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The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lasofoxifene 0.5 mg/day | Experimental |
| |
| placebo | Placebo Comparator |
| |
| lasofoxifene 0.25 mg/day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lasofoxifene | Drug | 0.5 mg once per day, orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| New morphometric vertebral fractures | 3 years | |
| New cases of breast cancer | 5 years | |
| New non-vertebral fractures | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events | 3 years | |
| All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events |
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Inclusion Criteria:
Postmenopausal at least 5 years; Screening bone mineral density more than or equal to 2.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.
Exclusion Criteria:
Metabolic bone disease other than osteoporosis; Taking approved medications for osteoporosis; Have had a recent osteoporotic fracture (within 1 year) and/or have a bone mineral density more than 4.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.
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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 | Birmingham | Alabama | 35205 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20937977 | Derived | Ensrud K, LaCroix A, Thompson JR, Thompson DD, Eastell R, Reid DM, Vukicevic S, Cauley J, Barrett-Connor E, Armstrong R, Welty F, Cummings S. Lasofoxifene and cardiovascular events in postmenopausal women with osteoporosis: Five-year results from the Postmenopausal Evaluation and Risk Reduction with Lasofoxifene (PEARL) trial. Circulation. 2010 Oct 26;122(17):1716-24. doi: 10.1161/CIRCULATIONAHA.109.924571. Epub 2010 Oct 11. | |
| 20181970 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| placebo |
| Other |
placebo |
|
| lasofoxifene | Drug | 0.25 mg once per day, orally |
|
| 5 years |
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Pfizer Investigational Site | La Jolla | California | 92037 | United States |
| Pfizer Investigational Site | La Jolla | California | 92093-0659 | United States |
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| Derived |
| Cummings SR, Ensrud K, Delmas PD, LaCroix AZ, Vukicevic S, Reid DM, Goldstein S, Sriram U, Lee A, Thompson J, Armstrong RA, Thompson DD, Powles T, Zanchetta J, Kendler D, Neven P, Eastell R; PEARL Study Investigators. Lasofoxifene in postmenopausal women with osteoporosis. N Engl J Med. 2010 Feb 25;362(8):686-96. doi: 10.1056/NEJMoa0808692. |
| 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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