Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus

Phase 2

Recruiting

• Conditions: Systemic lupus erythematosus

• Registration Number: JPRN-UMIN000008230
• Lead Sponsor: Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-22
• Study Completion: 2016-08-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

A. Objectives have never had corticosteroid treatment before the entry to the trial. B. Objectives have never been affected with osteonecrosis of the femoral head. C. Patients with any active bleeding lesion. D. Patients with any active infection. E. Patients have any contraindication to candidate drugs for the prevention. F. Patients have any past histories of anaphylaxis to candidate drugs for the prevention. G. Female in pregnancy, lactation period, having a possibility of pregnancy. H. Patients taking below contraindicative drugs. 1. antiplatelet drugs expect clopidogrel 2. anticoagulant 3. cyclosporine 4. fibrates I. Patients that have contraindication for MRI. J. Patients that are considered unsuitable for the entry to the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of osteonecrosis of the femoral head on MR imaging of hip joints within six months after the initial corticosteroid treatment.

Secondary Outcome Measures

Name	Time	Method
Safety of test drugs administration Risk factors of osteonecrosisis of the femoral head Symptomatic osteonecrosis at other than the femoral head