Risedronate in the Prevention of Osteoporosis in Postmenopausal Women

Phase 4

Completed

• Conditions: Osteoporosis, Postmenopausal

• Registration Number: NCT00402441
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

* To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal.

Secondary objectives:

* To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1 year of treatment in women who are 0.5-5 years postmenopausal

* To assess the general safety of 35-mg risedronate administered once weekly.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-22
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-28
• Last Update Posted: 2009-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle.

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline to Months 6 and 12 in lumbar spine BMD
and the percent change from baseline to Months 6, 12, and endpoint in total proximal femur, femoral neck, and trochanter BMD
Reported adverse events and changes in routine clinical laboratory tests, vital signs, and physical examinations.

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇸 Bridgewater, New Jersey, United States