Status:
COMPLETED
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy
Lead Sponsor:
Tuen Mun Hospital
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Osteoporosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This study is a double-blind placebo-controlled trial evaluating the efficacy of raloxifene in the prevention of bone mineral density loss in patients receiving long term corticosteroids.
Eligibility Criteria
Inclusion
- Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.
- Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone \<= 10 mg/day or equivalent).
- Baseline bone mineral density (BMD) of the lumbar spine T score \< -1.0.
Exclusion
- Patients with a history of thromboembolism.
- Patients with positive antiphospholipid antibodies.
- History of allergic reactions or intolerance to raloxifene or other SERMs.
- Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.
- Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
- Patients with abnormal uterine bleeding of unknown etiology.
- Patients with serum creatinine level of \>= 200 umol/L.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00371956
Start Date
September 1 2006
End Date
February 1 2010
Last Update
September 16 2010
Active Locations (1)
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1
Tuen Mun Hospital
Hong Kong, China