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Efficacy and Safety of Oral Weekly Ibandronate in the Treatment of Postmenopausal Osteoporosis

Southampton General Hospital (C.C.), Medical Research Council Environmental Epidemiology Unit, Southampton, SO16 6YD United Kingdom; Radiant Research (R.D.E.), Reading, Wyomissing, Pennsylvania 19610; University of Pittsburgh (R.H.M.), Pittsburgh, Pennsylvania 15261; Women’s College Hospital (G.H.), Toronto, Ontario, M5S 1B2 Canada; Division of Rheumatology (G.B.), ASL 3 Genovese, Ospedale La Colletta, Arenzano, 16011 Italy; and F. Hoffmann-La Roche Ltd. (K.W., R.C.S.), Basel, CH-4070 Switzerland

Address all correspondence and requests for reprints to: Professor Cyrus Cooper, Medical Research Council Environmental Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom SO16 6YD. E-mail: cc{at}mrc.soton.ac.uk.

Adherence to oral daily bisphosphonate regimens in postmenopausal osteoporosis is currently suboptimal. Less frequent dosing regimens are likely to improve patient adherence and thus, potentially, patient outcomes. A multicenter, randomized, double-blind, noninferiority study was conducted in 235 women (53–80 yr old; time since menopause 3 yr) with postmenopausal osteoporosis [lumbar spine (L1-L4) bone mineral density (BMD) T-score -2] to demonstrate the noninferiority of an oral weekly (20 mg) ibandronate regimen compared with an oral daily (2.5 mg) ibandronate regimen. All patients received daily calcium (500 mg) and vitamin D (400 IU). The primary analysis was the relative change in lumbar spine (L1-L4) BMD from baseline after 48 wk in the per- protocol population. Daily and weekly ibandronate significantly increased spinal BMD by 3.47 and 3.53%, respectively, and provided substantial and similar decreases in biochemical markers of bone turnover. In the primary analysis, noninferiority of the weekly regimen to the daily regimen was demonstrated, with the boundary of the one-sided confidence interval, -0.96%, within both the -1.65% prespecified margin and a more stringent margin of -1.10%. These results demonstrate that oral weekly ibandronate provides the same efficacy and safety as oral daily ibandronate in women with postmenopausal osteoporosis.

This study was sponsored by F. Hoffmann-La Roche Ltd., Basel, Switzerland.

Abbreviations: AUC, Area under the curve; BMD, bone mineral density; BONE, oral ibandronate osteoporosis vertebral fracture study in North America and Europe; CI, confidence interval; CTX, C-telopeptide of the -chain of type I collagen; GI, gastrointestinal; ITT, intent-to-treat; PP, per-protocol.

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