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

Tuen Mun Hospital

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: raloxifene; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00371956

HARECCTR0500058

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

114 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

raloxifene

Treatment:

Drug: raloxifene

2

Placebo Comparator group

Description:

placebo arm

Treatment:

Drug: placebo