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To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60 mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasofoxifene 0.25 mg | Experimental | lasofoxifene 0.25 mg/day |
|
| raloxifene | Active Comparator | raloxifene 60 mg/day |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lasofoxifene | Drug | lasofoxifene 0.25mg |
| |
| raloxifene |
| Measure | Description | Time Frame |
|---|---|---|
| Spine BMD after 2 years | Lumbar Spine Bome Mineral Density | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year | Direct low density lipoprotein cholesterol (LDL-C) at 24 months, vaginal pH at 24 months, vaginal epithelial parabasal cells at 12 months, and total hip BMD at 24 months. | Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 months |
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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 | Albany | California | 94706 | United States | ||
| Pfizer Investigational Site |
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| Drug |
raloxifene 60 mg/day |
|
| Placebo | Drug | 0 mg/day |
|
| Berkeley |
| California |
| 94705 |
| United States |
| Pfizer Investigational Site | La Jolla | California | 92037 | United States |
| Pfizer Investigational Site | La Jolla | California | 92093-0659 | United States |
| Pfizer Investigational Site | Oakland | California | 94609 | United States |
| Pfizer Investigational Site | Oakland | California | 94612 | United States |
| Pfizer Investigational Site | Palo Alto | California | 94304 | United States |
| Pfizer Investigational Site | Poway | California | 92064 | United States |
| Pfizer Investigational Site | San Diego | California | 92103 | United States |
| Pfizer Investigational Site | San Diego | California | 92123 | United States |
| Pfizer Investigational Site | San Diego | California | 92128 | United States |
| Pfizer Investigational Site | Newark | Delaware | 19713-2094 | United States |
| Pfizer Investigational Site | Brandon | Florida | 33511-5964 | United States |
| Pfizer Investigational Site | Gainesville | Florida | 32605 | United States |
| Pfizer Investigational Site | Gainesville | Florida | 32607 | United States |
| Pfizer Investigational Site | Key Largo | Florida | 33037 | United States |
| Pfizer Investigational Site | Lake Worth | Florida | 33461 | United States |
| Pfizer Investigational Site | Leesburg | Florida | 34748 | United States |
| Pfizer Investigational Site | Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Miami | Florida | 33173 | United States |
| Pfizer Investigational Site | Miami | Florida | 33176 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33607 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33613-3946 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33614-7118 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30308 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60610 | United States |
| Pfizer Investigational Site | Des Moines | Iowa | 50309 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67207 | United States |
| Pfizer Investigational Site | Portland | Maine | 04102 | United States |
| Pfizer Investigational Site | Bethesda | Maryland | 20817 | United States |
| Pfizer Investigational Site | Gaithersberg | Maryland | 20886 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48201 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48236 | United States |
| Pfizer Investigational Site | Southfield | Michigan | 48034 | United States |
| Pfizer Investigational Site | Arden Hills | Minnesota | 55112 | United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | 55415-1226 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87106 | United States |
| Pfizer Investigational Site | Akron | Ohio | 44312-1647 | United States |
| Pfizer Investigational Site | Akron | Ohio | 44314 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44195 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97213 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97220 | United States |
| Pfizer Investigational Site | Monessen | Pennsylvania | 15062 | United States |
| Pfizer Investigational Site | Mosessen | Pennsylvania | 15062 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Pfizer Investigational Site | West Reading | Pennsylvania | 19611 | United States |
| Pfizer Investigational Site | Wyomissing | Pennsylvania | 19610-2132 | United States |
| Pfizer Investigational Site | Wyomissing | Pennsylvania | 19610 | United States |
| Pfizer Investigational Site | Chattanooga | Tennessee | 37403 | United States |
| Pfizer Investigational Site | Chattanooga | Tennessee | 37412 | United States |
| Pfizer Investigational Site | Cordova | Tennessee | 38018 | United States |
| Pfizer Investigational Site | Germantown | Tennessee | 38138 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38119 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | American Fork | Utah | 84003 | United States |
| Pfizer Investigational Site | Pleasant Grove | Utah | 84062 | United States |
| Pfizer Investigational Site | Provo | Utah | 84064 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84102 | United States |
| Pfizer Investigational Site | West Jordan | Utah | 84088 | United States |
| Pfizer Investigational Site | Chesapeake | Virginia | 23320 | United States |
| Pfizer Investigational Site | Norfolk | Virginia | 23502 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23221 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23225 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23229 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23294 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23454 | United States |
| Pfizer Investigational Site | Virginia Beach | Virginia | 23454 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98104 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98144 | United States |
| 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 |
| D020849 | Raloxifene Hydrochloride |
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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