NCT06889415 Rheumatoid Arthritis and Osteosarcopenia: Associated Factors
| NCT ID | NCT06889415 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Konya Beyhekim Training and Research Hospital |
| Condition | Osteosarcopenia |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-08-15 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-08-15 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion criteria: 1. Being diagnosed with RA according to the ACR/EULAR 2010 criteria 2. Being a female or male over the age of 50 3. Having the mental and physical capacity to complete the study questionnaires and tests 4. Providing voluntary consent to participate in the study by signing the Informed Consent Form Exclusion Criteria: 1. Having an acute illness/disability or significant cognitive impairment that prevents understanding and performing the required tests 2. Having thyroid or parathyroid disease, uncontrolled diabetes, Cushing's syndrome, anemia. 3. History of malignancy 4. Severe cardiovascular disease, enal failure, advanced-stage COPD, decompensated liver disease 5. History of gastrointestinal (GIS) surgery 7-Having another coexisting autoimmune/inflammatory rheumatic disease (e.g., SLE, Ankylosing Spondylitis, etc.), psoriatic arthritis, vasculitis, familial Mediterranean fever...) 8-Having severe/symptomatic hand osteoarthritis and/or deformities 9-Severe/symptomatic osteoarthritis in the knee, lumbar, hip, or ankle region 10-Having Carpal Tunnel Syndrome, De Quervain, lateral epicondylitis, cubital tunnel syndrome or a history of traumatic hand injury 11-Having a significant neurological disease, stroke, MS, myopathy, Parkinson's disease, radiculopathy/polyneuropathy/brachial plexopathy or others nerve root compressions 12-History of surgical intervention on the upper and lower extremities or spine 13-Having severe kyphosis or scoliosis 14-Having any others disease causing balance disorders (neurological, orthopedic, metabolic, etc.) 15-Having a major/significant psychiatric disorder (based on the medical history, and hospital records) 16-Current use of androgens or estrogens 17-Having prostheses, being fully dependent, or immobilized
Contact & Investigator
İlhan ç KAYA
PRINCIPAL INVESTIGATOR
Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic
Frequently Asked Questions
Who can join the NCT06889415 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Osteosarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06889415 currently recruiting?
Yes, NCT06889415 is actively recruiting participants. Contact the research team at icaglar.kaya@gmail.com for enrollment information.
Where is the NCT06889415 trial being conducted?
This trial is being conducted at Konya, Turkey (Türkiye).
Who is sponsoring the NCT06889415 clinical trial?
NCT06889415 is sponsored by Konya Beyhekim Training and Research Hospital. The principal investigator is İlhan ç KAYA at Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic. The trial plans to enroll 200 participants.