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non-randomized, controlled, non-autoimmune disease patient group, open-label study to examine the association between changes in femoral head blood flow and the occurrence of osteonecrosis of femoral head in patients with autoimmune disease treated with corticosteroids.

Investigation of corticosteroid-induced osteonecrosis of the femoral head

Nakajima Hiroshi

Chiba University Hospital

1-8-1 Inohana, Chuou-ku, Chiba-shi, Chiba

nakajimh@faculty.chiba-u.jp

Yasui Masahiro

Chiba University Hospital

1-8-1 Inohana, Chuou-ku, Chiba

+81-43-222-7171

m.yasu0302@chiba-u.jp

Recruiting

Nov. 10, 2023

Interventional

non-randomized controlled trial

open(masking not used)

no treatment control/standard of care control

single assignment

other

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.

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.

Both

Systemic lupus erythematosus, dermatomyositis/polymyositis, ANCA-associated vasculitis

contrast-enhanced MRI

Systemic lupus erythematosus, dermatomyositis/polymyositis, ANCA-associated vasculitis

contrast-enhanced MRI

D008180, D003882/D017285, D055953

D000081364

No primary endpoint for exploratory study

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

+81-43-226-2616

Nov. 06, 2023

none