Rheumatoid Arthritis and Osteosarcopenia: Associated Factors
Recruiting · NCT06889415 · Observational (researchers observe without assigning treatment) · Lead sponsor: Konya Beyhekim Training and Research Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Our study is a cross-sectional study, and its aim is to compare and analyze the prevalence of sarcopenia and osteoporosis in patients with rheumatoid arthritis (RA) with a control group and to reveal the impact of sarcopenia on osteoporosis, fall risk, and fracture risk. This prospective cross-sectional study will include 100 rheumatoid arthritis patients and 100 healthy controls, matched for age and sex. Patients will be consecutively and meticulously enrolled based on inclusion and exclusion criteria. A detailed medical history and examination will be performed on the patients, and their clinical and sociodemographic characteristics will be recorded. Blood tests for RA (RF, Anti-Cyclic Citrullinated Peptide (anti-CCP), CRP, ESR) and disease activity levels (DAS28) will be recorded. The prevalence of osteosarcopenia will be assessed in both the RA and healthy control groups.These groups will be evaluated using various scales and tests (including power, performance tests) including musculoskeletal ultrasonographic measurements and clinical functional assessment tests. he sarcopenic group will be categorized based on the level of sarcopenia, according to the new ISarcoPRM criteria (non-sarcopenic, dynapenic, sarcopenic, and severe sarcopenic). Osteosarcopenia will be evaluated for both groups, and the collected data will be analyzed with primary and secondary outcomes. The analysis will explore the potential relationships between rheumatoid inflammation, sarcopenia, and osteoporosis.
Who can take part
Inclusion criteria
- Being diagnosed with RA according to the ACR/EULAR 2010 criteria
- Being a female or male over the age of 50
- Having the mental and physical capacity to complete the study questionnaires and tests
- Providing voluntary consent to participate in the study by signing the Informed Consent Form
Exclusion criteria
- Having an acute illness/disability or significant cognitive impairment that prevents understanding and performing the required tests
- Having thyroid or parathyroid disease, uncontrolled diabetes, Cushing's syndrome, anemia.
- History of malignancy
- Severe cardiovascular disease, enal failure, advanced-stage COPD, decompensated liver disease
- History of gastrointestinal (GIS) surgery
- Having another coexisting autoimmune/inflammatory rheumatic disease (e.g., SLE, Ankylosing Spondylitis, etc.), psoriatic arthritis, vasculitis, familial Mediterranean fever...)
- Having severe/symptomatic hand osteoarthritis and/or deformities
- Severe/symptomatic osteoarthritis in the knee, lumbar, hip, or ankle region
- Having Carpal Tunnel Syndrome, De Quervain, lateral epicondylitis, cubital tunnel syndrome or a history of traumatic hand injury
- Having a significant neurological disease, stroke, MS, myopathy, Parkinson's disease, radiculopathy/polyneuropathy/brachial plexopathy or others nerve root compressions
- History of surgical intervention on the upper and lower extremities or spine
- Having severe kyphosis or scoliosis
- Having any others disease causing balance disorders (neurological, orthopedic, metabolic, etc.)
- Having a major/significant psychiatric disorder (based on the medical history, and hospital records)
- Current use of androgens or estrogens
- Having prostheses, being fully dependent, or immobilized
Where it is running
2 locations listed.
- Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic - Konya, Selçuklu, Turkey (Türkiye)
- Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic - Konya, Selçuklu, Turkey (Türkiye)