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Clinical Trials in Turkey / NCT06889415
Recruiting Observational

Rheumatoid Arthritis and Osteosarcopenia: Associated Factors

NCT06889415 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2023-08-15
Last updated
2025-07-10

Condition(s) studied

OsteosarcopeniaRheumatoid Arthritis (RA)Sarcopenia

Investigational drug(s) / intervention(s)

Osteosarcopenia in Patients with Rheumatoid ArthritisOsteosarcopenia in Healthy Control Group

Osteosarcopenia in Patients with Rheumatoid Arthritis: The prevalence of osteosarcopenia will be examined in this group. Sarcopenia will be categorized into 4 groups. Both the prevalence of osteosarcopenia and the subgroups of sarcopenia will be compared with the healthy control group. Through this comparison, we will explain the relationship between sarcopenia and osteoporosis, the factors affecting this relationship, and the changes in fall and fracture risk using various questionnaires and tests.

Osteosarcopenia in Healthy Control Group: The prevalence of osteosarcopenia will be examined in this group. Sarcopenia will be categorized into 4 groups. The relationship between sarcopenia and osteoporosis, the factors affecting this relationship, and the risk of falls and fractures will be evaluated using various questionnaires and tests.

Study 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

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic Konya Selçuklu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06889415 on ClinicalTrials.gov ↗ ← All trials in Turkey