Osteoporosis, Postmenopausal Clinical Trial
Official title:
A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 35-mg Risedronate Administered Once a Week in the Prevention of Osteoporosis in Postmenopausal Women
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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