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

Rheumatoid Arthritis Clinical Trial

— RAFAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05269069
• Other study ID #: 2021_0845
• Secondary ID: 2021-A03187-34
• Status: Terminated
• Start date: August 17, 2022
• Est. completion date: April 2, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: April 2, 2024
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Obesity
• Rheumatoid Arthritis

Intervention

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)

Locations

Country	Name	City	State
France	Hop Salengro - Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Pfizer

Country where clinical trial is conducted

France, 

Outcome

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