NCT00397839

The Effect Of Oral Ibandronate In Male Osteoporosis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Male
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Male Osteoporosis

Interventions

Type	Name	Description
DRUG	Ibandronate	Ibandronate orally (tablet) at a dose of 150 mg once per month
DRUG	placebo	Placebo orally (tablet) at a dose of 150 mg once per month

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-11-10
• Last updated: 2009-12-21
• Results posted: 2009-12-21

Locations

41 sites across 1 country: United States