Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL) (PEARL)

This study has been completed.
Information provided by:
Ligand Pharmaceuticals Identifier:
First received: August 30, 2005
Last updated: August 8, 2011
Last verified: August 2011
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.

Condition Intervention Phase
Drug: lasofoxifene
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene

Resource links provided by NLM:

Further study details as provided by Ligand Pharmaceuticals:

Primary Outcome Measures:
  • New morphometric vertebral fractures [ Time Frame: 3 years ]
  • New cases of breast cancer [ Time Frame: 5 years ]
  • New non-vertebral fractures [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events [ Time Frame: 3 years ]
  • All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events [ Time Frame: 5 years ]

Estimated Enrollment: 8556
Study Start Date: November 2001
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lasofoxifene 0.5 mg/day Drug: lasofoxifene
0.5 mg once per day, orally
Placebo Comparator: placebo Other: placebo
Experimental: lasofoxifene 0.25 mg/day Drug: lasofoxifene
0.25 mg once per day, orally


Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00141323

  Show 201 Study Locations
Sponsors and Collaborators
Ligand Pharmaceuticals
Study Director: Pfizer Call Center Pfizer