The Effect Of Oral Ibandronate In Male Osteoporosis

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.

Timeline

Start

2007-01

Primary completion

2008-10

Completion

2008-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Ibandronate; p <0.001; Mean Difference (Net) 2.58 (95% CI 1.41 to 3.76); ANCOVA NCT00397839 ↗

Drugs

Indications