Risedronate in the Prevention of Osteoporosis in Postmenopausal Women

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00402441
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 4
Start date	September 2002
Completion date	June 2004

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