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To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasofoxifene Dose 1 | Experimental | 0.05 mg |
|
| Lasofoxifene Dose 2 | Experimental | 0.25 mg |
|
| Lasofoxifene Dose 3 | Experimental | 0.5 mg |
|
| Placebo | Placebo Comparator | 0 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lasofoxifene | Drug | 0.05 mg tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment | Percent change from baseline in lumbar spine BMD at Month 12 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year | Percent change from baseline in lumbar spine BMD at Month 6, percent change in baseline in hip BMD at Month 6 and Month 12, percent change from baseline in bone metabolism markers at Month 6 and Month 12, percent change from baseline in serum lipids, total cholesterol, high-density lipoprotein cholesterol, triglycerides, lipoprotein (a), apoliporpotein-A1, apolipoprotein-B at Month 6 and Month 12 and incidence of new vertebral fractures at Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Fukuoka | Fukuoka | 810-0021 | Japan | ||
| Pfizer Investigational Site |
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| Drug |
0 mg |
|
| Lasofoxifene | Drug | 0.25 mg tablets |
|
| Lasofoxifene | Drug | 0.5 mg tablets |
|
| Month 6 and Month 12 |
| Kagoshima |
| Kagoshima-ken |
| 892-0824 |
| Japan |
| Pfizer Investigational Site | Kagoshima | Kagoshima-ken | 892-0845 | Japan |
| Pfizer Investigational Site | Miyazaki | Miyazaki | 880-0052 | Japan |
| Pfizer Investigational Site | Fuchū | Tokyo | 183-0051 | Japan |
| Pfizer Investigational Site | Kiyose | Tokyo | 204-0021 | Japan |
| Pfizer Investigational Site | Minato-ku | Tokyo | 106-0032 | Japan |
| Pfizer Investigational Site | Minato-ku | Tokyo | 108-0075 | Japan |
| Pfizer Investigational Site | Setagaya-ku | Tokyo | 157-0066 | Japan |
| Pfizer Investigational Site | Yonago-shi | Tottori | 683-8504 | Japan |
| Pfizer Investigational Site | Kangnam-ku | Seoul | 135-710 | South Korea |
| Pfizer Investigational Site | Sonpagu | Seoul | 138-736 | South Korea |
| Pfizer Investigational Site | Youngdeungpo-gu | Seoul | 150-713 | South Korea |
| Pfizer Investigational Site | Changhua | Taiwan |
| Pfizer Investigational Site | Taipei | 100 | Taiwan |
| Pfizer Investigational Site | Taoyun 333 | Taiwan |
| Pfizer Investigational Site |
| 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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| ID | Term |
|---|---|
| C111332 | Lasofoxifene |
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