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

NCT05269069 | Terminated

• 2 other identifiers: 2021_08452021-A03187-34
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

Body composition; rheumatoid arthritis; visceral adiposity; marrow adiposity; bone mineral density

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Patients with rheumatoid arthritis

patients with rheumatoid arthritis

Other: Assessment of body composition, bone mineral density and bone marrow adiposity.

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.

Interventions

Assessment of body composition, bone mineral density and bone marrow adiposity. OTHER

DXA for body composition and bone mineral density, MRI for bone marrow adiposity and blood tests (leptine, CTX, P1NP)

Control group; Patients with rheumatoid arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with rheumatoid arthritis and controls

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Lille: lead
• Pfizer: collaborator

Study Sites (1)

Hop Salengro - Chu Lille

Lille, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Bone Density

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jean-Guillaume LETARTOUILLY, MD, MSc

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 7, 2022
• Study Start: August 17, 2022
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

FR (1)