Impact of Rheumatoid Arthritis on Body Composition, Bone Marrow Adiposity and Bone Mineral Density: a Case-control Study

Study Overview
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Brief Summary
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During rheumatoid arthritis (RA) (in comparison with control subjects), body composition is altered with a loss of lean body mass, bone mass and an accumulation of fat mass. Determination of total body fat and particularly its abdominal distribution (visceral adiposity) is important because of the cardiovascular (excess cardiovascular risk), metabolic (insulin resistance, diabetes and dyslipidemia) and bone (increased fracture risk) risks associated with this endocrine organ. Moreover, we do not have data concerning medullary adiposity in RA. This pilot case-control study will be compare body composition, bone marrow adiposity and bone mineral density in patients with RA versus healthy volunteers.

Official Title
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Impact of Rheumatoid Arthritis on Body Composition, Bone Marrow Adiposity and Bone Mineral Density: a Case-control Study

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Assessment of body composition, bone mineral density and bone marrow adiposity.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects: Males and females of age (age ≥ 18 years). Patients with RA according to American College of Rheumatology/EULAR 2010 criteria, Patients who have signed the informed consent Controls: Males and females of age (age ≥ 18 years). subjects who have signed the informed consent Exclusion Criteria: Patients who have received more than three anti-TNFinhibitors Patients who have previously received a Janus kinase (JAK) inhibitor Patients with concomitant therapies as described below : A combination with methotrexate is allowed if methotrexate is started ≥3 months before the start of the study and at a stable dosage (≤25 mg/week) for ≥4 weeks. A combination to conventional synthetic DMARDs (csDMARDs) other than methotrexate is not allowed within 4 weeks before and/or during the clinical trial Corticosteroid therapy >10mg/d prednisolone equivalent is not allowed Intra-articular injections of corticosteroids are allowed if their number is less than or equal to 4 Intravenous corticosteroid infusions are not allowed Immunosuppressants other than methotrexate are not allowed History or discovery of an osteoporotic fracture AND/OR T-score ≤-3 if ≥50 years old AND/OR Z-score ≤-3 if <50 years old during the screening phase, Corticosteroid therapy ≥ 10mg/d prednisolone equivalent, Pathologies or treatments affecting bone metabolism (breast cancer with antiaromatase, digestive malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism...), History of radiotherapy on the lumbar spine or the hip studied, Patients undergoing hormone replacement therapy (HRT) or patients already under anti-osteoporotic treatment (bisphosphonates, strontium ranelate, teriparatide or denosumab) apart from calcium and/or vitamin D supplementation, Chronic renal failure with creatinine clearance (CKD-EPI formula) ≤ 30 ml/min,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with rheumatoid arthritis<br> | Other: Assessment of body composition, bone mineral density and bone marrow adiposity.<br>* DXA for body composition and bone mineral density, MRI for bone marrow adiposity and blood tests (leptine, CTX, P1NP)<br>|
| Control group<br> | Other: Assessment of body composition, bone mineral density and bone marrow adiposity.<br>* DXA for body composition and bone mineral density, MRI for bone marrow adiposity and blood tests (leptine, CTX, P1NP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of visceral adiposity (VAT) in cm² at inclusion. | A whole body composition acquisition by dual energy x-ray absorptiometry (DXA) will calculate visceral adiposity | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of lean body mass (LBM) in kg |  | Baseline | 
| Measures of total body fat (TBF) in % |  | Baseline | 
| Bone mineral density (BMD) measurements (in mg/cm²) at the lumbar spine (L1-L4) and total non-dominant hip |  | Baseline | 
| Measurements of bone remodeling markers (CTX and P1NP) |  | Baseline | 
| Level of Leptin |  | Baseline | 
| Measurement of bone marrow adiposity (in %) at the lumbar spine |  | Baseline | 
| Short Physical Performance Battery (SPPB) |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body composition, rheumatoid arthritis, visceral adiposity, marrow adiposity, bone mineral density