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

Osteoporosis Clinical Trial

Official title:

Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-blind Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371956
• Other study ID #: HARECCTR0500058
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2006
• Last updated: September 15, 2010
• Start date: September 2006
• Est. completion date: February 2010

Study information

• Verified date: September 2010
• Source: Tuen Mun Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
China	Tuen Mun Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Tuen Mun Hospital	Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone turnover and bone mineral density		12 months	Yes
Secondary	Fracture, safety		12 months	Yes