Status:
COMPLETED
Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)
Lead Sponsor:
Ligand Pharmaceuticals
Conditions:
Osteoporosis
Eligibility:
FEMALE
60-80 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
8556 Patients enrolled
Trial Details
Trial ID
NCT00141323
Start Date
November 1 2001
End Date
December 1 2007
Last Update
August 15 2011
Active Locations (201)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35216
3
Pfizer Investigational Site
La Jolla, California, United States, 92037
4
Pfizer Investigational Site
La Jolla, California, United States, 92093-0659