Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)
- Registration Number
- NCT00141323
- Lead Sponsor
- Ligand Pharmaceuticals
- 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 in women with osteoporosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 8556
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - lasofoxifene 0.25 mg/day lasofoxifene - lasofoxifene 0.5 mg/day lasofoxifene -
- Primary Outcome Measures
Name Time Method New cases of breast cancer 5 years New morphometric vertebral fractures 3 years New non-vertebral fractures 5 years
- Secondary Outcome Measures
Name Time Method 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 5 years
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Northwood, Middlesex, United Kingdom