Article (Scientific journals)
Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study
Miller, Paul D.; McClung, Michael R.; Macovei, Liviu et al.
2005In Journal of Bone and Mineral Research, 20 (8), p. 1315-1322
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Keywords :
osteoporosis; bisphosphonate; ibandronate; noninferiority; monthly
Abstract :
[en] Introduction: Suboptimal adherence to daily and weekly oral bisphosphonates can potentially compromise therapeutic outcomes in postmenopausal osteoporosis. Although yet to be prospectively shown in osteoporosis, evidence from randomized clinical trials in several other chronic conditions shows that reducing dosing frequency enhances therapeutic adherence. Ibandronate is a new and potent bisphosphonate with antifracture efficacy proven for daily administration and also intermittent administration with a dose-free interval of > 2 months. This report presents comparative data on the efficacy and safety of monthly and daily oral ibandronate regimens. Materials and Methods: MOBILE is a 2-year, randomized, double-blind, phase III, noninferiority trial. A total of 1609 women with postmenopausal osteoporosis were assigned to one of four oral ibandronate regimens: 2.5 mg daily, 50 mg/50 mg monthly (single doses, consecutive days), 100 mg monthly, or 150 mg monthly. Results: After 1 year, lumbar spine BMD increased by 3.9%, 4.3%, 4.1%, and 4.9% in the 2.5, 50/50, 100, and 150 mg arms, respectively. All monthly regimens were proven noninferior, and the 150 mg regimen superior, to the daily regimen. All monthly regimens produced similar hip BMD gains, which were larger than those with the daily regimen. All regimens similarly decreased serum levels of C-telopeptide, a biochemical marker of bone resorption. Compared with the daily regimen, a significantly larger proportion of women receiving the 100 and 150 mg monthly regimens achieved predefined threshold levels for percent change from baseline in lumbar spine (6%) or total hip BMD (3%). All regimens were similarly well tolerated. Conclusions: Monthly ibandronate is at least as effective and well tolerated as the currently approved daily ibandronate regimen in postmenopausal osteoporosis.
Disciplines :
Endocrinology, metabolism & nutrition
Author, co-author :
Miller, Paul D.
McClung, Michael R.
Macovei, Liviu
Stakkestad, Jacob A.
Luckey, Marjorie
Bonvoisin, Bernard
Reginster, Jean-Yves  ;  Université de Liège - ULiège > Département des sciences de la santé publique > Epidémiologie et santé publique
Recker, Robert R.
Hughes, Claire
Lewiecki, E. Michael
Felsenberg, Dieter
Delmas, Pierre D.
Kendler, David L.;  University of British Columbia - UBC
Bolognese, Michael A.
Mairon, Nicole
Cooper, Cyrus
More authors (6 more) Less
Language :
English
Title :
Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study
Publication date :
August 2005
Journal title :
Journal of Bone and Mineral Research
ISSN :
0884-0431
eISSN :
1523-4681
Publisher :
Amer Soc Bone & Mineral Res, Washington, United States - Washington
Volume :
20
Issue :
8
Pages :
1315-1322
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 27 August 2009

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