TY - JOUR
T1 - Long-term fracture rates seen with continued ibandronate treatment
T2 - Pooled analysis of DIVA and MOBILE long-term extension studies
AU - Miller, P. D.
AU - Recker, R. R.
AU - Harris, S.
AU - Silverman, S.
AU - Felsenberg, D.
AU - Reginster, J.
AU - Day, B. M.
AU - Barr, C.
AU - Masanauskaite, D.
N1 - Funding Information:
This study was funded by Genentech and GlaxoSmithKline. Medical writing assistance was provided by Gill Sperrin CBiol MSB CMPP and Andrew Cooper PhD CMPP of Envision Scientific Solutions and funded by Genentech and GlaxoSmithKline. The authors received no financial support for this work and had complete control of the data.
Funding Information:
Dr Miller’s institution has received payment for consultancy from Amgen, Merck & Lilly, expert testimony from Novartis, and grants from Amgen, Merck & Lilly. Dr. Robert R. Recker is a paid consultant for Merck, Lilly, Wyeth, Procter and Gamble, Amgen, Roche, GlaxoSmithKline, Novartis, and NPS Allelix and has received grant/research support from Merck, Lilly, Wyeth, Procter and Gamble, Amgen, Roche, GlaxoSmithKline, Novartis, NPS Allelix, and Sanofi‐Aventis through grants to his institution. Dr. Jean‐Yves Reginster is a paid consultant for/has received payment for advisory boards from Servier, Novartis, Negma, Lilly, Wyeth, Amgen, GlaxoSmithKline, Roche, Merckle, Nycomed, NPS, Theramex, and UCB. He has received lecture fees when speaking at the invitation of a commercial sponsor for Merck Sharp and Dohme, Lilly, Rottapharm, IBSA, Genevrier, Novartis, Servier, Roche, GlaxoSmithKline, Teijin, Teva, Ebewee Pharma, Zodiac, Analis, Theramex, Nycomed, and Novo‐Nordisk. He has also received grant support from Bristol Myers Squibb, Merck Sharp & Dohme, Rottapharm, Teva, Lilly, Novartis, Roche, GlaxoSmithKline, Amgen, and Servier. Dr Harris has served as a Board member for Eli Lilly & Company, Merck; received consultancy fees from Amgen, Eli Lilly & Company, Merck, and Roche; has served as an expert advisor for Roche; and has received honoraria for Speakers Bureax from Amgen, Eli Lilly & Company, Genentech, GlaxoSmithKline, Procter & Gamble, Roche, Novartis, Warner Chilcott. De Silverman has received consultancy fees from The Alliance for Better Bone Health (Procter & Gamble Pharmaceuticals and Sanofi Aventis). Dr Felsenberg has received consulting fees or paid advisory board fees from Amgen, Chugai, GlaxoSmithKline, Lilly, MSD, Novartis, Nycomed, Roche, Servier, and TEVA; lecture fees from Amgen, Chugai, GE, GlaxoSmithKline, Lilly, MSD, Novartis, Nycomed, Roche, Servier, Teva, and WC; and grant support from Amgen, Chugai, Lilly, MSD, Novartis, Nycomed, Roche, Teva, Servier. Drs Bann‐Mo Day and Charles Barr are full‐time employees of Genentech. Dr. Daiva Masanauskaite is a full‐time employee of F. Hoffmann-La Roche.
PY - 2014/1
Y1 - 2014/1
N2 - Ibandronate reduces the risk of vertebral and non-vertebral fractures versus placebo in postmenopausal women with osteoporosis. This analysis, in which fractures were reported as safety events, showed that long-term use of ibandronate was associated with low fracture rates over 5 years of treatment. Introduction: A previous post-hoc meta-analysis of 2-3 year studies found that ibandronate regimens with annual cumulative exposure (ACE) of ≥10.8 mg reduced the risk of vertebral and nonvertebral fractures (NVFs) versus placebo in postmenopausal women. 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. Methods: Patients treated for 2 years in MOBILE with monthly oral ibandronate 150 mg (n = 176) and in DIVA with IV ibandronate every 2 months 2 mg (n = 253) or quarterly 3 mg (n = 263) who continued on the same regimens for 3 additional years in the LTEs were included. Three-year placebo data (n = 1,924) were obtained from the ibandronate osteoporosis vertebral fracture trial in North America and Europe (BONE) and IV Fracture Prevention trials. The primary endpoint was clinical fracture rate; clinical fracture data were collected as adverse events. Time to fracture was analyzed using Kaplan-Meier and statistical analysis was conducted using the log-rank test. All clinical fractures included all NVFs and symptomatic vertebral fractures. Results: For ibandronate regimens with ACE ≥10.8 mg, time to fracture was significantly longer for all clinical fractures, NVFs, and clinical vertebral fractures versus placebo (P = 0.005). For all fracture types, the rate of fracture appeared stable during the 5-year treatment period. Conclusion: In women with postmenopausal osteoporosis, continuous treatment with ibandronate over 5 years results in low sustained clinical fracture rate.
AB - Ibandronate reduces the risk of vertebral and non-vertebral fractures versus placebo in postmenopausal women with osteoporosis. This analysis, in which fractures were reported as safety events, showed that long-term use of ibandronate was associated with low fracture rates over 5 years of treatment. Introduction: A previous post-hoc meta-analysis of 2-3 year studies found that ibandronate regimens with annual cumulative exposure (ACE) of ≥10.8 mg reduced the risk of vertebral and nonvertebral fractures (NVFs) versus placebo in postmenopausal women. 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. Methods: Patients treated for 2 years in MOBILE with monthly oral ibandronate 150 mg (n = 176) and in DIVA with IV ibandronate every 2 months 2 mg (n = 253) or quarterly 3 mg (n = 263) who continued on the same regimens for 3 additional years in the LTEs were included. Three-year placebo data (n = 1,924) were obtained from the ibandronate osteoporosis vertebral fracture trial in North America and Europe (BONE) and IV Fracture Prevention trials. The primary endpoint was clinical fracture rate; clinical fracture data were collected as adverse events. Time to fracture was analyzed using Kaplan-Meier and statistical analysis was conducted using the log-rank test. All clinical fractures included all NVFs and symptomatic vertebral fractures. Results: For ibandronate regimens with ACE ≥10.8 mg, time to fracture was significantly longer for all clinical fractures, NVFs, and clinical vertebral fractures versus placebo (P = 0.005). For all fracture types, the rate of fracture appeared stable during the 5-year treatment period. Conclusion: In women with postmenopausal osteoporosis, continuous treatment with ibandronate over 5 years results in low sustained clinical fracture rate.
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U2 - 10.1007/s00198-013-2518-z
DO - 10.1007/s00198-013-2518-z
M3 - Article
C2 - 24136103
AN - SCOPUS:84891890835
VL - 25
SP - 349
EP - 357
JO - Osteoporosis International
JF - Osteoporosis International
SN - 0937-941X
IS - 1
ER -