Patients or Other Participants: Subjects were postmenopausal women (age, 55-80 yr; Ն3 yr post menopause; n ϭ 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-ϱ .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 (Ϫ56.7% and Ϫ40.7% in the 150-and 100-mg arms, respectively; P Ͻ 0.001 vs. placebo) and urinary CTX (Ϫ54.1% and Ϫ34.6%, respectively; P Ͻ 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 ϫ days) in serum CTX and urinary CTX indicated a dose-response relationship. The AUC 0-ϱ for ibandronate increased with dose but not in a dose-proportional manner.
Conclusions