NCT00371956CompletedPhase 4
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-blind Placebo-controlled Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Tuen Mun Hospital
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Bone turnover and bone mineral density
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
1
Active Comparator
raloxifene
Intervention: raloxifene (Drug)
2
Placebo Comparator
placebo arm
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Bone turnover and bone mineral density
Time Frame: 12 months
Secondary Outcomes
- Fracture, safety(12 months)
Investigators
Study Sites (1)
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