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

Raloxifene for prevention of bone loss in postmenopausal patients receiving chronic corticosteroid therapy: a randomized double-blind placebo-controlled study

Study Type: Interventional

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

Study Primary Completion Date: November 2009

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

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 <=10mg/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 >= 200umol/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  

Overall Contact: CC MOK, MD, FRCP  ccmok2006@gmail.com

Information obtained from ClinicalTrials.gov on October 10, 2008

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