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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs071180052
• Date of registration: 15/03/2019
• Prospective Registration: No
• Primary sponsor: Nakashima Yasuharu
• Public title: Control of steroid-associated osteonecrosis of the femoral head in SLE patients
• Scientific title: Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - None
• Date of first enrolment: 26/12/2014
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs071180052
• Study type: Interventional
• Study design: non-randomized controlled trial, open(masking not used), uncontrolled control, single assignment, prevention purpose
• Phase: 2

Contacts

• Name: Yasuharu Nakashima
• Affiliation: Department of Orthopaedic Surgery, Kyushu University

• Name: Goro Motomura
• Affiliation: Department of Orthopaedic Surgery, Kyushu University

Key inclusion & exclusion 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: (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.

Age minimum: >= 20age old
Age maximum: Not applicable
Gender: Both

Health Condition(s) or Problem(s) studied

D008180

systemic lupus erythematosus

Intervention(s)

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 on the first day, and a dose of 75mg once daily on subsequent days.
2. Pitavastatin Calcium (LIVALO)
Taking a dose of 2mg once daily.
3. Tocopherol Acetate (Juvela)
Taking a dose of 100mg three times daily (total of 300mg daily).

Primary Outcome(s)

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

Secondary Outcome(s)

1. Safety of test drugs administration
2. Risk factors of osteonecrosis of the femoral head

Ethics review

Status: Approval
Approval date: 25/02/2019
Contact:

[e-mail]

Kyushu University Certified Institutional Review Board for Clinical Trials

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