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

Tuen Mun Hospital1 site in 1 country114 target enrollmentSeptember 2006

ConditionsOsteoporosis

Interventionsraloxifene placebo

Drugsraloxifene placebo

Overview

Phase: Phase 4
Intervention: raloxifene
Conditions: Osteoporosis
Sponsor: Tuen Mun Hospital
Enrollment: 114
Locations: 1
Primary Endpoint: Bone turnover and bone mineral density
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

February 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Tuen Mun Hospital

Eligibility Criteria

Inclusion Criteria

•Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.
•Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone \<= 10 mg/day or equivalent).
•Baseline bone mineral density (BMD) of the lumbar spine T score \< -1.0.

Exclusion Criteria

•Patients with a history of thromboembolism.
•Patients with positive antiphospholipid antibodies.
•History of allergic reactions or intolerance to raloxifene or other SERMs.
•Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.
•Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
•Patients with abnormal uterine bleeding of unknown etiology.
•Patients with serum creatinine level of \>= 200 umol/L.