Overview

Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ligand Pharmaceuticals
Criteria
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.