Investigation of corticosteroid-induced osteonecrosis of the femoral head

JRCT ID: jRCTs032230443

Registered date:10/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic lupus erythematosus, dermatomyositis/polymyositis, ANCA-associated vasculitis
• Date of first enrollment: 10/11/2023
• Target sample size: 65
• Study type: Interventional
• Intervention(s): contrast-enhanced MRI

Outcome(s)

• Primary Outcome: No primary endpoint for exploratory study

Secondary Outcome

Efficacy endpoints
1) Evaluation of blood flow in the femoral head before, 4 weeks after, and 6 months after the start of corticosteroid treatment in patients with autoimmune diseases
2) Degree of change in blood flow in the femoral head before and 4 weeks after the start of corticosteroids and prediction of onset of osteonecrosis of the femoral head 6 months after the start of corticosteroids
3) Extraction of factors related to changes in femoral head blood flow and osteonecrosis of the femoral head
4) Incidence of femoral head necrosis by disease
5) Comparison of quantitative assessment of osteonecrosis of femoral head and femoral head blood flow between IVIM-MRI and contrast-enhanced MRI
6) Analysis of femoral head blood flow in patients with non-autoimmune diseases and comparison with patients with autoimmune diseases
Safety endpoints
1) Incidence rate of adverse events
2) Incidence rate of equipment failure

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

For patients with autoimmune disorders, the following criteria apply for inclusion:
1) Age at the time of consent is 18 years or older.
2) Patients who are newly diagnosed with autoimmune diseases (systemic lupus erythematosus, dermatomyositis/polymyositis, ANCA-associated vasculitis) and are scheduled to initiate corticosteroid therapy.
3) Patients receiving a daily dose of adrenal corticosteroids equivalent to or greater than 0.5 mg/kg/day of prednisolone.
4) Patients who have been adequately informed about their participation in this trial and have provided written consent prior to the commencement of the trial.

For patients without autoimmune disorders, the following criteria apply for inclusion:
1) Age at the time of consent is between 18 and 70 years.
2) Patients without autoimmune disorders who have hip joint conditions.
3) Patients who have been adequately informed about their participation in this trial and have provided written consent prior to the commencement of the trial.

Exclude criteria

Individuals meeting any of the following conditions will not be eligible for inclusion in both the group of patients with autoimmune disorders and the group of patients without autoimmune disorders:
1) Patients with a history of continuous adrenal corticosteroid administration for more than 3 weeks (local administration such as inhaled steroids, topical steroids, steroid eye drops, joint injections, etc., are not considered).
2) Patients with a history of excessive alcohol consumption (approximately equivalent to an average of 100g or more of pure alcohol per day).
3)Patients with congenital coagulation abnormalities.
4)Patients who are pregnant, may be pregnant, within 28 days postpartum, or breastfeeding.
5) Patients undergoing dialysis or with chronic kidney disease (eGFR less than 30 mL/min/1.73 m^2).
6) Patients unable to undergo MRI examinations.
7) Other patients deemed unsuitable for participation in this trial by the principal investigator or collaborating physicians due to safety concerns.

Related Information

• Primary Sponsor: Nakajima Hiroshi
• Source(s) of Monetary Support: Clinical Research Initiation-Fund (of Chiba University Hospital)