosphate-dependent phosphofructokinase (PFK)2004Journal 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.
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.
AID1774076Inhibition of 8-anilinonaphthalene-l-sulfonic acid binding to TTR V3OM mutant (unknown origin) expressed in Escherichia coli at 400 uM incubated for 1 hr in presence of 75 uM ANS by fluorescence method (Rvb = 91 +/- 0.92%)2021Journal of medicinal chemistry, 10-14, Volume: 64, Issue:19
Repositioning of the Anthelmintic Drugs Bithionol and Triclabendazole as Transthyretin Amyloidogenesis Inhibitors.
AID1054148Inhibition of human recombinant FPPS using GPP/[3H]IPP as substrate up to 10 uM incubated for 10 mins prior to substrate addition measured after 8 mins by scintillation counting analysis2013Journal of medicinal chemistry, Oct-24, Volume: 56, Issue:20
Thienopyrimidine bisphosphonate (ThPBP) inhibitors of the human farnesyl pyrophosphate synthase: optimization and characterization of the mode of inhibition.
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.
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.
AID1774078Stabilization of TTR V3OM mutant (unknown origin) assessed as acid-mediated protein aggregation inhibition ratio at 4 uM incubated for 1 week by absorbance method2021Journal of medicinal chemistry, 10-14, Volume: 64, Issue:19
Repositioning of the Anthelmintic Drugs Bithionol and Triclabendazole as Transthyretin Amyloidogenesis Inhibitors.
AID1205920Inhibition of Trypanosoma brucei FPPS2015ACS medicinal chemistry letters, Mar-12, Volume: 6, Issue:3
Farnesyl diphosphate synthase inhibitors with unique ligand-binding geometries.
AID9382850% lethal dose for inhibition of KB cells growth2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
AID208084In vitro growth inhibition of bloodstream-form Trypanosoma brucei rhodesiense Trypomastigotes2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
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.
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.
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID412958Growth inhibition of Plasmodium falciparum2008Journal of medicinal chemistry, Dec-25, Volume: 51, Issue:24
Bisphosphonate inhibition of a Plasmodium farnesyl diphosphate synthase and a general method for predicting cell-based activity from enzyme data.
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).
AID1054146Cytotoxicity against human RPMI8226 cells after 72 hrs by MTT assay2013Journal of medicinal chemistry, Oct-24, Volume: 56, Issue:20
Thienopyrimidine bisphosphonate (ThPBP) inhibitors of the human farnesyl pyrophosphate synthase: optimization and characterization of the mode of inhibition.
AID1224398Binding affinity to human FPPS assessed as change in thermal unfolding by differential scanning fluorimetry in presence of IPP and Mg2+2014Journal of medicinal chemistry, Jul-10, Volume: 57, Issue:13
Multistage screening reveals chameleon ligands of the human farnesyl pyrophosphate synthase: implications to drug discovery for neurodegenerative diseases.
AID1245159Binding affinity to FPPS (unknown origin) in presence of Mg2+ ions by neutron protein crystallography2015Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18
Protonation State and Hydration of Bisphosphonate Bound to Farnesyl Pyrophosphate Synthase.
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.
AID576219Inhibition of human GGPPS2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1205923Inhibition of human FPPS using pre-incubation of compound with enzyme2015ACS medicinal chemistry letters, Mar-12, Volume: 6, Issue:3
Farnesyl diphosphate synthase inhibitors with unique ligand-binding geometries.
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.
AID275054Antibacterial activity against Escherichia coli W31102006Journal of medicinal chemistry, Dec-14, Volume: 49, Issue:25
Isoprenoid biosynthesis as a drug target: bisphosphonate inhibition of Escherichia coli K12 growth and synergistic effects of fosmidomycin.
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).
AID576001Antiplasmodial activity against Plasmodium berghei NK65 infected in 12 wk old BALB/c mouse assessed as prepatent period at 17 mg/kg, ip administered once daily on the day of infection followed by day 1 postinfection for 2 days by microscopic analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID576215Antiplasmodial activity against 5 X 10'6 blood stream Plasmodium berghei NK65 infected in 12 wk old C57BL/6 mouse assessed as parasitemia at 20 mg/kg, ip administered once daily via a regimen of day 2, 1 pre-infection, on the day of infection followed by 2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID1061022Antimicrobial activity against Toxoplasma gondii tachyzoites expressing red fluorescence protein infected in hTerT cells measured daily by fluorescence assay2014Bioorganic & medicinal chemistry, Jan-01, Volume: 22, Issue:1
New insights into molecular recognition of 1,1-bisphosphonic acids by farnesyl diphosphate synthase.
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).
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1061019Inhibition of Trypanosoma cruzi recombinant FPPS assessed as incorporation of [4-14C]IPP with DMAPP into [4-14C]FPP after 30 mins by scintillation counting analysis2014Bioorganic & medicinal chemistry, Jan-01, Volume: 22, Issue:1
New insights into molecular recognition of 1,1-bisphosphonic acids by farnesyl diphosphate synthase.
AID567091Drug absorption in human assessed as human intestinal absorption rate2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Prediction of drug intestinal absorption by new linear and non-linear QSPR.
AID270725Antiproliferative activity against rat 13762 cell line2006Journal of medicinal chemistry, Sep-21, Volume: 49, Issue:19
Activity of nitrogen-containing and non-nitrogen-containing bisphosphonates on tumor cell lines.
AID576000Antiplasmodial activity against Plasmodium berghei NK65 infected in 12 wk old BALB/c mouse assessed as prepatent period at 5 mg/kg, ip administered once daily on the day of infection followed by day 1 postinfection for 2 days by microscopic analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID480322Inhibition of GGTase1 assessed as incorporation of [3H]GGPP into His-tagged canine rab1a after 30 mins2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
Synthesis, chiral high performance liquid chromatographic resolution and enantiospecific activity of a potent new geranylgeranyl transferase inhibitor, 2-hydroxy-3-imidazo[1,2-a]pyridin-3-yl-2-phosphonopropionic acid.
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.
AID576211Antiplasmodial activity against 5 X 10'6 blood stream Plasmodium berghei NK65 infected in 12 wk old C57BL/6 mouse assessed as prepatent period at 20 mg/kg, ip administered once daily via a regimen of day 2, 1 pre-infection, on the day of infection followe2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID326147Inhibition of Escherichia coli OPPS2007Proceedings of the National Academy of Sciences of the United States of America, Jun-12, Volume: 104, Issue:24
Bisphosphonates target multiple sites in both cis- and trans-prenyltransferases.
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.
AID259376Therapeutic index TI=LD50(KB)/IC50(TcHK)2006Journal of medicinal chemistry, Jan-12, Volume: 49, Issue:1
Inhibition of Trypanosoma cruzi hexokinase by bisphosphonates.
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1054145Ratio of IC50 for human recombinant FPPS incubated for 10 mins prior to substrate addition by scintillation counting analysis to IC50 for human recombinant FPPS incubated for 10 mins prior to substrate addition measured after 8 mins by scintillation count2013Journal of medicinal chemistry, Oct-24, Volume: 56, Issue:20
Thienopyrimidine bisphosphonate (ThPBP) inhibitors of the human farnesyl pyrophosphate synthase: optimization and characterization of the mode of inhibition.
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.
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.
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.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
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).
AID270724Antiproliferative activity against human SF-268 cell line by MTT assay2006Journal of medicinal chemistry, Sep-21, Volume: 49, Issue:19
Activity of nitrogen-containing and non-nitrogen-containing bisphosphonates on tumor cell lines.
AID208204In vitro rescue of growth inhibition of Trypanosoma uM of compound2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
AID270722Antiproliferative activity against human MCF7 cell line by MTT assay2006Journal of medicinal chemistry, Sep-21, Volume: 49, Issue:19
Activity of nitrogen-containing and non-nitrogen-containing bisphosphonates on tumor cell lines.
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).
AID685336Inhibition of human His6-tagged recombinant FPPS expressed in Escherichia coli BL21(DE3) using GPP and [3H]IPP as substrate incubated for 5 mins prior to substrate addition measured after 20 mins by liquid scintillation counting2012Bioorganic & medicinal chemistry, Sep-15, Volume: 20, Issue:18
Design of potent bisphosphonate inhibitors of the human farnesyl pyrophosphate synthase via targeted interactions with the active site 'capping' phenyls.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
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.
AID678722Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
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.
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).
AID480317Inhibition of RGGT-mediated Rab11 prenylation in mouse J774 cells after 24 hrs by Western blot analysis2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
Synthesis, chiral high performance liquid chromatographic resolution and enantiospecific activity of a potent new geranylgeranyl transferase inhibitor, 2-hydroxy-3-imidazo[1,2-a]pyridin-3-yl-2-phosphonopropionic acid.
AID208202In vitro rescue of growth inhibition of Trypanosoma uM of compound2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
AID575994Antimalarial activity against Plasmodium berghei NK65 infected in human HepG2 cells after 48 hrs by RT-PCR2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Lipophilic bisphosphonates are potent inhibitors of Plasmodium liver-stage growth.
AID208208In vitro rescue of growth inhibition of Trypanosoma uM of compound2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
AID685337Inhibition of human N-terminal His6-tagged recombinant human GGPS expressed in Escherichia coli BL21(DE3) using FPP and [14C]IPP as substrate at 10 uM by scintillation counting2012Bioorganic & medicinal chemistry, Sep-15, Volume: 20, Issue:18
Design of potent bisphosphonate inhibitors of the human farnesyl pyrophosphate synthase via targeted interactions with the active site 'capping' phenyls.
AID669074Inhibition of human recombinant N-terminal-His6 tagged FPPS expressed in Escherichia coli BL21 using [14C]IPP and GPP as substrate incubated for 10 mins prior to substrate addition measured after 10 mins by scintillation counting2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Design and synthesis of active site inhibitors of the human farnesyl pyrophosphate synthase: apoptosis and inhibition of ERK phosphorylation in multiple myeloma cells.
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.
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.
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1799536Enzymatic Assay from Article 10.1016/j.chembiol.2008.10.017: \\Targeting a uniquely nonspecific prenyl synthase with bisphosphonates to combat cryptosporidiosis.\\2008Chemistry & biology, Dec-22, Volume: 15, Issue:12
Targeting a uniquely nonspecific prenyl synthase with bisphosphonates to combat cryptosporidiosis.
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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,256)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's66 (5.25)18.2507
2000's633 (50.40)29.6817
2010's465 (37.02)24.3611
2020's92 (7.32)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 38.07

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 strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index38.07 (24.57)
Research Supply Index7.38 (2.92)
Research Growth Index5.18 (4.65)
Search Engine Demand Index57.35 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (38.07)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials290 (22.00%)5.53%
Reviews215 (16.31%)6.00%
Case Studies66 (5.01%)4.05%
Observational16 (1.21%)0.25%
Other731 (55.46%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (95)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus Calcium and Vitamin D Supplementation in the Treatment of Low Bone Mineral Density i [NCT01215890]Phase 40 participants InterventionalCompleted
Randomized, Double-blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Including an Extended Observational Period [NCT00051636]Phase 3172 participants (Actual)Interventional2001-01-31Completed
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
Effect of Bisphosphonate Use on Surgical Weight Loss Associated Bone Loss in Older Adults With Morbid Obesity [NCT03411902]Phase 424 participants (Actual)Interventional2018-06-15Completed
Effect of Actonel on Periodontal Health of Postmenopausal Women [NCT00594334]Phase 40 participants (Actual)Interventional2008-01-31Withdrawn(stopped due to Never started)
Do Bisphosphonates Alter the Skeletal Response to Mechanical Stimulation in Children With Osteogenesis Imperfecta? [NCT03208582]Phase 213 participants (Actual)Interventional2017-04-01Completed
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
A Comparative Study of Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty in Patients With Osteoporotic Femoral Neck Fractures [NCT02148848]Phase 486 participants (Anticipated)Interventional2013-06-30Recruiting
Randomized, Double-Blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Including an Extended Observation Period [NCT00103740]Phase 3185 participants (Actual)Interventional2002-04-30Completed
The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women [NCT01077817]684,815 participants (Actual)Observational2010-02-26Completed
Food Effects on the Relative Bioavailability of a Risedronate 20 mg Delayed-release [DR] Tablet and to Compare the 20 mg DR Tablet to 35 mg DR and 35 mg Immediate-release Tablets [NCT00717145]Phase 194 participants (Actual)Interventional2008-07-31Completed
Multicenter and Prospective Study to Determine the Satisfaction With Actonel (Risedronate Sodium) 35mg Once a Week Using Biochemical Markers of Bone as a Control, in Postmenopausal Women With Osteoporosis [NCT00632216]Phase 4464 participants (Actual)Interventional2004-05-31Completed
Two-year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study [NCT00619957]Phase 3285 participants (Actual)Interventional2002-06-30Completed
A Multicenter, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women [NCT05630768]Phase 4155 participants (Anticipated)Interventional2023-01-03Recruiting
A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis. [NCT00541658]Phase 3923 participants (Actual)Interventional2007-10-31Completed
A Randomized, Double Blinded Study of Actonel for the Prevention of Bone Loss in Patients Receiving High Dose Corticosteroids for the Treatment of Acute Lymphocytic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) [NCT00452439]Phase 372 participants (Actual)Interventional2004-02-29Completed
Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant [NCT00266708]Phase 1/Phase 260 participants (Actual)Interventional2002-10-31Completed
Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine BMD (Bone Mineral Density) in Men and Postmenopausal Women With Low Bone Mass and a Recent Pertrochanteric Hip Fracture [NCT00887354]Phase 4224 participants (Actual)Interventional2009-04-30Completed
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
A Randomized Multicenter Parallel Group Study to Determine if Knowledge of Baseline Vertebral Fracture Prevalence (as Determined by Hologic IVA) and Bone Turnover Marker Determinations Improves Persistence With Actonel 5mg Daily Therapy in Subjects Receiv [NCT00616694]Phase 4248 participants (Actual)Interventional2002-07-31Completed
Randomized, Double-blinded, Placebo Controlled Study to Assess Efficacy of Oral 35 mg Per Week Risedronate in Preventing Bone Loss in Postmenopausal Women With Aromatase Inhibitor Therapy for Breast Cancer. [NCT00859703]Phase 320 participants (Actual)Interventional2009-11-30Completed
A Crossover Study to Assess the Relative BA of Delayed-release Risedronate Compared When Dosed With Either Dinner, Breakfast or Breakfast Plus a Calcium/Vitamin D Tablet [NCT00868907]Phase 1101 participants (Actual)Interventional2009-03-31Completed
The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures [NCT00343252]Phase 3712 participants (Actual)Interventional2006-06-30Completed
Influence of a High-fat Meal on the Bioavailability of a Two Different Formulations of Risedronate [NCT00755872]Phase 176 participants (Actual)Interventional2007-11-30Completed
A 12-month, Multicenter, Double-blind, Randomized, Parallel Group Study Comparing 150 mg Once-a-month Risedronate and Placebo Using 3-dimensional Micro MRI (Magnetic Resonance Imaging). [NCT00577395]Phase 413 participants (Actual)Interventional2008-07-31Terminated
Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study [NCT00772395]Phase 478 participants (Actual)Interventional2006-04-30Completed
An 18-Month, Multicenter, Parallel-Group Study to Determine The Relative Efficacy of Risedronate Versus Raloxifene in Subjects Who Have Discontinued Hormone Replacement Therapy (HRT) for Early Intervention in Osteoporosis [NCT00790101]Phase 46 participants (Actual)Interventional2004-06-30Terminated
Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis Double-blind Randomized Study Versus Placebo [NCT02744482]Phase 33 participants (Actual)Interventional2016-05-31Terminated(stopped due to lack of patients)
Impact of NTx Point of Care (POC) Device on Patient Satisfication With Actonel 35mg Once a Seek Treatment a Multicenter Prospective Open Label Randomized Controlled Community Practice-based Study [NCT00549068]Phase 42,433 participants (Actual)Interventional2003-02-28Completed
A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Phase IV Study in Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Actonel(Rosedronate) is Administered 35mg Once a Week or 5mg [NCT00549965]Phase 4202 participants (Actual)Interventional2003-10-31Completed
Reconnecting: Improving Interoception to Reduce Suicidal Ideation in the Military [NCT04103385]195 participants (Actual)Interventional2020-06-01Completed
For 12months, the Multi Center, Randomized, Open-label Comparative Clinical Study to Evaluate the Efficacy and the Safety of Monthly(RisenexM Group) Versus Weekly Oral Risedronate(Risenexsplus Group) With Vitamin D in Compliance, Improvement of Vitamin D [NCT01904110]Phase 4196 participants (Actual)Interventional2012-12-31Completed
Record on Satisfaction of Patients With Actonel 35 mg Once a Week [NCT00544180]Phase 47 participants (Actual)Interventional2005-05-31Terminated(stopped due to The trial was terminated due to lack of compliance with GCP regulations.)
An Open Label, International, Multi Centre, Parallel Group, Phase III b, Randomised Trial, Investigating Lumbar Spine Bone Mineral Density (BMD) Changes in Postmenopausal Women With Primary Osteoporosis Initially Treated With 12 Months of Full Length Para [NCT00365456]Phase 3407 participants (Actual)Interventional2006-07-31Completed
A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT) [NCT00386360]Phase 3161 participants (Actual)Interventional2006-04-30Completed
Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine vBMD in Glucocorticoid-Induced Osteoporosis in Men [NCT00503399]Phase 392 participants (Actual)Interventional2007-07-31Completed
Randomized, Open-label, Multi-center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once Monthly Ibandronate and Once Weekly Risedronate. A Six Month, Two-sequence and Two-period Crossover Study. [NCT00377234]Phase 4356 participants (Actual)Interventional2006-05-31Completed
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
An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO [NCT00577421]Phase 332 participants (Actual)Interventional2003-06-30Completed
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
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone [NCT00445575]Phase 2/Phase 380 participants (Actual)Interventional2007-07-22Completed
Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Risedronate Daily or Weekly [NCT00837746]29 participants (Actual)Observational2003-04-30Completed
A Randomized, Open-label, 2-period, Crossover Study to Assess the Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets Administered as a Single Oral Dose in Healthy Male and Female Subjects [NCT00699777]Phase 196 participants (Actual)Interventional2008-01-31Completed
Study to Assess the Efficacy, Safety and Pharmacokinetics of Risedronate Upon Oral Administration of a 35 mg Delayed-Release, a 50 mg Delayed-Release or a 35 mg Immediate-Release Administered Weekly for 13 Weeks to Postmenopausal Women [NCT00577720]Phase 2181 participants (Actual)Interventional2006-07-31Completed
A Crossover Study to Assess the Bioequivalence of the Phase III and Commercial Risedronate 35 mg Delayed Release Formulations. [NCT00846196]Phase 1538 participants (Actual)Interventional2009-01-31Completed
Active-controlled, Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly in Postmenopausal Women With Low Bone Mineral Density [NCT00577837]Phase 2370 participants (Actual)Interventional2004-04-30Completed
Risedronate for Prevention of Osteoporosis After Spinal Cord Injury [NCT00150696]Phase 338 participants Interventional2000-02-29Completed
Benet 75 mg Tablets Special Drug Use Surveillance: Long-term Use (12-month Treatment Survey) [NCT02089997]3,304 participants (Actual)Observational2013-05-27Completed
Treatment of Childhood Cancer Therapy-induced Osteopenia in Growth Hormone Deficient Adult Survivors: Does Bisphosphonate Treatment Improve Bone Mineral Density? [NCT00145704]6 participants (Actual)Interventional2002-06-30Terminated(stopped due to due to low enrollment, participants are no longer being examined or treated)
A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 [NCT00358176]Phase 31,231 participants (Actual)Interventional2004-07-31Completed
A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Study pn Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Risedronate Sodium (Actonel) in Administered 35mg Once a Week or 5mg Once Daily [NCT00453492]Phase 4246 participants Interventional2004-01-31Completed
A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 24 Month, Monocenter Study Comparing Weekly Oral Risedronate 35 mg and Placebo [NCT00345644]Phase 3156 participants (Anticipated)Interventional2006-03-31Completed
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
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children [NCT00106028]Phase 3143 participants (Actual)Interventional2004-11-30Completed
Local (Brazil) Study, Multicenter, Opened, Comparative, Randomized, With Parallel Groups, Phase IV, in Post Menopausal Woman With Colles' Fracture of the Risedronate Sodium Usage in the Consolidation and in the Callus of the Colles'Fracture. [NCT00460733]Phase 4141 participants (Actual)Interventional2007-03-31Completed
[NCT00372372]Phase 4120 participants Interventional2004-01-31Completed
A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragil [NCT00082277]Phase 4237 participants (Actual)Interventional2004-04-30Completed
Effects of Bisphosphonates on OI-Related Hearing Loss: A Pilot Study [NCT04152551]Phase 4100 participants (Anticipated)Interventional2019-11-02Recruiting
A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 35-mg Risedronate Administered Once a Week in the Prevention of Osteoporosis in Postmenopausal Women [NCT00402441]Phase 4260 participants (Actual)Interventional2002-09-30Completed
a Six Month, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group Study to Estimate the Pharmacodynamic Response of Two Risedronate Regimens Compared With 5mg Daily : 150mg Monthly Dose for Six Months and 15mg Daily for Thirty Days Fol [NCT00351091]Phase 2150 participants (Actual)Interventional2002-11-30Completed
A Two-year, Multicenter, Double-blind, Randomized, Placebo-controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women (More Than 5 Years Postmenopausal) [NCT00353080]Phase 3171 participants (Actual)Interventional2002-12-31Completed
The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study) [NCT00118508]87 participants (Actual)Interventional2003-05-31Completed
A 1-year, Risedronate-free, Multicenter, Outpatient, Phase IIIb Extension Study to Assess Bone Turnover Recovery in Women With Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, and RVE1998080 (no NCT Study Numb [NCT01249261]Phase 361 participants (Actual)Interventional2001-10-31Completed
Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients [NCT00136058]Phase 3250 participants Interventional2002-01-31Completed
Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury [NCT00138866]Phase 346 participants (Anticipated)Interventional2004-11-30Completed
Antiepileptic Drugs and Osteoporotic Prevention Trial [NCT00869622]Phase 480 participants (Actual)Interventional2006-06-30Completed
A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned From Weekly or Daily Alendronate Therapy [NCT00919711]Phase 3870 participants (Actual)Interventional2009-09-01Completed
Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study [NCT00043069]Phase 371 participants (Actual)Interventional2002-11-30Completed
A Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of Risedronate (Actonel) For Prevention Of Bone Loss In Premenopausal Women Undergoing Chemotherapy For Primary Breast Carcinoma [NCT00054418]Phase 3216 participants (Actual)Interventional2003-03-31Completed
The Effect of Bisphosphonate on Bone Mass and Bone Turnover in Elderly, Postmenopausal Women With Breast Cancer Following Initiation of Aromatase Inhibitor Therapy [NCT00485953]Phase 4109 participants (Actual)Interventional2007-09-30Completed
For 4 Months, the Multi Center, Double Blinded, Randomized, Active Controlled, Comparative Clinical Study to Assess the Efficacy and the Safety to Improvement Effect of Vit.D of Risenex Plus M Tablet in Patients With In Post-menopausal Women Osteoporosis [NCT01806792]Phase 3150 participants (Actual)Interventional2009-11-30Completed
Open-Label Study to Determine How Prior Therapy With Alendronate or Risedronate in Postmenopausal Women With Osteoporosis Influences the Clinical Effectiveness of Teriparatide [NCT00130403]Phase 4290 participants (Actual)Interventional2004-03-31Completed
Randomized Control Trial of Bone Loading Exercises Versus Risedronate on Bone Health in Post-Menopausal Women [NCT02186600]Phase 3276 participants (Actual)Interventional2015-02-01Completed
A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO) [NCT00247273]Phase 31,294 participants (Actual)Interventional2005-10-31Completed
The Effect Of Risedronate On Bone Turnover And Bone Mass In Older Men [NCT00859027]Phase 450 participants (Actual)Interventional2003-01-31Completed
A Multicenter Prospective Study to Assess the Impact of Physician's Reinforcement on the Subject's Compliance and Persistence on Treatment Using Feedback on Bone Markers in Previously Undiagnosed Postmenopausal Osteoporotic Women Treated With Risedronate. [NCT00268632]Phase 30 participants Interventional1999-08-31Completed
Metabolism and Bone Health [NCT00244907]Phase 123 participants (Actual)Interventional2006-01-31Completed
A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Bone Biomarkers of Anastrozole When Used to Prevent Breast Cancer in Postmenopausal Women [NCT00324714]Phase 30 participants (Actual)Interventional2003-02-28Withdrawn
A Randomized Clinical Trial of Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT [NCT03861091]Phase 284 participants (Actual)Interventional2019-07-12Completed
Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture [NCT01950169]79 participants (Actual)Interventional2004-12-31Completed
IGF-1 and Bone Loss in Women With Anorexia Nervosa [NCT01406444]148 participants (Actual)Interventional2011-10-31Completed
For 12months, the Multi Center, Randomized, Open-label, Active Controlled Comparative Clinical Study to Assess the Efficacy and the Safety of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis [NCT01675297]Phase 41,053 participants (Actual)Interventional2011-07-04Completed
Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis [NCT01611571]Phase 331 participants (Actual)Interventional2003-12-31Completed
Replication of the VERO Osteoporosis Trial in Healthcare Claims Data [NCT04879420]12,757 participants (Actual)Observational2020-10-29Completed
IGF-1 and Bone Loss in Women Anorexia Nervosa [NCT00089843]Phase 2/Phase 377 participants (Actual)Interventional2003-06-30Completed
Risedronate With High-dose Vitamin D Resolves Hyperparathyroidism and Hypovitaminosis D But Not Osteoporosis in Mexican Postmenopausal Patients [NCT05346419]33 participants (Actual)Interventional2021-07-01Completed
Can Risedronate and Parathyroid Hormone Reverse Glucocorticoid Induced Osteoporosis? [NCT00221299]Phase 460 participants (Actual)Interventional2005-09-30Completed
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Ability of Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy: Hoosier Oncology Group GU02-41 [NCT00216060]Phase 363 participants (Actual)Interventional2003-10-31Terminated(stopped due to Terminated due to low accrual)
A Randomized, Single-blind, Placebo-controlled, Multicentre Study to Evaluate the Effect of Risedronate and Placebo on Bone Mineral Density in Men Undergoing Androgen Deprivation Therapy With Leuprolide Acetate [NCT00426777]Phase 3160 participants (Actual)Interventional2007-01-31Completed
36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets [NCT02106442]579 participants (Actual)Observational2013-05-13Completed
A Phase 2/3, Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Once-monthly Oral Administration of NE-58095DR Tablet (25 mg or 37.5 mg) Versus Once-daily Oral Administration of NE-58095IR Tablet [NCT02063854]Phase 2/Phase 3871 participants (Actual)Interventional2014-02-28Completed
Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery [NCT04922333]Phase 3200 participants (Anticipated)Interventional2023-03-28Recruiting
Sodium Risedronate 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance - [NCT02106455]315 participants (Actual)Observational2008-08-01Completed
Prevention of Osteoporosis in Breast Cancer Survivors [NCT00567606]249 participants (Actual)Interventional2002-04-01Completed
Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures [NCT01709110]Phase 41,366 participants (Actual)Interventional2012-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00051636 (11) [back to overview]Change in Pain Interference Score
NCT00051636 (11) [back to overview]Change in Pain Severity Score
NCT00051636 (11) [back to overview]Number of Participants With a Disease Relapse During the Extended Observation Period
NCT00051636 (11) [back to overview]Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period
NCT00051636 (11) [back to overview]Number of Participants With a Partial Disease Relapse During the Extended Observation Period
NCT00051636 (11) [back to overview]Number of Patients Who Achieve Therapeutic Response at 6 Months.
NCT00051636 (11) [back to overview]Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline
NCT00051636 (11) [back to overview]Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28
NCT00051636 (11) [back to overview]Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
NCT00051636 (11) [back to overview]Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10
NCT00051636 (11) [back to overview]Time to First Therapeutic Response
NCT00089843 (2) [back to overview]Bone Mineral Density
NCT00089843 (2) [back to overview]Markers of Bone Metabolism
NCT00103740 (11) [back to overview]Number of Patients Who Had Therapeutic Response at 6 Months
NCT00103740 (11) [back to overview]Relative Change in Serum Alkaline Phosphatase in U/L at Day 28
NCT00103740 (11) [back to overview]Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
NCT00103740 (11) [back to overview]Relative Change in Urine α-CTx in ug/mmol at Day 10
NCT00103740 (11) [back to overview]Time to First Therapeutic Response
NCT00103740 (11) [back to overview]Change in Pain Interference at Day 182
NCT00103740 (11) [back to overview]Change in Pain Severity at Day 182
NCT00103740 (11) [back to overview]Number of Participants With a Disease Relapse During the Extended Observation Period
NCT00103740 (11) [back to overview]Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period
NCT00103740 (11) [back to overview]Number of Participants With a Partial Disease Relapse During the Extended Observation Period
NCT00103740 (11) [back to overview]Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28
NCT00106028 (44) [back to overview]Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population
NCT00106028 (44) [back to overview]Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population
NCT00106028 (44) [back to overview]Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population
NCT00106028 (44) [back to overview]Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population
NCT00106028 (44) [back to overview]Bone Age (Years), Change From Baseline to Month 36, ITT Population
NCT00106028 (44) [back to overview]Bone Age (Years), Change From Baseline to Month 24, ITT Population
NCT00106028 (44) [back to overview]Bone Age (Years), Change From Baseline to Month 12, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population
NCT00106028 (44) [back to overview]Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population
NCT00106028 (44) [back to overview]Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population
NCT00106028 (44) [back to overview]Number of Clinical Fractures, Month 12, ITT Population
NCT00106028 (44) [back to overview]New Morphometric Vertebral Fracture at Month 36, ITT Population
NCT00106028 (44) [back to overview]New Morphometric Vertebral Fracture at Month 12, ITT Population
NCT00106028 (44) [back to overview]Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population
NCT00106028 (44) [back to overview]Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population
NCT00106028 (44) [back to overview]Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT
NCT00106028 (44) [back to overview]Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT
NCT00106028 (44) [back to overview]Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population
NCT00106028 (44) [back to overview]Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population
NCT00106028 (44) [back to overview]Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population
NCT00106028 (44) [back to overview]Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population
NCT00106028 (44) [back to overview]Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population
NCT00106028 (44) [back to overview]Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population
NCT00106028 (44) [back to overview]Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population
NCT00106028 (44) [back to overview]Serum BAP - Percent Change From Baseline to Month 36, ITT Population
NCT00106028 (44) [back to overview]Serum BAP - Percent Change From Baseline to Month 24, ITT Population
NCT00106028 (44) [back to overview]Serum BAP - Percent Change From Baseline to Month 12, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Total Body BMD at Month 36, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Total Body BMD at Month 24, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Total Body BMD at Month 12, ITT Population
NCT00106028 (44) [back to overview]Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Total Body BMC at Month 36, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Total Body BMC at Month 24, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Total Body BMC at Month 12, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population
NCT00106028 (44) [back to overview]Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population
NCT00216060 (7) [back to overview]Bone Turnover Marker Changes-- Serum BAP
NCT00216060 (7) [back to overview]Bone Turnover Marker Changes-- Urine N-telopeptide (NTX) Median
NCT00216060 (7) [back to overview]Three- Year Survival Rate
NCT00216060 (7) [back to overview]Bone Turnover Marker Changes-- Serum Osteocalcin (OC)
NCT00216060 (7) [back to overview]Numbers of SRE or Death Occurred Cumulatively
NCT00216060 (7) [back to overview]Rate of Patients Archiving a PSA (Prostate Specific Antigen) Nadir < 0.2 ng/mL
NCT00216060 (7) [back to overview]Bone Turnover Marker Changes -- Urine Total Deoxypyridinoline (DPD)
NCT00221299 (1) [back to overview]Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.
NCT00247273 (20) [back to overview]Percent Change From Baseline in Serum BAP at Month 24, ITT Population
NCT00247273 (20) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
NCT00247273 (20) [back to overview]Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
NCT00247273 (20) [back to overview]Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)
NCT00247273 (20) [back to overview]Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
NCT00247273 (20) [back to overview]Number of Participants With New Vertebral Fracture at Month 24, ITT Population
NCT00247273 (20) [back to overview]Number of Participants With New Vertebral Fracture at Month 12, ITT Population
NCT00247273 (20) [back to overview]Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population
NCT00247273 (20) [back to overview]Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
NCT00247273 (20) [back to overview]Percent Change From Baseline in Serum CTX at Month 24, ITT Population
NCT00247273 (20) [back to overview]Percent Change From Baseline in Serum BAP at Month 6, ITT Population
NCT00247273 (20) [back to overview]Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population
NCT00247273 (20) [back to overview]Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
NCT00247273 (20) [back to overview]Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
NCT00247273 (20) [back to overview]Change From Baseline in Serum BAP at Month 24, ITT Population
NCT00247273 (20) [back to overview]Change From Baseline in Serum CTX at Month 24, ITT Population
NCT00247273 (20) [back to overview]Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population
NCT00247273 (20) [back to overview]Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population
NCT00247273 (20) [back to overview]Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
NCT00247273 (20) [back to overview]Percent Change From Baseline in Serum CTX at Month 6, ITT Population
NCT00266708 (18) [back to overview]Bone Histomorphometry - Percent Bone Volume (BV/TV)
NCT00266708 (18) [back to overview]Bone Histomorphometry - Osteoid Volume (OV)
NCT00266708 (18) [back to overview]Bone Histomorphometry - Bone Formation Rate
NCT00266708 (18) [back to overview]Bone Histomorphometry - Mineralized Bone Volume (MdV)
NCT00266708 (18) [back to overview]Bone Mineral Density of Spine at 12 Months
NCT00266708 (18) [back to overview]Bone Mineral Density of Spine at 6 Months
NCT00266708 (18) [back to overview]Bone Mineral Density of the Hip at 12 Months
NCT00266708 (18) [back to overview]Bone Mineral Density of Forearm at 6 Months
NCT00266708 (18) [back to overview]Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)
NCT00266708 (18) [back to overview]Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)
NCT00266708 (18) [back to overview]Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)
NCT00266708 (18) [back to overview]Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)
NCT00266708 (18) [back to overview]Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)
NCT00266708 (18) [back to overview]Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)
NCT00266708 (18) [back to overview]Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)
NCT00266708 (18) [back to overview]Bone Mineral Density of the Hip at 6 Months
NCT00266708 (18) [back to overview]Bone Histomorphometry - Trabecular Thickness (TbTh)
NCT00266708 (18) [back to overview]Bone Mineral Density of Forearm at 12 Months
NCT00343252 (21) [back to overview]Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
NCT00343252 (21) [back to overview]Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
NCT00343252 (21) [back to overview]Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
NCT00343252 (21) [back to overview]Number of Participants With Adverse Events (Safety) During 12 Months
NCT00343252 (21) [back to overview]Number of Participants With Adverse Events (Safety) During 18 Months
NCT00343252 (21) [back to overview]Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
NCT00343252 (21) [back to overview]Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
NCT00343252 (21) [back to overview]Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
NCT00343252 (21) [back to overview]Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
NCT00343252 (21) [back to overview]Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
NCT00343252 (21) [back to overview]Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.
NCT00343252 (21) [back to overview]Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
NCT00343252 (21) [back to overview]Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
NCT00343252 (21) [back to overview]Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.
NCT00343252 (21) [back to overview]Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.
NCT00343252 (21) [back to overview]Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
NCT00343252 (21) [back to overview]Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
NCT00343252 (21) [back to overview]Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months
NCT00343252 (21) [back to overview]Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months
NCT00343252 (21) [back to overview]Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
NCT00343252 (21) [back to overview]Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
NCT00365456 (1) [back to overview]Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.
NCT00377234 (3) [back to overview]Intensity of Upper Gastrointestinal (GI) Symptoms
NCT00377234 (3) [back to overview]Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing
NCT00377234 (3) [back to overview]Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate
NCT00386360 (14) [back to overview]Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Lumbar Spine BMD, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Height, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Greater Trochanter BMD, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Femoral Neck BMD, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
NCT00386360 (14) [back to overview]Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12
NCT00452439 (2) [back to overview]Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months
NCT00452439 (2) [back to overview]Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at 12 Months
NCT00485953 (3) [back to overview]Markers of Bone Resorption and Bone Formation
NCT00485953 (3) [back to overview]BMD by DXA at the Femoral Neck and Total Hip
NCT00485953 (3) [back to overview]BMD of Spine by DXA
NCT00503399 (9) [back to overview]Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months
NCT00503399 (9) [back to overview]Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
NCT00503399 (9) [back to overview]Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months
NCT00503399 (9) [back to overview]Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months
NCT00503399 (9) [back to overview]Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months
NCT00503399 (9) [back to overview]Number of Participants With Adverse Events (AEs)
NCT00503399 (9) [back to overview]Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months
NCT00503399 (9) [back to overview]Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months
NCT00503399 (9) [back to overview]Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
NCT00541658 (51) [back to overview]Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population
NCT00541658 (51) [back to overview]Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint
NCT00541658 (51) [back to overview]Number of Patients With No New Fractured Vertebra, Week 52
NCT00541658 (51) [back to overview]Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population
NCT00541658 (51) [back to overview]Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint
NCT00541658 (51) [back to overview]Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint
NCT00541658 (51) [back to overview]Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint
NCT00541658 (51) [back to overview]Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population
NCT00541658 (51) [back to overview]Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population
NCT00541658 (51) [back to overview]Number of Patients With at Least One New Fractured Vertebra, Week 52
NCT00541658 (51) [back to overview]Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population
NCT00541658 (51) [back to overview]Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Number of Patients With No New Fractured Vertebra, Week 104
NCT00541658 (51) [back to overview]Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population
NCT00541658 (51) [back to overview]Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population
NCT00577720 (3) [back to overview]Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population
NCT00577720 (3) [back to overview]Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population
NCT00577720 (3) [back to overview]Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population
NCT00619957 (37) [back to overview]Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
NCT00619957 (37) [back to overview]Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
NCT00619957 (37) [back to overview]Change From Baseline in Body Height, Month 12, ITT Population.
NCT00619957 (37) [back to overview]Cumulative Incidence of Fractures, 12 Months, ITT Population
NCT00619957 (37) [back to overview]Cumulative Incidence of Fractures, 24 Months, ITT Population
NCT00619957 (37) [back to overview]Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in BAP, Month 12, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in BAP, Month 24, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in BAP, Month 6, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in CTx, Month 12, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in CTx, Month 6, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in CTx, Month 24, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
NCT00619957 (37) [back to overview]Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
NCT00619957 (37) [back to overview]Change From Baseline in Body Height, Month 24, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
NCT00619957 (37) [back to overview]Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
NCT00859027 (2) [back to overview]Percent Change in Bone Mineral Density
NCT00859027 (2) [back to overview]Percent Change of Bone Turnover Markers
NCT00869622 (2) [back to overview]Vertebral Fractures
NCT00869622 (2) [back to overview]Changes in Bone Mineral Density
NCT00887354 (7) [back to overview]"Timed Up and Go Test"
NCT00887354 (7) [back to overview]Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale
NCT00887354 (7) [back to overview]Visual Analog Scale (VAS)
NCT00887354 (7) [back to overview]Change in Lumbar Spine Areal Bone Mineral Density
NCT00887354 (7) [back to overview]Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb
NCT00887354 (7) [back to overview]Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire
NCT00887354 (7) [back to overview]Change in Lumbar Spine Areal Bone Mineral Density (BMD)
NCT00919711 (4) [back to overview]Total Hip BMD Percent Change From Baseline at Month 12
NCT00919711 (4) [back to overview]Serum CTX Percent Change From Baseline at Month 1
NCT00919711 (4) [back to overview]Lumbar Spine BMD Percent Change From Baseline at Month 12
NCT00919711 (4) [back to overview]Femoral Neck BMD Percent Change From Baseline at Month 12
NCT01077817 (2) [back to overview]Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)
NCT01077817 (2) [back to overview]Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)
NCT01249261 (12) [back to overview]Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population
NCT01249261 (12) [back to overview]Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population
NCT01249261 (12) [back to overview]Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
NCT01249261 (12) [back to overview]Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population
NCT01249261 (12) [back to overview]Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population
NCT01249261 (12) [back to overview]Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
NCT01249261 (12) [back to overview]Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population
NCT01249261 (12) [back to overview]Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population
NCT01249261 (12) [back to overview]Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
NCT01249261 (12) [back to overview]Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population
NCT01249261 (12) [back to overview]Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population
NCT01249261 (12) [back to overview]Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
NCT01406444 (2) [back to overview]Lateral Spine Bone Mineral Density by DXA
NCT01406444 (2) [back to overview]Postero-anterior Spine Bone Mineral Density by DXA
NCT01611571 (5) [back to overview]Change in FN BMD at 18 Months
NCT01611571 (5) [back to overview]Change in Hip Bone Density
NCT01611571 (5) [back to overview]Change in Spine Bone Density
NCT01611571 (5) [back to overview]Change in Forearm Bone Density
NCT01611571 (5) [back to overview]New Morphometric Vertebral Fractures
NCT01675297 (3) [back to overview]The Change of Bone Mineral Density (BMD) Value
NCT01675297 (3) [back to overview]PTH(Parathyroid Hormone Value)
NCT01675297 (3) [back to overview]The Change of 25OHD(25-hydroxyvitamin D)
NCT01709110 (12) [back to overview]Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)
NCT01709110 (12) [back to overview]Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)
NCT01709110 (12) [back to overview]Change From Baseline to 24 Months Endpoint in Height
NCT01709110 (12) [back to overview]Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale
NCT01709110 (12) [back to overview]Proportion of Participants With Pooled New and Worsening Vertebral Fractures
NCT01709110 (12) [back to overview]Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures
NCT01709110 (12) [back to overview]Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures
NCT01709110 (12) [back to overview]Proportion of Participants With Non-Vertebral Fragility Fractures
NCT01709110 (12) [back to overview]Proportion of Participants With New Vertebral Fractures
NCT01709110 (12) [back to overview]Proportion of Participants With New Multiple (2 or More) Vertebral Fractures
NCT01709110 (12) [back to overview]Proportion of Participants With Major Non-Vertebral Fragility Fractures
NCT01709110 (12) [back to overview]Proportion of Participants With New Moderate and/or Severe Vertebral Fractures
NCT01950169 (4) [back to overview]Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture.
NCT01950169 (4) [back to overview]Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture.
NCT01950169 (4) [back to overview]Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.
NCT01950169 (4) [back to overview]Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.
NCT02063854 (11) [back to overview]Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
NCT02063854 (11) [back to overview]Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
NCT02063854 (11) [back to overview]Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
NCT02063854 (11) [back to overview]Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
NCT02063854 (11) [back to overview]Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
NCT02063854 (11) [back to overview]Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
NCT02063854 (11) [back to overview]Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
NCT02063854 (11) [back to overview]Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)
NCT02063854 (11) [back to overview]Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
NCT02063854 (11) [back to overview]Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study
NCT02063854 (11) [back to overview]Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
NCT02089997 (12) [back to overview]Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment
NCT02089997 (12) [back to overview]Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment
NCT02089997 (12) [back to overview]Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment
NCT02089997 (12) [back to overview]Change From Baseline in Height
NCT02089997 (12) [back to overview]Percent Change From Baseline in Radius BMD at Final Assessment
NCT02089997 (12) [back to overview]Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment
NCT02089997 (12) [back to overview]Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
NCT02089997 (12) [back to overview]Number of Participants Who Had Lumbar Backache at Final Assessment
NCT02089997 (12) [back to overview]Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment
NCT02089997 (12) [back to overview]Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment
NCT02089997 (12) [back to overview]Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment
NCT02089997 (12) [back to overview]Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment
NCT02106442 (15) [back to overview]Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)
NCT02106442 (15) [back to overview]Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)
NCT02106442 (15) [back to overview]Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)
NCT02106442 (15) [back to overview]Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)
NCT02106442 (15) [back to overview]Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
NCT02106442 (15) [back to overview]Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
NCT02106442 (15) [back to overview]Number of Participants Who Had One or More Adverse Drug Reactions
NCT02106442 (15) [back to overview]Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)
NCT02106442 (15) [back to overview]Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)
NCT02106442 (15) [back to overview]Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)
NCT02106442 (15) [back to overview]Cumulative Percentage of Participants With Femur Fractures
NCT02106442 (15) [back to overview]Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
NCT02106442 (15) [back to overview]Cumulative Percentage of Participants With Non-Vertebral Body Fractures
NCT02106442 (15) [back to overview]Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
NCT02106442 (15) [back to overview]Change From Baseline in Height at Final Assessment (up to Month 36)
NCT02106455 (7) [back to overview]Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point
NCT02106455 (7) [back to overview]Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point
NCT02106455 (7) [back to overview]Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
NCT02106455 (7) [back to overview]Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point
NCT02106455 (7) [back to overview]Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point
NCT02106455 (7) [back to overview]Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point
NCT02106455 (7) [back to overview]Percentage of Participants Who Had One or More Adverse Drug Reactions
NCT02186600 (3) [back to overview]Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group.
NCT02186600 (3) [back to overview]Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group.
NCT02186600 (3) [back to overview]Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group.
NCT03411902 (7) [back to overview]Number of Enrolled Participants That Completed All 24 Week Procedures
NCT03411902 (7) [back to overview]Fat Pounds
NCT03411902 (7) [back to overview]Total Change in Lumbar Spine Density
NCT03411902 (7) [back to overview]Lean Pounds
NCT03411902 (7) [back to overview]Total Change in Femoral Neck Hip Density
NCT03411902 (7) [back to overview]Trabecular Bone Score (TBS)
NCT03411902 (7) [back to overview]Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density
NCT03861091 (5) [back to overview]Urine Concentration at 4 Time Points
NCT03861091 (5) [back to overview]4 Time Points Assessing Change in Mean Cortical Thickness of Bones
NCT03861091 (5) [back to overview]Number of Participants With Rib and Vertebral Fracture
NCT03861091 (5) [back to overview]Number of Participants With Chest Wall Pain
NCT03861091 (5) [back to overview]Changes in Mean Cortical Thickness

Change in Pain Interference Score

Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. (NCT00051636)
Timeframe: Baseline and day 182

InterventionUnits on a scale (Mean)
Zoledronic Acid and Placebo to Risedronate-0.2
Risedronate and Placebo to Zoledronic Acid0.1

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Change in Pain Severity Score

Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. (NCT00051636)
Timeframe: Baseline and day 182

InterventionUnits on a scale (Mean)
Zoledronic Acid and Placebo to Risedronate-0.5
Risedronate and Placebo to Zoledronic Acid-0.7

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Number of Participants With a Disease Relapse During the Extended Observation Period

Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value. (NCT00051636)
Timeframe: 8 years was the maximum

InterventionParticipants (Number)
Zoledronic Acid and Placebo to Risedronate0
Risedronate and Placebo to Zoledronic Acid7

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Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period

Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase. (NCT00051636)
Timeframe: 8 years was the maximum

InterventionParticipants (Number)
Zoledronic Acid and Placebo to Risedronate8
Risedronate and Placebo to Zoledronic Acid29

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Number of Participants With a Partial Disease Relapse During the Extended Observation Period

Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit. (NCT00051636)
Timeframe: 8 years was the maximum

InterventionParticipants (Number)
Zoledronic Acid and Placebo to Risedronate6
Risedronate and Placebo to Zoledronic Acid26

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Number of Patients Who Achieve Therapeutic Response at 6 Months.

Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months. (NCT00051636)
Timeframe: 6 months

Interventionparticipants (Number)
Zoledronic Acid and Placebo to Risedronate85
Risedronate and Placebo to Zoledronic Acid60

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Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline

Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. (NCT00051636)
Timeframe: Baseline and day 28

InterventionParticipants (Number)
Zoledronic Acid and Placebo to Risedronate5
Risedronate and Placebo to Zoledronic Acid0

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Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28

The percent change in serum alkaline phosphatase from baseline to day 28 was measured. (NCT00051636)
Timeframe: Baseline and day 28

Interventionpercent change (Mean)
Zoledronic Acid and Placebo to Risedronate-48.8
Risedronate and Placebo to Zoledronic Acid-28.4

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Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10

The percent change in serum C-telopeptide from baseline to day 10 was measured. (NCT00051636)
Timeframe: Baseline and day 10

Interventionpercent change (Mean)
Zoledronic Acid and Placebo to Risedronate-85.4
Risedronate and Placebo to Zoledronic Acid-36.7

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Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10

The percent change in urine alpha C-telopeptide from baseline to day 10 was measured. (NCT00051636)
Timeframe: Baseline and day 10

InterventionPercent change (Mean)
Zoledronic Acid and Placebo to Risedronate-90.3
Risedronate and Placebo to Zoledronic Acid-29.9

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Time to First Therapeutic Response

A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase. (NCT00051636)
Timeframe: 182 days

InterventionDays (Median)
Zoledronic Acid and Placebo to Risedronate64
Risedronate and Placebo to Zoledronic Acid78

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Bone Mineral Density

Percent change in postero-anterior (PA) spine bone mineral density as measured by dual energy x-ray absorptiometry (DXA)over a 12-month period. The differences in log-transformed values are reported as percent change. (NCT00089843)
Timeframe: Baseline and 12 months

Interventionpercent change (Mean)
Actonel (Risedronate) 35 mg Weekly3.2
Testosterone-0.6

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Markers of Bone Metabolism

type 1 collagen C-telopeptide(CTX); The differences in log-transformed values are reported as percent change. (NCT00089843)
Timeframe: Baseline to 12 months

Interventionpercent change of CTX (Mean)
Actonel (Risedronate)-41
Testosterone-11

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Number of Patients Who Had Therapeutic Response at 6 Months

A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months. (NCT00103740)
Timeframe: Baseline, 6 months

Interventionparticipants (Number)
Zoledronic Acid and Placebo to Risedronate84
Risedronate and Placebo to Zoledronic Acid67

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Relative Change in Serum Alkaline Phosphatase in U/L at Day 28

The percent change in serum alkaline phosphatase from baseline to Day 28 was measured. (NCT00103740)
Timeframe: Baseline and 28 days

Interventionpercent change (Mean)
Zoledronic Acid and Placebo to Risedronate-49.1
Risedronate and Placebo to Zoledronic Acid-24.3

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Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10

The percent change in serum C-telopeptide from baseline to Day 10 was measured. (NCT00103740)
Timeframe: Baseline and day 10

Interventionpercent change (Mean)
Zoledronic Acid and Placebo to Risedronate-74.2
Risedronate and Placebo to Zoledronic Acid-40.1

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Relative Change in Urine α-CTx in ug/mmol at Day 10

The percent change in urine α-CTx from baseline to Day 10 was measured. (NCT00103740)
Timeframe: Baseline and day 10

Interventionpercent change (Mean)
Zoledronic Acid and Placebo to Risedronate-87.5
Risedronate and Placebo to Zoledronic Acid-28.7

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Time to First Therapeutic Response

Therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase. (NCT00103740)
Timeframe: 182 days

Interventiondays (Median)
Zoledronic Acid and Placebo to Risedronate64
Risedronate and Placebo to Zoledronic Acid91

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Change in Pain Interference at Day 182

Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. (NCT00103740)
Timeframe: Baseline and day 182

Interventionunits on a scale (Mean)
Zoledronic Acid and Placebo to Risedronate-0.5
Risedronate and Placebo to Zoledronic Acid0.0

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Change in Pain Severity at Day 182

Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. (NCT00103740)
Timeframe: Baseline and day 182

Interventionunits on a scale (Mean)
Zoledronic Acid and Placebo to Risedronate-0.5
Risedronate and Placebo to Zoledronic Acid-0.1

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Number of Participants With a Disease Relapse During the Extended Observation Period

Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value. (NCT00103740)
Timeframe: 8 years was maximum

Interventionparticipants (Number)
Zoledronic Acid and Placebo to Risedronate0
Risedronate and Placebo to Zoledronic Acid15

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Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period

Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase. (NCT00103740)
Timeframe: 8 years was the maximum

Interventionparticipants (Number)
Zoledronic Acid and Placebo to Risedronate10
Risedronate and Placebo to Zoledronic Acid42

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Number of Participants With a Partial Disease Relapse During the Extended Observation Period

Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at Month 6 and at least 1.25 times the upper normal limit. (NCT00103740)
Timeframe: 8 years was the maximum

Interventionparticipants (Number)
Zoledronic Acid and Placebo to Risedronate9
Risedronate and Placebo to Zoledronic Acid37

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Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28

Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. Central laboratory reference ranges for serum alkaline phosphatase: 31-110 U/L (female & male 20-58 years) and 35-115 U/L (female & male >58 years). (NCT00103740)
Timeframe: Day 28

Interventionparticipants (Number)
Zoledronic Acid and Placebo to Risedronate8
Risedronate and Placebo to Zoledronic Acid1

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Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Placebo Daily42.367
Risedronate Daily48.407

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Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo Daily17.885
Risedronate Daily28.218

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Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population

"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values." (NCT00106028)
Timeframe: Baseline and Month 36

InterventionUnits on a Scale (Least Squares Mean)
Placebo Daily19.325
Risedronate Daily25.640

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Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population

"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values." (NCT00106028)
Timeframe: Baseline and Month 24

InterventionUnits on a Scale (Least Squares Mean)
Placebo Daily15.608
Risedronate Daily29.637

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Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population

"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values." (NCT00106028)
Timeframe: Baseline and Month 12

InterventionUnits on a Scale (Least Squares Mean)
Placebo Daily-6.028
Risedronate Daily25.648

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Bone Age (Years), Change From Baseline to Month 36, ITT Population

Bone Age determined by visual assessment of hand / wrist radiographs. (NCT00106028)
Timeframe: Baseline and Month 36

InterventionYears (Least Squares Mean)
Placebo Daily3.087
Risedronate Daily3.096

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Bone Age (Years), Change From Baseline to Month 24, ITT Population

Bone Age determined by visual assessment of hand / wrist radiographs. (NCT00106028)
Timeframe: Baseline and Month 24

InterventionYears (Least Squares Mean)
Placebo Daily2.147
Risedronate Daily2.155

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Bone Age (Years), Change From Baseline to Month 12, ITT Population

Bone Age determined by visual assessment of hand / wrist radiographs. (NCT00106028)
Timeframe: Baseline and Month 12

InterventionYears (Least Squares Mean)
Placebo Daily0.956
Risedronate Daily1.083

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Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population

Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12. (NCT00106028)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo Daily7.592
Risedronate Daily16.159

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Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population

Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)] (NCT00106028)
Timeframe: Baseline and Month 36

InterventionChange in Annualized Growth Velocity (Least Squares Mean)
Placebo Daily0.982
Risedronate Daily1.011

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Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population

Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)] (NCT00106028)
Timeframe: Baseline and Month 12

InterventionChange in Annualized Growth Velocity (Least Squares Mean)
Placebo Daily0.895
Risedronate Daily1.002

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Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population

Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. (NCT00106028)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Placebo Daily21.316
Risedronate Daily25.754

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Number of Clinical Fractures, Month 12, ITT Population

Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture. (NCT00106028)
Timeframe: 12 Months

,
InterventionParticipants (Number)
Number of FracturesNumber of Patients with FracturesNumber of Vertebral FracturesNumber Patients with Vertebral FracturesNumber of Non-Vertebral FracturesNumber Patients with Non-Vertebral FracturesNumber Long-Bone Non-Vertebral FracturesNumber Patients Long-Bone Non-Vertebral FracturesNumber Other Non-Vertebral FracturesNumber Patients with Other Non-Vertebral Fractures
Placebo Daily382400382427171110
Risedronate Daily422900422928181412

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New Morphometric Vertebral Fracture at Month 36, ITT Population

Morphometric Vertebral Fracture measured by SQ analysis of x-rays using the Genant scoring system. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit. (NCT00106028)
Timeframe: Baseline and Month 36

,
InterventionParticipants (Number)
At Least One New Fracture VertebraNo New Fractured Vertebra
Placebo Daily1431
Risedronate Daily2062

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New Morphometric Vertebral Fracture at Month 12, ITT Population

Morphometric Vertebral Fracture measured by semi-quantitative (SQ) analysis of x-rays using the Genant scoring system at endpoint. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit. (NCT00106028)
Timeframe: Baseline and Month 12

,
InterventionParticipants (Number)
At Least One New Fracture VertebraNo New Fractured Vertebra
Placebo Daily840
Risedronate Daily2860

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Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population

Patients aged 10-15 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3. (NCT00106028)
Timeframe: Month 12

,
InterventionParticipants (Number)
Number Patients with New Vertebral FracturesNumber of New Vertebral FracturesNumber Patients New Fractures & Mild SQ ScoreNumber Patients New Fractures & Mod/Sev SQ Score
Placebo Daily1110
Risedronate Daily1013101

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Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population

Patients aged 4-9 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3. (NCT00106028)
Timeframe: Month 12

,
InterventionParticipants (Number)
Number Patients with New Vertebral FracturesNumber of New Vertebral FracturesNumber Patients New Fractures & Mild SQ ScoreNumber Patients New Fractures & Mod/Sev SQ Score
Placebo Daily71973
Risedronate Daily1932173

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Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT

Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline. (NCT00106028)
Timeframe: Baseline and Month 36

,
InterventionParticipants (Number)
No New Fractured VertebraOne Fractured VertebraTwo Fractured VertebraThree or more Fractured Vertebra
Placebo Daily31653
Risedronate Daily621073

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Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT

Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline. (NCT00106028)
Timeframe: Baseline and Month 12

,
InterventionParticipants (Number)
No New Fractured VertebraOne Fractured VertebraTwo Fractured VertebraThree or more Fractured Vertebra
Placebo Daily40323
Risedronate Daily601783

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Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population

Wong-Baker FACES Pain Rating Scale (pain assessment scale using facial expressions, translated into a range from 0= no pain [smiling face] to 10= worst pain possible [distorted face with tears]; negative values indicate decrease in pain). Reference: Wong DL et al. (NCT00106028)
Timeframe: Baseline and Month 12

InterventionUnits on a Scale (Least Squares Mean)
Placebo Daily-0.056
Risedronate Daily-0.409

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Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population

Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment. (NCT00106028)
Timeframe: Baseline and Month 36

InterventionPercent Change (Least Squares Mean)
Placebo Daily-47.570
Risedronate Daily-52.609

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Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population

Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment. (NCT00106028)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Placebo Daily-40.358
Risedronate Daily-31.318

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Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population

Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment. (NCT00106028)
Timeframe: Baseline and Endpoint / Month 12

InterventionPercent Change (Least Squares Mean)
Placebo Daily-14.556
Risedronate Daily-41.185

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Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population

"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values." (NCT00106028)
Timeframe: Baseline and Month 36

InterventionUnits on a Scale (Least Squares Mean)
Placebo Daily7.146
Risedronate Daily-1.494

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Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population

"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values." (NCT00106028)
Timeframe: Baseline and Month 24

InterventionUnits on a Scale (Least Squares Mean)
Placebo Daily8.371
Risedronate Daily7.879

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Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population

"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values." (NCT00106028)
Timeframe: Baseline and Month 12

InterventionUnits on a Scale (Least Squares Mean)
Placebo Daily-20.661
Risedronate Daily16.933

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Serum BAP - Percent Change From Baseline to Month 36, ITT Population

Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment. (NCT00106028)
Timeframe: Baseline and 36 Months

InterventionPercent Change (Least Squares Mean)
Placebo Daily-19.884
Risedronate Daily-24.570

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Serum BAP - Percent Change From Baseline to Month 24, ITT Population

Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment. (NCT00106028)
Timeframe: Baseline and 24 Months

InterventionPercent Change (Least Squares Mean)
Placebo Daily-11.196
Risedronate Daily-11.128

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Serum BAP - Percent Change From Baseline to Month 12, ITT Population

Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment. (NCT00106028)
Timeframe: Baseline and 12 Months

InterventionPercent Change (Least Squares Mean)
Placebo Daily6.783
Risedronate Daily-4.895

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Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population

Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. (NCT00106028)
Timeframe: Baseline and Month 36

InterventionPercent Change (Least Squares Mean)
Placebo Daily33.216
Risedronate Daily34.753

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Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 36

InterventionPercent Change (Least Squares Mean)
Placebo Daily37.109
Risedronate Daily38.303

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Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Placebo Daily24.051
Risedronate Daily25.116

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Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo Daily11.405
Risedronate Daily14.939

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Percent Change From Baseline in Total Body BMD at Month 36, ITT Population

Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA. (NCT00106028)
Timeframe: Baseline and Month 36

InterventionPercent Change (Least Squares Mean)
Placebo Daily13.540
Risedronate Daily13.076

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Percent Change From Baseline in Total Body BMD at Month 24, ITT Population

Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA. (NCT00106028)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Placebo Daily9.716
Risedronate Daily10.214

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Percent Change From Baseline in Total Body BMD at Month 12, ITT Population

Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA. (NCT00106028)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo Daily4.252
Risedronate Daily5.806

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Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population

Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture. (NCT00106028)
Timeframe: Time to First Event (days) up to 12 Months

,
InterventionProbability of Fractures (Number)
Number Patients All FracturesAll Fractures/Kaplan-Meier Cumulative IncidenceNumber Patients Vertebral FracturesVertebral Fractures/Kaplan-Meier Cumulative Incid.Number Patients Non-Vertebral FracturesNon-Vertebral Fractures/Kaplan-Meier Cum. Incid.Number Patients Long Bone Non-Vertebral FracturesLong Bone Non-Vertebral Fractures/Kaplan-Meier CumNumber Patients Other Non-Vertebral FracturesOther Non-Vertebral Fractures/Kaplan-Meier Cum.
Placebo Daily240.504300240.5043170.3618100.204
Risedronate Daily290.31400290.314180.1954120.1311

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Percent Change From Baseline in Total Body BMC at Month 36, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 36

InterventionPercent Change (Least Squares Mean)
Placebo Daily56.211
Risedronate Daily56.526

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Percent Change From Baseline in Total Body BMC at Month 24, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Placebo Daily36.465
Risedronate Daily37.938

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Percent Change From Baseline in Total Body BMC at Month 12, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo Daily16.483
Risedronate Daily21.977

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Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population

Measured by DXA. (NCT00106028)
Timeframe: Baseline and Month 36

InterventionPercent Change (Least Squares Mean)
Placebo Daily24.952
Risedronate Daily23.292

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Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population

Measured by DXA. (NCT00106028)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Placebo Daily16.381
Risedronate Daily17.266

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Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population

Measured by DXA. (NCT00106028)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo Daily8.803
Risedronate Daily9.817

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Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 36

InterventionPercent Change (Least Squares Mean)
Placebo Daily68.054
Risedronate Daily68.333

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Bone Turnover Marker Changes-- Serum BAP

Serum BAP median changes between baseline and week 24. The Ostase assays are performed with an access immunoassay system, which is an assay of serum samples that provides a quantitative measurement of bone alkaline phosphatase (BAP). A mouse monoclonal antibody specific to BAP is added to a re-action vessel with paramagnetic particles coated with goat antimouse polyclonalantibody.Calibrators,controls,andsamplescontainingBAP are added to the coated particles and bind to the anti-BAP monoclonal antibody. After the formation of a solid phase/capture antibody/BAP complex, separation in a magnetic field and washing remove materials not bound to the solid phase. A chemiluminescent substrate, LumiPhos 530, is added to the reaction vessel, and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of BAP in the sample. The amount of analyte in thesample is determined from a stored multipoint calibration curve (NCT00216060)
Timeframe: 24 week

,
Interventionng/mL (Median)
24 weekbaseline
Placebo Arm13.1619.50
Risedronate Arm9.520.95

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Bone Turnover Marker Changes-- Urine N-telopeptide (NTX) Median

"Urine N-telopeptide (NTX) median changes between baseline and week 24. The assays are performed with the NTx Reagent Pack kit from Ortho-Clinical Diagnostics (Ortho-Clinical Diagnostics/Johnson & Johnson, Amersham, UK), which is a kit designed for the quantitative determination of N-terminal telopeptide (NTx) in human urine on the automated Vitros Immunodiagnostic System ECi (Ortho-Clinical Diagnostics/Johnson & Johnson, Amersham, UK). A competitive immunoassay technique is used. This depends on competition between NTx present in the sample and a synthetic NTx peptide coated on the wells for binding by a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-NTx). The conjugate is captured by the peptide coated on the wells; unbound materials are removed by washing.~The bound HRP conjugate is measured by a luminescent reaction." (NCT00216060)
Timeframe: 24 week

,
Interventionnmol BCE/mmol creatinine (Median)
at 24 weekbaseline
Placebo Arm62.9548.08
Risedronate Arm20.6341.33

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Three- Year Survival Rate

(NCT00216060)
Timeframe: 36 months

Interventionpercentage of participants (Number)
Risedronate72.5
Placebo71.5

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Bone Turnover Marker Changes-- Serum Osteocalcin (OC)

Serum Osteocalcin (OC) medians between baseline and 24 weeks areperformed with the Elecsys 2010 automated analyzer, which uses an electrochemiluminescence immunoassay technique for the in vitro quantitative determination of serum total osteocalcin in humanserum. The assay uses a sandwich test principle in which afirst biotinylated monoclonal antibody recognizing N-MID osteocalcin and a second monoclonal antibody against N-MID osteocalcin labeled with ruthenium are incubated with 20mL of serum. After a first incubation, streptavidin-coated microparticles are added for a second incubation, and the complex becomes bound to the solid phase by interaction of biotin and streptavidin.These microparticles are then magnetically captured onto the surface of an electrode. Application of a voltage on this electrode induces chemiluminescent emission, which is measured by a photomultiplierand compared with a calibration curve that is generated in aninstrument-specific manner by 2-point calibration. (NCT00216060)
Timeframe: 24 week

,
Interventionug/L (Median)
at 24 weekbaseline
Placebo Arm27.3518.24
Risedronate Arm11.8820.08

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Numbers of SRE or Death Occurred Cumulatively

Number of participants experiencing a SRE(skeletal-related event) or death occurred, cumulative from each arm ( a daily oral dose of 30 mg risedronate, or placebo) (NCT00216060)
Timeframe: 36 months

Interventionparticipants (Number)
Risedronate Arm11
Placebo Arm13

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Rate of Patients Archiving a PSA (Prostate Specific Antigen) Nadir < 0.2 ng/mL

(NCT00216060)
Timeframe: 36 months

Interventionpercentage of participants (Number)
Risedronate Arm50
Placebo Arm29

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Bone Turnover Marker Changes -- Urine Total Deoxypyridinoline (DPD)

"Urine total DPD median in response to treatment on both study arms at week 24. compare median from baseline and week 24.~Deoxypyridinoline (DPD) is measured in hydrolyzed urine samples using high-performance liquid chromatography technique. After extraction of the cross-links and elimination of the urine impurities by a Bio-Rad SPE cartridge (Bio-Rad Laboratories, Hercules, CA), total DPD is eluted from reverse-phase high-performance liquid chromatography by ion pair chromatography with isocratic elution.~The compounds are detected as a result of their natural fluorescence with a fluorescence detector" (NCT00216060)
Timeframe: 24 weeks

,
Interventionnmol/mmol creatinine (Median)
week 24baseline
Placebo Arm12.6210.12
Risedronate Arm6.918.83

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Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.

In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD. (NCT00221299)
Timeframe: BMD changes from year 1 to year 2

Interventionpercent change (Mean)
Parathyroid Hormone&Risedronate Placebo0.85
Parathyroid Hormone&Risedronate0.84
Parathyroid Hormone Placebo&Risedronate0.91

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Percent Change From Baseline in Serum BAP at Month 24, ITT Population

Assayed by ELISA (enzyme-linked immunosorbent assay) (NCT00247273)
Timeframe: Baseline to Month 24

InterventionPercent Change (Least Squares Mean)
5 mg Risedronate-25.84
150 mg Risedronate-25.07

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12). (NCT00247273)
Timeframe: Baseline to Month 12 - Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Risedronate3.425
150 mg Risedronate3.540

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Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. (NCT00247273)
Timeframe: Baseline to Month 24

InterventionPercent Change (Least Squares Mean)
5 mg Risedronate4.217
150 mg Risedronate4.302

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Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24). (NCT00247273)
Timeframe: Baseline to Month 24 - Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Risedronate3.927
150 mg Risedronate4.166

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Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. (NCT00247273)
Timeframe: Baseline to Month 12

InterventionPercent Change (Least Squares Mean)
5 mg Risedronate3.522
150 mg Risedronate3.598

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Number of Participants With New Vertebral Fracture at Month 24, ITT Population

At least 1 new fractured vertebra (NCT00247273)
Timeframe: Baseline to Month 24

InterventionParticipants (Number)
5 mg Risedronate14
150 mg Risedronate14

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Number of Participants With New Vertebral Fracture at Month 12, ITT Population

At least 1 new fractured vertebra (NCT00247273)
Timeframe: Baseline to Month 12

InterventionParticipants (Number)
5 mg Risedronate8
150 mg Risedronate8

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Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population

Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine (NCT00247273)
Timeframe: Baseline to Month 6

Interventionnmol BCE / mmol Creatinine (Least Squares Mean)
5 mg Risedronate-30.04
150 mg Risedronate-30.26

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Change From Baseline in Urine NTX/Cr at Month 24, ITT Population

Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. (NCT00247273)
Timeframe: Baseline to Month 24

Interventionnmol BCE / mmol Creatinine (Least Squares Mean)
5 mg Risedronate-28.88
150 mg Risedronate-29.87

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Percent Change From Baseline in Serum CTX at Month 24, ITT Population

Assayed by electrochemiluminescent immunoassay. (NCT00247273)
Timeframe: Baseline to Month 24

InterventionPercent Change (Least Squares Mean)
5 mg Risedronate-29.33
150 mg Risedronate-23.63

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Percent Change From Baseline in Serum BAP at Month 6, ITT Population

Assayed by ELISA (enzyme-linked immunosorbent assay) (NCT00247273)
Timeframe: Baseline to Month 6

InterventionPercent Change (Least Squares Mean)
5 mg Risedronate-33.34
150 mg Risedronate-34.66

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Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population

ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay. (NCT00247273)
Timeframe: Baseline to Month 6

Interventionng / mL (Least Squares Mean)
5 mg Risedronate-0.36
150 mg Risedronate-0.34

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Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. (NCT00247273)
Timeframe: Baseline to Month 12

Interventiong/cm^2 (Least Squares Mean)
5 mg Risedronate0.0256
150 mg Risedronate0.0261

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Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. (NCT00247273)
Timeframe: Baseline to Month 24

Interventiong/cm^2 (Least Squares Mean)
5 mg Risedronate0.0309
150 mg Risedronate0.0319

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Change From Baseline in Serum BAP at Month 24, ITT Population

Assayed by ELISA (enzyme-linked immunosorbent assay) (NCT00247273)
Timeframe: Baseline to Month 24

Interventionug / L (Least Squares Mean)
5 mg Risedronate-4.10
150 mg Risedronate-4.22

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Change From Baseline in Serum CTX at Month 24, ITT Population

Assayed by electrochemiluminescent immunoassay. (NCT00247273)
Timeframe: Baseline to Month 24

Interventionng / mL (Least Squares Mean)
5 mg Risedronate-0.22
150 mg Risedronate-0.20

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Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population

ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay) (NCT00247273)
Timeframe: Baseline to Month 6

Interventionug / L (Least Squares Mean)
5 mg Risedronate-5.31
150 mg Risedronate-5.48

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Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population

Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. (NCT00247273)
Timeframe: Baseline to Month 6

InterventionPercent Change (Least Squares Mean)
5 mg Risedronate-51.83
150 mg Risedronate-50.26

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Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population

Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. (NCT00247273)
Timeframe: Baseline to Month 24

InterventionPercent Change (Least Squares Mean)
5 mg Risedronate-49.45
150 mg Risedronate-46.62

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Percent Change From Baseline in Serum CTX at Month 6, ITT Population

Assayed by electrochemiluminescent immunoassay. (NCT00247273)
Timeframe: Baseline to Month 6

InterventionPercent Change (Least Squares Mean)
5 mg Risedronate-57.79
150 mg Risedronate-53.62

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Bone Histomorphometry - Percent Bone Volume (BV/TV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Percent Bone Volume is the percentage of total volume occupied by calcified bone. Percent Bone volume is calculated as Bone Volume (BV) divided by Tissue Volume (TV), where TV is bone plus marrow. (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionpercent (Mean)
Baselinemonth 12
Placebo13.39.7
Risedronate10.711.3

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Bone Histomorphometry - Osteoid Volume (OV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the Osteoid Volume (OV), the volume of bone that consists of unmineralized bone. (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionmicron^3 (Mean)
Baselinemonth 12
Placebo0.060.03
Risedronate0.060.10

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Bone Histomorphometry - Bone Formation Rate

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized. Bone formation rate (BFR) indicates how much of the bone is actively mineralizing; it is determined by the number of active OB and the average work of each OB. (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionmicron/day (Mean)
Baselinemonth 12
Placebo0.040.05
Risedronate0.020.10

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Bone Histomorphometry - Mineralized Bone Volume (MdV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Bone mineralization is the process of laying down minerals on the matrix of the bone, with calcium and phosphorus as the most abundant minerals. Mineralized Bone Volume (MdV) is the percentage of mineralized bone tissue. (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionpercent (Mean)
Baselinemonth 12
Placebo1.31.0
Risedronate1.21.2

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Bone Mineral Density of Spine at 12 Months

Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using same Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 12 of treatment

Interventiongm/cm^2 (Mean)
Risedronate1.00
Placebo1.00

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Bone Mineral Density of Spine at 6 Months

Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 6 of the treatment

Interventiongm/cm^2 (Mean)
Risedronate0.98
Placebo0.97

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Bone Mineral Density of the Hip at 12 Months

Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 12 of the treatment

Interventiongm/cm^2 (Mean)
Risedronate0.91
Placebo0.87

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Bone Mineral Density of Forearm at 6 Months

Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 6 of the treatment

Interventiongm/cm^2 (Mean)
Risedronate0.57
Placebo0.58

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Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones. Osteoclasts make and secret digestive enzymes tha break up or dissolve the bone tissue. An eroded surface (ES) is the surface of the lacuna ( a cavity or depression in the bone) generated by an active OC. The reported values indicate the percent of eroded surface relative to bone surface (BS). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionpercent (Mean)
Baselinemonth 12
Placebo1.360.82
Risedronate92.7

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Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Percent Mineralized Bone Volume is the percentage of Bone Volume consisting of mineralized bone. Percent Mineralized Bone Volume is calculated as Mineralized Bone Volume (MdV) divided by Bone Volume (BV). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionpercent (Mean)
Baselinemonth 12
Placebo9596
Risedronate9592

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Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized. Bone mass is a balance between the osteoblasts (OB) that form the bone and cells called osteoclasts (OC) that break down the bone. The reported values indicate the percent of bone surface (BS) that is made up of osteoblasts (OB). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionpercent (Mean)
Baselinemonth 12
Placebo1.30.75
Risedronate2.31.23

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Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones. Osteoclasts make and secrete digestive enzymes that break up or dissolve the bone tissue. Bone mass is a balance between the osteoblasts (OB) cells that form the bone and the osteoclasts (OC) cells that break down the bone. The reported values indicate the percent of bone surface (BS) that consists of osteoclasts (OC). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionpercent (Mean)
Baselinemonth 12
Placebo0.970.68
Risedronate1.50.28

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Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of bone surface that consists of unmineralized bone. It is equal to Osteoid Surface (OS) divided by Bone Surface (BS). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionpercent (Mean)
Baselinemonth 12
Placebo1514
Risedronate2324

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Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of a given volume of bone that consists of unmineralized bone. It is equal to Osteoid Volume (OV) divided by Bone Volume (BV). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionpercent (Mean)
Baselinemonth 12
Placebo4.64.9
Risedronate4.18.7

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Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of a given volume of tissue (bone + marrow) that consists of unmineralized bone. It is equal to Osteoid Volume (OV) divided by Tissue Volume (TV). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionpercent (Mean)
Baselinemonth 12
Placebo0.580.51
Risedronate0.490.90

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Bone Mineral Density of the Hip at 6 Months

Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 6 of the treatment

Interventiongm/cm^2 (Mean)
Risedronate0.88
Placebo0.86

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Bone Histomorphometry - Trabecular Thickness (TbTh)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. The ends of certain bones, known as cancellous bones, are actually not solid but are full of holes that are connected to each other by thin rods and plates of bone tissue known as trabeculae. Trabeculae of bone provide structural support to the spongy bone found at the ends of long bones. Trabeculae Trabecular Thickness (TbTh), a structural parameter, is the distance across individual trabecula. (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

,
Interventionmicron (Mean)
Baselinemonth 12
Placebo90.962.2
Risedronate72.672.1

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Bone Mineral Density of Forearm at 12 Months

Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 12 of the treatment

Interventiongm/cm^2 (Mean)
Risedronate0.55
Placebo0.58

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Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint

24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 12 Months

,
Interventionparticipants (Number)
Responder to TreatmentNon-Responder to Treatment
Risedronate220116
Teriparatide233115

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Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint

24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 18 Months

,
Interventionparticipants (Number)
ResponderNon-Responder
Risedronate234115
Teriparatide248112

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Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint

24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 6 Months

,
Interventionparticipants (Number)
Responder to TreatmentNon-Responder to Treatment
Risedronate193143
Teriparatide206142

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Number of Participants With Adverse Events (Safety) During 12 Months

Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section. (NCT00343252)
Timeframe: Baseline through 12 Months

,
Interventionparticipants (Number)
Serious Adverse EventsAdverse Events
Risedronate50266
Teriparatide39269

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Number of Participants With Adverse Events (Safety) During 18 Months

Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section. (NCT00343252)
Timeframe: Baseline through 18 Months

,
Interventionparticipants (Number)
Serious Adverse EventsAdverse Events
Risedronate66273
Teriparatide55277

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Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months

Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days. (NCT00343252)
Timeframe: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600

,
Interventionparticipants (Number)
Day 0Day 60Day 120Day 180Day 240Day 300Day 360Day 420Day 480Day 540Day 600
Risedronate074145181193206209220220220220
Teriparatide070151195206224226233233233233

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Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months

Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days. (NCT00343252)
Timeframe: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300

,
Interventionparticipants (Number)
Day 0Day 30Day 60Day 90Day 120Day 150Day 180Day 210Day 240Day 270Day 300
Risedronate02274111145164181192193193193
Teriparatide02670110151175195206206206206

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Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint

24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 6 Months

,
Interventionparticipants (Number)
Responder to TreatmentNon-Responder to Treatment
Risedronate211125
Teriparatide221126

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Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months

Time to first occurrence of >= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days. (NCT00343252)
Timeframe: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600

,
Interventionparticipants (Number)
Day 0Day 60Day 120Day 180Day 240Day 300Day 360Day 420Day 480Day 540Day 600
Risedronate086162200211220226238238238238
Teriparatide091175212221234238246246246246

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Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months

Time to first occurrence of >=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days. (NCT00343252)
Timeframe: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300

,
Interventionparticipants (Number)
Day 0Day 30Day 60Day 90Day 120Day 150Day 180Day 210Day 240Day 270Day 300
Risedronate03386130162178200210211211211
Teriparatide04091136175199212221221221221

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Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.

Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). (NCT00343252)
Timeframe: Baseline, 12 Months

Interventionunits on a scale (Least Squares Mean)
Teriparatide-2.09
Risedronate-2.12

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Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. (NCT00343252)
Timeframe: Baseline, 12 Months

Interventionunits on a scale (Least Squares Mean)
Teriparatide-5.74
Risedronate-5.27

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Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. (NCT00343252)
Timeframe: Baseline, 18 Months

Interventionunits on a scale (Least Squares Mean)
Teriparatide-5.67
Risedronate-5.17

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Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.

Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for. (NCT00343252)
Timeframe: Baseline, 18 Months

Interventionunits on a scale (Least Squares Mean)
Teriparatide-3.21
Risedronate-3.19

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Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.

Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). (NCT00343252)
Timeframe: Baseline, 3 Months

Interventionunits on a scale (Least Squares Mean)
Teriparatide-1.42
Risedronate-1.41

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Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.

Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). (NCT00343252)
Timeframe: Baseline, 6 Months

Interventionunits on a scale (Least Squares Mean)
Teriparatide-1.58
Risedronate-1.77

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Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. (NCT00343252)
Timeframe: Baseline, 6 Months

Interventionunits on a scale (Least Squares Mean)
Teriparatide-2.80
Risedronate-2.63

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Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months

Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days. (NCT00343252)
Timeframe: Baseline through 18 Months

Interventionparticipants (Number)
Teriparatide248
Risedronate234

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Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months

Time to first occurrence of >=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days. (NCT00343252)
Timeframe: Baseline through 18 Months

Interventionparticipants (Number)
Teriparatide260
Risedronate242

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Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint

24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 12 Months

,
Interventionparticipants (Number)
Responder to TreatmentNon-Responder to Treatment
Risedronate23898
Teriparatide246101

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Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint

24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 18 Months

,
Interventionparticipants (Number)
ResponderNon-responder
Risedronate242107
Teriparatide260100

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Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.

BMD was measured by Dual X-ray Absorptiometry (DXA). (NCT00365456)
Timeframe: 12 months

InterventionPercentage Change (Least Squares Mean)
PTH (1-84)1.002
Risedronate0.990

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Intensity of Upper Gastrointestinal (GI) Symptoms

Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list. (NCT00377234)
Timeframe: within 3 months

,
Interventionpercentage of participants (Number)
AnyMildModerateSevere
Ibandronate46.141.332.315.6
Risedronate56.549.136.012.4

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Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing

Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire. (NCT00377234)
Timeframe: at 6 months

Interventionpercentage of participants (Number)
During Sequence A81.7
During Sequence B78.2
Total79.9

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Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate

Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire. (NCT00377234)
Timeframe: within 6 months

Interventionpercentage of participants (Number)
During Sequence A85.5
During Sequence B87.0
Total86.3

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Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-0.976
Risedronate0.468

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Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12

Electrochemiluminescence assay method by central lab (NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-5.762
Risedronate-46.031

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Lumbar Spine BMD, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-1.797
Risedronate1.473

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Height, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-0.163
Risedronate-0.071

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Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-0.440
Risedronate-0.106

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Greater Trochanter BMD, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-0.462
Risedronate0.996

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Femoral Neck BMD, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-1.422
Risedronate-0.014

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Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-0.784
Risedronate-0.173

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Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-0.786
Risedronate-0.301

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Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-2.121
Risedronate-1.578

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Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12

ELISA / enzyme-linked immunosorbent assay method by central lab (NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo1.537
Risedronate-38.002

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Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-1.486
Risedronate-1.255

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Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo0.785
Risedronate0.725

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Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-1.820
Risedronate-1.156

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Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months

bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 6 months. (NCT00452439)
Timeframe: 6 months

,
InterventionPercent of change (Mean)
Lumbar Spine 6 MonthsRight Hip 6 MonthsLeft Hip 6 Months
Actonel-2.4-7.6-8.2
Placebo-3.5-11-11

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Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at 12 Months

bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 12 months (NCT00452439)
Timeframe: 12 months

,
Interventionpercentage of change (Mean)
Lumbar Spine 12 MonthsRight Hip 12 MonthsLeft Hip 12 Months
Actonel-0.6-4.8-4.1
Placebo-5-5.8-7

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Markers of Bone Resorption and Bone Formation

(NCT00485953)
Timeframe: at 24 months

,
Interventionpercentage change (Mean)
CTXP1NP
Active Medicine Group-14.906-46.863
Placebo Group-4.077-1.630

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BMD by DXA at the Femoral Neck and Total Hip

BMD is the bone mineral density of the femoral neck and total hip measured using the dual-energy x-ray absorptiometry (DXA) scan. (NCT00485953)
Timeframe: at 24 months

,
Interventionpercentage change (Mean)
Total Hip BMDFemoral Neck BMD
Active Medication Group0.5580.408
Placebo Group-2.748-2.137

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BMD of Spine by DXA

BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan. (NCT00485953)
Timeframe: at 24 months

Interventionpercentage change (Mean)
Active Medicine Group2.269
Placebo Group-1.735

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Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months

Dual x-ray absorptiometry (DXA) techniques validated this measurement at skeletal sites that are at risk of osteoporotic fracture, such as lumbar spine, femoral neck, and hip. (NCT00503399)
Timeframe: Baseline, 18 months

,
Interventiongrams per square centimeter (g/cm^2) (Mean)
Lumbar spine (n=38; n=39)Hip (n=38; n=37)Femoral neck (n=38; n=37)
Risedronate0.0370.007-0.007
Teriparatide0.0680.0140.014

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Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength

Axial compression was measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated the strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. (NCT00503399)
Timeframe: Baseline, 6 months, 18 months

,
InterventionNewton per millimeter (N/mm) (Least Squares Mean)
Axial compression stiffness at 6 monthsAxial compression stiffness at 18 monthsAxial compression strength at 6 monthsAxial compression strength at 18 months
Risedronate407.6363.7313.6209.4
Teriparatide890.71973.9580.71287.5

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Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months

Three-dimensional (3-D) microstructure variables of T12 were assessed by HR-QCT. In contrast with regular QCT that assessed 3 millimeter (mm) slide thickness, HR-QCT used segmentation of 1 single vertebra with approximately 100 consecutive slides reconstructed at 300-400 micrometer (µm) slice increments covering the complete vertebral body. Least Squares (LS) Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. (NCT00503399)
Timeframe: Baseline, 6 months, 18 months

,
Interventionmilligram per cubic centimeter (mg/cm^3) (Least Squares Mean)
Integral BMD at 6 monthsIntegral BMD at 18 monthsTrabecular BMD at 6 monthsTrabecular BMD at 18 months
Risedronate-1.910.68-0.870.22
Teriparatide-0.4210.72-0.709.53

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Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months

P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid. (NCT00503399)
Timeframe: Baseline, 3 months, 6 months, 18 months

,
Interventionmicrograms per deciliter (μg/dL) (Least Squares Mean)
P1NP at 3 monthsP1NP at 6 monthsP1NP at 18 months
Risedronate-16.09-16.50-15.58
Teriparatide27.3352.5528.48

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Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months

β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix. (NCT00503399)
Timeframe: 3, 6, 18 months

,
Interventionnanograms per deciliter (ng/dL) (Least Squares Mean)
β-CTx at 3 monthsβ-CTx at 6 monthsβ-CTx at 18 months
Risedronate-0.15-0.14-0.11
Teriparatide0.120.250.03

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Number of Participants With Adverse Events (AEs)

Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. Fractures that occurred during the study were collected separately as an additional safety variable. The number of participants experiencing hypercalcemia was summarized for each treatment arm. Hypercalcemia was defined as a serum calcium level corrected for albumin of >2.7 millimole per liter (mmol/L) (10.8 milligram per deciliter [mg/dL]). (NCT00503399)
Timeframe: Baseline up to 18 months

,
Interventionparticipants (Number)
Serious Adverse Events (SAEs)Other Non-serious AEsFracturesHypercalcemia
Risedronate223050
Teriparatide132200

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Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months

Least Squares (LS) Means were adjusted for age, baseline propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. (NCT00503399)
Timeframe: Baseline, 6 months

Interventionmilligram per cubic centimeter (mg/cm^3) (Least Squares Mean)
Teriparatide4.31
Risedronate2.52

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Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months

Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. (NCT00503399)
Timeframe: Baseline, 18 months

Interventionmilligram per cubic centimeter (mg/cm^3) (Least Squares Mean)
Teriparatide12.28
Risedronate2.94

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Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength

Anterior bending and axial torsion were measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. (NCT00503399)
Timeframe: Baseline, 6 months, 18 months

,
InterventionNewton/millimeter/radian (N/mm/rad) (Least Squares Mean)
Anterior bending stiffness at 6 monthsAnterior bending stiffness at 18 monthsAxial torsion stiffness at 6 monthsAxial torsion stiffness at 18 monthsAnterior bending strength at 6 monthsAnterior bending strength at 18 monthsAxial torsion strength at 6 monthsAxial torsion strength at 18 months
Risedronate415705.0233283.077830.756639.38827.24822.03664.02545.8
Teriparatide664969.01209225.0142902.9279392.812490.926046.46127.714181.3

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Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-42.223
35 mg After Breakfast-47.263
35 mg Before Breakfast-46.863

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Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint

(NCT00541658)
Timeframe: Week 104 / Endpoint

InterventionParticipants (Number)
5 mg Before Breakfast269
35 mg After Breakfast263
35 mg Before Breakfast267

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Number of Patients With No New Fractured Vertebra, Week 52

(NCT00541658)
Timeframe: Week 52

InterventionParticipants (Number)
5 mg Before Breakfast255
35 mg After Breakfast255
35 mg Before Breakfast254

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Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-43.075
35 mg After Breakfast-45.705
35 mg Before Breakfast-47.692

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Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-41.451
35 mg After Breakfast-49.253
35 mg Before Breakfast-48.752

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Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-49.188
35 mg After Breakfast-53.927
35 mg Before Breakfast-53.186

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Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-46.261
35 mg After Breakfast-51.079
35 mg Before Breakfast-49.454

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Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast1.785
35 mg After Breakfast2.073
35 mg Before Breakfast2.075

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Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast2.177
35 mg After Breakfast2.821
35 mg Before Breakfast2.764

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Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast2.028
35 mg After Breakfast2.551
35 mg Before Breakfast2.496

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Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population

(NCT00541658)
Timeframe: Week 13

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-42.331
35 mg After Breakfast-46.781
35 mg Before Breakfast-46.054

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Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-44.386
35 mg After Breakfast-49.183
35 mg Before Breakfast-49.358

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Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: 52 weeks / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast3.069
35 mg After Breakfast3.302
35 mg Before Breakfast3.365

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Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast3.035
35 mg After Breakfast3.293
35 mg Before Breakfast3.357

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Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast2.685
35 mg After Breakfast2.816
35 mg Before Breakfast2.529

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Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg IRBB3.069
35 mg DRFB + DRBB3.334

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Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast4.352
35 mg After Breakfast5.506
35 mg Before Breakfast5.396

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Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast1.530
35 mg After Breakfast2.108
35 mg Before Breakfast2.328

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Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast4.147
35 mg After Breakfast5.205
35 mg Before Breakfast5.068

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Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

InterventionPercent (Least Squares Mean)
5 mg Before Breakfast1.809
35 mg After Breakfast2.130
35 mg Before Breakfast2.099

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Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast1.613
35 mg After Breakfast1.748
35 mg Before Breakfast1.685

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Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-44.410
35 mg After Breakfast-49.185
35 mg Before Breakfast-50.048

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Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-42.172
35 mg After Breakfast-48.724
35 mg Before Breakfast-47.703

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Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-44.155
35 mg After Breakfast-51.985
35 mg Before Breakfast-52.538

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Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint

(NCT00541658)
Timeframe: Week 52 / Endpoint

InterventionParticipants (Number)
5 mg Before Breakfast268
35 mg After Breakfast259
35 mg Before Breakfast268

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Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast1.155
35 mg After Breakfast1.482
35 mg Before Breakfast1.717

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Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-31.895
35 mg After Breakfast-33.450
35 mg Before Breakfast-33.507

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Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-31.367
35 mg After Breakfast-32.802
35 mg Before Breakfast-32.829

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Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-31.273
35 mg After Breakfast-33.680
35 mg Before Breakfast-32.582

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Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population

(NCT00541658)
Timeframe: Week 13

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-23.386
35 mg After Breakfast-25.141
35 mg Before Breakfast-25.191

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Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-33.394
35 mg After Breakfast-36.143
35 mg Before Breakfast-36.810

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Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-32.572
35 mg After Breakfast-34.769
35 mg Before Breakfast-34.824

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Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast2.297
35 mg After Breakfast2.854
35 mg Before Breakfast2.819

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Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint

(NCT00541658)
Timeframe: Week 52 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast2.186
35 mg After Breakfast2.732
35 mg Before Breakfast2.764

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Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast3.056
35 mg After Breakfast4.152
35 mg Before Breakfast4.246

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Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint

(NCT00541658)
Timeframe: Week 104 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast2.772
35 mg After Breakfast3.691
35 mg Before Breakfast3.828

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Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population

Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. (NCT00541658)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
5 mg Before Breakfast82.6
35 mg After Breakfast89.2
35 mg Before Breakfast92.3

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Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast1.180
35 mg After Breakfast1.507
35 mg Before Breakfast1.717

[back to top]

Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast1.120
35 mg After Breakfast1.385
35 mg Before Breakfast1.246

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Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

InterventionParticipants (Number)
5 mg Before Breakfast5
35 mg After Breakfast2
35 mg Before Breakfast6

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Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

InterventionParticipants (Number)
5 mg Before Breakfast5
35 mg After Breakfast2
35 mg Before Breakfast4

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Number of Patients With at Least One New Fractured Vertebra, Week 52

(NCT00541658)
Timeframe: Week 52

InterventionParticipants (Number)
5 mg Before Breakfast2
35 mg After Breakfast2
35 mg Before Breakfast3

[back to top]

Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

InterventionParticipants (Number)
5 mg Before Breakfast2
35 mg After Breakfast2
35 mg Before Breakfast3

[back to top]

Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast1.900
35 mg After Breakfast2.148
35 mg Before Breakfast2.164

[back to top]

Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast1.431
35 mg After Breakfast1.986
35 mg Before Breakfast2.047

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Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population

Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. (NCT00541658)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
5 mg Before Breakfast81
35 mg After Breakfast87.5
35 mg Before Breakfast86.4

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Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population

Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. (NCT00541658)
Timeframe: Week 52 / Endpoint

InterventionPercentage of Participants (Number)
5 mg Before Breakfast81.5
35 mg After Breakfast87.4
35 mg Before Breakfast86.0

[back to top]

Number of Patients With No New Fractured Vertebra, Week 104

(NCT00541658)
Timeframe: Week 104

InterventionParticipants (Number)
5 mg Before Breakfast239
35 mg After Breakfast231
35 mg Before Breakfast233

[back to top]

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population

Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. (NCT00541658)
Timeframe: Week 52 / Endpoint

InterventionPercentage of Participants (Number)
5 mg Before Breakfast81.8
35 mg After Breakfast87.9
35 mg Before Breakfast90.1

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Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population

(NCT00541658)
Timeframe: Week 13

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-42.595
35 mg After Breakfast-46.366
35 mg Before Breakfast-45.420

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Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

InterventionPercent Change (Least Squares Mean)
5 mg Before Breakfast-40.227
35 mg After Breakfast-46.599
35 mg Before Breakfast-44.630

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Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population

(NCT00577720)
Timeframe: Baseline and Week 13

InterventionPercent Change (Least Squares Mean)
35 mg IRBB (Immediate Release Before Breakfast)-38.57
35 mg DRFB (Delayed Release Following Breakfast)-46.60
50 mg DRFB-43.65
50 mg DRBB (Delayed Release Before Breakfast)-54.27

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Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population

(NCT00577720)
Timeframe: Baseline and Week 13

InterventionPercent Change (Least Squares Mean)
35 mg IRBB (Immediate Release Before Breakfast)-10.99
35 mg DRFB (Delayed Release Following Breakfast)-10.41
50 mg DRFB-20.00
50 mg DRBB (Delayed Release Before Breakfast)-17.36

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Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population

(NCT00577720)
Timeframe: Baseline and Week 13

InterventionPercent Change (Least Squares Mean)
35 mg IRBB (Immediate Release Before Breakfast)-43.20
35 mg DRFB (Delayed Release Following Breakfast)-62.08
50 mg DRFB-65.11
50 mg DRBB (Delayed Release Before Breakfast)-66.30

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Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008 (NCT00619957)
Timeframe: Baseline to Month 12

InterventionPercent Change (Least Squares Mean)
Placebo0.62
Risedronate1.49

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Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008 (NCT00619957)
Timeframe: Baseline to Month 24

InterventionPercent Change (Least Squares Mean)
Placebo0.42
Risedronate1.65

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Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD[lunar]) - 0.008 (NCT00619957)
Timeframe: Baseline to Month 6

InterventionPercent Change (Least Squares Mean)
Placebo0.48
Risedronate0.98

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Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. (NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

InterventionPercent Change (Least Squares Mean)
Placebo0.57
Risedronate2.73

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Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. (NCT00619957)
Timeframe: Baseline to Month 12

InterventionPercent Change (Least Squares Mean)
Placebo0.81
Risedronate1.89

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Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.

(NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

Interventionmillimeters (Least Squares Mean)
Placebo-2.39
Risedronate-2.68

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Change From Baseline in Body Height, Month 12, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 12

Interventionmillimeters (Least Squares Mean)
Placebo-0.77
Risedronate-0.92

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Cumulative Incidence of Fractures, 12 Months, ITT Population

Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year (NCT00619957)
Timeframe: Baseline to Month 12

InterventionFractures / 100 patients / year (Number)
Placebo3.4
Risedronate2.7

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Cumulative Incidence of Fractures, 24 Months, ITT Population

Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years (NCT00619957)
Timeframe: Baseline to Month 24

InterventionFractures / 100 patients / 2 years (Number)
Placebo7.7
Risedronate4.9

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Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 3

Interventionpercent (Least Squares Mean)
Placebo-8.89
Risedronate-24.53

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Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.

(NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

InterventionPercent Change (Least Squares Mean)
Placebo1.99
Risedronate-25.27

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Percent Change From Baseline in BAP, Month 12, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-7.11
Risedronate-29.51

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Percent Change From Baseline in BAP, Month 24, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 24

Interventionpercent (Least Squares Mean)
Placebo2.95
Risedronate-25.20

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Percent Change From Baseline in BAP, Month 6, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 6

InterventionPercent Change (Least Squares Mean)
Placebo-8.68
Risedronate-29.78

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Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 3

InterventionPercent Change (Least Squares Mean)
Placebo-14.56
Risedronate-58.16

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Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.

(NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

InterventionPercent Change (Least Squares Mean)
Placebo6.39
Risedronate-38.76

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Percent Change From Baseline in CTx, Month 12, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-19.12
Risedronate-61.46

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Percent Change From Baseline in CTx, Month 6, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 6

InterventionPercent Change (Least Squares Mean)
Placebo-13.72
Risedronate-58.44

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). (NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

InterventionPercent Change (Least Squares Mean)
Placebo1.22
Risedronate5.75

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Percent Change From Baseline in CTx, Month 24, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 24

InterventionPercent Change (Least Squares Mean)
Placebo9.28
Risedronate-37.27

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Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. (NCT00619957)
Timeframe: Baseline to Month 24

InterventionPercent Change (Least Squares Mean)
Placebo0.52
Risedronate2.83

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Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. (NCT00619957)
Timeframe: Baseline to Month 6

InterventionPercent Change (Least Squares Mean)
Placebo0.67
Risedronate1.24

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Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). (NCT00619957)
Timeframe: Baseline to Month 12

InterventionPercent Change (Least Squares Mean)
Placebo1.42
Risedronate4.60

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Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). (NCT00619957)
Timeframe: Baseline to Month 24

InterventionPercent Change (Least Squares Mean)
Placebo1.40
Risedronate5.98

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Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 3

InterventionPercent Change (Least Squares Mean)
Placebo-17.41
Risedronate-33.28

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Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.

(NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

InterventionPercent Change (Least Squares Mean)
Placebo-20.45
Risedronate-36.82

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Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 12

InterventionPercent Change (Least Squares Mean)
Placebo-16.46
Risedronate-38.42

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Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 24

InterventionPercent Change (Least Squares Mean)
Placebo-22.27
Risedronate-37.38

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Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 6

InterventionPercent Change (Least Squares Mean)
Placebo-7.98
Risedronate-29.97

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Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). (NCT00619957)
Timeframe: Baseline to Month 24

InterventionPercent Change (Least Squares Mean)
Placebo0.06
Risedronate1.76

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Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). (NCT00619957)
Timeframe: Baseline to Month 6

InterventionPercent Change (Least Squares Mean)
Placebo0.76
Risedronate1.16

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Percent of Responders Lumbar Spine BMD, Month 24, ITT Population

responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24 (NCT00619957)
Timeframe: Baseline to Month 24

InterventionPercentage of Participants (Number)
Placebo60.3
Risedronate89.5

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Change From Baseline in Body Height, Month 24, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 24

Interventionmillimeters (Least Squares Mean)
Placebo-2.66
Risedronate-3.13

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Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). (NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

InterventionPercent Change (Least Squares Mean)
Placebo0.24
Risedronate1.71

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Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). (NCT00619957)
Timeframe: Baseline to Month 6

InterventionPercent Change (Least Squares Mean)
Placebo1.03
Risedronate3.60

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Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). (NCT00619957)
Timeframe: Baseline to Month 12

InterventionPercent Change (Least Squares Mean)
Placebo0.74
Risedronate1.38

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Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008 (NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

InterventionPercent Change (Least Squares Mean)
Placebo0.53
Risedronate1.59

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Percent Change in Bone Mineral Density

BMD was measured by dual-energy X-ray absorptiometry (Lunar DXA-IQ, Madison, WI, USA). The BMD of the femoral neck, total hip, and lumbar spine (L1-L4) was measured. Underlying data are no longer available; reported means have been estimated from the results publication. (NCT00859027)
Timeframe: baseline and 6 months

,
InterventionPercent Change (Mean)
Femoral NeckTotal HipLumbar Spine
Calcium and Vitamin D Daily (Placebo Group)-2-2.2-1.3
Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily0.10.21.7

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Percent Change of Bone Turnover Markers

Bone turnover markers including N-telopeptide (NTX), serum C-telopeptide (CTX) and procollagen peptide (P1NP), and 25-OH vitamin D and intact parathyroid hormone (PTH) were measured at baseline and at 6 months. Reported means have been estimated from the results publication as the underlying data are no longer available. Data for Vitamin D and PTH were not included in the publication. (NCT00859027)
Timeframe: Baseline and 6 months

,
InterventionPercent Change (Mean)
NTXCTXP1NPVitamin DPTH
Calcium and Vitamin D Daily (Placebo Group)215541NANA
Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily-15-5-1NANA

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Vertebral Fractures

(NCT00869622)
Timeframe: 2 years

InterventionVertebral Fractures (Number)
Risedronate0
Placebo + Calcium and Vitamin D5

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Changes in Bone Mineral Density

"Patients with a T-Score of > -2.5 were randomized into two possible arms. A bisphosphonate group received 35mg risedronate weekly while another group received an identical placebo tablet weekly. Both groups received supplemental calcium and vitamin D.~Enrolled patients had bone density measurements of bilateral proximal femur, A-P lumbar spine, total body, forearm and L-P spine. All measurements were performed on a GE Lunar Bone Densitometer (iDXA) instrument. Measurements of 25-hydroxy vitamin D, NTX , serum calcium and blood chemistries occurred at scheduled intervals." (NCT00869622)
Timeframe: 2 years

,
Interventiong/cm2 (Mean)
Bilateral Proximal FemoraL1-L4 AP SpineTotal Body BMD
Placebo Sugar Pill0.9991.2451.192
Risedronate1.0251.3321.205

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"Timed Up and Go Test"

"Timed Up and Go test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score." (NCT00887354)
Timeframe: 6, 12, 18, and 26 Weeks

,
Interventionseconds (sec) (Least Squares Mean)
Week 6Week 12Week 18Week 26
Risedronate32.3824.4821.1419.91
Teriparatide26.4520.1317.7516.69

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Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale

Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous. (NCT00887354)
Timeframe: Baseline

,
Interventionpercentage of participants (Number)
0-No pain1- Pain slight or intermittent2- Pain occurs only after some activity3- Pain is tolerable4- Pain severe on attempting to walk5- Pain severe and spontaneous
Risedronate8.212.920.038.815.34.7
Teriparatide9.44.723.536.520.05.9

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Visual Analog Scale (VAS)

Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction. (NCT00887354)
Timeframe: 6, 12, 18, and 26 Weeks

,
Interventionmillimeter (mm) (Least Squares Mean)
Week 6Week 12Week 18Week 26
Risedronate23.5419.2418.1913.74
Teriparatide16.449.286.904.48

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Change in Lumbar Spine Areal Bone Mineral Density

Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No). (NCT00887354)
Timeframe: Baseline, Week 26; Baseline, Week 52

,
Interventiong/cm^2 (Least Squares Mean)
Week 26Week 52
Risedronate0.0320.044
Teriparatide0.0530.078

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Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb

"Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) .~Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use." (NCT00887354)
Timeframe: Baseline, Week 26; Baseline, Week 52; Baseline, Week 78

,
Interventiong/cm^2 (Least Squares Mean)
Total Hip 26 WeeksTotal Hip 52 WeeksTotal Hip 78 WeeksFemoral Neck 26 WeeksFemoral Neck 52 WeeksFemoral Neck 78 Weeks
Risedronate-0.001-0.0010.005-0.009-0.006-0.007
Teriparatide-0.0010.0010.0070.002-0.0000.012

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Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire

SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No). (NCT00887354)
Timeframe: Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26

,
Interventionunits on a scale (Least Squares Mean)
Week 6Week 12Week 18Week 26
Risedronate5.1011.0912.8114.36
Teriparatide7.3711.3214.3716.34

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Change in Lumbar Spine Areal Bone Mineral Density (BMD)

Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No). (NCT00887354)
Timeframe: Baseline, Week 78

Interventiongram per square centimeter (g/cm^2) (Least Squares Mean)
Teriparatide0.094
Risedronate0.055

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Total Hip BMD Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry (NCT00919711)
Timeframe: Baseline to month 12

InterventionPercent Change From Baseline (Mean)
Risedronate 150 mg QM0.5
Denosumab 60 mg Q6M2.0

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Serum CTX Percent Change From Baseline at Month 1

Serum Type-1 Collagen C-Telopeptide Percent Change From Baseline at Month 1 (NCT00919711)
Timeframe: Baseline to month 1

InterventionPercent Change From Baseline (Median)
Risedronate 150 mg QM-17.0
Denosumab 60 mg Q6M-77.7

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Lumbar Spine BMD Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry (NCT00919711)
Timeframe: Baseline to month 12

InterventionPercent Change From Baseline (Mean)
Risedronate 150 mg QM1.1
Denosumab 60 mg Q6M3.4

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Femoral Neck BMD Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry (NCT00919711)
Timeframe: Baseline to month 12

InterventionPercent Change From Baseline (Mean)
Risedronate 150 mg QM0.0
Denosumab 60 mg Q6M1.4

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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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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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Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population

Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 12 (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate1.9561
Risedronate2.2334

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Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population

Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 12 (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate-2.2999
Risedronate0.6672

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Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population

Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate-1.1148
Risedronate3.2192

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Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population

Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 12 (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate-0.2530
Risedronate3.2192

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Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population

Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 6 (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate-1.3867
Risedronate3.3871

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Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population

Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate-3.2799
Risedronate0.6672

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Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population

Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 6 (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate-1.0384
Risedronate1.4797

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Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population

Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 6 (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate6.2217
Risedronate12.7784

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Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population

Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate5.5312
Risedronate13.3472

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Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population

Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 12 (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate5.5312
Risedronate13.3472

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Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population

Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 6 (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate1.6386
Risedronate4.4060

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Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population

Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR). (NCT01249261)
Timeframe: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)

InterventionPercent Change (Mean)
Placebo/Risedronate1.4058
Risedronate2.2334

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Lateral Spine Bone Mineral Density by DXA

Lateral spine bone mineral density by dual-energy X-ray absorptiometry (NCT01406444)
Timeframe: 12 Months

Interventiong/cm2 (Least Squares Mean)
rhIGF-1 Followed by Risedronate0.695
Risedronate0.677
Placebo0.666

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Postero-anterior Spine Bone Mineral Density by DXA

Postero-anterior spine bone mineral density by dual-energy X-ray absorptiometry (NCT01406444)
Timeframe: 12 Months

Interventiong/cm2 (Least Squares Mean)
rhIGF-1 Followed by Risedronate0.891
Risedronate0.887
Placebo0.874

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Change in FN BMD at 18 Months

Change in the Femoral Neck BMD at 18 month (NCT01611571)
Timeframe: 18 months

Intervention% change in TH BMD (Mean)
Active Risedronate Active Teriparatide8.45
Active Risedronte Placebo Teriparatide0.5
Placebo Risedronate Active Teriparatide3.89

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Change in Hip Bone Density

change in hip bone density measured by DXA (NCT01611571)
Timeframe: baseline and 18 months

Intervention% change in TH BMD (Mean)
Active Risedronate Active Teriparatide3.86
Active Risedronte Placebo Teriparatide0.82
Placebo Risedronate Active Teriparatide0.29

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Change in Spine Bone Density

change in spine bone density at 18 months measured by DXA 18 and 24 months (NCT01611571)
Timeframe: 18 months

Intervention% change in LS BMD (Least Squares Mean)
Active Risedronate Active Teriparatide6.95
Active Risedronte Placebo Teriparatide3.76
Placebo Risedronate Active Teriparatide5.68

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Change in Forearm Bone Density

change in 1/3 radius of forearm bone density as measured by DXA (NCT01611571)
Timeframe: baseline and 18 months

Intervention% change in 1/3 Radius BMD (Mean)
Active Risedronate Active Teriparatide1.6
Active Risedronte Placebo Teriparatide0.11
Placebo Risedronate Active Teriparatide0.02

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New Morphometric Vertebral Fractures

counting the total new morphometric vertebral fractures as determined by x-ray from baseline through end of study (NCT01611571)
Timeframe: baseline through 18 months

Interventionvertebral fracture (Number)
Active Risedronate Active Teriparatide1
Active Risedronte Placebo Teriparatide1
Placebo Risedronate Active Teriparatide0

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The Change of Bone Mineral Density (BMD) Value

Higher Bone Mineral Density(BMD) value mean a better outcome. (NCT01675297)
Timeframe: baseline and 12 months

,
Interventiong/cm^2 (Mean)
baseline12 monthschange(12months-baseline)
Risedronate0.770.800.03
Risendronate/Cholecalciferol Combination0.770.810.04

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PTH(Parathyroid Hormone Value)

"range of PTH: 13~54 Higher PTH scores mean a worse outcome.~If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed." (NCT01675297)
Timeframe: baseline, 6months, 12months

,
Interventionpg/ml (Mean)
PTH(baseline)PTH(6months)PTH(12months)PTH change(6months-baseline)PTH change(12months-baseline)
Risedronate39.1742.4045.273.396.16
Risendronate/Cholecalciferol Combination40.4837.3439.17-2.78-1.34

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The Change of 25OHD(25-hydroxyvitamin D)

"range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.~If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed." (NCT01675297)
Timeframe: baseline, 6months, 12months

,
Interventionng/ml (Mean)
25OHD(baseline)25OHD(6months)25OHD(12months)25OHD change(6months-baseline)25OHD change(12months-baseline)
Risedronate17.8319.4718.351.680.53
Risendronate/Cholecalciferol Combination18.2328.9330.5710.7412.33

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Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)

The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United States (US) cross walk algorithm, with scores ranging from -0.11 to 1.0. A higher score indicates better health state. (NCT01709110)
Timeframe: Baseline, 24 Months

,
Interventionunits on a scale (Mean)
Baseline24 Months
Risedronate0.720.76
Teriparatide0.700.74

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Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)

The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0. A higher score indicates better health state. (NCT01709110)
Timeframe: Baseline, 24 Months

,
Interventionunits on a scale (Mean)
Baseline24 Months
Risedronate0.620.68
Teriparatide0.590.65

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Change From Baseline to 24 Months Endpoint in Height

(NCT01709110)
Timeframe: Baseline, 24 Months

,
InterventionCentimeter (cm) (Mean)
Baseline24 Months
Risedronate155.0154.5
Teriparatide154.7154.3

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Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale

Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit. An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used. (NCT01709110)
Timeframe: Baseline, 24 Months

,
Interventionunits on a scale (Mean)
Baseline24 Months
Risedronate4.53.4
Teriparatide4.53.4

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Proportion of Participants With Pooled New and Worsening Vertebral Fractures

Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as ~20 to 25% (mild), ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4). (NCT01709110)
Timeframe: Baseline through 24 Months

InterventionParticipants (with at least one event) (Number)
Teriparatide31
Risedronate69

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Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures

Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object. (NCT01709110)
Timeframe: Baseline through 24 Months

InterventionParticipants (with at least one event) (Number)
Teriparatide40
Risedronate57

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Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures

"A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture.~All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader." (NCT01709110)
Timeframe: Baseline through 24 Months

InterventionParticipants (with at least one event) (Number)
Teriparatide30
Risedronate61

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Proportion of Participants With Non-Vertebral Fragility Fractures

A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures. (NCT01709110)
Timeframe: Baseline through 24 Months

InterventionParticipants (with at least one event) (Number)
Teriparatide25
Risedronate38

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Proportion of Participants With New Vertebral Fractures

"The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation.~A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture." (NCT01709110)
Timeframe: Baseline through 24 Months

InterventionParticipants (with at least one event) (Number)
Teriparatide28
Risedronate64

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Proportion of Participants With New Multiple (2 or More) Vertebral Fractures

(NCT01709110)
Timeframe: Baseline through 24 Months

InterventionParticipants (with at least one event) (Number)
Teriparatide2
Risedronate12

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Proportion of Participants With Major Non-Vertebral Fragility Fractures

A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving. (NCT01709110)
Timeframe: Baseline through 24 Months

InterventionParticipants (with at least one event) (Number)
Teriparatide18
Risedronate31

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Proportion of Participants With New Moderate and/or Severe Vertebral Fractures

Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4). (NCT01709110)
Timeframe: Baseline through 24 Months

InterventionParticipants (with at least one event) (Number)
Teriparatide26
Risedronate63

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Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture.

Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up.To normalize for body size, FM was divided by height squared to calculate fat mass index (FMI, kg/m^2). (NCT01950169)
Timeframe: Baseline, 6 and 12 months

,,
Interventionkg/m^2 (Mean)
follow up at 6 monthsfollow up at 12 months
B, Bisphosphonate-0.6-0.3
BN/N, Bisphosphonate Along With Nutritional Supplementation0.10.1
C, Control-0.1-0.1

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Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture.

Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up. The sum of lean mass (LM) and BMC represents fat-free mass (FFM). To normalize for body size, FFM was divided by height squared to calculate fat-free mass index (FFMI, kg/m^2). (NCT01950169)
Timeframe: Baseline, 6 and 12 months

,,
Interventionkg/m^2 (Mean)
follow up at 6 monthsfollow up at 12 months
B, Bisphosphonate-0.4-0.5
BN/N, Bisphosphonate Along With Nutritional Supplementation-0.9-0.8
C, Control-0.4-0.5

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Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.

Total body mineral density (BMD) were assessed by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm^2). The change in BMD between baseline, 6 and 12 months was registered. (NCT01950169)
Timeframe: Baseline, 6 months and 12 months

,,
Interventiong/cm^2 (Mean)
follow-up at 6 monthsfollow-up at 12 months
B, Bisphosphonate-0.005-0.003
BN/N, Bisphosphonate Along With Nutritional Supplementation-0.0060.0006
C, Control-0.012-0.017

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Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.

Total hip bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm^2). The change in BMD between baseline, 6 and 12 months was registered. (NCT01950169)
Timeframe: Baseline, 6 months and 12 months

,,
Interventiong/cm^2 (Mean)
follow up at 6 monthsfollow up at 12 months
B, Bisphosphonate-0.008-0.012
BN/N, Bisphosphonate Along With Nutritional Supplementation0.005-0.004
C, Control-0.017-0.018

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Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study. (NCT02063854)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)

,,,,,,
Interventionpercent change (Mean)
Month 1 (n=199, 66, 204, 68, 65, 200, 66)Month 3 (n=193, 63, 193, 65, 60, 184, 63)Month 6 (n=188, 61, 190, 60, 58, 178, 63)Month 9 (n=185, 60, 185, 59, 55, 175, 61)Month 12 (n=181, 55, 178, 59, 54, 170, 60)End of Study (n=199, 66, 204, 68, 65, 200, 66)
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast-18.80-28.76-35.33-27.99-23.68-24.33
NE-58095 DR 25 mg Once Monthly Following Breakfast-15.53-24.80-24.39-16.75-16.42-16.27
NE-58095 DR 25 mg Once Monthly on Awakening-17.42-29.29-36.97-33.61-32.11-29.94
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast-19.34-29.94-35.13-30.97-24.62-26.28
NE-58095 DR 37.5 mg Once Monthly Following Breakfast-24.74-31.30-37.65-34.50-31.56-32.33
NE-58095 DR 37.5 mg Once Monthly on Awakening-33.52-36.36-44.28-42.94-40.00-39.58
NE-58095 IR 2.5 mg Once Daily on Awakening-41.02-47.79-52.42-52.44-48.98-47.61

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Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study. (NCT02063854)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)

,,,,,,
Interventionpercent change (Mean)
Month 1 (n=196, 66, 206, 68, 64, 200, 66)Month 3 (n=192, 63, 194, 64, 59, 184, 63)Month 6 (n=187, 61, 191, 60, 57, 178, 63)Month 9 (n=184, 61, 186, 59, 54, 175, 61)Month 12 (n=180, 55, 179, 59, 53, 170, 60)End of Study (n=198, 66, 206, 68, 64, 200, 66)
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast-9.73-34.30-39.21-36.41-31.80-30.67
NE-58095 DR 25 mg Once Monthly Following Breakfast-7.70-29.09-33.02-27.74-25.32-25.51
NE-58095 DR 25 mg Once Monthly on Awakening-9.08-32.19-39.51-34.80-35.65-32.03
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast-10.07-34.14-40.90-32.09-29.11-29.13
NE-58095 DR 37.5 mg Once Monthly Following Breakfast-9.86-36.80-42.21-38.32-31.33-31.74
NE-58095 DR 37.5 mg Once Monthly on Awakening-13.68-45.91-51.40-46.14-42.75-40.82
NE-58095 IR 2.5 mg Once Daily on Awakening-6.55-45.59-50.83-46.82-42.90-41.93

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Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit

Urine samples for urine bone turnover markers were collected at specified visits according to the study schedule. Urine samples were to be collected at about the same time of the day, as far as possible, throughout the study. Urine NTX was corrected by creatinine value. (NCT02063854)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)

,,,,,,
Interventionpercent change (Mean)
Month 1 (n=199, 66, 206, 68, 65, 200, 66)Month 3 (n=193, 63, 194, 65, 60, 184, 63)Month 6 (n=188, 61, 191, 60, 58, 178, 63)Month 9 (n=185, 61, 186, 59, 55, 175, 61)Month 12 (n=181, 55, 179, 59, 54, 170, 60)End of Study (n=199, 66, 206, 68, 65, 200, 66)
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast-17.15-20.24-19.51-19.48-24.87-23.18
NE-58095 DR 25 mg Once Monthly Following Breakfast-12.42-15.64-7.96-7.71-4.66-4.72
NE-58095 DR 25 mg Once Monthly on Awakening-11.79-22.32-29.69-17.23-27.45-25.83
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast-12.64-20.70-20.92-14.07-21.94-24.14
NE-58095 DR 37.5 mg Once Monthly Following Breakfast-16.42-22.60-20.79-15.90-17.68-21.06
NE-58095 DR 37.5 mg Once Monthly on Awakening-29.81-31.27-36.99-31.25-31.74-31.55
NE-58095 IR 2.5 mg Once Daily on Awakening-32.73-37.94-35.00-30.97-35.64-35.30

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Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit

The change in BMD in the femur (femoral neck) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray. (NCT02063854)
Timeframe: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)

,,,,,,
Interventionpercent change (Mean)
Month 6 (n=189, 62, 194, 61, 59, 180, 63)Month 12 (n=181, 58, 180, 59, 55, 172, 61)End of Study (n=189, 62, 194, 61, 59, 180, 63)
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast0.491.471.55
NE-58095 DR 25 mg Once Monthly Following Breakfast0.711.341.30
NE-58095 DR 25 mg Once Monthly on Awakening0.900.780.99
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast0.670.560.52
NE-58095 DR 37.5 mg Once Monthly Following Breakfast0.571.241.29
NE-58095 DR 37.5 mg Once Monthly on Awakening1.011.000.96
NE-58095 IR 2.5 mg Once Daily on Awakening1.072.001.96

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Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit

The change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray. (NCT02063854)
Timeframe: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)

,,,,,,
Interventionpercent change (Mean)
Month 6 (n=189, 62, 194, 61, 59, 180, 63)Month 12 (n=181, 58, 180, 59, 55, 172, 61)End of Study (n=189, 62, 194, 61, 59, 180, 63)
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast0.541.151.15
NE-58095 DR 25 mg Once Monthly Following Breakfast0.430.950.89
NE-58095 DR 25 mg Once Monthly on Awakening0.911.321.30
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast0.551.481.39
NE-58095 DR 37.5 mg Once Monthly Following Breakfast0.781.451.45
NE-58095 DR 37.5 mg Once Monthly on Awakening0.771.381.33
NE-58095 IR 2.5 mg Once Daily on Awakening1.102.011.96

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Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit

The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray. (NCT02063854)
Timeframe: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)

,,,,,,
Interventionpercent change (Mean)
Month 6 (n=189, 62, 194, 61, 59, 180, 63)Month 12 (n=181, 58, 180, 59, 55, 172, 61)End of Study (n=189, 62, 194, 61, 59, 180, 63)
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast0.801.661.64
NE-58095 DR 25 mg Once Monthly Following Breakfast0.701.361.35
NE-58095 DR 25 mg Once Monthly on Awakening1.571.801.67
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast0.531.901.85
NE-58095 DR 37.5 mg Once Monthly Following Breakfast1.091.941.94
NE-58095 DR 37.5 mg Once Monthly on Awakening1.462.472.42
NE-58095 IR 2.5 mg Once Daily on Awakening1.342.592.52

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Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit

The change in BMD in each vertebra, L2 to L4, and the averages of L2 to L4 at each visit relative to baseline. DXA is a means of measuring BMD through x-ray. (NCT02063854)
Timeframe: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)

,,,,,,
Interventionpercent change (Mean)
Month 6 (n=190, 62, 194, 61, 59, 181, 63)Month 12 (n=178, 58, 180, 58, 55, 171, 60)End of Study (n=190, 62, 194, 61, 59, 181, 63)
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast2.403.983.93
NE-58095 DR 25 mg Once Monthly Following Breakfast1.923.533.36
NE-58095 DR 25 mg Once Monthly on Awakening1.733.833.82
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast2.644.384.36
NE-58095 DR 37.5 mg Once Monthly Following Breakfast2.704.054.11
NE-58095 DR 37.5 mg Once Monthly on Awakening3.675.044.81
NE-58095 IR 2.5 mg Once Daily on Awakening3.185.005.07

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Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)

New non-traumatic vertebral fractures were identified by interpretable X-ray images of 13 vertebrae from the fourth thoracic to the fourth lumbar vertebra. A Central Review Committee member for X-ray determined the presence or absence of new vertebral fractures, the number of new fractures, the presence or absence of worsening pre-existing vertebral fractures, and the number of worsened fractures. The assessment of new vertebral fractures and the worsening of pre-existing vertebral fractures was semiquantitative. The X-ray images were visually inspected and classified into normal (Grade 0), mild deformation (Grade 1), moderate deformation (Grade 2), or severe deformation (Grade 3). If the assessment of any vertebra became worse by at least 1 grade after starting the treatment, its height was measured. A new vertebral fracture or a worsening pre-existing vertebral fracture was concluded if the vertebra's height was reduced from the baseline by at least 20% and by at least 4 mm. (NCT02063854)
Timeframe: Baseline to Month 12

,,,,,,
Interventionpercentage of participants (Number)
YesNo
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast3.296.8
NE-58095 DR 25 mg Once Monthly Following Breakfast2.197.9
NE-58095 DR 25 mg Once Monthly on Awakening3.396.7
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast1.698.4
NE-58095 DR 37.5 mg Once Monthly Following Breakfast1.198.9
NE-58095 DR 37.5 mg Once Monthly on Awakening3.496.6
NE-58095 IR 2.5 mg Once Daily on Awakening2.197.9

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Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study. (NCT02063854)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)

,,,,,,
Interventionpercent change (Mean)
Month 1 (n=199, 66, 205, 68, 65, 200, 66)Month 3 (n=193, 63, 193, 65, 60, 184, 63)Month 6 (n=188, 61, 190, 60, 58, 178, 63)Month 9 (n=185, 61, 185, 59, 55, 175, 61)Month 12 (n=181, 55, 178, 59, 54, 170, 60)End of Study (n=199, 66, 205, 68, 65, 200, 66)
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast-21.05-27.46-29.38-24.78-20.54-21.29
NE-58095 DR 25 mg Once Monthly Following Breakfast-17.49-23.85-23.87-19.44-13.25-13.86
NE-58095 DR 25 mg Once Monthly on Awakening-17.26-25.46-29.15-25.82-23.70-22.93
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast-22.06-27.13-30.67-29.71-23.21-24.46
NE-58095 DR 37.5 mg Once Monthly Following Breakfast-25.20-28.36-31.49-28.83-24.31-25.93
NE-58095 DR 37.5 mg Once Monthly on Awakening-30.75-33.70-37.16-32.78-31.03-31.97
NE-58095 IR 2.5 mg Once Daily on Awakening-32.38-37.27-39.48-37.64-34.91-34.76

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Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study

The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray. (NCT02063854)
Timeframe: Baseline and End of Study (up to Month 12)

Interventionpercent change (Mean)
NE-58095 IR 2.5 mg Once Daily on Awakening5.07
NE-58095 DR 25 mg Once Monthly Following Breakfast3.36
NE-58095 DR 37.5 mg Once Monthly Following Breakfast4.11

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Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study. (NCT02063854)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)

,,,,,,
Interventionpercent change (Mean)
Month 1 (n=199, 66, 205, 68, 65, 200, 66)Month 3 (n=193, 63, 193, 65, 60, 184, 63)Month 6 (n=188, 61, 190, 60, 58, 178, 63)Month 9 (n=185, 61, 185, 59, 55, 175, 61)Month 12 (n=181, 55, 178, 59, 54, 170, 60)End of Study (n=199, 66, 205, 68, 65, 200, 66)
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast-3.61-15.99-23.90-28.00-30.51-27.21
NE-58095 DR 25 mg Once Monthly Following Breakfast-2.61-13.31-17.93-22.48-24.91-23.11
NE-58095 DR 25 mg Once Monthly on Awakening-2.93-13.64-20.92-25.23-29.23-26.27
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast-2.44-13.83-23.80-25.84-27.74-27.08
NE-58095 DR 37.5 mg Once Monthly Following Breakfast-3.69-17.52-24.06-28.70-29.58-27.52
NE-58095 DR 37.5 mg Once Monthly on Awakening-4.16-24.85-31.06-33.15-38.06-33.94
NE-58095 IR 2.5 mg Once Daily on Awakening-3.04-21.56-28.66-32.84-34.53-33.34

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Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment

BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

InterventionPercent change (Mean)
Sodium Risedronate 75 mg4.700

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Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

InterventionPercent change (Mean)
Sodium Risedronate 75 mg-32.016

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Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

InterventionPercent change (Mean)
Sodium Risedronate 75 mg-46.302

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Change From Baseline in Height

(NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

InterventionCentimeter (Mean)
Sodium Risedronate 75 mg-0.37

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Percent Change From Baseline in Radius BMD at Final Assessment

BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the radius at end of study relative to baseline. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

InterventionPercent change (Mean)
Sodium Risedronate 75 mg1.173

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Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment

BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at end of study relative to baseline. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

InterventionPercent change (Mean)
Sodium Risedronate 75 mg1.745

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Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)

Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment. (NCT02089997)
Timeframe: Up to Month 12

InterventionParticipants (Number)
Sodium Risedronate 75 mg231

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Number of Participants Who Had Lumbar Backache at Final Assessment

(NCT02089997)
Timeframe: Final assessment (Month 12)

InterventionParticipants (Number)
Sodium Risedronate 75 mg663

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Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

InterventionPercent change (Mean)
Sodium Risedronate 75 mg-19.449

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Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

InterventionPercent change (Mean)
Sodium Risedronate 75 mg-14.024

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Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment

Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

InterventionPercent change (Mean)
Sodium Risedronate 75 mg-22.010

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Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment

BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the femur (neck region) at end of study relative to baseline. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

InterventionPercent change (Mean)
Sodium Risedronate 75 mg1.008

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Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)

(NCT02106442)
Timeframe: Baseline and final assessment (up to Month 36)

InterventionPercent Change (Mean)
Sodium Risedronate 75 mg-20.023

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Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)

BMD was measured by dual-energy X-ray absorptiometry. (NCT02106442)
Timeframe: Baseline and final assessment (up to Month 36)

InterventionPercent Change (Mean)
Sodium Risedronate 75 mg1.067

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Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)

(NCT02106442)
Timeframe: Baseline and final assessment (up to Month 36)

InterventionPercent Change (Mean)
Sodium Risedronate 75 mg-40.838

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Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)

(NCT02106442)
Timeframe: Baseline and final assessment (up to Month 36)

InterventionPercent Change (Mean)
Sodium Risedronate 75 mg-15.539

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Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)

(NCT02106442)
Timeframe: Baseline and final assessment (up to Month 36)

InterventionPercent Change (Mean)
Sodium Risedronate 75 mg-15.756

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Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)

(NCT02106442)
Timeframe: Baseline and final assessment (up to Month 36)

InterventionPercent Change (Mean)
Sodium Risedronate 75 mg-25.285

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Number of Participants Who Had One or More Adverse Drug Reactions

Adverse drug reaction refers to adverse events related to the administered drug. (NCT02106442)
Timeframe: Up to Month 36

InterventionParticipants (Count of Participants)
Sodium Risedronate 75 mg57

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Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)

BMD was measured by dual-energy X-ray absorptiometry. (NCT02106442)
Timeframe: Baseline and final assessment (up to Month 36)

InterventionPercent Change (Mean)
Sodium Risedronate 75 mg6.848

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Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)

BMD was measured by dual-energy X-ray absorptiometry. (NCT02106442)
Timeframe: Baseline and final assessment (up to Month 36)

InterventionPercent Change (Mean)
Sodium Risedronate 75 mg3.498

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Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)

BMD was measured by dual-energy X-ray absorptiometry. (NCT02106442)
Timeframe: Baseline and final assessment (up to Month 36)

InterventionPercent Change (Mean)
Sodium Risedronate 75 mg1.496

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Cumulative Percentage of Participants With Femur Fractures

The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36. (NCT02106442)
Timeframe: From baseline up to Month 36

InterventionPercentage of Participants (Number)
Month 6Month 12Month 18Month 24Month 30Month 36
Sodium Risedronate 75 mg0.190.460.781.141.141.58

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Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures

The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36. (NCT02106442)
Timeframe: From baseline up to Month 36

InterventionPercentage of Participants (Number)
Month 6Month 12Month 18Month 24Month 30Month 36
Sodium Risedronate 75 mg5.437.357.808.829.9712.58

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Cumulative Percentage of Participants With Non-Vertebral Body Fractures

The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36. (NCT02106442)
Timeframe: From baseline up to Month 36

InterventionPercentage of Participants (Number)
Month 6Month 12Month 18Month 24Month 30Month 36
Sodium Risedronate 75 mg1.722.783.404.116.156.59

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Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)

(NCT02106442)
Timeframe: Final assessment (up to Month 36)

InterventionParticipants (Count of Participants)
Sodium Risedronate 75 mg116

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Change From Baseline in Height at Final Assessment (up to Month 36)

(NCT02106442)
Timeframe: Baseline and final assessment (up to Month 36)

InterventionCentimeter (Mean)
Sodium Risedronate 75 mg-0.82

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Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point

Percentage of changes from baseline in urinary DPD level at final assessment point (up to 48 weeks) was reported. Urinary DPD is one of bone metabolism markers. (NCT02106455)
Timeframe: Baseline and final assessment point (Up to 48 weeks)

InterventionPercentage of change (Mean)
Sodium Risedronate 17.5 mg-10.01

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Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point

Percentage of changes from baseline in urinary NTX level at final assessment point (up to 48 weeks) was reported. Urinary NTX is one of bone metabolism markers. (NCT02106455)
Timeframe: Baseline and final assessment point (Up to 48 weeks)

InterventionPercentage of change (Mean)
Sodium Risedronate 17.5 mg-51.01

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Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period

"Treatment compliance of this outcome measure refers to the percentage of participants who correctly follow medication. The reported data are percentage of participants in the classification including 4 specific degrees of treatment compliance; 90 % or more; 67 % or more and <90 %; 25 % or more and <67 %; less than 25 % or unknown." (NCT02106455)
Timeframe: Up to 48 weeks

InterventionPercentage of participants (Number)
90 % or More67 % or More and <90 %25 % or More and <67 %Less than 25 %Unknown
Sodium Risedronate 17.5 mg95.112.610.650.331.30

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Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point

Percentage of changes from baseline in excess serum ALP level at final assessment point (up to 48 weeks) was reported. (NCT02106455)
Timeframe: Baseline and final assessment point (Up to 48 weeks)

InterventionPercentage of change (Mean)
Sodium Risedronate 17.5 mg-72.47

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Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point

Percentage of changes from baseline in serum ALP level at final assessment point (up to 48 weeks) was reported. (NCT02106455)
Timeframe: Baseline and final assessment point (Up to 48 weeks)

InterventionPercentage of change (Mean)
Sodium Risedronate 17.5 mg-31.71

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Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point

Percentage of changes from baseline in serum BAP level at final assessment point (up to 48 weeks) was reported. Serum BAP is one of bone metabolism markers. (NCT02106455)
Timeframe: Baseline and final assessment point (Up to 48 weeks)

InterventionPercentage of change (Mean)
Sodium Risedronate 17.5 mg-43.57

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Percentage of Participants Who Had One or More Adverse Drug Reactions

Adverse drug reaction refers to adverse events related to administered drug. (NCT02106455)
Timeframe: Up to 48 weeks

InterventionPercentage of Participants (Number)
Sodium Risedronate 17.5 mg14.98

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Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group.

Bone turnover is the process of removing old bone (resorption by osteoclasts) and replacing it with new bone (formation by osteoblasts). Menopause results in a brief period (~5 years) of accelerated turnover with resorption far exceeding formation. In this study, resorption will be measured by Serum NTx. (NCT02186600)
Timeframe: Baseline, 6, 12 months

,,
InterventionnanoMolar Bone Collagen Equivalents/L (Mean)
Baseline6 Months12 Months
Control13.9912.1612.36
Exercise15.0313.3613.92
Risedronate14.3110.3011.42

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Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group.

"Change in Bone Strength Index (BSI) of the distal tibia based on randomization to Control, Risedronate, or Exercise group.~BSI (mg2/mm4) at the 4% tibial site will be measured using peripheral quantitative computed tomography (pQCT)." (NCT02186600)
Timeframe: Baseline, 6, and 12 months

,,
Interventionmg^2/mm^4 (Mean)
Baseline6 Months12 Months
Control2098.72105.892107.2
Exercise20011987.422009.2
Risedronate1993.31997.322014.2

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Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group.

Bone mineral density is the gold standard for diagnosis of low bone mass and osteoporosis and will be measured at the spine using Dual Energy X-ray Absorptiometry (DXA). (NCT02186600)
Timeframe: Baseline,6, and 12 months

,,
Interventiong/cm^2 (Mean)
Baseline6 Months12 Months
Control0.889.8870.885
Exercise0.886.8780.885
Risedronate0.892.9070.911

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Number of Enrolled Participants That Completed All 24 Week Procedures

(NCT03411902)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Risedronate8
Placebo13

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Fat Pounds

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition (NCT03411902)
Timeframe: 24 weeks

Interventionpounds (Mean)
Risedronate45.6
Placebo40.6

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Total Change in Lumbar Spine Density

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm^2 (NCT03411902)
Timeframe: Baseline and 24 weeks

Interventiong/cm^2 (Mean)
Risedronate0.028
Placebo-0.029

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Lean Pounds

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition (NCT03411902)
Timeframe: 24 weeks

Interventionpounds (Mean)
Risedronate50.4
Placebo50.7

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Total Change in Femoral Neck Hip Density

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm^2 (NCT03411902)
Timeframe: Baseline and 24 weeks

Interventiong/cm^2 (Mean)
Risedronate-0.028
Placebo-0.047

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Trabecular Bone Score (TBS)

TBS of the lumbar spine measured by two dimensional (2D) variogram acquired through duel-energy x-ray absorptiometry (DXA). Trabecular bone score is a unitless index of bone microarchitecture. A high TBS value means that bone microarchitecture is dense and well connected, with little space between trabeculae. The following normal range for TBS values in postmenopausal women has been proposed: TBS >=1.350 is considered to be normal; TBS between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and TBS <=1.200 defines degraded microarchitecture (NCT03411902)
Timeframe: 24 weeks

Interventionscore on a scale (Mean)
Risedronate1.478
Placebo1.485

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Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density

Total change in ultradistal radius density measure in g/cm^2 (NCT03411902)
Timeframe: 24 weeks

,
Interventiong/cm^2 (Mean)
Radius 33 BMD (g/cm^2)Radius UD BMD (g/cm^2)
Placebo-0.016-0.013
Risedronate-0.0020.000

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Urine Concentration at 4 Time Points

The urine concentration of an osteoclast-specific biomarker, urinary N-telopeptide (U-NTX) indicating osteoclastic activity will be assessed prior to SBRT and at each routine follow up visit (at 3 months, 6 months, 9 months, and 12 months post SBRT). (NCT03861091)
Timeframe: At 3 months, 6 months, 9 months and 12 months post radiation

,
Interventionpg/mL (Mean)
Urinary NTX values at BLUrinary NTX values at 3moUrinary NTX values at 6moUrinary NTX values at 9moUrinary NTX values at 12mo
Matching Placebo524.9494.5350.7507.0411.7
Risedronate499.3460.2669.9536.1611.0

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4 Time Points Assessing Change in Mean Cortical Thickness of Bones

The percent change in mean C.Th of bones will be assessed in regions of bone that received 0 - 10 Gy, >10 - 20 Gy, > 20 - 30 Gy, > 30 - 40 Gy, and > 40 Gy at all time points including 3 months, 6 months, 9 months, and 12 months. (NCT03861091)
Timeframe: At baseline, 3 months, 6 months, 9 months and 12 months post radiation

,
Interventionpercent change in mm cortical thickness (Mean)
% change cort thickness in region <10 Gy--time 3mo to bl% change cort thickness in region <10 Gy--time 6mo to bl% change cort thickness in region <10 Gy--time 9mo to bl% change cort thickness in region <10 Gy--time 12mo to bl% change cort thickness in region 10-20 Gy--time 3mo to bl% change cort thickness in region 10-20 Gy--time 6mo to bl% change cort thickness in region 10-20 Gy--time 9mo to bl% change cort thickness in region 10-20 Gy--time 12mo to bl% change cort thickness in region 20-30 Gy--time 3mo to bl% change cort thickness in region 20-30 Gy--time 6mo to bl% change cort thickness in region 20-30 Gy--time 9mo to bl% change cort thickness in region 20-30 Gy--time12mo to bl% change cort thickness in region 30-40 Gy--time 3mo to bl% change cort thickness in region 30-40 Gy--time 6mo to bl% change cort thickness in region 30-40 Gy--time 9mo to bl% change cort thickness in region 30-40 Gy--time12mo to bl% change cort thickness in region >30 Gy--time 3mo to bl% change cort thickness in region >30 Gy--time 6mo to bl% change cort thickness in region >30 Gy--time 9mo to bl% change cort thickness in region >30 Gy--time 12mo to bl% change cort thickness in region >40 Gy--time 3mo to bl% change cort thickness in region >40 Gy--time 6mo to bl% change cort thickness in region >40 Gy--time 9mo to bl% change cort thickness in region >40 Gy--time 12mo to bl
Matching Placebo5.575.768.079.424.973.955.657.303.700.104.947.235.203.219.6411.777.146.1110.3211.7212.8220.3021.3717.17
Risedronate13.0410.3712.1011.589.276.247.7110.118.405.416.487.424.901.983.702.234.241.662.12-0.425.835.626.03-1.44

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Number of Participants With Rib and Vertebral Fracture

Incidence of rib and vertebral fractures (as noted on CT imaging) that occur within 12 months of irradiation and are within the within 50% isodose line. (NCT03861091)
Timeframe: At 12 months post radiation

InterventionParticipants (Count of Participants)
Risedronate15
Matching Placebo11

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Number of Participants With Chest Wall Pain

Chest wall pain incidence and grade will be collected as per modified CTCAE v. 5 within the within the 50% isodose line. Appendix K. Below we report numbers with any chest wall pain of grades 3+ over the year of followup. (NCT03861091)
Timeframe: At baseline, 3 months, 6 months, 9 months and 12 months post radiation

InterventionParticipants (Count of Participants)
Risedronate2
Matching Placebo4

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Changes in Mean Cortical Thickness

The primary outcome measure is the percent change in mean cortical thickness (C.Th) of bones receiving 30 Gy or more at 3 months post SBRT, when compared to pre-SBRT cortical thickness (NCT03861091)
Timeframe: At baseline and at 3 months post radiation

Interventionpercent change in mm cortical thickne (Mean)
Risedronate4.24
Matching Placebo7.14

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