JPRN-UMIN000008230
Recruiting
Phase 2
Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - Control of steroid-induced osteonecrosis of the femoral head in SLE patients
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University0 sites150 target enrollmentJune 22, 2012
ConditionsSystemic lupus erythematosus
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Systemic lupus erythematosus
- Sponsor
- Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
- Enrollment
- 150
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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