Status:
COMPLETED
Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss
Lead Sponsor:
Ligand Pharmaceuticals
Conditions:
Osteoporosis
Eligibility:
FEMALE
48-75 years
Phase:
PHASE3
Brief Summary
To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60 mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.
Eligibility Criteria
Inclusion
- Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings
Exclusion
- Presence of metabolic bone disease, fractures, blood clots, or recent cancer.
- Any use of selective estrogen receptor modulators, investigational drugs, or recent use of osteoporosis treatments, certain hormones, or medication for blood clots or seizures.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00163137
Start Date
May 1 2003
End Date
October 1 2005
Last Update
August 12 2011
Active Locations (72)
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1
Pfizer Investigational Site
Albany, California, United States, 94706
2
Pfizer Investigational Site
Berkeley, California, United States, 94705
3
Pfizer Investigational Site
La Jolla, California, United States, 92037
4
Pfizer Investigational Site
La Jolla, California, United States, 92093-0659