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Long-term fracture rates seen with continued ibandronate treatment: pooled analysis of DIVA and MOBILE long-term extension studies

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Abstract

Summary

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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Acknowledgments

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.

Conflicts of interest

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, Tei**, 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.

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Authors and Affiliations

  1. Colorado Center for Bone Research, 3190 S Wadsworth Blvd, Lakewood, CO, 80227, USA

    P. D. Miller

  2. Osteoporosis Research Center, Creighton University, 2500 California Plaza, Omaha, NE, 68178, USA

    R. R. Recker

  3. University of California, 1111 Franklin St., Oakland, CA, 94607, USA

    S. Harris

  4. Cedars-Sinai Medical Center/UCLA, 8700 Beverly Blvd., Los Angeles, CA, USA

    S. Silverman

  5. Centre Muscle and Bone Research, Charite-Campus Benjamin Franklin, Berlin, Germany

    D. Felsenberg

  6. University of Liège, Place du Vingt Aout 7, 4000, Liege, Belgium

    J. Reginster

  7. Genentech, South San Francisco, CA, USA

    B-M. Day & C. Barr

  8. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland

    D. Masanauskaite

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Miller, P.D., Recker, R.R., Harris, S. et al. Long-term fracture rates seen with continued ibandronate treatment: pooled analysis of DIVA and MOBILE long-term extension studies. Osteoporos Int 25, 349–357 (2014). https://doi.org/10.1007/s00198-013-2518-z

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