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TerminatedNo phase

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