Osteosarcopenia in Axial Spondyloarthritis
Recruiting · NCT06577350 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ankara University
View the official record on ClinicalTrials.gov →What this trial is about
Axial spondyloarthritis is a chronic inflammatory disease affecting the spine, sacroiliac joints, entheses, and sometimes peripheral joints with a close link to HLAB27. Typical features include inflammatory back pain, limited spinal mobility, and sacroiliitis. The term axial spondyloarthritis (AxSpA) includes both Ankylosing Spondylitis (AS) where sacroiliitis is diagnosed by X-rays, and non-radiographic AxSpA, where sacroiliitis is diagnosed via magnetic resonance imaging (MRI). Osteoporosis is common in AS patients, and sarcopenia may also develop due to inflammation and immobilization. Osteosarcopenia, the co-occurrence of osteoporosis and sarcopenia, might have an impact on morbidity and mortality of AxSpA patients. This cross-sectional study aims to determine the frequency of osteosarcopenia in AxSpA patients and to investigate its relationship with various demographic and clinical factors. A control group with similar age and gender distribution will be recruited to evaluate osteosarcopenia. Our hypothesis is that osteosarcopenia will be more frequent in the AxSpA group compared to the control group. The study will also identify the demographic and clinical factors associated with osteosarcopenia in AxSpa.
Who can take part
Inclusion criteria
- Patient group:
- Participants with a diagnosis of AxSpA: Participants with diagnosis of Ankylosing Spondylitis according to the modified New York criteria and participants with diagnosis of non-radiographic Spondyloarthritis (SpA) according to the Assessment of SpondyloArthritis International Society (ASAS) 2009 criteria.
- Aged 18-65 years
- Who gave consent to participate in the study
- Healthy control group:
- Age- and gender-matched healthy participants (age 18-65)
- Who gave consent to participate in the study
Exclusion criteria
- Systemic high-dose steroid use (\>5mg/day of prednisone for more than 3 months)
- Possible other causes of secondary sarcopenia (uncontrolled diabetes, chronic heart failure, thyroid/parathyroid disease, chronic renal failure, chronic liver failure)
- Hand-related disorders/diseases that could affect the healthy assessment of grip strength
- Use of any medication that could potentially affect the bone metabolism (bisphosphonates, teriparatide, anticonvulsants, heparin, and anticoagulants)
- Psoriasis, inflammatory bowel disease
- Infection in the thigh area where ultrasonographic evaluation will be performed
- Body weight over 100 kg (contraindication to be positioned in the BMD device)
- Presence of malnutrition (individuals scoring 11 or below on the Mini Nutritional Assessment-Short Form (MNA))
Where it is running
1 location listed.
- Ankara University Hospitals, Department of Physical Medicine and Rehabilitation - Ankara, Turkey (Türkiye)