A Two-year, Multicenter, Double-blind, Randomized, Placebo-controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women (More Than 5 Years Postmenopausal)

NCT00353080 Phase 3 COMPLETED

To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption To confirm general safety of 5 mg daily risedronate as compared to placebo

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	171
Start date	2002-12
Completion	2005-04

Conditions

• Osteoporosis, Postmenopausal

Interventions

• risedronate (HMR4003)

Primary outcomes

• Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.

Countries

Finland, Netherlands, Norway, Spain, Sweden