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

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.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Assessment of body composition, bone mineral density and bone marrow adiposity.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hop Salengro - Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with rheumatoid arthritis and controls

Description

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,

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with rheumatoid arthritis; patients with rheumatoid arthritis	Other: Assessment of body composition, bone mineral density and bone marrow adiposity.; DXA for body composition and bone mineral density, MRI for bone marrow adiposity and blood tests (leptine, CTX, P1NP)
Control group; healthy volunteers without rheumatoid arthritis matched for age, sex, BMI and menopausal status	Other: Assessment of body composition, bone mineral density and bone marrow adiposity.; DXA for body composition and bone mineral density, MRI for bone marrow adiposity and blood tests (leptine, CTX, P1NP)

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Pfizer
• Investigators: Principal Investigator: Jean-Guillaume LETARTOUILLY, MD, MSc, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): April 2, 2024
• Study Completion (Actual): April 2, 2024

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; Body composition; bone mineral density; visceral adiposity; marrow adiposity
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Obesity; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 2021_0845; 2021-A03187-34 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No