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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008230

Enrollment

150

Registered

2012-06-22

Start date

2014-08-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Systemic lupus erythematosus

Interventions

Objectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment. 1. Clopidgrel Bisulfate (Plavix) Taking a dose of 300mg once daily on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Objectives must have been classified as systemic lupus erythematosus (SLE) based on the classification criteria of the American College of Rheumatology. (2) Objectives need a systemic corticosteroid treatment of a dose of equal to or more than 0.5mg/kg/day (converted to prednisolone dose) for SLE. (3) Objectives are hospitalized. (4) Objectives are age of 20 or more. (5) Objectives have consented to participate in the study after fully informed. (6) Objectives that the laboratory data meets all the following. i) Patients with more than 70,000/microL of platelets. ii) Patients with less than 100IU/L of AST or ALT. iii) Patients with more than 50ml/min of creatinine clearance.

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Safety of test drugs administration Risk factors of osteonecrosisis of the femoral head Symptomatic osteonecrosis at other than the femoral head	—

Countries

Japan

Contacts

Public ContactTakuaki Yamamoto

Graduate School of Medical Sciences, Kyushu University Department of Orthopaedic Surgery

yamataku@ortho.med.kyushu-u.ac.jp092-642-5488

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026