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

NCT00402441 Phase 4 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	Phase 4
Status	COMPLETED
Enrolment	260
Start date	2002-09
Completion	2004-06

Conditions

• Osteoporosis, Postmenopausal

Interventions

• Risedronate (HMR4003)

Primary outcomes

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

Countries

United States