RecruitingNCT06889415

Rheumatoid Arthritis and Osteosarcopenia: Associated Factors

The Frequency of Osteosarcopenia in Patients With Rheumatoid Arthritis and the Factors Affecting the Sarcopenia-osteoporosis Relationship


Sponsor

Konya Beyhekim Training and Research Hospital

Enrollment

200 participants

Start Date

Aug 15, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 50 Years

Inclusion Criteria4

  • 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 Criteria16

  • 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

Interventions

DIAGNOSTIC_TESTOsteosarcopenia 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.

DIAGNOSTIC_TESTOsteosarcopenia 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.


Locations(1)

Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic

Konya, Selçuklu, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06889415


Related Trials