Osteoporosis Clinical Trial
— CORALOfficial title:
Double-Blind Placebo-Controlled Trial Of The Safety, Toleration and Efficacy Of Lasofoxifene 0.25 Mg/D and Raloxifene 60Mg/D For The Prevention Of Bone Loss In Postmenopausal Women
| Verified date | August 2011 |
| Source | Ligand Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 540 |
| Est. completion date | October 2005 |
| Est. primary completion date | October 2005 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 48 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings Exclusion Criteria: - Presence of metabolic bone disease, fractures, blood clots, or recent cancer. - Any use of selective estrogen receptor modulators, investigational drugs, or recent use of osteoporosis treatments, certain hormones, or medication for blood clots or seizures. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Akron | Ohio |
| United States | Pfizer Investigational Site | Akron | Ohio |
| United States | Pfizer Investigational Site | Albany | California |
| United States | Pfizer Investigational Site | Albuquerque | New Mexico |
| United States | Pfizer Investigational Site | Albuquerque | New Mexico |
| United States | Pfizer Investigational Site | American Fork | Utah |
| United States | Pfizer Investigational Site | Arden Hills | Minnesota |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Berkeley | California |
| United States | Pfizer Investigational Site | Bethesda | Maryland |
| United States | Pfizer Investigational Site | Brandon | Florida |
| United States | Pfizer Investigational Site | Chattanooga | Tennessee |
| United States | Pfizer Investigational Site | Chattanooga | Tennessee |
| United States | Pfizer Investigational Site | Chesapeake | Virginia |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Cordova | Tennessee |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Des Moines | Iowa |
| United States | Pfizer Investigational Site | Detroit | Michigan |
| United States | Pfizer Investigational Site | Detroit | Michigan |
| United States | Pfizer Investigational Site | Gainesville | Florida |
| United States | Pfizer Investigational Site | Gainesville | Florida |
| United States | Pfizer Investigational Site | Gaithersberg | Maryland |
| United States | Pfizer Investigational Site | Germantown | Tennessee |
| United States | Pfizer Investigational Site | Key Largo | Florida |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | Lake Worth | Florida |
| United States | Pfizer Investigational Site | Leesburg | Florida |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Monessen | Pennsylvania |
| United States | Pfizer Investigational Site | Mosessen | Pennsylvania |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | Newark | Delaware |
| United States | Pfizer Investigational Site | Norfolk | Virginia |
| United States | Pfizer Investigational Site | Oakland | California |
| United States | Pfizer Investigational Site | Oakland | California |
| United States | Pfizer Investigational Site | Palo Alto | California |
| United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
| United States | Pfizer Investigational Site | Pleasant Grove | Utah |
| United States | Pfizer Investigational Site | Portland | Maine |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Poway | California |
| United States | Pfizer Investigational Site | Provo | Utah |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Southfield | Michigan |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Virginia Beach | Virginia |
| United States | Pfizer Investigational Site | West Jordan | Utah |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| United States | Pfizer Investigational Site | West Reading | Pennsylvania |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Wyomissing | Pennsylvania |
| United States | Pfizer Investigational Site | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Ligand Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Spine BMD after 2 years | Lumbar Spine Bome Mineral Density | 2 years | |
| Secondary | 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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