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

Phase 4

Completed

• Conditions: Osteoporosis
• Interventions: Drug: raloxifene; Drug: placebo

• Registration Number: NCT00371956
• Lead Sponsor: Tuen Mun Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-01
• Study First Submitted QC: 2006-09-01
• Study First Posted: 2006-09-04
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-15
• Last Update Posted: 2010-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	raloxifene	raloxifene
2	placebo	placebo arm

Primary Outcome Measures

Name	Time	Method
Bone turnover and bone mineral density	12 months

Secondary Outcome Measures

Name	Time	Method
Fracture, safety	12 months

Trial Locations

Locations (1)

Tuen Mun Hospital; 🇨🇳 Hong Kong, China