Official Title: “Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-Blind Placebo-Controlled Study”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2010

Intervention(s) in this Clinical Trial

• Drug: raloxifene
  • 60mg/day
• Drug: placebo
  • tab 1 daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • raloxifene
• Placebo Comparator: 2
  • placebo arm

Primary Measures

• Bone turnover and bone mineral density
  • Time Frame: 12 months
    Safety Issue?: Yes

Secondary Measures

• Fracture, safety
  • Time Frame: 12 months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Tuen Mun Hospital

Overall Clinical Trial Officials and Contacts

CC MOK, MD, FRCP Principal Investigator Tuen Mun Hospital, Hong Kong  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00371956

Study ID Number: HARECCTR0500058

ClinicalTrials.gov Identifier: NCT00371956

Health Authority: Hong Kong: Ethics Committee