At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Parallel, Placebo-controlled, Randomized (2:1) Double-blind Study of One Year Duration to Assess the Effect of Oral Ibandronate 150 mg Given Once-monthly Versus Placebo on LS BMD in Men With Osteoporosis
In Brief
A Phase 3 clinical trial evaluating Ibandronate and placebo for Male Osteoporosis. Completed, enrolled 135 participants across 41 sites.
Detailed Summary
Male osteoporosis is a common and important clinical problem, associated with significant morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given 150 mg once-monthly for 12 months versus placebo in men with primary osteoporosis. Less frequent, once monthly, dosing is expected to improve patient's treatment adherence compared to a weekly dosing regimen.
Study Details
Timeline
Interventions
Ibandronate orally (tablet) at a dose of 150 mg once per month
Placebo orally (tablet) at a dose of 150 mg once per month