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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141323
First Posted: September 1, 2005
Last Update Posted: August 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ligand Pharmaceuticals
  Purpose
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
Osteoporosis Drug: lasofoxifene Other: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
placebo
Experimental: lasofoxifene 0.25 mg/day Drug: lasofoxifene
0.25 mg once per day, orally

  Eligibility

Information from the National Library of Medicine

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141323


  Show 201 Study Locations
Sponsors and Collaborators
Ligand Pharmaceuticals
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information