Conditions: Male Osteoporosis
Keywords: male osteoporosis osteoporosis bisphonates bone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ibandronate intervention 2: placebo
Intervention descriptions: intervention 1: Ibandronate orally (tablet) at a dose of 150 mg once per month intervention 2: Placebo orally (tablet) at a dose of 150 mg once per month

Protocol document: