Objectives: The recent U.S. Surgeon General's report recommends using strategies that improve adherence in PMO, including ‘simplifying and organizing the treatment regimen and addressing patient concerns about side effects.' Ibandronate is a novel, potent bisphosphonate with proven antifracture efficacy when given daily or in extended intervals (>2 month dosing interval2). The ongoing MOBILE (Monthly Oral iBandronate In LadiEs) study is investigating the efficacy and safety of monthly oral ibandronate and results are reported at year 1.
Methods: MOBILE is a double-blind, phase III, non-inferiority study comparing the efficacy and safety of monthly versus daily oral ibandronate. Postmenopausal women (aged 55-80 years; ≥5 years since menopause) with osteoporosis (lumbar spine [L2–L4] bone mineral density [BMD] T-score <-2.5 and ≥-5) were randomized to receive either monthly (50/50mg [single doses on two consecutive days], 100mg [single day], 150mg [single day]) or daily (2.5mg) oral ibandronate. Women were not specifically excluded if they had a history of upper GI disorder or were receiving concomitant medications with a potential for upper GI irritation. AEs were monitored throughout the study with upper GI adverse events being of particular interest. Results: After 1 year, substantial and comparable increases in lumbar spine BMD were observed in all treatment arms. All monthly oral regimens were at least as effective as the daily regimen, with the most robust response demonstrated by 150mg once-monthly (p=0.002). Lumbar spine bone mineral density increased by 4.3%, 4.1% and 4.9% in the 50/50mg, 100mg and 150mg monthly groups, respectively, and 3.9% in the daily group. The increases observed in total hip BMD were 2.2%, 2.7% and 3.1% for the monthly groups, respectively, and 2% for the daily group. Substantial decreases in sCTx were also observed in all treatment arms after 1 year, with the 150mg monthly regimen providing the greatest magnitude of suppression. Oral ibandronate was well tolerated and AE-related discontinuation was infrequent with values at 6.3%, 9.1% and 7.8% in the monthly groups, respectively, and 9.1% in the daily group.
Conclusion: Monthly oral ibandronate is an effective therapy for women with PMO - all monthly regimens were proven non-inferior to the daily regimen. The incidence of AEs in the monthly arms was low and similar to daily (which has previously shown placebo-level AE incidence2). No upper GI safety concerns were identified, even in patients with a history of upper GI disorder or receiving concomitant medications. Monthly oral ibandronate may provide a valuable alternative to conventional daily and weekly regimens.
1.Bone Health and Osteoporosis:A Report of the Surgeon General (2004). http://www.hhs.gov/surgeongeneral/library/bonehealth/content.html. Accessed November 5, 2004.
2.Chesnut CH, et al. J Bone Miner Res 2004;19(8):1241-9.
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Faculty Member's Name: Michael A. Bolognese, MD
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