Status:
COMPLETED
Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Postmenopause
Osteoporosis
Eligibility:
FEMALE
45+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00384072
Start Date
May 1 2006
End Date
September 1 2007
Last Update
December 28 2007
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing, China, 100700
2
Beijing, China, 100730
3
Nanjing, China, 210008
4
Shanghai, China, 100730