Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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.|
- Percent change from baseline in lumbar spine bone mineral density (BMD) at
- Month 12 measured by dual-energy X-ray absorptiometry (DXA).
- Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers.
- Safety: AEs, clinical laboratory values, bone biopsies.
- Intact serum parathyroid hormone (PTH 1-84)before treatment and after 3, 12 and 24 months of treatment in approximately 25% of randomly selected trial participants.
- Physical examination before treatment and after 12 and 24 months of treatment.
|Study Start Date:||July 2004|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|San Isidro, Argentina|
|Macquarie Park, Australia|
|Prague, Czech Republic|
|Midrand, South Africa|
|Guildford Surrey, United Kingdom|
|Study Director:||ICD CSD||Sanofi|