Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT00481169|
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : August 21, 2009
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: Bazedoxifene Acetate (TSE-424)||Phase 3|
Primary objective: To evaluate the safety and efficacy of 3 doses of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with those of placebo and raloxifene in preventing osteoporosis in postmenopausal women.
Secondary objective: To evaluate the effect of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with that of placebo and raloxifene on endometrium, metabolic parameters, vasomotor symptoms, adverse events, and quality of life. Samples will be collected for population pharmacokinetic (PK) analysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1742 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicenter, Double Blind, Randomized, Placebo and Raloxifene Controlled Study to Assess Safety and Efficacy of TSE-424 (Bazedoxifene Acetate) in the Prevention of Postmenopausal Osteoporosis|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||July 2004|
|Actual Study Completion Date :||September 2004|
- The percent change from baseline in lumbar spine bone mineral density (BMD) after 24 months. [ Time Frame: 24 months ]
- Additional BMD evaluation including total hip, femoral neck and trochanter at months 6, 12, 18 and 24. Serum bone markers at months 3, 6, 9, 12, 18 and 24. Lipid panel at months 3, 6, 12, 18 and 24. [ Time Frame: Up to 24 months ]
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): NCT00481169
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|