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Efficacy of monthly oral ibandronate is sustained over 5 years: the MOBILE long-term extension study

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Abstract

Summary

The long-term efficacy and safety of once-monthly ibandronate were studied in this extension to the 2-year Monthly Oral Ibandronate in Ladies (MOBILE) trial. Over 5 years, lumbar spine bone mineral density (BMD) increased from baseline with monthly ibandronate 150 mg (8.4%). Long-term monthly ibandronate is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis.

Introduction

Once-monthly therapy with ibandronate has been studied for up to 5 years in a long-term extension (LTE) to the 2 year MOBILE trial.

Methods

This multicenter, double-blind extension study of monthly ibandronate involved postmenopausal women who had completed 2 years of the MOBILE core study, with ≥75% adherence. Patients were reallocated, or were randomized from daily therapy, to ibandronate 100 mg monthly or 150 mg monthly for a further 3 years.

Results

A pooled intent-to-treat (ITT) analysis of 344 patients receiving monthly ibandronate from the core MOBILE baseline showed increases over 5 years in lumbar spine BMD (8.2% with 100 mg and 8.4% with 150 mg). Three-year data relative to MOBILE LTE baseline in the full ITT population of all 698 patients randomized or reallocated from MOBILE (including those previously on daily treatment) showed, on average, maintenance of proximal femur BMD gains achieved in the core 2-year study, with further small gains in lumbar spine BMD. In general, maintenance of efficacy was also indicated by markers of bone metabolism.

Conclusions

There were no tolerability concerns or new safety signals. Monthly treatment with ibandronate 100 and 150 mg is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis.

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Acknowledgments

Support for third-party writing assistance for this manuscript was provided by F. Hoffmann-La Roche Ltd. and GlaxoSmithKline. We would also like to acknowledge the contribution of Professor Dieter Felsenberg, who assisted in interpreting the data and revising the manuscript for important intellectual content.

Funding sources

The MOBILE LTE study was funded by F. Hoffmann-La Roche and GlaxoSmithKline.

Conflicts of interest

Dr. Bente Juel Riis is an employee of Nordic Bioscience and Consultant for CCBR/Synarc, Center for Clinical and Basic Research. Dr. Jacob A. Stakkestad, Dr. Peter Lakatos, Prof. Roman Lorenc, and Prof. Edward Czerwinski declared no conflicts of interest. 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. Daiva Masanauskaite is a full-time employee of F. Hoffmann-La Roche. Dr. Andy Kenwright is a full-time employee of Roche Products Ltd. and owns stock in said company. 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. Paul Miller has received scientific grants from Warner Chillcott, Genentech, Eli Lilly, Merck & Co., Novartis Pharmaceuticals, and Amgen. He has also participated in speaker boards and advisory boards and provided consultations for Warner Chillcott, Merck & Co., Eli Lilly, Amgen, Novartis Pharmaceuticals, Genentech, and GlaxoSmithKline. Dr. Miller does not own any stock in these companies.

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Authors and Affiliations

  1. Colorado Center for Bone Research, Lakewood, CO, USA

    P. D. Miller

  2. Osteoporosis Research Center, Omaha, NE, USA

    R. R. Recker

  3. University of Liège, Liège, Belgium

    J.-Y. Reginster

  4. Center for Clinical and Basic Research, Ballerup, Denmark

    B. J. Riis

  5. Krakow Medical Centre, Krakow, Poland

    E. Czerwinski

  6. F. Hoffmann-La Roche Ltd., Basel, Switzerland

    D. Masanauskaite

  7. Roche Products Limited, Welwyn Garden City, UK

    A. Kenwright

  8. The Children’s Memorial Institute, Warsaw, Poland

    R. Lorenc

  9. CECOR, Haugesund, Norway

    J. A. Stakkestad

  10. Semmelweis University, Budapest, Hungary

    P. Lakatos

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  1. P. D. Miller
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Correspondence to P. D. Miller.

Additional information

Results from this manuscript have previously been presented in abstract form at ECCEO 2009 and IOF-WCO-ECCEO 2010.

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Miller, P.D., Recker, R.R., Reginster, JY. et al. Efficacy of monthly oral ibandronate is sustained over 5 years: the MOBILE long-term extension study. Osteoporos Int 23, 1747–1756 (2012). https://doi.org/10.1007/s00198-011-1773-0

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  • DOI: https://doi.org/10.1007/s00198-011-1773-0

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