Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuen Mun Hospital
• Collaborator: Eli Lilly and Company
• Treatments: Raloxifene Hydrochloride

Criteria

Inclusion Criteria:

1. Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.

2. Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone <= 10 mg/day or equivalent).

3. Baseline bone mineral density (BMD) of the lumbar spine T score < -1.0.

Exclusion Criteria:

1. Patients with a history of thromboembolism.

2. Patients with positive antiphospholipid antibodies.

3. History of allergic reactions or intolerance to raloxifene or other SERMs.

4. Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.

5. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.

6. Patients with abnormal uterine bleeding of unknown etiology.

7. Patients with serum creatinine level of >= 200 umol/L.