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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00371956

Enrollment

114

Registered

2006-09-04

Start date

2006-09-30

Completion date

2010-02-28

Last updated

2010-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

raloxifene, estrogen, receptor, modulation, osteoporosis, steroid, Steroids

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.

Interventions

DRUGraloxifene

60mg/day

DRUGplacebo

tab 1 daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Bone turnover and bone mineral density	12 months

Secondary

Measure	Time frame
Fracture, safety	12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026