Efficacy of monthly oral ibandronate is sustained over 5 years

The MOBILE long-term extension study

P. D. Miller, Robert R. Recker, J. Y. Reginster, B. J. Riis, E. Czerwinski, D. Masanauskaite, A. Kenwright, R. Lorenc, J. A. Stakkestad, P. Lakatos

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27 Citations (Scopus)

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 ≫l75% 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.

Original languageEnglish
Pages (from-to)1747-1756
Number of pages10
JournalOsteoporosis International
Volume23
Issue number6
DOIs
StatePublished - Jun 2012

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Bone Density
Postmenopausal Osteoporosis
Spine
ibandronic acid
Maintenance
Safety
Therapeutics
Double-Blind Method
Femur
Bone and Bones
Population

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism

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Miller, P. D., Recker, R. R., Reginster, J. Y., Riis, B. J., Czerwinski, E., Masanauskaite, D., ... Lakatos, P. (2012). Efficacy of monthly oral ibandronate is sustained over 5 years: The MOBILE long-term extension study. Osteoporosis International, 23(6), 1747-1756. https://doi.org/10.1007/s00198-011-1773-0

Efficacy of monthly oral ibandronate is sustained over 5 years : The MOBILE long-term extension study. / Miller, P. D.; Recker, Robert R.; Reginster, J. Y.; Riis, B. J.; Czerwinski, E.; Masanauskaite, D.; Kenwright, A.; Lorenc, R.; Stakkestad, J. A.; Lakatos, P.

In: Osteoporosis International, Vol. 23, No. 6, 06.2012, p. 1747-1756.

Research output: Contribution to journalArticle

Miller, PD, Recker, RR, Reginster, JY, Riis, BJ, Czerwinski, E, Masanauskaite, D, Kenwright, A, Lorenc, R, Stakkestad, JA & Lakatos, P 2012, 'Efficacy of monthly oral ibandronate is sustained over 5 years: The MOBILE long-term extension study', Osteoporosis International, vol. 23, no. 6, pp. 1747-1756. https://doi.org/10.1007/s00198-011-1773-0
Miller, P. D. ; Recker, Robert R. ; Reginster, J. Y. ; Riis, B. J. ; Czerwinski, E. ; Masanauskaite, D. ; Kenwright, A. ; Lorenc, R. ; Stakkestad, J. A. ; Lakatos, P. / Efficacy of monthly oral ibandronate is sustained over 5 years : The MOBILE long-term extension study. In: Osteoporosis International. 2012 ; Vol. 23, No. 6. pp. 1747-1756.
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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 ≫l75{\%} 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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AU - Reginster, J. Y.

AU - Riis, B. J.

AU - Czerwinski, E.

AU - Masanauskaite, D.

AU - Kenwright, A.

AU - Lorenc, R.

AU - Stakkestad, J. A.

AU - Lakatos, P.

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N2 - 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 ≫l75% 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.

AB - 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 ≫l75% 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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