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

Phase 2

Recruiting

• Conditions: D008180; systemic lupus erythematosus

• Registration Number: JPRN-jRCTs071180052
• Lead Sponsor: akashima Yasuharu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

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

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

(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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Safety of test drugs administration<br>2. Risk factors of osteonecrosis of the femoral head