Control of steroid-associated osteonecrosis of the femoral head in SLE patients

Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - None

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071180052

Enrollment

150

Registered

2019-03-15

Start date

2014-12-26

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. Clopidogrel Bisulfate (Plavix) Taking a dose of 300mg once daily o

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 the 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: (1) Objectives have never had corticosteroid treatment before the entry to the trial. (2) Objectives have never been affected with osteonecrosis of the femoral head. (3) Patients with any active bleeding lesion. (4) Patients with any active infection. (5) Patients have any contraindication to candidate drugs for prevention. (6) Patients have any past histories of anaphylaxis to test drugs for prevention. (7) Female in pregnancy, lactation period, having a possibility of pregnancy. (8) Patients taking below contraindicative drugs. 1. antiplatelet drugs expect clopidogrel 2. anticoagulant 3. fibrates 4. cyclosporine (9) Patients that have a contraindication for MRI. (10) Patients that are considered unsuitable for the entry to the trial.

Design outcomes

Primary

Measure	Time frame
The incidence of osteonecrosis of the femoral head on MRI of hip joints within six months after the initial test drugs administration.	—

Secondary

Measure	Time frame
1. Safety of test drugs administration 2. Risk factors of osteonecrosis of the femoral head	—

Contacts

Public ContactGoro Motomura

Department of Orthopaedic Surgery, Kyushu University

goromoto@ortho.med.kyushu-u.ac.jp+81-92-642-5487

Outcome results

None listed

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