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ibandronic acid

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Description

Ibandronic acid is a bisphosphonate medication used to treat osteoporosis, Paget's disease of bone, and hypercalcemia of malignancy. It works by inhibiting the activity of osteoclasts, the cells responsible for breaking down bone. Ibandronic acid is synthesized through a multi-step process involving the reaction of diethyl phosphite with an aromatic aldehyde followed by a series of reactions to introduce the bisphosphonate moiety. Studies have shown that ibandronic acid can effectively increase bone mineral density and reduce fracture risk in patients with osteoporosis. Its importance lies in its ability to treat bone disorders, potentially preventing fractures and improving quality of life in affected individuals. Ibandronic acid is extensively studied to investigate its efficacy and safety in different populations and for different indications, including the development of new formulations and potential use in other bone-related diseases.'

Ibandronic Acid: Aminobisphosphonate that is a potent inhibitor of BONE RESORPTION. It is used in the treatment of HYPERCALCEMIA associated with malignancy, for the prevention of fracture and bone complications in patients with breast cancer and bone metastases, and for the treatment and prevention of POSTMENOPAUSAL OSTEOPOROSIS. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID60852
CHEMBL ID997
SCHEMBL ID9183
MeSH IDM0197524

Synonyms (71)

Synonym
AC-521
AB01275485-01
gtpl3059
bondenza
114084-78-5
nsc-722623
phosphonic acid, [1-hydroxy-3-(methylpentylamino)propylidene]bis-
[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphono-propyl]phosphonic acid
bfq ,
ibandronate
[1-hydroxy-3-(methyl-pentyl-amino)-1-phosphono-propyl]-phosphonic acid
DB00710
ibandronic acid
ibandronic acid [inn:ban]
(1-hydroxy-3-(methylpentylamino)propylidene)diphosphonic acid
phosphonic acid, (1-hydroxy-3-(methylpentylamino)propylidene)bis-
bdbm12577
chembl997 ,
jmc515594 compound 53
{1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl}phosphonic acid
bisphosphonate 2
HMS2090A13
ibandronic acid sandoz
ibandronic acid accord
ibandronic acid teva
[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphonic acid
ibandronic acid (inn)
D08056
A803131
[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphono-propyl]phosphonic acid; sodium
unii-umd7g2653w
acid ibandronico
umd7g2653w ,
nsc 722623
R484 ,
FT-0602640
ibandronic acid [mart.]
ibandronic acid [inn]
ibandronic acid [ema epar]
iasibon
ibandronate [vandf]
ibandronic acid [mi]
ibandronic acid [who-dd]
AKOS015855723
BRD-K08681769-323-01-1
MPBVHIBUJCELCL-UHFFFAOYSA-N
HY-B0515A
SCHEMBL9183
(1-hydroxy-3-(methyl(pentyl)amino)propane-1,1-diyl)diphosphonic acid
DTXSID5048340 ,
J-003052
sr-05000001496
SR-05000001496-1
SR-05000001496-2
1-hydroxy-3-(methylpentylamino)propylidene bisphosphonic acid
FT-0670253
1-hydroxy-3-(methyl(pentyl)amino)propane-1,1-diyldiphosphonic acid
{1-hydroxy-3-[methyl(pentyl)amino]propane-1,1-diyl}bis(phosphonic acid)
mfcd00868772
AS-12948
BCP13798
Q166825
p,p'-[1-hydroxy-3-(methylpentylamino)propylidene]bisphosphonic acid
bph 24
EN300-304883
phosphonic acid, p,p'-[1-hydroxy-3-(methylpentylamino)propylidene]bis-
dtxcid6028315
acidum ibandronicum
m05ba06
acide ibandronique
ibandronic acid (mart.)

Research Excerpts

Overview

Ibandronic acid (Bondronat) is a potent, new-generation, nitrogen-containing bisphosphonate. It is known to cause prolongation of the QT interval due to hypocalcaemia.

ExcerptReferenceRelevance
"Ibandronic acid is a frequently used agent in the treatment of osteoporosis and is known to cause prolongation of the QT interval due to hypocalcaemia."( Ventricular tachycardia-based long QT without hypocalcaemia after use of ibandronic acid.
Alihanoglu, YI; Eryilmaz, U; Evrengul, H; Kilic, ID; Uludag, B, 2013
)
1.34
"Ibandronic acid (Bondronat) is a potent, new-generation, nitrogen-containing bisphosphonate, available in both intravenous and oral formulations, which effectively inhibits osteoclast-mediated bone resorption. "( Ibandronic acid: a review of its use in the treatment of bone metastases of breast cancer.
McCormack, PL; Plosker, GL, 2006
)
3.22
"Ibandronic acid is a single-nitrogen bisphosphonate with high efficacy against bone events and metastatic bone pain, and a renal safety profile compar- able to that of placebo."( Long-term safety of intravenous ibandronic acid for up to 4 years in metastatic breast cancer: an open-label trial.
Bergström, B; Body, JJ; Diel, I; Pecherstorfer, M; Rivkin, S, 2006
)
1.34

Effects

ExcerptReferenceRelevance
"Ibandronic acid has proven efficacy for treatment of bone metastasis secondary to breast cancer."( Apoptosis-mediated cytotoxic effects of ibandronic acid on hormone- and drug-refractory prostate cancer cells and human breast cancer cells.
Atmaca, H; Cengiz, E; Gorumlu, G; Karabulut, B; Kucukzeybek, Y; Sanli, UA; Sezgin, C; Uslu, R; Uzunoglu, S,
)
1.12

Toxicity

ExcerptReferenceRelevance
"0955 is an effective and safe way to treat cancer-associated hypercalcemia."( Methylpentylaminopropylidenebisphosphonate (BM 21.0955): a new potent and safe bisphosphonate for the treatment of cancer-associated hypercalcemia.
Clemens, MR; Ghielmini, M; Jaeger, P; Krahl, D; Manegold, C; Scharla, SH; Schöter, KH; Thiébaud, D; Wüster, C, 1993
)
0.29
" The rapid infusion over 30 minutes is safe and could be given in the setting of a day care unit."( Safety and efficacy of the new bisphosphonate ibandronate in the management of bone metastasis following rapid infusion.
Antonaki, E; Katirtzoglou, N; Michalaki, V; Mitromaras, A; Pliarchopoulou, F; Roussou, P; Syrigos, KN,
)
0.13
" Adverse events were monitored."( Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial.
Apffelstaedt, J; Bergstrom, B; Budde, M; Lazarev, A; Lichinitzer, M; MacLachlan, SA; Tripathy, D, 2004
)
0.32
" Intravenous ibandronate was well tolerated with a similar incidence of adverse events to placebo."( Efficacy and safety of ibandronate given by intravenous injection once every 3 months.
Adami, S; Christiansen, C; Coutant, K; Delmas, PD; Felsenberg, D; Lorenc, RS; Mahoney, P; Robinson, J; Schimmer, RC, 2004
)
0.32
" The nitrogen-containing bisphosphonate pamidronate was significantly more toxic on a panel of eight neuroblastoma cell lines than the non-nitrogen-containing bisphosphonates, clodronate and tiludronate."( In vitro toxicity of bisphosphonates on human neuroblastoma cell lines.
Boos, J; Lanvers-Kaminsky, C; Vorotnjak, M, 2004
)
0.32
" The safety profiles among all intravenous bisphosphonates were similar; patients treated with intravenous bisphosphonates reported notably less bone pain but a higher incidence of mild to moderate transient infusion-related adverse events (eg, nausea, vomiting, myalgia, and anorexia) compared with placebo."( Efficacy and safety of intravenous bisphosphonates for patients with breast cancer metastatic to bone: a review of randomized, double-blind, phase III trials.
Gordon, DH, 2005
)
0.33
"The incidence of adverse events in patients aged > or = 70 years receiving oral daily and intermittent ibandronate was similar and comparable to placebo."( Safety and tolerability of oral daily and intermittent ibandronate are not influenced by age.
Ettinger, MP; Felsenberg, D; Harris, ST; Hiltbrunner, V; Miller, PD; Schimmer, RC; Skag, A; Wasnich, R; Wilson, K, 2005
)
0.33
"Older patients (> or = 70 yrs) receiving oral daily and intermittent ibandronate are at no greater risk of adverse events than older patients receiving placebo."( Safety and tolerability of oral daily and intermittent ibandronate are not influenced by age.
Ettinger, MP; Felsenberg, D; Harris, ST; Hiltbrunner, V; Miller, PD; Schimmer, RC; Skag, A; Wasnich, R; Wilson, K, 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
"Despite their widespread use in metastatic bone disease, some bisphosphonate drugs are associated with adverse events (AEs), particularly renal toxicity, adding to treatment burdens and increasing healthcare costs."( Long-term safety of intravenous ibandronic acid for up to 4 years in metastatic breast cancer: an open-label trial.
Bergström, B; Body, JJ; Diel, I; Pecherstorfer, M; Rivkin, S, 2006
)
0.62
" 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
" Most adverse events were mild or moderate."( Renal safety profiles of ibandronate 6 mg infused over 15 and 60 min: a randomized, open-label study.
Angst, R; Bergstrom, B; Caspar, CB; Greil, R; Inauen, R; Pecherstorfer, M; Schmieding, K; Thürlimann, B; von Moos, R, 2008
)
0.35
" Adverse events and safety laboratory parameters were monitored continuously."( Efficacy and safety of monthly oral ibandronate in the prevention of postmenopausal bone loss.
Bolognese, MA; McClung, MR; Miller, PD; Recker, RR; Sedarati, F, 2009
)
0.35
" The total cases of unwanted effect were 21 that showed the common adverse events like other bisphosphonate."( Safety and antisorptive power of Ibandronate applied in the real-life setting.
Bunyaratavej, N; Kittimanon, N; Kitumnuoypong, T; Lektrakoon, S; Pauvilai, P; Wajanavisit, W, 2009
)
0.35
" Tolerance of the treatment, compliance and adverse effects were recorded."( Efficacy and safety of once monthly ibandronate treatment in patients with reduced bone mineral density--ESTHER study.
Buković, S; Grujić, Z; Mijailović-Ivković, M; Milić, N; Novković, S; Pasalić-Simić, K; Perunicić, G; Petrović, V; Petrović-Rackov, L; Prodanović, N; Vujasinović-Stupar, N; Vukasinović, D,
)
0.13
" The treatment was tolerated well, with no serious adverse reactions."( Efficacy and safety of once monthly ibandronate treatment in patients with reduced bone mineral density--ESTHER study.
Buković, S; Grujić, Z; Mijailović-Ivković, M; Milić, N; Novković, S; Pasalić-Simić, K; Perunicić, G; Petrović, V; Petrović-Rackov, L; Prodanović, N; Vujasinović-Stupar, N; Vukasinović, D,
)
0.13
" Most adverse events were mild to moderate in intensity."( Long-term renal safety profile of ibandronate 6 mg infused over 15 minutes.
Angst, R; Caspar, CB; Inauen, R; Schmieding, K; Steiner, R; Thürlimann, B; von Moos, R, 2010
)
0.36
" No evidence of any treatment-related deterioration in renal function was noted, and no new or unexpected adverse events occurred."( Long-term renal safety profile of ibandronate 6 mg infused over 15 minutes.
Angst, R; Caspar, CB; Inauen, R; Schmieding, K; Steiner, R; Thürlimann, B; von Moos, R, 2010
)
0.36
" Death and serious adverse event rates did not differ between groups."( Renal safety of ibandronate 6 mg infused over 15 min versus 60 min in breast cancer patients with bone metastases: a randomized open-label equivalence trial.
Abadie-Lacourtoisie, S; Dür, C; Frimat, L; Lefeuvre, C; Letessier, S; Lortholary, A; Mefti-Lacheraf, F; Morvan, P; Pivot, X; Pujade-Lauraine, E, 2011
)
0.37
" A once monthly 150 mg regimen produced greater increases in lumbar spine, total hip, femoral neck, and trochanter BMD than daily treatment, with a similar incidence of adverse events between the groups."( Efficacy and safety of monthly 150 mg oral ibandronate in women with postmenopausal osteoporosis: a systematic review and meta-analysis of randomized controlled trials.
Lee, YH; Song, GG, 2011
)
0.37
"The number of patients with adverse events was significantly higher in zoledronic acid as compared to ibandronate-treated patients, primarily because of a larger number of post-dose symptoms after bisphosphonate administrations (54."( Intravenous bisphosphonates for postmenopausal osteoporosis: safety profiles of zoledronic acid and ibandronate in clinical practice.
Kraenzlin, CA; Kraenzlin, ME; Lardelli, P; Meier, C; Sieber, P, 2013
)
0.39
" adverse effects (AE) were recorded."( Efficacy and safety of once-monthly ibandronate treatment in patients with low bone mineral density-ESTHER Study: 24 months of follow-up.
Pasalić, KS,
)
0.13
") ibandronate versus oral alendronate, (2) a correlation exists between adherence and persistence to medication and drug efficacy, and (3) any unexpected adverse events/serious adverse events (AEs/SAEs) may occur."( The non-interventional BonViva Intravenous Versus Alendronate (VIVA) study: real-world adherence and persistence to medication, efficacy, and safety, in patients with postmenopausal osteoporosis.
Amling, M; Felsenberg, D; Hadji, P; Hofbauer, LC; Kandenwein, JA; Kurth, A, 2014
)
0.4
" Eighty-four adverse events (AEs) were reported in 24 of 32 subjects receiving DP-R206, and 14 AEs were reported in 8 of 29 subjects receiving the vitamin D3 24,000-IU tablet."( Comparison of the pharmacokinetics, safety, and tolerability of vitamin D3 in DP-R206 (150-mg ibandronate/24,000-IU vitamin D3 tablet) and as monotherapy (24,000 iu) in healthy male Korean adults.
Chae, SW; Im, YJ; Jeon, JY; Jun, H; Kim, EY; Kim, MG; Kim, Y; Lee, JW; Lee, SY; Lee, TW; Park, TS, 2014
)
0.4
" However, one of their main adverse side-effects is bisphosphonate-induced nephrotoxicity."( Lack of difference in acute nephrotoxicity of intravenous bisphosphonates zoledronic acid and ibandronate in women with breast cancer and bone metastases.
Bohlmann, MK; Luedders, DW; Rody, A; Steinhoff, J; Thill, M, 2015
)
0.42
"Both applied bisphosphonates were found to be well-tolerated and safe with regard to renal toxicity during a six-month treatment period in patients with otherwise healthy kidneys having advanced breast cancer and bone metastases."( Lack of difference in acute nephrotoxicity of intravenous bisphosphonates zoledronic acid and ibandronate in women with breast cancer and bone metastases.
Bohlmann, MK; Luedders, DW; Rody, A; Steinhoff, J; Thill, M, 2015
)
0.42
"Several reports suggest that adverse events caused by ibandronate are less serious than those associated with the other bisphosphonates."( Risks of serious adverse events and kidney injury in patients treated with ibandronate: A systematic review and meta-analysis.
Kotake, K; Mitsuboshi, S, 2022
)
0.72
" The primary outcome was all serious adverse events and the secondary outcome was kidney injury."( Risks of serious adverse events and kidney injury in patients treated with ibandronate: A systematic review and meta-analysis.
Kotake, K; Mitsuboshi, S, 2022
)
0.72
" No significant difference in the rate of serious adverse events or that of kidney injury was found between ibandronate and placebo or between ibandronate and other bisphosphonates."( Risks of serious adverse events and kidney injury in patients treated with ibandronate: A systematic review and meta-analysis.
Kotake, K; Mitsuboshi, S, 2022
)
0.72
"Limited evidence was found to suggest that ibandronate may carry a lower risk of serious adverse events compared with other bisphosphonates."( Risks of serious adverse events and kidney injury in patients treated with ibandronate: A systematic review and meta-analysis.
Kotake, K; Mitsuboshi, S, 2022
)
0.72
" Secondary outcomes included alterations in serum bone turnover markers and the incidence of adverse events."( Verification of efficacy and safety of ibandronate or denosumab for postmenopausal osteoporosis after 12-month treatment with romosozumab as sequential therapy: The prospective VICTOR study.
Kobayakawa, T; Miyazaki, A; Nakamura, Y; Takahashi, J, 2022
)
0.72
"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
" Blood samples for pharmacokinetic analyses were drawn 20 min, 40 min, 60 min, 2 h, 4 h, and 6 h after the first and last administration of the study drug."( Association between pharmacokinetics of oral ibandronate and clinical response in bone mass and bone turnover in women with postmenopausal osteoporosis.
Christiansen, C; Neugebauer, G; Ravn, P, 2002
)
0.31
" 21 (1993) 457] to describe pharmacodynamic responses utilizing inhibitory or stimulatory E(max) type functions."( Explicit solutions for a class of indirect pharmacodynamic response models.
Gieschke, R; Jordan, P, 2005
)
0.33
" Ibandronate pharmacokinetic (PK) data were used to develop a PK model that could ultimately be incorporated into a PK pharmacodynamic (PD) model to assist the ibandronate development program through computer-assisted trial design."( Population pharmacokinetics of ibandronate in Caucasian and Japanese healthy males and postmenopausal females.
Barrett, J; Gieschke, R; Goggin, T; Pillai, G; Steimer, JL; Worth, E, 2006
)
0.33
" 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
"0ng/ml, allowing an appropriate evaluation of the plasma concentrations of ibandronate, expected at therapeutic dosage, as proved by application to a pharmacokinetic study."( High-throughput HPLC-MS/MS method to determine ibandronate in human plasma for pharmacokinetic applications.
Boaru, I; Gheorghe, MC; Savu, SR; Silvestro, L; Tarcomnicu, I; Tudoroniu, A, 2009
)
0.35
"This study aims to characterize the pharmacodynamic properties of denosumab, a RANK ligand inhibitor, and ibandronate, a bisphosphonate, using an integrated bone homeostasis model in postmenopausal women."( Integrated model for denosumab and ibandronate pharmacodynamics in postmenopausal women.
Mager, DE; Marathe, A; Marathe, DD, 2011
)
0.37
" Pharmacokinetic parameters were calculated, and the 90% CIs of the ratios of the geometric means of the parameters were determined from the logarithmically transformed data by using ANOVA."( Comparison of the pharmacokinetics, safety, and tolerability of vitamin D3 in DP-R206 (150-mg ibandronate/24,000-IU vitamin D3 tablet) and as monotherapy (24,000 iu) in healthy male Korean adults.
Chae, SW; Im, YJ; Jeon, JY; Jun, H; Kim, EY; Kim, MG; Kim, Y; Lee, JW; Lee, SY; Lee, TW; Park, TS, 2014
)
0.4
" To establish the optimal dose for oral administration of ibandronate in Japanese osteoporotic patients, we investigated the pharmacokinetics of and pharmacodynamic response to ibandronate following oral and intravenous administrations to Japanese subjects."( The optimal oral dose selection of ibandronate in Japanese patients with osteoporosis based on pharmacokinetic and pharmacodynamic properties.
Hashimoto, J; Iida, S; Kawanishi, T; Nakai, K; Tobinai, M, 2016
)
0.43

Compound-Compound Interactions

ExcerptReferenceRelevance
" Bisphosphonates are powerful inhibitors of osteoclast activity, and are therefore used in combination with standard chemotherapy or hormonal therapy for the treatment of cancer-associated osteolytic metastases."( Additive antitumor activities of taxoids in combination with the bisphosphonate ibandronate against invasion and adhesion of human breast carcinoma cells to bone.
Boissier, S; Clezardin, P; Delmas, PD; Magnetto, S, 1999
)
0.3
" The aim of this study was to investigate the effect of the IBN/SNAC formulation on the steady-state pharmacokinetics of metformin (CAS 657-24-9) and to assess safety and tolerability of IBN/SNAC when dosed in combination with metformin."( Drug-drug interaction study between a novel oral ibandronate formulation and metformin.
Bittner, B; Jordan, P; McIntyre, C; Schmidt, J, 2011
)
0.37
"We present clinical and radiologic data of periodontal tissue involvement preceding the appearance of osteonecrosis of the jaw (ONJ) in 5 patients with solid tumors, who received antiresorptives alone or in combination with targeted therapies."( Periodontal disease preceding osteonecrosis of the jaw (ONJ) in cancer patients receiving antiresorptives alone or combined with targeted therapies: report of 5 cases and literature review.
Galiti, D; Galitis, E; Karampeazis, A; Labropoulos, S; Migliorati, C; Nicolatou-Galitis, O; Razis, E; Sgouros, J; Tsimpidakis, A, 2015
)
0.42
"Clinical and radiologic signs of periodontal tissue involvement, before dental extraction in patients treated with antiresorptives alone or in combination with targeted therapy, may represent developing osteonecrosis."( Periodontal disease preceding osteonecrosis of the jaw (ONJ) in cancer patients receiving antiresorptives alone or combined with targeted therapies: report of 5 cases and literature review.
Galiti, D; Galitis, E; Karampeazis, A; Labropoulos, S; Migliorati, C; Nicolatou-Galitis, O; Razis, E; Sgouros, J; Tsimpidakis, A, 2015
)
0.42

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
"Oral bisphosphonates are well established for the treatment and prevention of postmenopausal osteoporosis; however, they are poorly absorbed from the gastrointestinal (GI) tract and have been associated with GI adverse events."( Effect of daily and intermittent use of ibandronate on bone mass and bone turnover in postmenopausal osteoporosis: a review of three phase II studies.
Bauss, F; Schimmer, RC, 2003
)
0.32
") therapy may have advantages, including lack of gastrointestinal AEs, improved bioavailability and increased compliance."( Three-monthly ibandronate bolus injection offers favourable tolerability and sustained efficacy advantage over two years in established corticosteroid-induced osteoporosis.
Dorst, A; Faber, H; Ibach, K; Preuss, J; Ringe, JD, 2003
)
0.32
" Oral ibandronate is rapidly absorbed (t(max) < 1 hour), with a low bioavailability (0."( Ibandronate: a clinical pharmacological and pharmacokinetic update.
Barrett, J; Bauss, F; Epstein, S; Worth, E, 2004
)
0.32
" The purpose of this study was to investigate the local bioavailability and the distribution of ibandronate in the infarcted head at the avascular and vascular phases of the disease process."( Local bioavailability and distribution of systemically (parenterally) administered ibandronate in the infarcted femoral head.
Athavale, S; Bauss, F; Bian, H; Kim, HK; Sanders, M, 2006
)
0.33
"Individual patient data from the intent-to-treat populations of the BONE, IV fracture prevention, MOBILE, and DIVA studies were grouped into three dose levels based on annual cumulative exposure (ACE), defined as the annual dose (mg) x bioavailability (0."( Ibandronate and the risk of non-vertebral and clinical fractures in women with postmenopausal osteoporosis: results of a meta-analysis of phase III studies.
Blumentals, WA; Harris, ST; Miller, PD, 2008
)
0.35
"The novel excipient, sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC, CAS 203787-91-1) increases the oral bioavailability of co-formulated ibandronate (IBN, CAS 138926-19)."( Drug-drug interaction study between a novel oral ibandronate formulation and metformin.
Bittner, B; Jordan, P; McIntyre, C; Schmidt, J, 2011
)
0.37
" In four cohorts of 28, 21, 19 and 29 healthy volunteers, the impact of the carrier molecule sodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC, CAS number: 203787-91-1) on the bioavailability of IBN was investigated."( Phase I clinical study to select a novel oral formulation for ibandronate containing the excipient sodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC).
Ahmed, H; Bittner, B; Chokshi, H; Fotaki, N; Infeld, M; Jordan, P; Ma, H; McIntyre, C; Phuapradit, W; Portron, A; Schmidt, J; Shah, N; Tang, K; Tian, H, 2012
)
0.38
" This study was conducted to investigate whether N(α)-deoxycholyl-L-lysyl-methylester (DCK), an absorption enhancer derived from deoxycholic acid, can increase the oral bioavailability of ibandronate."( Enhanced oral absorption of ibandronate via complex formation with bile acid derivative.
Byun, Y; Hwang, SR; Jeon, OC; Moon, HT; Park, JW, 2013
)
0.39
" This study suggests that the lower incidence of BP-ONJ in alendronate treatment is not originated by its potency, but might be due to the low bioavailability of alendronate, lower dosing on a daily basis, and having no additional therapies."( Effects of an oral bisphosphonate and three intravenous bisphosphonates on several cell types in vitro.
Al-Nawas, B; Jung, J; Kwon, YD; Pabst, AM; Park, JS; Righesso, L; Walter, C, 2018
)
0.48
"48-fold higher bioavailability of ibandronate in Taiwanese postmenopausal women."( Racial difference in bioavailability of oral ibandronate between Caucasian and Taiwanese postmenopausal women.
Chiu, WY; Lin, CJ; Reginster, JY; Tsai, KS; Yang, WS, 2020
)
0.56
" These results suggested a larger bioavailability in the Taiwanese group which resulted in the differences in the CL/F and Vd/F."( Racial difference in bioavailability of oral ibandronate between Caucasian and Taiwanese postmenopausal women.
Chiu, WY; Lin, CJ; Reginster, JY; Tsai, KS; Yang, WS, 2020
)
0.56

Dosage Studied

ExcerptRelevanceReference
" The dose-response data of the first year have been published previously (Ravn et al."( Changes in biochemical markers and bone mass after withdrawal of ibandronate treatment: prediction of bone mass changes during treatment.
Baumann, M; Christensen, JO; Clemmesen, B; Ravn, P, 1998
)
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
"The objective of this study was to compare efficacy and safety of continuous versus intermittent oral dosing of ibandronate."( Ibandronate: a comparison of oral daily dosing versus intermittent dosing in postmenopausal osteoporosis.
Bagger, Y; Christiansen, C; Ise, J; Riis, BJ; von Stein, T, 2001
)
0.31
"There were no differences between the various regimens, suggesting that it is the total dose of ibandronate rather than the treatment schedule that is important for efficacy, at least within the tested dosing intervals."( Total administered dose of ibandronate determines its effects on bone mass and architecture in ovariectomized aged rats.
Bauss, F; Hothorn, LH; Wagner, M, 2002
)
0.31
" Thus, current dosing guidelines recommend that the patient not eat or lie down for at least 30 minutes after taking oral bisphosphonates, a requirement that is inconvenient and may be associated with reduced compliance."( Effect of daily and intermittent use of ibandronate on bone mass and bone turnover in postmenopausal osteoporosis: a review of three phase II studies.
Bauss, F; Schimmer, RC, 2003
)
0.32
"Since effective prevention and treatment of osteoporosis demands a high degree of long-term compliance, optimization of the dosing regimen in terms of efficacy and convenience of drug intake is a critical issue of oral bisphosphonate treatment."( The efficacy of 48-week oral ibandronate treatment in postmenopausal osteoporosis when taken 30 versus 60 minutes before breakfast.
Christiansen, C; Mahoney, P; McClung, MR; Schimmer, RC; Tankó, LB, 2003
)
0.32
"The aims of the present study were to investigate how changes in the cumulative dose and the frequency of dosing influence the short-term antiresorptive efficacy of oral ibandronate treatment and whether serial measurements of bone markers could provide a useful diagnostic tool for the revelation of noncompliance to established treatments with antiresorptive drugs."( Oral ibandronate: changes in markers of bone turnover during adequately dosed continuous and weekly therapy and during different suboptimally dosed treatment regimens.
Baumann, M; Christgau, S; Christiansen, C; Hoyle, N; Lehmann, HJ; Moelgaard, A; Mouritzen, U; Qvist, P; Tankó, LB; Warming, L; Wieczorek, L, 2003
)
0.32
" However, the least significant change (LSC) analysis performed at the individual level highlighted individuals who at certain time points showed apparently greater suppression of formation than resorption, which could also contribute to the inefficacy of this dosing regime."( Dose dependent effects on bone resorption and formation of intermittently administered intravenous ibandronate.
Baumann, M; Christgau, S; Christiansen, C; Hoyle, N; Moelgaard, A; Qvist, P; Tankó, LB; Warming, L; Wieczorek, L, 2003
)
0.32
" Ibandronate is a highly potent nitrogen-containing bisphosphonate that has been given orally or intravenously at variable dosing intervals for the prevention and treatment of osteoporosis."( Ibandronate: a potent new bisphosphonate in the management of postmenopausal osteoporosis.
Papapoulos, SE, 2003
)
0.32
"To investigate the efficacy, safety, and dose-response of once-weekly oral ibandronate in the prevention of postmenopausal bone loss."( Oral weekly ibandronate prevents bone loss in postmenopausal women.
Burdeska, A; Christiansen, C; Czerwiński, E; Felsenberg, D; Hughes, C; Jonkanski, I; Tankó, LB, 2003
)
0.32
" Dosing at 3-month intervals is appropriate; further studies will have to demonstrate the efficacy of annual dosing."( Bisphosphonates in the management of metastatic prostate cancer.
Heidenreich, A, 2003
)
0.32
" In rats, a single dose and intermittent dosing of ibandronate resulted in a similar incidence (one of six and two of six rats, respectively) and severity score (1."( The renal effects of minimally nephrotoxic doses of ibandronate and zoledronate following single and intermittent intravenous administration in rats.
Atzpodien, E; Bauss, F; Pfister, T, 2003
)
0.32
" Less frequent dosing regimens are likely to improve patient adherence and thus, potentially, patient outcomes."( Efficacy and safety of oral weekly ibandronate in the treatment of postmenopausal osteoporosis.
Bianchi, G; Cooper, C; Emkey, RD; Hawker, G; McDonald, RH; Schimmer, RC; Wilson, K, 2003
)
0.32
" However, current oral bisphosphonates, which are given either daily or weekly, are associated with stringent, inconvenient dosing guidelines."( Intermittent intravenous ibandronate injections reduce vertebral fracture risk in corticosteroid-induced osteoporosis: results from a long-term comparative study.
Dorst, A; Faber, H; Ibach, K; Ringe, JD; Sorenson, F, 2003
)
0.32
" The effect of intravenous infusions of bisphosphonates are, to a large extent, similar to equivalent intramuscular administrations, but doses and dosing intervals represent the critical issues."( Injectable bisphosphonates in the treatment of postmenopausal osteoporosis.
Adami, S; Crepaldi, G; Filipponi, P; Sartori, L, 2003
)
0.32
" Bisphosphonate dosing by intravenous injection could provide a convenient alternative to intravenous infusion that would be suitable for use in the primary care setting and would avoid many of the complications associated with prolonged infusions."( Ibandronate: new options in the treatment of osteoporosis.
Adami, S; Viapiana, O, 2003
)
0.32
" bisphosphonates, good tolerability and dosing convenience."( Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies.
Bell, R; Bergstrom, B; Body, JJ; Diel, IJ; Lazarev, A; Lichinitzer, M; Pecherstorfer, M; Tripathy, D, 2004
)
0.32
" Alternative, simplified dosing regimens that improve tolerability and promote convenience may be advantageous."( Efficacy and safety of ibandronate given by intravenous injection once every 3 months.
Adami, S; Christiansen, C; Coutant, K; Delmas, PD; Felsenberg, D; Lorenc, RS; Mahoney, P; Robinson, J; Schimmer, RC, 2004
)
0.32
"Less frequent bisphosphonate dosing in women with postmenopausal osteoporosis has the potential to promote therapy adherence through improved convenience."( Insufficiently dosed intravenous ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis.
Chesnut, CH; Christiansen, C; Delmas, PD; Ettinger, M; Hoiseth, A; Mahoney, P; Recker, R; Schimmer, RC; Skag, A; Stakkestad, JA, 2004
)
0.32
" The mechanisms underlying the remarkable efficacy of intermittent bisphosphonate dosing are not fully understood and further research is needed."( Ibandronate in osteoporosis: preclinical data and rationale for intermittent dosing.
Bauss, F; Russell, RG, 2004
)
0.32
" However, they are currently associated with stringent dosing instructions that may impair patient compliance and hence therapeutic efficacy."( Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis.
Chesnut, CH; Christiansen, C; Delmas, PD; Felsenberg, D; Gilbride, J; Hoiseth, A; Huss, H; Recker, R; Schimmer, RC; Skag, A; Stakkestad, JA, 2004
)
0.32
" This dosing schedule is equivalent to a 3-monthly dosing regimen in human subjects over 4 years."( Intermittent ibandronate preserves bone quality and bone strength in the lumbar spine after 16 months of treatment in the ovariectomized cynomolgus monkey.
Bauss, F; Hannan, M; Müller, R; Smith, SY, 2004
)
0.32
" a dose-response model as opposed to a dose-concentration-response model)."( A semimechanistic and mechanistic population PK-PD model for biomarker response to ibandronate, a new bisphosphonate for the treatment of osteoporosis.
Gieschke, R; Goggin, T; Jacqmin, P; Pillai, G; Schimmer, RC; Steimer, JL, 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
"BONE (oral iBandronate Osteoporosis vertebral fracture trial in North America and Europe) determined whether less frequent dosing of ibandronate (dose-free interval > 2 months) provided similar antifracture efficacy to daily dosing."( Ibandronate produces significant, similar antifracture efficacy in North American and European women: new clinical findings from BONE.
Baylink, DJ; Chesnut, CH; Emkey, R; Ettinger, MP; Harris, ST; Miller, PD; Recker, RR; Schimmer, RC; Wasnich, RD; Watts, NB, 2005
)
0.33
" However, the inconvenience of frequent dosing is known to negatively affect adherence to therapy in the long term."( A new concept for bisphosphonate therapy: a rationale for the development of monthly oral dosing of ibandronate.
Adami, S; Bolognese, MA; Bonvoisin, B; Civitelli, R; Cooper, C; Delmas, PD; Dumont, E; Felsenberg, D; Kendler, DL; McClung, MR; Miller, PD; Recker, RR; Reginster, JY; Stakkestad, JA, 2006
)
0.33
" Analysis of the area under the effect curve (d 1-91) for change from baseline (percent x days) in serum CTX and urinary CTX indicated a dose-response relationship."( Monthly oral ibandronate is well tolerated and efficacious in postmenopausal women: results from the monthly oral pilot study.
Barrett, J; Bonvoisin, B; Dumont, E; Reginster, JY; Wilson, KM, 2005
)
0.33
" Although yet to be prospectively shown in osteoporosis, evidence from randomized clinical trials in several other chronic conditions shows that reducing dosing frequency enhances therapeutic adherence."( Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study.
Bolognese, MA; Bonvoisin, B; Cooper, C; Delmas, PD; Felsenberg, D; Hughes, C; Kendler, DL; Lewiecki, EM; Luckey, M; Macovei, L; Mairon, N; McClung, MR; Miller, PD; Recker, RR; Reginster, JY; Stakkestad, JA, 2005
)
0.33
" Although weekly rather than daily dosing of bisphosphonates has improved adherence, there remains a significant problem, and dosing less frequently than weekly has been suggested as a possible means for further improving adherence."( Biological properties and mechanism of action of ibandronate: application to the treatment of osteoporosis.
Epstein, S; Zaidi, M, 2005
)
0.33
" In other disease areas, reduced dosing frequency has been shown to improve therapeutic adherence."( Oral ibandronate: a less frequently administered therapeutic option for postmenopausal osteoporosis.
Reginster, JY, 2005
)
0.33
" No withdrawal of bisphosphonates was performed in view of the information on the direct correlation of total dosage and duration of drug intake to systemic incorporation and the long time for drug release."( Does avascular necrosis of the jaws in cancer patients only occur following treatment with bisphosphonates?
Fietkau, R; Gundlach, KK; Lenz, JH; Mueller, PC; Schmidt, W; Steiner-Krammer, B, 2005
)
0.33
" Phase II, open-label studies show that intensive ibandronate dosing does not compromise renal safety in patients with metastatic bone pain from a variety of tumor types."( Renal safety of ibandronate.
Jackson, GH, 2005
)
0.33
" Current oral bisphosphonates are effective and generally well tolerated, but are hampered by strict dosing requirements."( Oral and intravenous ibandronate in the management of postmenopausal osteoporosis: a comprehensive review.
Reginster, JY, 2005
)
0.33
"Reducing bisphosphonate dosing frequency may improve suboptimal adherence to treatment and therefore therapeutic outcomes in postmenopausal osteoporosis."( Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study.
Adami, S; Bonvoisin, B; Christiansen, C; Cooper, C; Delmas, PD; Drezner, MK; Emkey, R; Felsenberg, D; Greenwald, M; Lakatos, P; Mairon, N; Miller, PD; Reginster, JY; Rowell, L; Silverman, SL; Stepan, JJ, 2006
)
0.33
"To confirm the 1 year results and provide more extensive safety and tolerability information for once-monthly dosing by a 2 year analysis."( Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study.
Adami, S; Bonvoisin, B; Christiansen, C; Cooper, C; Delmas, PD; Drezner, MK; Emkey, R; Felsenberg, D; Greenwald, M; Lakatos, P; Mairon, N; Miller, PD; Reginster, JY; Rowell, L; Silverman, SL; Stepan, JJ, 2006
)
0.33
" After repeated dosing ibandronate bone-uptake remained stable and was independent of osteoclast activity or PTH levels."( High bone-binding capacity of ibandronate in hemodialysis patients.
Bals, G; Bergner, R; Henrich, D; Hoffmann, M; Lenz, T; Ullmann, M; Uppenkamp, M, 2005
)
0.33
" However, they are associated with stringent dosing procedures, and some patients may experience upper gastrointestinal side-effects following administration."( Adherence, patient preference and dosing frequency: understanding the relationship.
Neuprez, A; Rabenda, V; Reginster, JY, 2006
)
0.33
" Bisphosphonate regimens with dosing intervals beyond a week have therefore been developed to address this issue."( Beyond daily dosing: clinical experience.
Cooper, C, 2006
)
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
" Initial clinical trials explored the optimal dosing regimens for oral administration in humans."( Ibandronate treatment for osteoporosis: rationale, preclinical, and clinical development of extended dosing regimens.
Epstein, S, 2006
)
0.33
" In ovariectomized (OVX) rats, intermittent (dosing interval 2, 4, and 6 weeks) and continuous ibandronate regimens provided equivalent results per total dose irrespective of the dosing regimen."( Ibandronate: pharmacology and preclinical studies.
Russell, RG, 2006
)
0.33
"To improve upon the currently suboptimal level of therapeutic adherence with bisphosphonates in postmenopausal osteoporosis, there is a need to examine less-frequently dosed regimens that offer patients greater convenience than weekly dosing."( Once-monthly dosing: an effective step forward.
Reid, DM, 2006
)
0.33
" The experimental intravenous dosage is 2 mg every 3 months for treatment or prevention of osteoporosis, and 2-6 mg every 3-4 weeks or in a single dose for treatment of bone metastases or hypercalcemia of malignancy, respectively."( Ibandronate, an experimental intravenous bisphosphonate for osteoporosis, bone metastases, and hypercalcemia of malignancy.
Guay, DR, 2006
)
0.33
"Although oral bisphosphonates are effective treatments for postmenopausal women with osteoporosis, oral dosing may be unsuitable for some patients."( Intravenous ibandronate injections in postmenopausal women with osteoporosis: one-year results from the dosing intravenous administration study.
Adami, S; Bolognese, M; Christiansen, C; Civitelli, R; Delmas, PD; Drezner, MK; Felsenberg, D; Hughes, C; Masanauskaite, D; Recker, RR; Reginster, JY; Reid, DM; Sambrook, P; Stakkestad, JA; Strugala, C; Ward, P, 2006
)
0.33
" A good way to reduce the risk of osteoporotic fractures is through development of equally efficacious formulations with more convenient dosing regimens."( Ibandronate: the evolution of a once-a-month oral therapy for postmenopausal osteoporosis.
Bolognese, MA; Dempster, DW,
)
0.13
" In March 2005, the FDA approved once-monthly dosing with ibandronate for the same indications."( Once-monthly ibandronate for postmenopausal osteoporosis: review of a new dosing regimen.
Pyon, EY, 2006
)
0.33
" Problems with adherence are thought to be linked to several factors, including frequency of dosing and bisphosphonate-associated intolerability."( Less frequent dosing of bisphosphonates in osteoporosis: focus on ibandronate.
Burke, MS; Simonelli, C, 2006
)
0.33
" The molecular characteristics of ibandronate that support extended dosing are described, and trial outcomes for oral and intravenous ibandronate are summarized, in the context of other available bisphosphonates, based on the results of a search of MEDLINE publications (January 1975-December 2005)."( Less frequent dosing of bisphosphonates in osteoporosis: focus on ibandronate.
Burke, MS; Simonelli, C, 2006
)
0.33
" Recent reports have suggested simplifying the dosage regimen as a strategy to help address this issue."( Treating osteoporosis with bisphosphonates and addressing adherence: a review of oral ibandronate.
Chesnut, CH, 2006
)
0.33
"" This dosing regimen has allowed rapid and effective relief of MBP without the unwanted side effects associated with opioids and other analgesics."( Ibandronate: its role in metastatic breast cancer.
Cameron, D; Diel, I; Fallon, M, 2006
)
0.33
" This review describes the preclinical evidence for the preservation of bone quality with ibandronate, irrespective of the dosing regimen and even when administered at doses higher than those used therapeutically."( Effects of ibandronate on bone quality: preclinical studies.
Bauss, F; Dempster, DW, 2007
)
0.34
") dosing regimens."( Clinical utility of a pharmacostatistical model for ibandronate in postmenopausal osteoporosis.
Gieschke, R; Reginster, JY, 2006
)
0.33
" The current study is designed to investigate anti-tumour effects of OPG and ibandronate (IBN), dosed alone or in combination, on tumour growth to determine if there is experimental support for combination treatments and to provide evidence for the presence of direct anti-tumour effects."( Inhibition of bone resorption, rather than direct cytotoxicity, mediates the anti-tumour actions of ibandronate and osteoprotegerin in a murine model of breast cancer bone metastasis.
Blair, JM; Brennan, K; Dunstan, CR; Modzelewski, JR; Seibel, MJ; Zheng, Y; Zhou, H, 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
") injection in regimens with extended dosing intervals; unlike in Caucasian women, the efficacy and safety of this formulation is yet to be fully explored in Japanese with osteoporosis."( [Therapeutic agents for disorders of bone and calcium metabolism: Ibandronate].
Hashimoto, J, 2007
)
0.34
"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
" Antifracture efficacy has been demonstrated for at least three nitrogen-containing bisphosphonates in oral formulations that are designed to be administered in weekly or monthly dosing regimens."( Use of intravenous bisphosphonates in osteoporosis.
Armamento-Villareal, R; Civitelli, R; Napoli, N, 2007
)
0.34
"New therapies will not only have to demonstrate safety and efficacy, but also provide some advantage to patient persistence through either less frequent dosing schedules or elimination of gastrointestinal disturbances, the most common adverse effects encountered with bisphosphonates."( New and emerging treatments for osteoporosis.
Maricic, M, 2007
)
0.34
" In addition, the benefit of metabonomics as an open approach as compared to targeted methods was demonstrated by the identification of an unknown molecule in the urine of rats dosed with zoledronate."( Application of metabonomics in a comparative profiling study reveals N-acetylfelinine excretion as a biomarker for inhibition of the farnesyl pathway by bisphosphonates.
Binder, M; Dieterle, F; Ross, A; Schlotterbeck, G; Senn, H; Suter, L, 2007
)
0.34
" 10 years), dosing frequency (monthly vs."( Osteoporosis medication profile preference: results from the PREFER-US study.
McHorney, CA; Weiss, TW, 2007
)
0.34
" Effectiveness was ranked as the most important determinant of preference (79% ranked it #1) compared with time on market (14%), dosing procedure (4%) and dosing frequency (3%)."( Osteoporosis medication profile preference: results from the PREFER-US study.
McHorney, CA; Weiss, TW, 2007
)
0.34
" Drug effectiveness was the most important determinant of preference, while dosing frequency was the least important determinant."( Osteoporosis medication profile preference: results from the PREFER-US study.
McHorney, CA; Weiss, TW, 2007
)
0.34
" Less-frequently administered dosage regimens or nonoral routes may enhance compliance and so maximize the therapeutic benefit of bisphosphonates."( Quarterly intravenous injection of ibandronate to treat osteoporosis in postmenopausal women.
Sambrook, P, 2007
)
0.34
"While initial preclinical studies provide an important starting point for dose selection, they may not provide adequate information to identify the optimal dosage for an extended treatment regimen."( Progression of efficacy with ibandronate: a paradigm for the development of new bisphosphonates.
Chesnut, CH; Epstein, S; Harris, ST; Kohles, JD; Zaidi, M, 2007
)
0.34
" It allows for intermittent dosage in 1-month (oral form) or 3-month (intravenous form) intervals, whilst the high efficiency of treatment and good safety profile are preserved."( [The benefit from ibandronate in the treatment of postmenopausal osteoporosis].
Málek, Z, 2007
)
0.34
" The Dosing IntraVenous Administration (DIVA) study was designed to identify the optimal ibandronate IV injection schedule for the treatment of postmenopausal osteoporosis by comparing the efficacy and tolerability of 2- and 3-monthly injections with the previously evaluated daily oral ibandronate regimen."( Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-year results from the DIVA study.
Adami, S; Civitelli, R; Czerwinski, E; Delmas, PD; Eisman, JA; Felsenberg, D; Hughes, C; Mairon, N; Masanauskaite, D; Prince, R; Recker, RR; Recknor, C; Reginster, JY; Reid, DM; Zaidi, M, 2008
)
0.35
" Recent randomised controlled trial evidence suggests that intermittent high dosage oral ibandronate may be as efficacious as a daily low dose regime for the treatment of post-menopausal osteoporosis, with only a mild increase in adverse events."( Ibandronate in benign bone disease.
Jones, G; Winzenberg, T, 2008
)
0.35
"Gastrointestinal (GI) symptoms and high dosing frequency have been cited as reasons for inadequate adherence to daily or weekly oral bisphosphonate therapy."( Adherence to and gastrointestinal tolerability of monthly oral or quarterly intravenous ibandronate therapy in women with previous intolerance to oral bisphosphonates: a 12-month, open-label, prospective evaluation.
Babbitt, AM; Bone, HG; Lewiecki, EM; Ozturk, ZE; Piziak, VK, 2008
)
0.35
" Both dosing regimens were generally well tolerated."( Adherence to and gastrointestinal tolerability of monthly oral or quarterly intravenous ibandronate therapy in women with previous intolerance to oral bisphosphonates: a 12-month, open-label, prospective evaluation.
Babbitt, AM; Bone, HG; Lewiecki, EM; Ozturk, ZE; Piziak, VK, 2008
)
0.35
" There was a dose-response trend with increasing ACE doses (7."( Ibandronate for the prevention of nonvertebral fractures: a pooled analysis of individual patient data.
Adachi, JD; Adami, S; Cooper, C; Cranney, A; Delmas, PD; Miller, PD; Papapoulos, S; Reginster, JY; Sambrook, PN; Silverman, S; Siris, E; Wells, GA; Yetisir, E, 2009
)
0.35
"A dose-response effect on nonvertebral fractures was observed when comparing high with low ACE doses."( Ibandronate for the prevention of nonvertebral fractures: a pooled analysis of individual patient data.
Adachi, JD; Adami, S; Cooper, C; Cranney, A; Delmas, PD; Miller, PD; Papapoulos, S; Reginster, JY; Sambrook, PN; Silverman, S; Siris, E; Wells, GA; Yetisir, E, 2009
)
0.35
"0% of patients thought that monthly dosing was more convenient."( Preference for weekly and monthly bisphosphonates among patients with postmenopausal osteoporosis: results from the Croatian PROMO Study.
Altabas, V; Crncevic Orlic, Z; Kastelan, D; Kolak, Z; Korsic, M; Lozo, P; Milas Ahic, J; Miskic, B; Stamenkovic, D; Vlak, T, 2009
)
0.35
" Oral bisphosphonate treatment requires stringent dosing guidelines to minimize gastrointestinal irritation and enhance absorption."( Quarterly intravenous ibandronate for postmenopausal osteoporosis.
Emkey, RD, 2008
)
0.35
" The once-monthly oral and quarterly intravenous dosage regimens have the potential to improve treatment adherence and persistence, and hence clinical outcomes, compared with more frequently administered oral bisphosphonates."( Ibandronate: a review of its use in the management of postmenopausal osteoporosis.
Frampton, JE; Perry, CM, 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
" The availability of a well-tolerated, effective, IV bisphosphonate regimen for postmenopausal osteoporosis would increase physicians' options, allowing treatment of patients who cannot tolerate oral therapy, for whom oral bisphosphonates should be avoided or patients who are unable to comply with the oral dosing recommendations."( Renal tolerability of intermittent intravenous ibandronate treatment for patients with postmenopausal osteoporosis: a review.
Body, JJ; Leigh, C; Miller, PD; Pfister, T; Ward, P,
)
0.13
" Longer dosing intervals stimulate patient compliance, and consequently increase efficacy and cost effectiveness."( [Ibandronate in the treatment of postmenopausal osteoporosis].
Lakatos, P, 2008
)
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
" They have been shown to inhibit proliferation, induce apoptosis and decrease capillary-like tube formation, but often the in vitro concentrations and dosing schedules used do not reflect drug pharmacokinetics or clinical dosing regimens."( Metronomic administration of ibandronate and its anti-angiogenic effects in vitro.
Jeremiah, S; Morgan, C; Wagstaff, J, 2009
)
0.35
"Human umbilical vein endothelial cells were exposed to physiologically relevant doses of the bisphosphonate ibandronate, mimicking the clinical administration of oral ibandronate (1 h daily dosing over 8 days at concentrations ranging from 1-10 microM)."( Metronomic administration of ibandronate and its anti-angiogenic effects in vitro.
Jeremiah, S; Morgan, C; Wagstaff, J, 2009
)
0.35
" The Dosing Intravenous Administration (DIVA) study demonstrated evidence for the high efficacy and good tolerability of intravenous ibandronate delivered by quarterly injections."( Ibandronate: a review of its vertebral and nonvertebral antifracture efficacy.
Amling, M; Kurth, A, 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
"Data from two open-label trials (PRIOR and CURRENT) of women with postmenopausal osteoporosis or osteopenia were evaluated to assess whether monthly oral and quarterly intravenous (IV) ibandronate dosing improved self-reported gastrointestinal (GI) tolerability for patients who had previously experienced GI irritation with bisphosphonate (BP) use."( Gastrointestinal tolerability with ibandronate after previous weekly bisphosphonate treatment.
Babbitt, A; Derman, R; Kohles, JD, 2009
)
0.35
"In the Dosing IntraVenous Administration (DIVA) study, IV ibandronate injections (15-30 s duration) provided significantly greater gains in bone mineral density than daily oral ibandronate (P<0."( Effects of intermittent intravenous ibandronate injections on bone quality and micro-architecture in women with postmenopausal osteoporosis: the DIVA study.
Bonvoisin, B; Czerwinski, E; Felsenberg, D; Langdahl, B; Masanauskaite, D; Recker, RR; Rowell, L; Ste-Marie, LG, 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
" Then the clinical development by new intermittent dosing method was accelerated, aiming at the improvement of compliance/adherence which is one of the issues when the bisphosphonates are administered orally."( [Ibandronate].
Tobinai, M, 2011
)
0.37
" The results of this study demonstrate the profile of IV ibandronate, which allows it to be dosed as an IV injection in the primary care setting without the need for an infusion, even in patients with pre-existing hypertension or diabetes mellitus."( Effects of intravenous ibandronate injection on renal function in women with postmenopausal osteoporosis at high risk for renal disease--the DIVINE study.
Jonkanski, I; Mautalen, C; Miller, PD; Ragi-Eis, S; Ramirez, F, 2011
)
0.37
"Long-term bone mineral density (BMD) gains, bone marker levels, and safety of 3 mg quarterly intravenous (IV) ibandronate were studied in this 3-year extension to the Dosing IntraVenous Administration (DIVA) trial."( Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension.
Bianchi, G; Burdeska, A; Czerwinski, E; Felsenberg, D; Kenwright, A; Recker, RR, 2012
)
0.38
" We evaluated the effect of ibandronate dosing interval duration on healing following surgical "fracture" (osteotomy) using a rat femoral fracture model."( Effect of dosing interval duration of intermittent ibandronate treatment on the healing process of femoral osteotomy in a rat fracture model.
Iwata, K; Kaji, Y; Komatsubara, S; Manabe, T; Mashiba, T; Mori, S; Yamamoto, T, 2012
)
0.38
" The aim of this study was to investigate the effect of the IBN/SNAC formulation on the steady-state pharmacokinetics of metformin (CAS 657-24-9) and to assess safety and tolerability of IBN/SNAC when dosed in combination with metformin."( Drug-drug interaction study between a novel oral ibandronate formulation and metformin.
Bittner, B; Jordan, P; McIntyre, C; Schmidt, J, 2011
)
0.37
"Less frequently dosed IV bisphosphonates have not resolved the problem of suboptimal adherence with prescription osteoporosis medications."( Adherence with intravenous zoledronate and intravenous ibandronate in the United States Medicare population.
Curtis, JR; Delzell, E; Matthews, R; Saag, KG; Yun, H, 2012
)
0.38
" 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
"Six months of PTH(1-84), used over 2 yr with a bisphosphonate in either of our dosing regimens increased BMD substantially."( Six months of parathyroid Hormone (1-84) administered concurrently versus sequentially with monthly ibandronate over two years: the PTH and ibandronate combination study (PICS) randomized trial.
Black, DM; Eastell, R; Hietpas, J; Palermo, L; Schafer, AL; Sellmeyer, DE; Shoback, DM, 2012
)
0.38
"A meta-analysis of spine BMD dose-response relationships for alendronate, risedronate, and ibandronate was performed."( A meta-analysis characterizing the dose-response relationships for three oral nitrogen-containing bisphosphonates in postmenopausal women.
Yates, J, 2013
)
0.39
"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
" Monthly dosing regimens are welcomed by women because of higher satisfaction and better adherence."( [Efficacy of ibandronat 150 mg given once a month in the treatment of postmenopausal osteoporosis on the basis of biochemical bone markers--adhero study].
Paro, JN; Ristanović, V; Tijana, I; Zavisić, BK,
)
0.13
" These results demonstrate that the ibandronate-DCK formulation can improve the oral absorption of ibandronate, allowing less frequent dosing to avoid side effects as well to enhance patient compliance."( Enhanced oral absorption of ibandronate via complex formation with bile acid derivative.
Byun, Y; Hwang, SR; Jeon, OC; Moon, HT; Park, JW, 2013
)
0.39
"5% of administrated dosage remains in kidney tissue."( Determination of renal tissue ibandronate levels in rats with normal and mildly impaired renal function.
Bergner, R; Faust, H; Gretz, N; Kränzlin, B; Pfister, T; Siegrist, B,
)
0.13
" This post-hoc analysis used individual patient data from the 2-year monthly oral ibandronate in ladies (MOBILE) and dosing intravenous administration (DIVA) studies, including the 3-year long-term extensions (LTEs), to assess fracture risk in patients treated with ibandronate for 5 years."( Long-term fracture rates seen with continued ibandronate treatment: pooled analysis of DIVA and MOBILE long-term extension studies.
Barr, C; Day, BM; Felsenberg, D; Harris, S; Masanauskaite, D; Miller, PD; Recker, RR; Reginster, J; Silverman, S, 2014
)
0.4
" The objectives were: (1) to compare adherence to oral weekly and monthly bisphosphonates with emphasis on dosing instructions; and (2) to study associations between adherence and beliefs about the bisphosphonate treatment among women ≥ 55 years."( Adherence to oral bisphosphonates: 30 more minutes in dosing instructions matter.
Fuksa, L; Horak, P; Ladova, K; Matoulkova, P; Palicka, V; Stepan, J; Touskova, T; Vytrisalova, M, 2015
)
0.42
" Osteoporosis Specific Morisky Medication Adherence Scale (OS-MMAS), questions on compliance with five dosing instructions and Beliefs about Medicines Questionnaire (BMQ) Specific were used."( Adherence to oral bisphosphonates: 30 more minutes in dosing instructions matter.
Fuksa, L; Horak, P; Ladova, K; Matoulkova, P; Palicka, V; Stepan, J; Touskova, T; Vytrisalova, M, 2015
)
0.42
" Only 44% of respondents were compliant with all dosing instructions."( Adherence to oral bisphosphonates: 30 more minutes in dosing instructions matter.
Fuksa, L; Horak, P; Ladova, K; Matoulkova, P; Palicka, V; Stepan, J; Touskova, T; Vytrisalova, M, 2015
)
0.42
"Despite relatively high adherence to the treatment, most patients do not follow dosing instructions."( Adherence to oral bisphosphonates: 30 more minutes in dosing instructions matter.
Fuksa, L; Horak, P; Ladova, K; Matoulkova, P; Palicka, V; Stepan, J; Touskova, T; Vytrisalova, M, 2015
)
0.42
"A previous animal study compared the nephrotoxic effect of ibandronate (IBN) and zoledronate (ZOL), but interpretation of these study results was limited because of the model of minimal nephrotoxic dosage with a dosage ratio of 1:3."( Nephrotoxicity of ibandronate and zoledronate in Wistar rats with normal renal function and after unilateral nephrectomy.
Bergner, R; Gretz, N; Kränzlin, B; Pohlmeyer-Esch, G; Siegrist, B, 2015
)
0.42
"The purpose of this study was to perform a meta-analysis on the efficacy of ibandronate by evaluating the effect sizes of different dosing regimens."( Dose-Effectiveness Relationships Determining the Efficacy of Ibandronate for Management of Osteoporosis: A Meta-Analysis.
Ding, H; Gu, K; Hou, Y; Liu, C; Tuoheti, Y; Xu, C, 2015
)
0.42
" Ibandronate (IBN) is a highly potent, nitrogen-containing bisphosphonate, which is administered orally or intravenously at extended dosing intervals."( Treatment with the combination of ibandronate plus eldecalcitol has a synergistic effect on inhibition of bone resorption without suppressing bone formation in ovariectomized rats.
Bauss, F; Endo, K; Hashimoto, J; Sakai, S; Shimizu, M; Shimonaka, Y; Sugimoto, M; Takeda, S; Yogo, K, 2015
)
0.42
" One comparing two different dosing regimens for the maintenance of remission in people with ulcerative colitis (CODA), and the other comparing an orally administered treatment to an intravenously administered treatment in preventing skeletal-related events in patients with bone metastases from breast cancer (ZICE)."( The use of randomisation-based efficacy estimators in non-inferiority trials.
Barrett-Lee, P; Casbard, A; Farewell, D; Gillespie, D; Hawthorne, AB; Hood, K; Hurt, C; Murray, N; Probert, C; Stenson, R, 2017
)
0.46
" This study suggests that the lower incidence of BP-ONJ in alendronate treatment is not originated by its potency, but might be due to the low bioavailability of alendronate, lower dosing on a daily basis, and having no additional therapies."( Effects of an oral bisphosphonate and three intravenous bisphosphonates on several cell types in vitro.
Al-Nawas, B; Jung, J; Kwon, YD; Pabst, AM; Park, JS; Righesso, L; Walter, C, 2018
)
0.48
" Findings reveal parenteral medications requiring reduced dosing frequency have higher compliance than oral therapies."( Persistence and adherence to parenteral osteoporosis therapies: a systematic review.
Goetz, V; Homik, J; Kendler, D; Koller, G; McAlister, FA; Vandermeer, B; Ye, C, 2020
)
0.56
"Romosozumab is a potent drug for treating postmenopausal osteoporosis but has a limited dosing period of 12 months."( Verification of efficacy and safety of ibandronate or denosumab for postmenopausal osteoporosis after 12-month treatment with romosozumab as sequential therapy: The prospective VICTOR study.
Kobayakawa, T; Miyazaki, A; Nakamura, Y; Takahashi, J, 2022
)
0.72
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Pathways (1)

PathwayProteinsCompounds
Ibandronate Action Pathway2143

Protein Targets (2)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Geranylgeranyl pyrophosphate synthaseHomo sapiens (human)IC50 (µMol)80.32320.00401.02764.5000AID1798541; AID391371; AID74507
Farnesyl pyrophosphate synthaseHomo sapiens (human)IC50 (µMol)0.41120.00020.71099.3600AID318593; AID318594; AID72181; AID72667; AID72669
Farnesyl pyrophosphate synthaseHomo sapiens (human)Ki0.08150.00010.21651.9000AID318593; AID318594; AID72668
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (6)

Processvia Protein(s)Taxonomy
isoprenoid metabolic processGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
geranyl diphosphate biosynthetic processGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
geranylgeranyl diphosphate biosynthetic processGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
farnesyl diphosphate biosynthetic processGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
isoprenoid biosynthetic processGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
cholesterol biosynthetic processFarnesyl pyrophosphate synthaseHomo sapiens (human)
geranyl diphosphate biosynthetic processFarnesyl pyrophosphate synthaseHomo sapiens (human)
farnesyl diphosphate biosynthetic processFarnesyl pyrophosphate synthaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (8)

Processvia Protein(s)Taxonomy
dimethylallyltranstransferase activityGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
farnesyltranstransferase activityGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
geranyltranstransferase activityGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
protein bindingGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
identical protein bindingGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
metal ion bindingGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
prenyltransferase activityGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
RNA bindingFarnesyl pyrophosphate synthaseHomo sapiens (human)
protein bindingFarnesyl pyrophosphate synthaseHomo sapiens (human)
metal ion bindingFarnesyl pyrophosphate synthaseHomo sapiens (human)
dimethylallyltranstransferase activityFarnesyl pyrophosphate synthaseHomo sapiens (human)
geranyltranstransferase activityFarnesyl pyrophosphate synthaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (5)

Processvia Protein(s)Taxonomy
nucleoplasmGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
cytoplasmGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
cytosolGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
Z discGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
perinuclear region of cytoplasmGeranylgeranyl pyrophosphate synthaseHomo sapiens (human)
nucleoplasmFarnesyl pyrophosphate synthaseHomo sapiens (human)
cytosolFarnesyl pyrophosphate synthaseHomo sapiens (human)
cytoplasmFarnesyl pyrophosphate synthaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (85)

Assay IDTitleYearJournalArticle
AID249229Effect of compound on osteoclasts formation (compound concentration of 100 nM, RANKL at 50 ng/ml and ODQ at 10 uM) as observed in clonal RAW264.7 cells2005Journal of medicinal chemistry, Mar-10, Volume: 48, Issue:5
Synthesis of NO-donor bisphosphonates and their in-vitro action on bone resorption.
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.
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).
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID221770Effective concentration to activate gammadelta T cells2002Journal of medicinal chemistry, Oct-24, Volume: 45, Issue:22
Quantitative structure--activity relations for gammadelta T cell activation by phosphoantigens.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
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).
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).
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.
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.
AID475444Inhibition of osteoclastogenesis in RANKL-stimulated mouse RAW264.7 cells assessed as mature osteoclasts containing 3 or more nuclei at 10 uM after 3 days by using TRAP staining2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Synthesis and preliminary pharmacological characterisation of a new class of nitrogen-containing bisphosphonates (N-BPs).
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
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.
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).
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).
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.
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.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
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.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID475447Inhibition of FPPS in rat liver S10 supernatant assessed as conversion of (R,S)-[2-14C]mevalonic acid to [14C]squalene at 1 uM after 60 mins2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Synthesis and preliminary pharmacological characterisation of a new class of nitrogen-containing bisphosphonates (N-BPs).
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
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.
AID475452Binding affinity to bone mineral hydroxyapatite assessed as residual concentration of compound after 6 hrs2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Synthesis and preliminary pharmacological characterisation of a new class of nitrogen-containing bisphosphonates (N-BPs).
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
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).
AID249228Effect of compound on osteoclasts formation (compound concentration of 100 nM and RANKL at 50 ng/ml) as observed in clonal RAW264.7 cells2005Journal of medicinal chemistry, Mar-10, Volume: 48, Issue:5
Synthesis of NO-donor bisphosphonates and their in-vitro action on bone resorption.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
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).
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.
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.
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).
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.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
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.
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.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
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.
AID475454Inhibition of squalene synthase in rat liver S10 supernatant assessed as conversion of (R,S)-[2-14C]mevalonic acid to [14C]squalene at 10 uM after 60 mins2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Synthesis and preliminary pharmacological characterisation of a new class of nitrogen-containing bisphosphonates (N-BPs).
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.
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.
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.
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.
AID210170Effective dose after subcutaneous administration to TPTX rats for 50% reduction of hypercalcemia2002Journal of medicinal chemistry, Aug-15, Volume: 45, Issue:17
Highly potent geminal bisphosphonates. From pamidronate disodium (Aredia) to zoledronic acid (Zometa).
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).
AID475443Inhibition of squalene synthase in rat liver S10 supernatant assessed as conversion of (R,S)-[2-14C]mevalonic acid to [14C]squalene at 1 uM after 60 mins2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Synthesis and preliminary pharmacological characterisation of a new class of nitrogen-containing bisphosphonates (N-BPs).
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).
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
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.
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.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
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.
AID475453Binding affinity to bone mineral hydroxyapatite assessed as residual concentration of compound after 24 hrs2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Synthesis and preliminary pharmacological characterisation of a new class of nitrogen-containing bisphosphonates (N-BPs).
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).
AID208217Predicted pIC50 against Trypomastigotes Brucei rhodesiense.2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
Activity of bisphosphonates against Trypanosoma brucei rhodesiense.
AID475448Inhibition of FPPS in rat liver S10 supernatant assessed as conversion of (R,S)-[2-14C]mevalonic acid to [14C]squalene at 10 uM after 60 mins2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Synthesis and preliminary pharmacological characterisation of a new class of nitrogen-containing bisphosphonates (N-BPs).
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.
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).
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).
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.
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.
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.
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.
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.
AID391371Inhibition of human recombinant geranylgeranyl diphosphate synthase2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Inhibition of geranylgeranyl diphosphate synthase by bisphosphonates: a crystallographic and computational investigation.
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.
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.
AID475449Vasodilatory activity in Wistar rat endothelium-intact thoracic aortic strip assessed as inhibition of phenylephrine-induced contraction after 120 mins2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Synthesis and preliminary pharmacological characterisation of a new class of nitrogen-containing bisphosphonates (N-BPs).
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.
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.
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.
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).
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.
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.
AID475446Inhibition of squalene synthase in rat liver microsomes assessed as conversion of [1-3H]FPP to [3H]squalene level after 60 mins by liquid scintillation counting2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Synthesis and preliminary pharmacological characterisation of a new class of nitrogen-containing bisphosphonates (N-BPs).
AID1346818Rat farnesyl diphosphate synthase (Lanosterol biosynthesis pathway)2008Toxicology in vitro : an international journal published in association with BIBRA, Jun, Volume: 22, Issue:4
Preclinical evidence for nitrogen-containing bisphosphonate inhibition of farnesyl diphosphate (FPP) synthase in the kidney: implications for renal safety.
AID1346813Rat squalene synthase (Lanosterol biosynthesis pathway)2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Synthesis and preliminary pharmacological characterisation of a new class of nitrogen-containing bisphosphonates (N-BPs).
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 (752)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's48 (6.38)18.2507
2000's362 (48.14)29.6817
2010's284 (37.77)24.3611
2020's58 (7.71)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 67.72

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

MetricThis Compound (vs All)
Research Demand Index67.72 (24.57)
Research Supply Index6.89 (2.92)
Research Growth Index5.12 (4.65)
Search Engine Demand Index117.69 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (67.72)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials184 (23.17%)5.53%
Reviews175 (22.04%)6.00%
Case Studies58 (7.30%)4.05%
Observational9 (1.13%)0.25%
Other368 (46.35%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (75)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety of BONVIVA(Ibandronate) Administered in Korean Patients According to the Prescribing Information [NCT01381393]659 participants (Actual)Observational2007-06-30Completed
A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients [NCT02598934]Phase 4308 participants (Actual)Interventional2004-08-31Completed
A Randomized, Double-blind, Placebo-controlled Study to Determine Time to Onset of Suppression of the Bone Resorption Marker sCTX With Once Monthly Ibandronate in the Treatment of Postmenopausal Osteoporosis [NCT00303485]Phase 467 participants (Actual)Interventional2006-02-28Completed
Double-blind, Placebo-controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of Oral Ibandronate Once Monthly in Postmenopausal Women With Osteopenia [NCT00129623]Phase 4160 participants (Actual)Interventional2005-12-31Completed
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer [NCT00127205]Phase 36,097 participants (Actual)Interventional2005-07-31Completed
A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis [NCT00048074]Phase 31,395 participants (Actual)Interventional2002-06-30Completed
A Prospective, Open-Label, Multi-Center, Two-Part Study to Investigate Patient Satisfaction With Monthly Dosed Ibandronate Therapy in Women With Post-Menopausal Osteoporosis or Osteopenia Transitioned From Once-Weekly Alendronate or Risendronate [NCT02604836]Phase 41,711 participants (Actual)Interventional2004-06-30Completed
The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women [NCT01077817]684,815 participants (Actual)Observational2010-02-26Completed
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Persistence of the Effect of Oral Monthly Ibandronate on Bone Reception in Postmenopausal Women in Osteoporosis [NCT00092053]Phase 3203 participants (Actual)Interventional2004-12-31Completed
COMPARE: Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Patients With Multiple Myeloma [NCT02739594]Phase 389 participants (Actual)Interventional2006-02-28Terminated(stopped due to Slow recruitment)
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety of BONVIVA(Ibandronate) Injection Administered in Korean Patients According to the Prescribing Information [NCT01376102]657 participants (Actual)Observational2007-11-30Completed
Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics [NCT01128257]6,054 participants (Actual)Observational2010-04-30Completed
Efficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term Glucocorticoids [NCT01287533]Phase 4167 participants (Actual)Interventional2010-04-30Completed
An Open Label Study of the Efficacy, Safety, and Pharmacoeconomics of Oral Ibandronate (Bondronat 50 mg) in Treatment of Metastatic Bone Disease [NCT02564107]Phase 448 participants (Actual)Interventional2004-11-30Completed
Changes of Bone Turnover Markers and Bone Mineral Density After Treatment in Osteoporotic Patients [NCT02156999]Phase 4100 participants (Anticipated)Interventional2014-06-30Recruiting
Double Blind Randomized Study Comparing Ibandronate Versus Placebo in Hip Osteonecrosis Stage 1 and 2 [NCT02114489]Phase 38 participants (Actual)Interventional2014-06-30Terminated(stopped due to Troubles recruiting patients)
Randomized, Open Label Study to Assess the Efficacy and Safety of the Intravenous and Oral Ibandronic Acid for Improving the Performance Status of Patients With Malignant Bone Disease Secondary to Solid Tumors and Hematological Malignancies [NCT02561039]Phase 397 participants (Actual)Interventional2006-12-31Completed
Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis [NCT00048061]Phase 31,609 participants (Actual)Interventional2002-04-30Completed
Open-Label Study to Establish the Short Term Efficacy of Intravenous Loading-Doses of Bondronat 6 mg in Patients With Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain, Within 7 Days After Initiation of Treatment [NCT02553707]Phase 4182 participants (Actual)Interventional2006-07-31Completed
An Open-Label, Multi-Center Study to Determine Level of Adherence to Monthly Oral or Every Three Month Intravenous Ibandronate Treatment in Post-Menopausal Women With Osteoporosis or Osteopenia, Who Are GI Intolerant of Daily or Weekly Alendronate or Rise [NCT02598453]Phase 4545 participants (Actual)Interventional2005-01-31Completed
Whole Exome Sequencing to Identify Genetic Predisposition to Atypical Femoral Fractures in Women Using Bisphosphonates for Osteoporosis [NCT02731040]38 participants (Actual)Observational2016-04-30Completed
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
'Open, Prospective, Multi-center, Two-part Study of Patient Preference With Monthly Ibandronate Therapy in Women With Postmenopausal Osteoporosis Switched From Once-daily or Once Weekly Alendronate or Risendronate - BONCURE (BONviva for Current Bisphospho [NCT00545779]Phase 3677 participants (Actual)Interventional2006-12-31Completed
A Randomized Open-Label Study to Investigate the Impact of Bone Marker Feedback at 3 Months on Adherence to Monthly Oral Bonviva in Women With Post-Menopausal Osteoporosis Supported by a Patient Relationship Program [NCT00545363]Phase 4716 participants (Actual)Interventional2006-04-30Completed
A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women [NCT00545051]Phase 4140 participants (Actual)Interventional2006-05-31Completed
A Randomized, Controlled Study of Ibandronate for the Prevention of Bone Loss in Patients Who Have Received Allogeneic Bone Marrow Transplantation for Hematological Malignancies [NCT00824993]Phase 378 participants (Actual)Interventional2008-12-09Completed
A Randomized, Open-Label, Muti-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A Six Month, Two-Sequence, and Two-Period Crossover Study [NCT02598440]Phase 4341 participants (Actual)Interventional2004-03-31Completed
[NCT00767169]Phase 216 participants (Actual)Interventional2008-10-31Completed
Long-Term Bone Quality in Women With Breast Cancer (A Companion Study to S0307) [NCT00873808]0 participants (Actual)Observational2008-10-31Withdrawn(stopped due to lack of accrual)
Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort [NCT00662077]Phase 40 participants (Actual)InterventionalWithdrawn(stopped due to Financial difficulties)
Randomized, Open Label Study to Evaluate Renal Safety of Intravenous Bondronat 6 mg Infusions Over 15 Minutes Versus 60 Minutes in Patients With Metastatic Bone Disease Due to Breast Cancer [NCT02716792]Phase 3334 participants (Actual)Interventional2006-01-31Completed
A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates [NCT00936897]Phase 3833 participants (Actual)Interventional2009-07-31Completed
An Open-label, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva [NCT00545090]Phase 4561 participants (Actual)Interventional2006-08-31Completed
A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia [NCT00545207]Phase 3150 participants (Actual)InterventionalCompleted
A Randomized, Open-label Study to Investigate the Impact of Bone Marker Feedback on Persistence to Once Monthly Oral Bonviva (Ibandronate) Treatment for Post-menopausal Osteoporosis. [NCT00545480]Phase 4596 participants (Actual)Interventional2006-07-31Completed
A Randomised, Open Label Study to Investigate the Impact of Bone Marker Feedback at 2 Months on Adherence to Monthly Oral Bonviva (Ibandronate) in Women With Post-menopausal Osteoporosis. [NCT00545909]Phase 4585 participants (Actual)Interventional2006-03-31Completed
Ibandronate Versus Placebo as add-on to Active Vitamin D and Calcium in the Prevention of Bone Loss After Renal Transplantation. [NCT00423384]Phase 2/Phase 3130 participants (Anticipated)Interventional2007-01-31Active, not recruiting
An Open-label, Multi-centre, Randomized Study to Investigate Patient Preference on Dosing in the Once-monthly Ibandronate and the Once-weekly Risedronate in Korean Women With Postmenopausal Osteoporosis. A Six-month, Two-sequence, and Two Period Crossover [NCT00405392]Phase 4365 participants (Actual)Interventional2007-03-22Completed
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
A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R206 and Bonviva for the Improvement of Vitamin D in Postmenopausal Women With Osteoporosis [NCT01581320]Phase 3201 participants (Actual)Interventional2011-12-31Completed
Ibandronate With or Without Capecitabine in Elderly Patients With Early Breast Cancer [NCT00196859]Phase 31,500 participants (Anticipated)Interventional2004-06-30Completed
Post Authorization Safety Study of iv Ibandronate (Bonviva) in Postmenopausal Osteoporosis, Observational, Non-interventional Open Label Trial [NCT02271204]700 participants (Actual)Observational2009-03-31Completed
A Single--blind, Randomized, Placebo--controlled Phase II Study to Evaluate the Impact of Oral Bisphosphonate Treatment on Bone Mineral Density in Osteopenic Women Receiving Adjuvant Aromatase Inhibitors - BONADIUV Trial [NCT02616744]Phase 2171 participants (Actual)Interventional2011-01-31Completed
Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus-Prevalence,Risk Factors and Treatment [NCT00668330]Phase 440 participants (Actual)Interventional2007-04-30Completed
Randomized, Open-label Crossover Study to Evaluate Comparative Pharmacokinetics of Ibandronate Between DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 Complex Tablet) and a 150mg Ibandronate Tablet in Healthy Adult Volunteers [NCT01429675]Phase 1105 participants (Actual)Interventional2011-08-31Completed
[NCT00446589]Phase 419 participants (Actual)Interventional2006-07-31Terminated(stopped due to due to financial problems)
Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Comparative Study With Sodium Risedronate Hydrate(RIS) With Vertebral Fracture as an Index - [NCT00447915]Phase 31,265 participants (Actual)Interventional2007-03-31Completed
A Randomized Study to Evaluate the Safety and Efficacy of Loading Dose of Bondronat Versus Standard Dose of Bondronat in Patients With Lung Cancer and Skeletal Metastasis Experiencing Moderate to Severe Pain [NCT00492843]Phase 420 participants (Actual)Interventional2007-07-31Terminated(stopped due to It is too difficult to recruit suitable patients.)
A Randomized, Double-blind Study of the Efficacy of Intravenous Bonviva in the Relief of Pain After Recent Vertebral Osteoporotic Fracture in Osteoporotic Patients. [NCT00493623]Phase 368 participants (Actual)Interventional2007-06-30Completed
An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Bone Pain in Patients With Breast Cancer and Skeletal Metastases [NCT00502736]Phase 213 participants (Actual)Interventional2008-01-31Completed
Interventional, Single Arm, Open Label Study of the Efficacy, Safety and Compliance to the Treatment With Intravenous (IV) Ibandronate (Bonviva®) in the Postmenopausal Osteoporosis Treatment of Bisphosphonates naïve Patients in Daily Practice [NCT01290094]Phase 341 participants (Actual)Interventional2011-04-30Completed
Study Into the Effect of Ibandronate for the Treatment of Bone Marrow Edema in Relation to Spontaneous or Non-traumatic Osteonecrosis of the Knee: A Randomized Double-blind, Placebo-controlled Trial [NCT00532220]Phase 330 participants (Actual)Interventional2007-12-31Completed
Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate [NCT04321837]Phase 260 participants (Anticipated)Interventional2020-02-05Recruiting
Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy: A Randomized, Double Blind, Placebo Controlled Trial [NCT06022237]80 participants (Anticipated)Interventional2023-09-01Not yet recruiting
A Randomized, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain [NCT00099177]Phase 396 participants (Actual)Interventional2005-08-31Terminated
A Randomized, Placebo-controlled, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain [NCT00099203]Phase 3163 participants (Actual)Interventional2005-07-31Terminated
An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases. [NCT00478270]Phase 20 participants (Actual)Interventional2007-06-30Withdrawn
A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis [NCT02948881]Phase 4100 participants (Actual)Interventional2005-08-31Completed
An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-menopausal Osteoporosis. [NCT00493532]0 participants Expanded Access2007-06-30No longer available
Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases [NCT00381368]Phase 260 participants Interventional2006-10-31Recruiting
A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain [NCT00082927]Phase 3580 participants (Anticipated)Interventional2003-04-30Completed
A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150 mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis [NCT00148915]Phase 498 participants (Actual)Interventional2005-08-31Completed
Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial [NCT05266261]121 participants (Actual)Interventional2018-10-01Completed
A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease. [NCT00503113]Phase 4801 participants (Actual)Interventional2007-07-31Completed
Randomized Double-Blind Placebo-Controlled and Parallel Group Study to Evaluate the Impact of One Year Therapy With Monthly Oral Ibandronate 150 mg on Structural Properties of Bone in Postmenopausal Osteoporosis Without Vertebral Fractures [NCT00271713]Phase 470 participants (Actual)Interventional2006-03-31Completed
Zoledronate Versus Ibandronate Comparative Evaluation: A Randomized Phase III, Open-Label, Multicenter, Parallel Group Clinical Trial to Evaluate and Compare the Efficacy, Safety Profile and Tolerability of Oral Ibandronate Versus Intravenous Zoledronate [NCT00326820]Phase 31,404 participants (Actual)Interventional2006-01-31Active, not recruiting
A Multi Centre, Randomised, Open Label, Cross-over Study to Evaluate the Percentage of False Negative Osteoporosis Diagnosis's Using the Standard Case-finding Procedure as Described by the Dutch Institute for Healthcare (CBO) and to Determine the Preferen [NCT00327990]Phase 4300 participants (Actual)Interventional2005-04-30Completed
A Phase III Randomized, Multicenter Non-Inferiority Trial Evaluating the Efficacy of Oral Ibandronate Versus Intravenous Zoledronate in the Reduction of Skeletal-Related Events in Patients With Metastatic Breast Cancer [NCT00301886]Phase 30 participants (Actual)Interventional2006-05-31Withdrawn(stopped due to withdrawn support for study)
Open-Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover Oral Bioequivalence Study Of Ibandronate Sodium 150 mg Tablets Of Dr. Reddy's Laboratories Limited, India and 'BONIVA®' 150 mg (Ibandronate Sodium) Tablets Of [NCT01627886]Phase 1100 participants (Actual)Interventional2008-09-30Completed
PROSPECTIVE STUDY OF PROFILE OF HEPATIC OSTEODYSTROPHY IN PATIENTS WITH NON-CHOLEASTATIC LIVER CIRRHOSIS AND IMPACT OF BISPHOSPHONATE SUPPLEMENTATION [NCT02249741]Phase 447 participants (Actual)Interventional2012-08-31Completed
Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550 [NCT00551174]Phase 4781 participants (Actual)Interventional2004-10-31Completed
Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549 [NCT00081653]Phase 4719 participants (Actual)Interventional2004-05-31Completed
A Parallel, Placebo-controlled, Randomized (2:1) Double-blind Study of One Year Duration to Assess the Effect of Oral Ibandronate 150 mg Given Once-monthly Versus Placebo on LS BMD in Men With Osteoporosis [NCT00397839]Phase 3135 participants (Actual)Interventional2007-01-31Completed
Examination of Bone Metabolism and Bone Mineral Density in Primary and Secondary Osteoporosis Treated by Oral Ibandronate [NCT03186131]Phase 2100 participants (Anticipated)Interventional2017-10-12Recruiting
PTH & Ibandronate Combination Study (PICS): Optimizing the Use of PTH With Boniva (Pilot Randomized Controlled Trial) [NCT00683163]Phase 2/Phase 344 participants (Actual)Interventional2008-05-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00048061 (16) [back to overview]Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
NCT00048061 (16) [back to overview]Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
NCT00048061 (16) [back to overview]Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
NCT00048061 (16) [back to overview]Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
NCT00048061 (16) [back to overview]Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
NCT00048061 (16) [back to overview]Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
NCT00048061 (16) [back to overview]Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
NCT00048061 (16) [back to overview]Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
NCT00048061 (16) [back to overview]Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
NCT00048061 (16) [back to overview]Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
NCT00048061 (16) [back to overview]Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
NCT00048061 (16) [back to overview]Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
NCT00048061 (16) [back to overview]Absolute Change In Baseline in Serum CTX to Months 12 and 24
NCT00048061 (16) [back to overview]Number of Participants With Any Adverse Events and Serious Adverse Event
NCT00048061 (16) [back to overview]Number Of Participants With Marked Laboratory Abnormalities
NCT00048061 (16) [back to overview]Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
NCT00048074 (16) [back to overview]Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24
NCT00048074 (16) [back to overview]Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months
NCT00048074 (16) [back to overview]Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
NCT00048074 (16) [back to overview]Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months
NCT00048074 (16) [back to overview]Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
NCT00048074 (16) [back to overview]Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24
NCT00048074 (16) [back to overview]Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24
NCT00048074 (16) [back to overview]Number of Participants With Any Marked Abnormality in Laboratory Parameters
NCT00048074 (16) [back to overview]Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24
NCT00048074 (16) [back to overview]Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)
NCT00048074 (16) [back to overview]Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
NCT00048074 (16) [back to overview]Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24
NCT00048074 (16) [back to overview]Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24
NCT00048074 (16) [back to overview]Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
NCT00048074 (16) [back to overview]Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
NCT00048074 (16) [back to overview]Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24
NCT00081653 (6) [back to overview]Relative Percent Change From Baseline in Mean Total Hip BMD
NCT00081653 (6) [back to overview]Relative Percent Change From Baseline of Trough Serum CTX
NCT00081653 (6) [back to overview]Absolute Change From Baseline of Trough Serum CTX
NCT00081653 (6) [back to overview]Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)
NCT00081653 (6) [back to overview]Absolute Change From Baseline in Mean Total Hip BMD
NCT00081653 (6) [back to overview]Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
NCT00127205 (4) [back to overview]Disease-free Survival
NCT00127205 (4) [back to overview]Overall Survival
NCT00127205 (4) [back to overview]Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT00127205 (4) [back to overview]Distributions of Sites of First Recurrence on the Three Arms.
NCT00129623 (9) [back to overview]Percentage of Responders
NCT00129623 (9) [back to overview]Relative Change From Baseline in Mean Proximal Femur BMD at Month 12
NCT00129623 (9) [back to overview]Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)
NCT00129623 (9) [back to overview]Absolute Change From Baseline in BMD of the Proximal Femur at Month 12
NCT00129623 (9) [back to overview]Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12
NCT00129623 (9) [back to overview]Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12
NCT00129623 (9) [back to overview]Absolute Change From Baseline in sCTX
NCT00129623 (9) [back to overview]Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00129623 (9) [back to overview]Number of Participants With Marked Laboratory Abnormalities
NCT00303485 (10) [back to overview]Number of Participants With Any Marked Abnormality in Laboratory Parameters
NCT00303485 (10) [back to overview]Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
NCT00303485 (10) [back to overview]Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments
NCT00303485 (10) [back to overview]Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
NCT00303485 (10) [back to overview]Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
NCT00303485 (10) [back to overview]Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
NCT00303485 (10) [back to overview]Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
NCT00303485 (10) [back to overview]Number of Participants With Any Adverse Event or Serious Adverse Event
NCT00303485 (10) [back to overview]Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3
NCT00303485 (10) [back to overview]Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations
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
NCT00397839 (5) [back to overview]Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12
NCT00397839 (5) [back to overview]Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6
NCT00397839 (5) [back to overview]Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months
NCT00397839 (5) [back to overview]Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12
NCT00397839 (5) [back to overview]Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6
NCT00405392 (3) [back to overview]Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration
NCT00405392 (3) [back to overview]Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate
NCT00405392 (3) [back to overview]Mean Percent Change of Serum C-terminal Telopeptide (CTx) From Baseline to Visit 3 for Once-monthly Dosing of Ibandronate & Once-weekly Dosing of Risedronate
NCT00503113 (8) [back to overview]Absolute Change From Baseline in Mean Serum Creatinine.
NCT00503113 (8) [back to overview]Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
NCT00503113 (8) [back to overview]Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
NCT00503113 (8) [back to overview]Relative Change From Baseline in Actual GFR (Using CG Formula)
NCT00503113 (8) [back to overview]Relative Change From Baseline in Mean Serum Creatinine.
NCT00503113 (8) [back to overview]Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
NCT00503113 (8) [back to overview]Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
NCT00503113 (8) [back to overview]Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
NCT00545051 (5) [back to overview]Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6
NCT00545051 (5) [back to overview]Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
NCT00545051 (5) [back to overview]Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months
NCT00545051 (5) [back to overview]Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12
NCT00545051 (5) [back to overview]Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12
NCT00545363 (4) [back to overview]Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores
NCT00545363 (4) [back to overview]Percentage of Participants With Adherence to Treatment
NCT00545363 (4) [back to overview]Percent Change From Baseline in CTX Based on Adherence to Ibandronate
NCT00545363 (4) [back to overview]Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score
NCT00545779 (8) [back to overview]Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B
NCT00545779 (8) [back to overview]Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ
NCT00545779 (8) [back to overview]Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B
NCT00545779 (8) [back to overview]Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group
NCT00545779 (8) [back to overview]Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B
NCT00545779 (8) [back to overview]Percentage of Participants Who Reported Preference for Monthly Ibandronate
NCT00545779 (8) [back to overview]Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B
NCT00545779 (8) [back to overview]Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ)
NCT00551174 (4) [back to overview]Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months
NCT00551174 (4) [back to overview]Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months
NCT00551174 (4) [back to overview]Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months
NCT00551174 (4) [back to overview]Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months
NCT00683163 (2) [back to overview]P1NP (ng/ml) Change From Baseline.
NCT00683163 (2) [back to overview]Change From Baseline in Trabecular Spine vBMD
NCT00824993 (1) [back to overview]Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months
NCT00936897 (4) [back to overview]Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
NCT00936897 (4) [back to overview]Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
NCT00936897 (4) [back to overview]Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1
NCT00936897 (4) [back to overview]Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
NCT01077817 (2) [back to overview]Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)
NCT01077817 (2) [back to overview]Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)
NCT01290094 (8) [back to overview]Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24
NCT01290094 (8) [back to overview]Percent Change From Baseline in Mean Hip BMD at Month 24
NCT01290094 (8) [back to overview]Percent Change From Baseline in Mean Hip Bone BMD at Month 12
NCT01290094 (8) [back to overview]Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24
NCT01290094 (8) [back to overview]Percent Change From Baseline in Total Hip T-score at Month 12 and 24
NCT01290094 (8) [back to overview]Percentage of Participants Who Received All Planned Study Medication (Compliance)
NCT01290094 (8) [back to overview]Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
NCT01290094 (8) [back to overview]Correlation Coefficient of Participant's Profile With Compliance
NCT02598934 (6) [back to overview]Percent Change From Baseline to Month 6 in Serum Osteocalcin
NCT02598934 (6) [back to overview]Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)
NCT02598934 (6) [back to overview]Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
NCT02598934 (6) [back to overview]Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)
NCT02598934 (6) [back to overview]"Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6"
NCT02598934 (6) [back to overview]Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)
NCT02739594 (14) [back to overview]Percentage of Participants With Skeletal-Related Events (SREs)
NCT02739594 (14) [back to overview]Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44
NCT02739594 (14) [back to overview]Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)
NCT02739594 (14) [back to overview]Percentage of Participants With Zoledronate Dose Reduction
NCT02739594 (14) [back to overview]Time to First SRE
NCT02739594 (14) [back to overview]Percent Change From Baseline in Alpha (A) 1-Microglobulin
NCT02739594 (14) [back to overview]Number of Zoledronate Dose Reductions for Each Participant
NCT02739594 (14) [back to overview]Number of Events of Osteonecrosis of Jaw for Each Participant
NCT02739594 (14) [back to overview]Percent Change From Baseline in CrCl
NCT02739594 (14) [back to overview]Number of SREs for Each Participant
NCT02739594 (14) [back to overview]Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)
NCT02739594 (14) [back to overview]Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92
NCT02739594 (14) [back to overview]Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline
NCT02739594 (14) [back to overview]Percentage of Participants With Osteonecrosis of Jaw

Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD

Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center. (NCT00048061)
Timeframe: From Baseline (Month 0) to Months 12 and 24

,,,
InterventionPercent change (Mean)
Total hip At Month 12, n = 315,319,306,316Total hip At Month 24, n = 292,291,277,289Trochanter At Month 12, n = 315,319,306,316Trochanter At Month 24, n = 292,291,277,289Femoral neck At Month 12, n = 315,319,306,316Femoral neck At Month 24, n=292,291,277,289
Ibandronate 100 mg2.68783.51653.82265.31351.87972.6209
Ibandronate 150 mg3.00924.16014.59046.17552.19143.1195
Ibandronate 2.5 mg1.96262.49553.19174.02041.71641.9087
Ibandronate 50/50 mg2.21722.81323.49314.62891.81412.0581

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Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD

Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24. (NCT00048061)
Timeframe: From Baseline (Month 0) to Month 24

InterventionPercent change (Mean)
Ibandronate 2.5 mg4.9623
Ibandronate 50/50 mg5.3350
Ibandronate 100 mg5.5760
Ibandronate 150 mg6.5503

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Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline. (NCT00048061)
Timeframe: Months 12 and 24

,,,
InterventionPercentage of participants (Number)
At Month 12, n = 314,318,304,310At Month 24, n = 292,291,276,287
Ibandronate 100 mg60.971.0
Ibandronate 150 mg68.775.6
Ibandronate 2.5 mg62.463.4
Ibandronate 50/50 mg64.563.9

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Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline. (NCT00048061)
Timeframe: Months 12 and 24

,,,
InterventionPercentage of participants (Number)
At Month 12, n = 314,318,304,310At Month 24, n = 292,291,276,287
Ibandronate 100 mg77.679.3
Ibandronate 150 mg83.587.1
Ibandronate 2.5 mg65.670.5
Ibandronate 50/50 mg72.375.3

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Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. (NCT00048061)
Timeframe: Months 12 and 24

,,,
InterventionPercentage of participants (Number)
At Month 12, n = 314,318,304,310At Month 24, n = 292,291,276,287
Ibandronate 100 mg78.080.1
Ibandronate 150 mg84.288.2
Ibandronate 2.5 mg68.875.7
Ibandronate 50/50 mg75.577.3

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Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD

The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated. (NCT00048061)
Timeframe: From Baseline (Month 0) to Months 12 and 24

,,,
Interventiong/cm2 (Mean)
At 12 months, n = 314, 322, 306, 314At 24 months, n = 294, 294, 278, 291
Ibandronate 100 mg0.0300.042
Ibandronate 150 mg0.0360.049
Ibandronate 2.5 mg0.0280.036
Ibandronate 50/50 mg0.0330.039

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Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. (NCT00048061)
Timeframe: Months 12 and 24

,,,
InterventionPercentage of participants (Number)
At Month 12, n = 315,319,306,306At Month 24, n = 292,291,277,289
Ibandronate 100 mg86.988.8
Ibandronate 150 mg90.593.4
Ibandronate 2.5 mg76.878.4
Ibandronate 50/50 mg81.283.2

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Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. (NCT00048061)
Timeframe: Months 12 and 24

,,,
InterventionPercentage of participants (Number)
At Month 12, n = 315,319,306,316At Month 24, n = 292,291,277,289
Ibandronate 100 mg88.289.9
Ibandronate 150 mg92.494.1
Ibandronate 2.5 mg80.084.2
Ibandronate 50/50 mg83.186.6

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Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24

Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique). (NCT00048061)
Timeframe: From Baseline (Month 0) to Months 3, 6, 12, 24

,,,
InterventionPercent change (Mean)
At Month 3, n = 269,278,271,276At Month 6, n = 270,272,274,278At Month 12, n = 272,276,276,267At Month 24, n = 221,215,211,235
Ibandronate 100 mg-50.2368-55.9614-58.1046-49.5567
Ibandronate 150 mg-57.3433-66.4354-67.070361.8822
Ibandronate 2.5 mg-49.545855.5900-58.8244-51.2360
Ibandronate 50/50 mg-46.4771-53.9838-57.5363-51.3040

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Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. (NCT00048061)
Timeframe: Months 12 and 24

,,,
InterventionPercentage of participants (Number)
At Month 12, n = 314,322,306,314At Month 24, n = 294,294,278,291
Ibandronate 100 mg86.687.8
Ibandronate 150 mg90.893.5
Ibandronate 2.5 mg83.886.4
Ibandronate 50/50 mg87.687.8

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Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density

Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis. (NCT00048061)
Timeframe: From Baseline (Month 0) to Month 12

InterventionPercent change (Mean)
Ibandronate 2.5 mg3.7427
Ibandronate 50/50 mg4.3395
Ibandronate 100 mg4.0328
Ibandronate 150 mg4.7611

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Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.

Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center (NCT00048061)
Timeframe: From Baseline (Month 0) to Months 12 and 24

,,,
Interventiong/cm2 (Mean)
Total hip At Month 12, n = 315,319,306,316Total hip At Month 24, n = 292,291,277,290Trochanter At Month 12, n = 315,319,306,316Trochanter At Month 24, n = 292,291,277,290Femoral neck At Month 12, n = 315,319,306,316Femoral neck At Month 24, n = 315,319,306,316
Ibandronate 100 mg0.0200.0260.0220.0300.0120.017
Ibandronate 150 mg0.0220.0310.0260.0350.0140.020
Ibandronate 2.5 mg0.0140.0180.0180.0230.0110.012
Ibandronate 50/50 mg0.0160.0210.0200.0270.0110.013

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Absolute Change In Baseline in Serum CTX to Months 12 and 24

Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique). (NCT00048061)
Timeframe: From Baseline (Month 0) to Months 12 and 24

,,,
Interventionng/ml (Mean)
Month 12, n = 272, 276, 276, 267Month 24, n = 221, 215, 211, 235
Ibandronate 100 mg-0.340-0.312
Ibandronate 150 mg-0.377-0.340
Ibandronate 2.5 mg-0.323-0.285
Ibandronate 50/50 mg-0.326-0.298

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Number of Participants With Any Adverse Events and Serious Adverse Event

An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. (NCT00048061)
Timeframe: Up to Month 24

,,,
InterventionParticipants (Number)
Any AESAE
Ibandronate 100 mg31855
Ibandronate 150 mg31745
Ibandronate 2.5 mg30238
Ibandronate 50/50 mg31354

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Number Of Participants With Marked Laboratory Abnormalities

Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L]. (NCT00048061)
Timeframe: Up to Month 24

,,,
InterventionParticipants (Number)
Hematocrit Low, n = 389,387,382,385Hemoglobin High, n = 389,389,382,385Hemoglobin Low, n = 389,389,382,385WBC Low, n = 389,389,382,385ALT (SGPT) High, n = 390,390,385,385BUN High, n = 390,390,385,385Creatinine High, n = 390,390,385,385Chloride Low, n =3 89,390,385,384Potassium Low, n = 389,390,385,383Sodium High, n = 389,390,385,384Sodium Low, n = 389,390,385,384Calcium High, n = 390,390,385,385Phosphate High, n = 390,390,385,385Phosphate Low, n = 390,390,385,385
Ibandronate 100 mg11648000010032
Ibandronate 150 mg30348013120111
Ibandronate 2.5 mg20319213002142
Ibandronate 50/50 mg00318013001032

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Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. (NCT00048061)
Timeframe: Months 12 and 24

,,,
InterventionPercentage of participants (Number)
At Month 12, n = 315,319,306,316At Month 24, n = 292,291,277,289
Ibandronate 100 mg69.078.7
Ibandronate 150 mg75.381.0
Ibandronate 2.5 mg71.169.2
Ibandronate 50/50 mg72.471.1

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Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24

BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: Baseline, Month 12 and Month 24

,,
InterventionAbsolute Change (g/cm^2) (Mean)
Month 12, n= 368, 350, 359Month 24, n= 334, 320, 334
Ibandronate 2.5mg Daily0.0280.036
Ibandronate 2mg q 2 mo IV0.0370.047
Ibandronate 3mg q 3 mo IV0.0350.046

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Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months

BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline) (NCT00048074)
Timeframe: Baseline and Month 24

InterventionPercent Change (Mean)
Ibandronate 2.5mg Daily4.8412
Ibandronate 2mg q 2 mo IV6.3999
Ibandronate 3mg q 3 mo IV6.2777

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Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24

A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: At Month 12 and 24

,,
InterventionPercentage of participants (Number)
Above baseline, Month 12, n = 363, 343, 355Above baseline, Month 24, n = 330, 314, 332
Ibandronate 2.5mg Daily58.459.7
Ibandronate 2mg q 2 mo IV69.472.3
Ibandronate 3mg q 3 mo IV64.571.7

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Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months

BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline) (NCT00048074)
Timeframe: Baseline and Month 12

InterventionPercent Change (Mean)
Ibandronate 2.5mg Daily3.8199
Ibandronate 2mg q 2 mo IV5.0872
Ibandronate 3mg q 3 mo IV4.8188

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Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24

BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: Baseline, Month 12 and Month 24

,,
InterventionAbsolute Change (g/cm^2) (Mean)
Total hip, Month 12, n = 364, 343, 357Total hip, Month 24, n = 330, 316, 333Trochanter, Month 12, n = 364, 343, 357Trochanter, Month 24, n = 330, 316, 333Femoral neck , Month 12, n = 364, 343, 357Femoral neck , Month 24, n = 330, 316, 333
Ibandronate 2.5mg Daily0.0130.0150.0160.0190.0100.014
Ibandronate 2mg q 2 mo IV0.0180.0250.0220.0290.0130.018
Ibandronate 3mg q 3 mo IV0.0160.0220.0200.0260.0140.018

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Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24

Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: Baseline, At Month 6, 12, and 24.

,,
InterventionPercent Change (Mean)
Month 6, n = 358, 342, 345Month 12, n = 360, 342, 347Month 24, n = 310, 301, 298
Ibandronate 2.5mg Daily-54.715-54.387-51.549
Ibandronate 2mg q 2 mo IV-55.539-48.042-41.338
Ibandronate 3mg q 3 mo IV-51.196-49.873-44.325

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Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24

Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: Baseline, At Month 6, 12, and 24.

,,
InterventionAbsolute Change (ng/mL) (Mean)
Month 6, n = 358, 342, 345Month 12, n = 360, 342, 347Month 24, n = 310, 301, 298
Ibandronate 2.5mg Daily-0.318-0.321-0.324
Ibandronate 2mg q 2 mo IV-0.322-0.318-0.285
Ibandronate 3mg q 3 mo IV-0.281-0.290-0.276

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Number of Participants With Any Marked Abnormality in Laboratory Parameters

Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 - 700 * 10^9/L), low and high white blood cell (WBC) (3.0 - 18.0 * 10^9/L), high alanine aminotransferase (ALAT) (0 - 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 - 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 - 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 - 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/L). (NCT00048074)
Timeframe: Approximately 2 years

,,
Interventionparticipants (Number)
Hematocrit - High, n = 453, 433, 456Hematocrit - low, n = 453, 433, 456Hemoglobin - High, n = 453, 433, 456Hemoglobin - Low n = 453, 433, 456Platelets - High, n = 452, 431, 455Platelets - Low, n = 452, 431, 455WBC - High, n = 453, 433, 456WBC - Low, n = 453, 433, 456ALAT (SGPT) - High, n = 453, 434, 456BUN - High, n = 453, 434, 456Creatinine - High, n = 453, 434, 456Albumin - Low, n = 453, 434, 456Chloride - High, n = 453, 433, 456Chloride - Low, n = 453, 433, 456Potassium - Low, n = 453, 433, 456Sodium - Low, n = 453, 433, 456Calcium - High, n = 453, 434, 456Phosphate - High, n = 453, 434, 456Phosphate - Low, n = 453, 434, 456
Ibandronate 2.5mg Daily00020204131001400076
Ibandronate 2mg q 2 mo IV02152014122210311143
Ibandronate 3mg q 3 mo IV15151122180000301062

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Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24

A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: At Month 12 and 24

,,
InterventionPercentage of participants (Number)
Above baseline, Month 12, n = 364, 343, 357Above baseline, Month 24, n = 330, 316, 333
Ibandronate 2.5mg Daily65.167.6
Ibandronate 2mg q 2 mo IV74.177.5
Ibandronate 3mg q 3 mo IV70.076.6

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Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. (NCT00048074)
Timeframe: Approximately 2 years

,,
Interventionparticipants (Number)
Any AEAny SAE
Ibandronate 2.5mg Daily40867
Ibandronate 2mg q 2 mo IV39773
Ibandronate 3mg q 3 mo IV40062

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Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24

BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: Baseline, Month 12 and Month 24

,,
InterventionPercent Change (Mean)
Total hip, Month 12, n = 364, 343, 357Total hip , Month 24, n = 330, 316, 333Trochanter, Month 12, n = 364, 343, 357Trochanter, Month 24, n = 330, 316, 333Femoral neck, Month 12, n = 364, 343, 357Femoral neck, Month 24, n = 330, 316, 333
Ibandronate 2.5mg Daily1.78572.20112.97213.46691.61292.2457
Ibandronate 2mg q 2 mo IV2.51503.36994.02755.04281.97002.7449
Ibandronate 3mg q 3 mo IV2.36043.12793.81444.91652.30552.7849

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Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24

A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: At Month 12 and 24

,,
InterventionPercentage of participants (Number)
Above baseline, Month 12, n = 364, 343, 357Above baseline, Month 24, n = 330, 316, 333
Ibandronate 2.5mg Daily76.680.0
Ibandronate 2mg q 2 mo IV88.692.1
Ibandronate 3mg q 3 mo IV86.388.6

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Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24

A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: At Month 12 and 24

,,
InterventionPercentage of participants (Number)
Above baseline, Month 12, n = 364, 343, 357Above baseline, Month 24, n = 330, 316, 333
Ibandronate 2.5mg Daily74.577.0
Ibandronate 2mg q 2 mo IV86.088.6
Ibandronate 3mg q 3 mo IV82.685.6

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Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24

A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: At Month 12 and 24

,,
InterventionPercentage of participants (Number)
Above baseline, Month 12, n = 363, 343, 355Above baseline, Month 24, n = 330, 314, 332
Ibandronate 2.5mg Daily68.070.9
Ibandronate 2mg q 2 mo IV83.485.7
Ibandronate 3mg q 3 mo IV79.783.1

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Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24

A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: At Month 12 and 24

,,
InterventionPercentage of participants (Number)
Above baseline, Month 12, n = 363, 343, 355Above baseline, Month 24, n = 330, 314, 332
Ibandronate 2.5mg Daily66.968.8
Ibandronate 2mg q 2 mo IV80.583.1
Ibandronate 3mg q 3 mo IV76.380.1

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Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24

A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. (NCT00048074)
Timeframe: At Month 12 and 24

,,
InterventionPercentage of participants (Number)
Above baseline, Month 12, n = 368, 350, 359Above baseline, Month 24, n = 334, 320, 334
Ibandronate 2.5mg Daily85.184.7
Ibandronate 2mg q 2 mo IV92.392.8
Ibandronate 3mg q 3 mo IV91.692.8

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Relative Percent Change From Baseline in Mean Total Hip BMD

BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones). (NCT00081653)
Timeframe: Baseline, 12, 24 and 36 months

,
Interventionpercent change in BMD (Mean)
Change from Baseline at Month 12 (n=344,345)Change from Baseline at Month 24 (n=319,335)Change from Baseline at Month 36 (n=298,320)
Ibandronate 100 mg-0.0169-0.1092-0.8045
Ibandronate 150 mg0.34590.4378-0.3496

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Relative Percent Change From Baseline of Trough Serum CTX

CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values. (NCT00081653)
Timeframe: Baseline, 6,12, 24 and 36 months

,
Interventionpercent change (Mean)
Baseline (n=56,68)Month 6 Postdose (n=56, 67)Change from Baseline at Month 6 Postdose (n=55,67)Month 12 (n=57,67)Change from Baseline at Month 12 (n=56,67)Month 24 (n=54,65)Change from Baseline at Month 24 (n=53,65)Month 36 (51,60)Change from Baseline at Month 36 (n=50,60)
Ibandronate 100 mg0.2320.176-24.6220.27931.1210.30958.6570.410121.106
Ibandronate 150 mg0.21933.109-33.1090.20825.1250.26653.7040.380138.502

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Absolute Change From Baseline of Trough Serum CTX

CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values. (NCT00081653)
Timeframe: Baseline, 6, 12, 24 and 36 months

,
Interventionng/mL (Mean)
Baseline (n= 56,68)Month 6 Postdose (n=56,68)Change from Baseline at Month 6 Postdose (n=55,67)Month 12 (n=57,67)Change from Baseline at Month 12 (n=56,67)Month 24 (n=54,65)Change from Baseline at Month 24 (n=53,65)Month 36 (n=51,60)Change from Baseline at Month 12 (n=50,60)
Ibandronate 100 mg0.2320.176-0.0550.2790.0480.3090.0880.4100.205
Ibandronate 150 mg0.2190.126-0.0930.208-0.0110.2660.0480.3800.174

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Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)

BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]). (NCT00081653)
Timeframe: Baseline and Months 12, 24 and 36

,
Interventionpercent change (Mean)
Change from Baseline at Month 12 (n=346,343)Change from Baseline at Month 24 (n=322,333)Change from Baseline at Month 36 (n=307,318)
Ibandronate 100 mg0.83481.69212.1794
Ibandronate 150 mg1.25501.78652.4322

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Absolute Change From Baseline in Mean Total Hip BMD

BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones). (NCT00081653)
Timeframe: Baseline and 12, 24 and 36 months

,
Interventiong/cm^2 (Mean)
Baseline (n=345,348)Month 12 (n=347,346)Change from Baseline at Month 12 (n=344,345)Month 24 (n=322,336)Change from Baseline at Month 24 (n=319,335)Month 36 (n=301,321)Change from Baseline at Month 36 (n=298,320)
Ibandronate 100 mg0.76800.7669-0.00040.7686-0.00100.7663-0.0061
Ibandronate 150 mg0.78620.78880.00250.78820.00310.7834-0.0030

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Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD

Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]). (NCT00081653)
Timeframe: Baseline and Months 12, 24 and 36

,
Interventiong/cm^2 (Mean)
Baseline (n=347,346)Month 12 (n=347,346)Change from Baseline at Month 12 (n=346,343)Month 24 (n=323,336)Change from Baseline at Month 24 (n=322,333)Month 36 (n=308,320)Change from Baseline at Month 36 (n=307, 318)
Ibandronate 100 mg0.79160.79770.00610.80480.01310.80900.0172
Ibandronate 150 mg0.79770.80690.00970.81110.01400.81550.0194

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Disease-free Survival

Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate. (NCT00127205)
Timeframe: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence

Interventionpercentage of analyzed participants (Number)
Arm I Zoledronate88
Arm II Clodronate88
Arm III Ibandronate87

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Overall Survival

Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The outcome for overall survival will be presented as 5 year overall survival rate. (NCT00127205)
Timeframe: follow up completed every 6 months for 5 years and then annually for 5 years or until death

Interventionpercentage of analyzable patients (Number)
Arm I Zoledronate93
Arm II Clodronate92
Arm III Ibandronate93

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Distributions of Sites of First Recurrence on the Three Arms.

All sites of invasive disease documented within 30 days of first documentation of invasive recurrence. (NCT00127205)
Timeframe: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence

,,
InterventionParticipants (Count of Participants)
Local/Regional onlyContralateral onlyDistant recurrenceUnknown location of recurrenceBone as 1st site of distant recurrenceBone onlyBone and nodes onlyBone and other distant sites (beside nodes)Liver/lung/other visceral without bone recurrenceBrain/other CNS (+/- any other site)
Arm I Zoledronate411721810110622465731
Arm II Clodronate551820715108482586724
Arm III Ibandronate36171461082442364022

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Percentage of Responders

Percent responders were defined as follows: Participants with a) lumbar spine (LS) BMD, equal to or above Baseline at Month 12 b) proximal femur BMD, equal to or above Baseline at Month 12 c) Both lumbar spine and proximal femur BMD, equal or above Baseline at Month 12. BMD of the lumbar spine was defined as the BMD of at least two vertebrae (L2-L4) that were not fractured and not affected by an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. Proximal femur included total hip, trochanter and femoral neck sites. (NCT00129623)
Timeframe: Up to 12 months

,
InterventionPercentage (Number)
Lumbar spine equal to or above baselineProximal femur equal to or above baselineLS and proximal femur equal to or above baseline
Ibandronate (IBN) 150 mg Monthly88.260.354.4
Placebo38.615.58.5

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Relative Change From Baseline in Mean Proximal Femur BMD at Month 12

BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The relative (%) change from Baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account. (NCT00129623)
Timeframe: Baseline and Month 12

,
InterventionPercentage (Mean)
Total hipTrochanterFemoral Neck
Ibandronate (IBN) 150 mg Monthly1.48552.86881.0930
Placebo-0.9265-0.9120-0.7537

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Absolute Change From Baseline in BMD of the Proximal Femur at Month 12

BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The absolute change from baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account. (NCT00129623)
Timeframe: Baseline and Month 12

,
Interventiong/cm^2 (Mean)
Total hipTrochanterFemoral neck
Ibandronate (IBN) 150 mg Monthly0.01330.01820.0078
Placebo-0.0083-0.0061-0.0061

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Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12

BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was measured as g/cm^2 and summarized using descriptive statistics. (NCT00129623)
Timeframe: Baseline and Month 12

Interventiong/cm^2 (Mean)
Placebo-0.0039
Ibandronate (IBN) 150 mg Monthly0.0322

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Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12

BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline) (NCT00129623)
Timeframe: Baseline and Month 12

InterventionPercentage (Least Squares Mean)
Placebo-0.3941
Ibandronate (IBN) 150 mg Monthly3.7285

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Absolute Change From Baseline in sCTX

Fasting blood samples were collected from participants for analysis of sCTX, which is a biochemical marker of bone resorption. Absolute change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics. (NCT00129623)
Timeframe: Baseline and 3, 6, 12 months

,
Interventionng/ml (Median)
Month 3, n = 81, 72Month 6, n = 77, 72Month 12, n = 75, 68
Ibandronate (IBN) 150 mg Monthly-0.2570-0.2675-0.2560
Placebo-0.0350-0.0350-0.0320

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Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. (NCT00129623)
Timeframe: Up to 15 days after end of study treatment (Approximately 2 years)

,
Interventionparticipants (Number)
Any AESAE
Ibandronate (IBN) 150 mg Monthly603
Placebo641

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Number of Participants With Marked Laboratory Abnormalities

Blood for laboratory tests was taken at screening and immediately before participants received their monthly study medication at months 3, 6, and 12. The laboratory tests included: Hematology [white blood cells (WBCs), platelets, hematocrit, and hemoglobin] and Chemistry [albumin, creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), total calcium, 25-hydroxy vitamin D, phosphate, magnesium, sodium, potassium, and chloride]. (NCT00129623)
Timeframe: Screening up to 12 months

,
Interventionparticipants (Number)
WBC, lowALT, highPhosphate, high
Ibandronate (IBN) 150 mg Monthly000
Placebo121

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Number of Participants With Any Marked Abnormality in Laboratory Parameters

Marked laboratory abnormalities are those which exceed the marked abnormality range (i.e., greater or less than the Roche defined marked abnormality range; i.e Low or High) and which also represents a clinically relevant change from Baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows : Hematocrit (0.31- 0.56 fraction), hemoglobin (110 - 200 g/L), platelets (100 - 550 *10^9/L), white blood cell (WBC) (3.0 - 18.0 *10^9/L), alanine aminotransferase (ALT) (0 - 110 U/L), creatinine (0 - 154 µmol/L), chloride (95 - 115 mmol/L), phosphate (0.75 - 1.60 mmol/L ). Creatinine clearance was calculated using the Cockroft-Gault formula. (NCT00303485)
Timeframe: Up to 7 months

,
InterventionParticipants (Number)
Hematocrit-Low, (n = 46,16)Hemoglobin-Low, (n = 46, 16)Platelets-High, (n = 46, 15)White blood cells-Low, (n = 46, 16)ALT- High, (n = 48, 16)Creatinine-High, (n = 48, 16)Chloride-Low, (n = 48, 16)Potassium-High, (n = 48, 16)Phosphate-High, (n = 48, 16)
Ibandronate110211001
Placebo001000110

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Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time

sCTX is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX Time point- sCTX Baseline) / (sCTX Baseline) * 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1. (NCT00303485)
Timeframe: Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6

,
InterventionPercent change (Median)
M1D1, (n = 46, 16)M1D7, (n = 47, 16)M1D14, (n = 47, 15)M1D21, (n = 46, 16)M1D28, (n = 46, 15)M2D7, (n = 46, 15)M2D14, (n = 45, 16)M2D21, (n = 44, 15)M2D28, (n = 45, 15)M3D7, (n = 44, 15)M3D14, (n = 44, 15)M3D21, (n = 45, 14)M3D28, (n = 46, 16)M4D7, (n = 45, 16)M4D14, (n = 47, 16)M4D21, (n = 45, 15)M4D28, (n = 46, 13)M5D7, (n = 46, 14)M5D14, (n = 44, 14)M5D21, (n = 47, 13)M5D28, (n = 43, 12)M6D7, (n = 45, 12)M6D14, (n = 44, 14)M6D21, (n = 47, 15)M6D28, (n = 46, 15)
Ibandronate-70.16-73.62-61.19-50.98-43.53-75.57-68.51-53.68-50.32-76.58-66.28-59.77-54.49-76.98-69.50-62.80-59.40-75.40-66.08-58.52-54.00-78.09-71.41-67.52-57.97
Placebo-5.96-12.69-21.99-4.46-6.29-7.42-5.01-7.64-14.33-13.84-17.10-21.69-17.13-21.37-6.82-9.97-2.10-2.86-16.42-4.60-31.85-14.59-18.49-15.97-14.92

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Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments

Parathyroid hormone (PTH) regulates calcium and phosphate metabolism in bone and kidney, and is measured in picogram/milliliter (pg/mL). The relative percent change in PTH was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (PTH time point- PTH Baseline) / (PTH Baseline) * 100. Post treatment assessments were done at Baseline, Month (M)1 Day (D)7, and M6D7 (NCT00303485)
Timeframe: Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7

,
InterventionPercent change (Median)
Month 1 Day 7Month 6 Day 7
Ibandronate37.7429.63
Placebo-1.724.81

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Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time

BSAP is a biochemical marker of bone formation and measured in units per litre (U/L). The relative percent change in BSAP was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (BSAP time point- BSAP Baseline) / (BSAP Baseline) * 100. The greater the percent decrease from Baseline, the greater the response to therapy. Baseline visit was defined as Visit 1. (NCT00303485)
Timeframe: Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6

,
InterventionPercent change (Median)
M1D7, (n = 47, 16)M1D28, (n = 46,15)M2D7, (n = 46, 15)M2D28, (n = 46,15)M3D7, (n = 45, 15)M3D28, (n = 45,16)M4D7, (n = 44, 16)M4D28, (n = 46,14)M5D7, (n = 46, 14)M5D28, (n = 43,11)M6D7, (n = 46, 12)M6D28, (n = 47,15)
Ibandronate1.30-12.24-16.41-23.84-22.61-29.82-30.26-36.88-39.30-38.28-38.54-40.26
Placebo-2.42-9.78-12.30-11.04-12.84-13.24-15.64-19.71-21.16-20.39-13.86-19.24

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Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent

The Cochran-Mantel Haenszel test stratified by Baseline sCTX category was used to compare the 2 treatment groups for proportion of participants whose sCTX concentration was between 0.011 and 0.631 ng/mL (premenopausal normal range mean +/- 2 SD) who achieved a decrease in sCTX of at least 8% from Baseline. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD=0.155 ng/mL. Baseline visit was defined as Visit 1. (NCT00303485)
Timeframe: Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6

,
InterventionPercentage of participants (Number)
Baseline, (n = 49, 17)M1D3, (n = 46,16)M1D7, (n = 47,16)M1D14, (n = 47, 15)M1D21, (n = 46, 16)M1D28, (n = 46, 15)M2D7, (n = 46, 15)M2D14, (n = 45, 16)M2D21, (n = 44, 15)M2D28, (n = 45, 15)M3D7, (n = 44, 15)M3D14, (n = 44, 15)M3D21, (n = 45, 14)M3D28, (n = 46, 16)M4D7, (n = 45, 16)M4D14, (n = 47, 16)M4D21, (n = 45, 15)M4D28, (n = 46, 13)M5D7, (n = 46, 14)M5D14, (n = 44, 14)M5D21, (n = 47, 13)M5D28, (n = 43, 12)M6D7, (n = 45, 12)M6D14, (n = 44, 14)M6D21, (n=47, 15)M6D28, (n = 46,15)
Ibandronate59.287.887.887.883.785.789.883.781.683.783.785.781.683.791.889.883.785.791.887.889.881.689.885.791.887.8
Placebo58.858.876.564.758.864.764.758.864.764.764.770.652.976.576.564.764.758.864.764.758.864.752.964.764.764.7

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Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL

Percentage of participants whose sCTX concentration was between 0.011 and 0.476 ng/mL (Mean -2 to + 1 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL. Baseline visit was defined as Visit 1. (NCT00303485)
Timeframe: Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6

,
InterventionPercentage of participants (Number)
Baseline, (n = 49, 17)M1D3, (n = 46,16)M1D7, (n = 47,16)M1D14, (n = 47, 15)M1D21, (n = 46, 16)M1D28, (n = 46, 15)M2D7, (n = 46, 15)M2D14, (n = 45, 16)M2D21, (n = 44, 15)M2D28, (n = 45, 15)M3D7, (n = 44, 15)M3D14, (n = 44, 15)M3D21, (n = 45, 14)M3D28, (n = 46, 16)M4D7, (n = 45, 16)M4D14, (n = 47, 16)M4D21, (n = 45, 15)M4D28, (n = 46, 13)M5D7, (n = 46, 14)M5D14, (n = 44, 14)M5D21, (n = 47, 13)M5D28, (n = 43, 12)M6D7, (n = 45, 12)M6D14, (n = 44, 14)M6D21, (n=47, 15)M6D28, (n = 46, 15)
Ibandronate46.918.410.224.522.432.78.214.324.530.614.316.320.426.514.314.318.422.410.218.420.420.48.212.222.418.4
Placebo41.247.158.847.147.152.952.952.958.864.752.947.135.352.964.747.141.241.241.247.141.241.229.447.135.347.1

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Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL

Percentage of participants whose sCTX concentration was between 0.011 and 0.321 ng/mL (Mean -2 to + 0 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL. (NCT00303485)
Timeframe: Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6

,
InterventionPercentage of participants (Number)
Baseline, (n = 49, 17)M1D3, (n = 46,16)M1D7, (n = 47,16)M1D14, (n = 47, 15)M1D21, (n = 46, 16)M1D28, (n = 46, 15)M2D7, (n = 46, 15)M2D14, (n = 45, 16)M2D21, (n = 44, 15)M2D28, (n = 45, 15)M3D7, (n = 44, 15)M3D14, (n = 44, 15)M3D21, (n = 45, 14)M3D28, (n = 46, 16)M4D7, (n = 45, 16)M4D14, (n = 47, 16)M4D21, (n = 45, 15)M4D28, (n = 46, 13)M5D7, (n = 46, 14)M5D14, (n = 44, 14)M5D21, (n = 47, 13)M5D28, (n = 43, 12)M6D7, (n = 45, 12)M6D14, (n = 44, 14)M6D21, (n= 47, 15)M6D28, (n = 46,15)
Ibandronate16.36.12.08.210.218.46.16.18.26.14.14.18.24.14.12.00.06.12.04.16.18.24.14.110.26.1
Placebo23.529.435.311.817.623.523.529.435.329.423.535.317.623.529.417.617.611.811.823.517.617.617.623.523.529.4

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Number of Participants With Any Adverse Event or Serious Adverse Event

An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. (NCT00303485)
Timeframe: Up to 7 months

,
InterventionParticipants (Number)
Any AEsAny SAEs
Ibandronate401
Placebo122

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Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3

Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. It is measured in units of nanograms (ng) per milliliter (mL). The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline) * 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1. (NCT00303485)
Timeframe: Baseline (Visit 1) and Day 3

InterventionPercent change (Median)
Ibandronate-70.16
Placebo-5.96

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Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations

Overall minimum and maximum relative percent change in sCTX concentrations from Baseline were calculated for all participants over D7, D14, D21 and D28 of Month 6 and the difference between it was analyzed. (NCT00303485)
Timeframe: Day (D)7, D14, D21 and D28 of Month 6

InterventionPercent change (Median)
Ibandronate17.23
Placebo22.89

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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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Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12

BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans. (NCT00397839)
Timeframe: 12 months

Interventionpercent (Least Squares Mean)
Placebo.94
Ibandronate3.52

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Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6

BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans. (NCT00397839)
Timeframe: 6 months

Interventionpercent (Least Squares Mean)
Placebo0.78
Ibandronate1.64

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Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months

Responders are defined as participants who have BMD values >= their baseline values at Months 6 and 12, and not any pre-defined percentage increase in BMD values of clinical significance. (NCT00397839)
Timeframe: 12 months

,
Interventionparticipants (Number)
Month 6: Lumbar SpineMonth 6: Total HipMonth 6: Lumbar Spine and Total HipMonth 12: Lumbar SpineMonth 12: Total HipMonth 12: Lumbar Spine and Total Hip
Ibandronate625746716459
Placebo301410332016

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Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12

BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans. (NCT00397839)
Timeframe: 12 months

,
Interventionpercent (Least Squares Mean)
Total HipFemoral NeckTrochanter
Ibandronate1.821.212.15
Placebo-0.31-0.230.43

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Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6

BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans. (NCT00397839)
Timeframe: 6 months

,
Interventionpercent (Least Squares Mean)
Total HipFemoral NeckTrochanter
Ibandronate1.270.962.59
Placebo-0.48-0.220.55

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Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration

Participant's preference for convenient treatment was compared between monthly ibandronate and weekly risedronate. Analysis population was mITT. Preference for convenient treatment was calculated as percentage. Percentage of participants who think once-monthly ibandronate dosing is more convenient over once-weekly risedronate dosing were presented. Those participants who answered the two treatments equally convenient were excluded while reporting. (NCT00405392)
Timeframe: Visit 4 (Week 24)

InterventionPercentage of particiants (Number)
Ibandronate 150 mg Once Monthly72.93
Risedronate 35 mg Once Weekly13.69

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Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate

Preference of monthly ibandronate and weekly risedronate was compared. Modified-intention-to-treat (mITT) population was used for analysis. Any participant randomly assigned, received the study drug, and participants were asked to fill the preference questionnaire on completion of study. Preference was calculated as percentage. Data for percentage of participants with preference to once-monthly dosing of ibandronate to the once-weekly dosing of risedronate was presented. (NCT00405392)
Timeframe: Visit 4 (Week 24)

InterventionPercentage of participants (Number)
Ibandronate 150 mg Once Monthly62.42
Risedronate 35 mg Once Weekly21.02

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Mean Percent Change of Serum C-terminal Telopeptide (CTx) From Baseline to Visit 3 for Once-monthly Dosing of Ibandronate & Once-weekly Dosing of Risedronate

The difference of change in serum CTX from basal value between the two sequences was tested using ANCOVA at 95% confidence interval at 3 months (Visit 3) after the administration. Analysis was done with PP population. Baseline was value at Week 0, Change from baseline was calculated by subtracting Baseline value from value at specified time point. (NCT00405392)
Timeframe: Baseline (Week 0) and Visit 3 (Week 12)

InterventionPercent change (Mean)
Ibandronate 150 mg Once Monthly-57.23
Risedronate 35 mg Once Weekly-56.95

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Absolute Change From Baseline in Mean Serum Creatinine.

(NCT00503113)
Timeframe: Baseline and 9 months

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

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

(NCT00503113)
Timeframe: Baseline and 9 months

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

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

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

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

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

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

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

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Relative Change From Baseline in Mean Serum Creatinine.

(NCT00503113)
Timeframe: Baseline and 9 months

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

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

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

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

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

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

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

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

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

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

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

Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance. (NCT00545051)
Timeframe: Baseline and Month 6

Interventionpercent change in BMD (Mean)
Ibandronate2.6
Placebo0.3

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Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12

Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance. (NCT00545051)
Timeframe: Baseline and Month 12

Interventionpercent change in BMD (Mean)
Ibandronate3.2
Placebo-0.1

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Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months

Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site. (NCT00545051)
Timeframe: Month 6

Interventionpercentage of participants (Number)
Ibandronate0.0
Placebo0.0

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Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12

Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements. (NCT00545051)
Timeframe: Baseline and Months 1, 6 and 12

,
Interventionpercent change in bone turnover markers (Mean)
sCTX Month 1 (n=68,68)sCTX Month 6 (n=62,66)sCTX Month 12 (n=65,65)P1NP Month 1 (n=68,68)P1NP Month 6 (n=60,66)P1NP Month 12 (n=64,67)TRACP Month 1 (n=68,68)TRACP Month 6 (n=62,66)TRACP Month 12 (n=65,67)
Ibandronate-44.7-53.3-42.0-23.8-62.5-48.8-31.3-32.9-27.4
Placebo-3.8-3.511.6-2.3-3.712.5-7.3-7.1-6.3

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Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12

Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements. (NCT00545051)
Timeframe: Baseline and Months 6 and 12

,
Interventionpercent change in BMD (Mean)
Month 6 (n=62,66)Month 12 (n=66,65)
Ibandronate0.71.2
Placebo0.0-0.7

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Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores

The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1 - 6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11 - 16). Satisfaction with treatment was assessed using the OPSAT-Q composite satisfaction score, which was the average of the scores from the four domains of the OPSAT-Q converted to a 0 - 100-point scale. Higher scores indicated greater treatment satisfaction. A score of 80 or more was considered as high score. (NCT00545363)
Timeframe: At Month 6

Interventionpercentage of participants (Number)
BMF Participants87.72
No BMF Participants87.62

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Percentage of Participants With Adherence to Treatment

Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on case report form (CRF) and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively. (NCT00545363)
Timeframe: Up to 6 months

Interventionpercentage of participants (Number)
BMF Participants98.5
No BMF Participants98.6

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Percent Change From Baseline in CTX Based on Adherence to Ibandronate

Serum CTX, a biochemical marker of bone resorption, was assessed for all participants at baseline and at final visit (Month 6). The sampling was done at the same time of the day each time to overcome the effect of circadian fluctuations. Participants were considered adherent to treatment if they took at least 83% of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on CRF and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively. (NCT00545363)
Timeframe: Baseline, Month 6

,
Interventionpercent change (Least Squares Mean)
Adherence-Yes (n=279, 281)Adherence-No (n=1, 6)
BMF Participants-47.5-71.74
No BMF Participants-47.5-25.8

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Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score

OPPS: A standardized 6-item satisfaction questionnaire for osteoporosis medical care and treatment received during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction. OMSQ: A standardized 18-item satisfaction questionnaire for osteoporosis medical care, treatment received and blood test and their results during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction. (NCT00545363)
Timeframe: At Month 6

Interventionpercentage of participants (Number)
BMF Participants74.9
No BMF Participants72.2

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Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B

The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1-6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11-16). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0-100-point scale, in which higher scores indicate greater satisfaction. (NCT00545779)
Timeframe: Baseline, Month 6

Interventionunits on a scale (Mean)
Baseline: ConvenienceMonth 6: ConvenienceBaseline: Confidence with daily functioningMonth 6: Confidence with daily functioningBaseline: Overall satisfactionMonth 6: Overall satisfactionBaseline: Side effectsMonth 6: Side effects
Ibandronate58.489.262.686.661.489.183.793.2

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Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ

(NCT00545779)
Timeframe: Visit 0 (<= Day -30)

Interventionpercentage of participants (Number)
Answered Yes to at least 1 question in CIQAnswered NO to every question in CIQ
Ibandronate68.131.9

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Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B

"Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions:~I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule~More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication~Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication" (NCT00545779)
Timeframe: Month 6

Interventionpercentage of participants (Number)
CIQ Question 1 = Yes (n=422)CIQ Question 1 = No (n=205)CIQ Question 2 = Yes (n=115)CIQ Question 2 = No (n=512)CIQ Question 3 = Yes (n=97)CIQ Question 3 = No (n=530)
Ibandronate88.280.093.083.894.883.8

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Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group

Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction. (NCT00545779)
Timeframe: Month 6

Interventionpercentage of participants (Number)
Participants answer Yes with previous Fr (n=115)Participants answer Yes without previous Fr(n=310)Participants answer NO with previous Fr (n=47)Participants answer NO without previous Fr (n=155)
Ibandronate86.189.087.277.4

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Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B

(NCT00545779)
Timeframe: Up to Month 6

Interventionpercentage of participants (Number)
Ibandronate98.6

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Percentage of Participants Who Reported Preference for Monthly Ibandronate

Percentage of participants who reported preference for monthly ibandronate were reported. (NCT00545779)
Timeframe: Visit 0 (<= Day -30)

Interventionpercentage of participants (Number)
Ibandronate67.5

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Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B

(NCT00545779)
Timeframe: Visit 0 (<= Day -30)

Interventionpercentage of participants (Number)
Ibandronate99.4

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Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ)

"The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option.~In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions:~I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule.~More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication.~Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication." (NCT00545779)
Timeframe: Visit 0 (less than or equal to [<=] Day -30)

Interventionpercentage of participants (Number)
Ibandronate68.1

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Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months

Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline. (NCT00551174)
Timeframe: Baseline, 6 months

,
InterventionPercent change (Mean)
BaselinePercent Change from Baseline at Month 6
2 mg Ibandronate q2mo0.232-78.024
3 mg Ibandronate q3mo0.264-81.617

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Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months

Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline. (NCT00551174)
Timeframe: Baseline,12, 24 and 36 months

,
InterventionPercent change (Mean)
BaselinePercent Change from Baseline at Month 12Percent Change from Baseline Month 24Percent Change from Baseline at Month 36
2 mg Ibandronate q2mo0.76510.44870.0483-0.1546
3 mg Ibandronate q3mo0.76650.1258-0.049-0.2619

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Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months

Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline. (NCT00551174)
Timeframe: Baseline,12, 24 and 36 months

,
InterventionPercent change (Mean)
BaselinePercent Change from Baseline at Month 12Percent Change from Baseline at Month 24Percent Change from Baseline at Month 36
2 mg Ibandronate q2mo0.79690.83781.67851.9813
3 mg Ibandronate q3mo0.78610.88451.57422.0559

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P1NP (ng/ml) Change From Baseline.

After an overnight fast, serum was drawn at baseline and 1, 3, 6, 12, 15, 18 and 24 months. Samples were stored at -70C until batch assayed in a central laboratory. Serum N-propeptide of type I collagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) were measured by electrochemiluminescent immunoassay. Bone-specified alkaline phosphate (BAP) was measured by paramagnetic particle immunoassay. P1NP was the bone turnover marker upon which we based sample size calculations. (NCT00683163)
Timeframe: Baseline, 3 months

InterventionPercent change from baseline (Geometric Mean)
Concurrent (A)42
Sequential (B)186

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Change From Baseline in Trabecular Spine vBMD

Areal bone mineral density (aBMD) at the lumbar spine, hip, and distal one-third radius was assessed by dual-energy X-ray absorption at baseline and 6, 12, 18, and 24 months. The precision for aBMD is 1.0%. Volumetric BMD and bone geometry in trabecular and cortical compartments were assessed by quantitative computed tomography (QCT) at the spine and hip. The left hip was used for analysis. The precision for trabecular spine vBMD measurement is 1.0%. Trabecular spine vBMD was our primary BMD outcome, thus the one presented here. (NCT00683163)
Timeframe: Baseline, 24 months.

InterventionPercent change from baseline (Mean)
Concurrent (A)12.5
Sequential (B)13.7

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Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months

The primary outcome measure was the percentage change in BMD in the lumbar spine, femoral neck and total hip at 6 and 12 months (±4 weeks) after allo-SCT relative to baseline. (NCT00824993)
Timeframe: Baseline to 6 months and Baseline to 12 months

,
InterventionPercentage change (Mean)
% change baseline to 6m, LS% change baseline to 6m, FN% change baseline to 6m, TH% change baseline to 12m, LS% change baseline to 12m, FN% change baseline to 12, TH
Control-2.61-4.85-4.72-1.81-5.2-5.68
Ibandronate0.06-3.63-2.731.27-4.29-4.85

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

(NCT00936897)
Timeframe: Baseline to Month 12

InterventionPercentage Change From Baseline (Mean)
Denosumab 60 mg SC Q6M1.7
Ibandronate 150 mg PO QM0.5

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

(NCT00936897)
Timeframe: Baseline to month 12

InterventionPercentage Change From Baseline (Mean)
Denosumab 60 mg SC Q6M4.1
Ibandronate 150 mg PO QM2.1

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Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1

(NCT00936897)
Timeframe: Baseline to month 1

InterventionPercentage Change From Baseline (Median)
Denosumab 60 mg SC Q6M-81.1
Ibandronate 150 mg PO QM-35.0

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

(NCT00936897)
Timeframe: Baseline to month 12

InterventionPercentage Change From Baseline (Mean)
Denosumab 60 mg SC Q6M2.2
Ibandronate 150 mg PO QM0.9

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

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

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

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

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

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

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Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24

"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline." (NCT01290094)
Timeframe: Baseline, Month 24

Interventionpercent change (Mean)
Ibandronate5.27

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Percent Change From Baseline in Mean Hip BMD at Month 24

"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline." (NCT01290094)
Timeframe: Baseline, Month 24

Interventionpercent change (Mean)
Ibandronate1.71

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Percent Change From Baseline in Mean Hip Bone BMD at Month 12

"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline." (NCT01290094)
Timeframe: Baseline, Month 12

Interventionpercent change (Mean)
Ibandronate2.68

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Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24

"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis." (NCT01290094)
Timeframe: Baseline, Month 12, Month 24

Interventionpercent change (Mean)
Change at Month 12 (n=40)Change at Month 24 (n=35)
Ibandronate13.4712.48

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Percent Change From Baseline in Total Hip T-score at Month 12 and 24

"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis." (NCT01290094)
Timeframe: Baseline, Month 12, Month 24

Interventionpercent change (Mean)
Change at Month 12 (n=40)Change at Month 24 (n=35)
Ibandronate9.315.98

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Percentage of Participants Who Received All Planned Study Medication (Compliance)

(NCT01290094)
Timeframe: Baseline up to Month 12

Interventionpercentage of participants (Number)
Ibandronate100

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Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12

"Percent change was calculated as [(measure at time t minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline." (NCT01290094)
Timeframe: Baseline, Month 12

Interventionpercent change (Mean)
Ibandronate5.67

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Correlation Coefficient of Participant's Profile With Compliance

Participant's profile included age, year since menopause, fracture history, and BMD at baseline. (NCT01290094)
Timeframe: Baseline up to Month 12

Interventioncorrelation coefficient (Number)
IbandronateNA

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Percent Change From Baseline to Month 6 in Serum Osteocalcin

Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). (NCT02598934)
Timeframe: Baseline, Month 6

Interventionpercent change (Mean)
Ibandronate (All Participants)-41.51

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Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)

Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). (NCT02598934)
Timeframe: Baseline, Month 6

Interventionpercent change (Mean)
Ibandronate (All Participants)-55.26

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Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)

Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). (NCT02598934)
Timeframe: Baseline, Month 6

Interventionpercent change (Mean)
Ibandronate (All Participants)-58.14

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Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)

Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). (NCT02598934)
Timeframe: Baseline, Month 6

Interventionpercent change (Mean)
Ibandronate (All Participants)-35.34

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"Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6"

The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.' A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone. (NCT02598934)
Timeframe: Month 6

,
Interventionpercentage of participants (Number)
(1) Effective in treating osteoporosis(2) Reduces risk of breaking bone(1) or (2)(1) and (2)
Ibandronate (Consult Group)68.864.972.161.7
Ibandronate (Non-consult Group)51.950.055.246.8

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Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)

Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). (NCT02598934)
Timeframe: Baseline, Month 6

Interventionpercent change (Mean)
Ibandronate (All Participants)-45.98

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Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44

CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30 percent (%) from Baseline or an absolute value less than or equal to (≤) 30 milliliters per minute (mL/min) at Week 44. The last available value on/before Week 44 was used in the calculation. The percentage of participants with deterioration in renal function at Week 44 was reported. (NCT02739594)
Timeframe: Baseline, Week 44

Interventionpercentage of participants (Number)
Ibandronate9.8
Zoledronate12.5

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Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)

The percent change in GGT was calculated as [Week 44 or 92 GGT minus Baseline GGT] divided by Baseline GGT, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation. (NCT02739594)
Timeframe: Baseline and Weeks 44, 92

,
Interventionpercent change (Median)
Week 44Week 92
Ibandronate-6.0-2.5
Zoledronate3.83.8

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Percentage of Participants With Zoledronate Dose Reduction

The percentage of participants with at least 1 zoledronate dose reduction during the study was reported. (NCT02739594)
Timeframe: From Baseline to end of study (up to Week 96)

Interventionpercentage of participants (Number)
Zoledronate30.0

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Time to First SRE

SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. Time to first SRE was defined as the time from first dose of study drug to the time of SRE during the study. The median time to first SRE was estimated by Kaplan-Meier analysis and expressed in days. (NCT02739594)
Timeframe: From Baseline to end of study (up to Week 96)

Interventiondays (Median)
Ibandronate393.0
Zoledronate244.5

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Percent Change From Baseline in Alpha (A) 1-Microglobulin

The percent change in A1-microglobulin was calculated as [Week 44 or 92 A1-microglobulin minus Baseline A1-microglobulin] divided by Baseline A1-microglobulin, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation. (NCT02739594)
Timeframe: Baseline and Weeks 44, 92

,
Interventionpercent change (Median)
Week 44Week 92
Ibandronate0.00.0
Zoledronate0.00.0

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Number of Zoledronate Dose Reductions for Each Participant

The number of zoledronate dose reductions was averaged across all participants, including those participants who did not have any dose reductions during the study. (NCT02739594)
Timeframe: From Baseline to end of study (up to Week 96)

Interventiondose reductions (Mean)
Zoledronate0.8

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Number of Events of Osteonecrosis of Jaw for Each Participant

The number of events of osteonecrosis of jaw was averaged across all participants, including those participants who did not experience the event during the study. (NCT02739594)
Timeframe: From Baseline to end of study (up to Week 96)

Interventionevents of osteonecrosis of jaw (Mean)
Ibandronate0.0
Zoledronate0.0

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Percent Change From Baseline in CrCl

CrCl was calculated from blood samples using the Cockcroft-Gault formula, and was also measured by urinalysis. The percent change in CrCl was calculated as [Week 44 or 92 CrCl minus Baseline CrCl] divided by Baseline CrCl, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation. (NCT02739594)
Timeframe: Baseline and Weeks 44, 92

,
Interventionpercent change (Mean)
Week 44, Calculated/Blood (n=41,40)Week 44, Measured/Urinalysis (n=37,37)Week 92, Calculated/Blood (n=41,40)Week 92, Measured/Urinalysis (n=37,37)
Ibandronate-0.56.9-0.73.1
Zoledronate-0.43.9-4.32.0

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Number of SREs for Each Participant

SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The number of SREs was averaged across all participants, including those participants who did not experience SREs during the study. (NCT02739594)
Timeframe: From Baseline to end of study (up to Week 96)

InterventionSREs (Mean)
Ibandronate0.3
Zoledronate0.5

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Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)

The percent change in B-NAG was calculated as [Week 44 or 92 B-NAG minus Baseline B-NAG] divided by Baseline B-NAG, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation. (NCT02739594)
Timeframe: Baseline and Weeks 44, 92

,
Interventionpercent change (Median)
Week 44Week 92
Ibandronate-15.7-17.2
Zoledronate10.69.3

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Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92

CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30% from Baseline or an absolute value ≤30 mL/min at Week 92. The last available value on/before Week 92 was used in the calculation. The percentage of participants with deterioration in renal function at Week 92 was reported. (NCT02739594)
Timeframe: Baseline, Week 92

Interventionpercentage of participants (Number)
Ibandronate14.6
Zoledronate12.5

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Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline

Elevation in SCr was defined as an increase greater than (>) 0.5 milligrams per deciliter (mg/dL) for participants with Baseline SCr less than (<) 1.4 mg/dL, or an increase >1.0 mg/dL for participants with Baseline SCr greater than or equal to (≥) 1.4 mg/dL. For the Week 44 analysis, the last available value on/before Week 44 was used. For the Week 92 analysis, the last available value on/before Week 92 was used. The percentage of participants with elevation of SCr at Weeks 44 and 92 was reported. (NCT02739594)
Timeframe: Baseline and Weeks 44, 92

,
Interventionpercentage of participants (Number)
Week 44Week 92
Ibandronate2.47.3
Zoledronate2.52.5

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Percentage of Participants With Osteonecrosis of Jaw

The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported. (NCT02739594)
Timeframe: From Baseline to end of study (up to Week 96)

Interventionpercentage of participants (Number)
Ibandronate0.0
Zoledronate0.0

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