Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

This study has been completed.
Sponsor:
Information provided by:
Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00141323
First received: August 30, 2005
Last updated: August 8, 2011
Last verified: August 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • New cases of breast cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • New non-vertebral fractures [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   60 Years to 80 Years
Genders 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
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 ClinicalTrials.gov identifier: NCT00141323

  Show 202 Study Locations
Sponsors and Collaborators
Ligand Pharmaceuticals
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Ligand Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Project Management, Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00141323     History of Changes
Other Study ID Numbers: A2181002
Study First Received: August 30, 2005
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 29, 2014