Trials / Completed
CompletedNCT00141323
Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)
PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 8,556 (estimated)
- Sponsor
- Ligand Pharmaceuticals · Industry
- Sex
- Female
- Age
- 60 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lasofoxifene | 0.5 mg once per day, orally |
| OTHER | placebo | placebo |
| DRUG | lasofoxifene | 0.25 mg once per day, orally |
Timeline
- Start date
- 2001-11-01
- Primary completion
- 2007-12-01
- Completion
- 2007-12-01
- First posted
- 2005-09-01
- Last updated
- 2011-08-15
Locations
201 sites across 32 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Costa Rica, Croatia, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Lithuania, Mexico, Norway, Poland, Romania, Russia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT00141323. Inclusion in this directory is not an endorsement.