Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00141323

Run by

Ligand Pharmaceuticals

People needed

8556

Starts

2001-11-01

Expected to finish

2007-12-01

Last updated by the study team

2011-08-15

Who can join

Age: 60 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — Palm Desert, California, United States
• Pfizer Investigational Site — Palm Springs, California, United States
• Pfizer Investigational Site — Palm Springs, California, United States
• Pfizer Investigational Site — Poway, California, United States
• Pfizer Investigational Site — Rancho Mirage, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Brandon, Florida, United States
• Pfizer Investigational Site — Leesburg, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — West Palm Beach, Florida, United States
• Pfizer Investigational Site — Des Plaines, Illinois, United States
• Pfizer Investigational Site — Morton Grove, Illinois, United States
• Pfizer Investigational Site — Des Moines, Iowa, United States
• Pfizer Investigational Site — Bethesda, Maryland, United States
• Pfizer Investigational Site — Montgomery Village, Maryland, United States
• Pfizer Investigational Site — Arden Hills, Minnesota, United States
• Pfizer Investigational Site — Minneapolis, Minnesota, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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