Long-term fracture rates seen with continued ibandronate treatment

Pooled analysis of DIVA and MOBILE long-term extension studies

P. D. Miller, Robert R. Recker, S. Harris, S. Silverman, D. Felsenberg, J. Reginster, B. M. Day, C. Barr, D. Masanauskaite

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish
Pages (from-to)349-357
Number of pages9
JournalOsteoporosis International
Volume25
Issue number1
DOIs
StatePublished - Jan 2014

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Intravenous Administration
Placebos
Therapeutics
Osteoporosis
ibandronic acid
Postmenopausal Osteoporosis
Kaplan-Meier Estimate
North America
Meta-Analysis
Safety

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism

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Long-term fracture rates seen with continued ibandronate treatment : Pooled analysis of DIVA and MOBILE long-term extension studies. / Miller, P. D.; Recker, Robert R.; Harris, S.; Silverman, S.; Felsenberg, D.; Reginster, J.; Day, B. M.; Barr, C.; Masanauskaite, D.

In: Osteoporosis International, Vol. 25, No. 1, 01.2014, p. 349-357.

Research output: Contribution to journalArticle

Miller, PD, Recker, RR, Harris, S, Silverman, S, Felsenberg, D, Reginster, J, Day, BM, Barr, C & Masanauskaite, D 2014, 'Long-term fracture rates seen with continued ibandronate treatment: Pooled analysis of DIVA and MOBILE long-term extension studies', Osteoporosis International, vol. 25, no. 1, pp. 349-357. https://doi.org/10.1007/s00198-013-2518-z
Miller, P. D. ; Recker, Robert R. ; Harris, S. ; Silverman, S. ; Felsenberg, D. ; Reginster, J. ; Day, B. M. ; Barr, C. ; Masanauskaite, D. / Long-term fracture rates seen with continued ibandronate treatment : Pooled analysis of DIVA and MOBILE long-term extension studies. In: Osteoporosis International. 2014 ; Vol. 25, No. 1. pp. 349-357.
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abstract = "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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