Impact of Rheumatoid Arthritis on Body Composition, Bone Marrow Adiposity and Bone Mineral Density: a Case-control Study
Key facts
- Who runs it
- University Hospital, Lille
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 52 people enrolled
- Started
- 17 Aug 2022
- Ended
- 2 Apr 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- Assessment of body composition, bone mineral density and bone marrow adiposity.
- Record updated
- 16 May 2024
- Why it stopped
- The sponsor decided to stop financing the study.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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,
- 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,
- Immunosuppressants other than methotrexate are not allowed
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Patients with rheumatoid arthritis
Treatment: 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
Treatment: Assessment of body composition, bone mineral density and bone marrow adiposity.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 16 May 2024