A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 Months.

NCT00358176 Phase 3 COMPLETED

To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis. To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption. To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	1231
Start date	2004-07
Completion	2007-03

Conditions

• Osteoporosis Postmenopausal

Interventions

• Risedronate (HMR4003)

Primary outcomes

• Percent change from baseline in lumbar spine bone mineral density (BMD) at
• Month 12 measured by dual-energy X-ray absorptiometry (DXA).

Countries

United States, Argentina, Australia, Canada, Czechia, France, Lebanon, Poland, South Africa, Turkey (Türkiye), United Kingdom