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Rheumatoid Arthritis and Osteosarcopenia: Associated Factors

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 3 entries Show 7 more changesShow less
    • Trial completed
    • Enrollment target: estimated 200 to confirmed 201
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 16 of 18 entries
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06889415
Lead Sponsor Konya Beyhekim Training and Research Hospital
Conditions
(from sponsor)		 Osteosarcopenia, Rheumatoid Arthritis (RA), Sarcopenia
Related terms Arthritis, Rheumatoid, Sarcopenia
Enrollment 201 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov