The Effect Of Oral Ibandronate In Male Osteoporosis

Phase 3

Completed

• Conditions: Male Osteoporosis
• Interventions: Drug: placebo; Drug: Ibandronate

• Registration Number: NCT00397839
• Lead Sponsor: Hoffmann-La Roche

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

Not available

Study Timeline

• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-10
• Study Start: 2007-01
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-11
• Results First Submitted: 2009-11-17
• Results First Submitted QC: 2009-11-17
• Last Update Submitted: 2009-11-17
• Results First Posted: 2009-12-21
• Last Update Posted: 2009-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Ibandronate	Ibandronate	-

Primary Outcome Measures

Name	Time	Method
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12	12 months	BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6	6 months	BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12	12 months	BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6	6 months	BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months	12 months	Responders are defined as participants who have BMD values \>= their baseline values at Months 6 and 12, and not any pre-defined percentage increase in BMD values of clinical significance.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Madison, Wisconsin, United States