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Submitted on September 3, 2004
Accepted on June 14, 2005
Unité d'Exploration du Metabolisme de l'Os et du Cartilage (J-Y.R.), University of Liège, Liège, Belgium; F. Hoffmann-La Roche Ltd (K.M.W., B.B., J.B.), Basel, CH-4070, Switzerland; GlaxoSmithKline (E.D.), 1250 South Collegeville Road, Collegeville, Pennsylvania 19426, USA
* To whom correspondence should be addressed. 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. To investigate the safety, pharmacodynamics, and pharmacokinetics of once-monthly oral ibandronate.
Design. Randomized, 3-month, double-blind, placebo-controlled, phase I study (Monthly Oral Pilot Study).
Setting. Clinical trial centers.
Patients or Other Participants. Postmenopausal women (aged 55-80 yr; 
3 yr postmenopause; n = 144).
Intervention(s). Once-monthly oral placebo, 50 mg, 100 mg, or 150 mg ibandronate. After the first cycle, the 50 mg arm was split into two, with participants continuing on either 50 mg or 100 mg.
Main Outcome Measure(s). Safety; serum and urinary C-telopeptide (CTX); serum ibandronate AUC0-
.
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 sCTX (-56.7% and -40.7% in the 150 mg and 100 mg arms, respectively; P < 0.001 vs. placebo) and uCTX (-54.1% and -34.6%, respectively; P < 0.001 vs. placebo) were observed at day 91 (30 days after the final dose). Analysis of the area under the effect curve (day 1-91) for change from baseline (% x days) in sCTX and uCTX indicated a dose-response relationship. The AUC0- 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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J-Y Reginster, S Adami, P Lakatos, M Greenwald, J J Stepan, S L Silverman, C Christiansen, L Rowell, N Mairon, B Bonvoisin, et al. Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study Ann Rheum Dis, May 1, 2006; 65(5): 654 - 661. [Abstract] [Full Text] [PDF]
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