Not Signed In -
Osteoporosis |
Bone Loss |
Clinical Trial: Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene (PEARL)
This study is no longer recruiting patients.
|
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 Drug: Placebo | Phase III |
MedlinePlus related topics: Osteoporosis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene
Further Study Details:
Primary Outcomes: New radiographic vertebral fractures at 3 years
Secondary Outcomes: All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events at 3 years
Expected Total Enrollment: 7500
Secondary Outcomes: All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events at 3 years
Expected Total Enrollment: 7500
Study start: November 2001
Eligibility
Ages Eligible for Study: 60 Years - 80 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Screening bone mineral density must be less than or equal to -2.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.
Exclusion Criteria:
Location Information
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A2181002
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00141323
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00141323
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- "Calcium Crisis" Affects American Youth (National Institute of Child Health and Human Development)
- Alcohol and Bone Health (National Institute of Arthritis and Musculoskeletal and Skin Diseases)
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