Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
Phase 3
Completed
- Conditions
- PostmenopauseOsteoporosis
- Registration Number
- NCT00384072
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to placebo on bone mineral density after 6 months of therapy in a population of postmenopausal Asian women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 500
Inclusion Criteria
-
Generally healthy Asian women 45 years of age or older who are at least 1 year postmenopausal
-
Subjects must qualify for one of the following categories (a or b):
- Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors
- Equal or greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (values of -1 and -2.5 are acceptable) with at least one osteoporosis risk factor
Exclusion Criteria
- One (1) or more osteoporotic vertebral fractures (T4 - L4)
- BMD T-score at the lumbar spine or femoral neck less than -2.5
- Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
- Secondary Outcome Measures
Name Time Method Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months Serum bone markers at 3 and 6 months Lipid profile at 3 and 6 months