Risedronate in the Prevention of Osteoporosis in Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT00402441|
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : April 29, 2009
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis, Postmenopausal||Drug: Risedronate (HMR4003)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||September 2002|
|Primary Completion Date :||June 2004|
|Study Completion Date :||June 2004|
- Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle.
- Percent change from baseline to Months 6 and 12 in lumbar spine BMD
- and the percent change from baseline to Months 6, 12, and endpoint in total proximal femur, femoral neck, and trochanter BMD
- Reported adverse events and changes in routine clinical laboratory tests, vital signs, and physical examinations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402441
|United States, New Jersey|
|Sanofi-Aventis Administrative Office|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Ellen Matzkin||Sanofi|