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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
History of Changes

August 30, 2005
August 8, 2011
November 2001
December 2007   (final data collection date for primary outcome measure)
  • 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 ]
New radiographic vertebral fractures at 3 years
Complete list of historical versions of study NCT00141323 on ClinicalTrials.gov Archive Site
  • 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 ]
All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events at 3 years
Not Provided
Not Provided
 
Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)
PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoporosis
  • Drug: lasofoxifene
    0.5 mg once per day, orally
  • Other: placebo
    placebo
  • Drug: lasofoxifene
    0.25 mg once per day, orally
  • Experimental: lasofoxifene 0.5 mg/day
    Intervention: Drug: lasofoxifene
  • Placebo Comparator: placebo
    Intervention: Other: placebo
  • Experimental: lasofoxifene 0.25 mg/day
    Intervention: Drug: lasofoxifene

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8556
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Female
60 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Costa Rica,   Croatia,   Denmark,   Egypt,   Estonia,   Finland,   France,   Germany,   Hong Kong,   Hungary,   India,   Ireland,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Mexico,   Norway,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Turkey,   United Kingdom
 
NCT00141323
A2181002
Yes
Director, Project Management, Ligand Pharmaceuticals
Ligand Pharmaceuticals
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Ligand Pharmaceuticals
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP