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Monthly Oral Ibandronate Is Well Tolerated and Efficacious in Postmenopausal Women: Results from the Monthly Oral Pilot Study

Unité d’Exploration du Metabolisme de l’Os et du Cartilage (J.-Y.R.), University of Liège, B-4020 Liège, Belgium; F. Hoffmann-La Roche Ltd. (K.M.W., B.B., J.B.), Basel, CH-4070, Switzerland; and GlaxoSmithKline (E.D.), Collegeville, Pennsylvania 19426

Address all correspondence and requests for reprints to: Professor Jean-Yves Reginster, Unité d’Exploration du Metabolisme de l’Os et du Cartilage, Centre Hospitalier Universitaire Centre Ville, B-4020 Liège, Belgium. E-mail: jyreginster{at}ulg.ac.be.

Context: Ibandronate, a potent, nitrogen-containing bisphosphonate developed for intermittent administration in postmenopausal osteoporosis, aims to overcome current adherence issues with daily and weekly oral bisphosphonates through once-monthly oral dosing.

Objective: The purpose of this study was to investigate the safety, pharmacodynamics, and pharmacokinetics of once-monthly oral ibandronate.

Design: A randomized, 3-month, double-blind, placebo-controlled, phase I study (Monthly Oral Pilot Study) was conducted.

Setting: The study was conducted at five clinical trial centers in the United Kingdom and Belgium.

Patients or Other Participants: Subjects were postmenopausal women (age, 55–80 yr; 3 yr post menopause; n = 144).

Intervention(s): Once-monthly oral ibandronate 50, 100, or 150 mg or placebo was used. After the first cycle, the 50-mg arm was split, with participants continuing on either 50 or 100 mg.

Main Outcome Measure(s): Primary outcome measures were safety, serum and urinary C-telopeptide (CTX), and serum ibandronate AUC_0-.

Results: Once-monthly oral ibandronate was well tolerated, with a similar overall and upper gastrointestinal safety profile to placebo. Once-monthly ibandronate was also highly effective in decreasing bone turnover; substantial reductions from baseline in serum CTX (–56.7% and –40.7% in the 150- and 100-mg arms, respectively; P < 0.001 vs. placebo) and urinary CTX (–54.1% and –34.6%, respectively; P < 0.001 vs. placebo) were observed at d 91 (30 d after the final dose). Analysis of the area under the effect curve (d 1–91) for change from baseline (percent x days) in serum CTX and urinary CTX indicated a dose-response relationship. The AUC_0- for ibandronate increased with dose but not in a dose-proportional manner.

Conclusions: These findings indicate a potential role for once-monthly oral ibandronate in the treatment of postmenopausal osteoporosis.

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