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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bazedoxifene BZA-20 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For China, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Taiwan, medinfo@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 100700 | China | ||||
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| Beijing |
| 100730 |
| China |
| Nanjing | 210008 | China |
| Shanghai | 100730 | China |
| Shanghai | 200011 | China |
| Shanghai | 200040 | China |
| Tianjin | 200233 | China |
| Tianjin | 300052 | China |
| Tianjin | 300211 | China |
| Seoul | 110-744 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 133-792 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 138-736 | South Korea |
| Suwon | 443-721 | South Korea |
| Kaohsuing | 833 | Taiwan |
| Kaoshsuing | 807 | Taiwan |
| Tainan | 704 | Taiwan |
| Taipei | 100 | Taiwan |
| Tapei | 105 | Taiwan |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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