PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene
Phase 3
60 Years
80 Years
60 Years
80 Years
Not Enrolling
Female
Osteoporosis
Female
Osteoporosis
Trial Information
PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
New morphometric vertebral fractures
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A2181002
NCT ID:
NCT00141323
Start Date:
November 2001
Completion Date:
December 2007
Related Keywords:
- Osteoporosis
- Osteoporosis
Name | Location |
|---|---|
| Pfizer Investigational Site | Birmingham, Alabama 35205 |
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Cedar Rapids, Iowa 52403 |
| Pfizer Investigational Site | Westminster, Maryland 21157 |
| Pfizer Investigational Site | Santa Fe, New Mexico 87505 |
| Pfizer Investigational Site | Eugene, Oregon 97401 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Omaha, Nebraska 68198 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
