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

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.
 
ClinicalTrials.gov Identifier: NCT00141323
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : August 15, 2011
Sponsor:
Information provided by:
Ligand Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: lasofoxifene Other: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8556 participants
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
Study Start Date : November 2001
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
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.


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


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Director, Project Management, Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00141323    
Other Study ID Numbers: A2181002
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: August 15, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases