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

Sponsor

Tuen Mun Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00371956

Collaborator

Eli Lilly and Company (Industry)

114

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: raloxifene Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 raloxifene	Drug: raloxifene 60mg/day
Placebo Comparator: 2 placebo arm	Drug: placebo tab 1 daily

Arm

Intervention/Treatment

Active Comparator: 1

raloxifene

Drug: raloxifene

60mg/day

Placebo Comparator: 2

placebo arm

Drug: placebo

tab 1 daily

Outcome Measures

Primary Outcome Measures

Bone turnover and bone mineral density [12 months]

Secondary Outcome Measures

Fracture, safety [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.