NCT06577350 Osteosarcopenia in Axial Spondyloarthritis
| NCT ID | NCT06577350 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ankara University |
| Condition | Axial Spondyloarthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 97 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2025-01 |
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 97 participants in total. It began in 2023-09-01 with a primary completion date of 2025-01.
⚠ 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
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.
Eligibility Criteria
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: 1. Systemic high-dose steroid use (\>5mg/day of prednisone for more than 3 months) 2. Possible other causes of secondary sarcopenia (uncontrolled diabetes, chronic heart failure, thyroid/parathyroid disease, chronic renal failure, chronic liver failure) 3. Hand-related disorders/diseases that could affect the healthy assessment of grip strength 4. Use of any medication that could potentially affect the bone metabolism (bisphosphonates, teriparatide, anticonvulsants, heparin, and anticoagulants) 5. Psoriasis, inflammatory bowel disease 6. Infection in the thigh area where ultrasonographic evaluation will be performed 7. Body weight over 100 kg (contraindication to be positioned in the BMD device) 8. Presence of malnutrition (individuals scoring 11 or below on the Mini Nutritional Assessment-Short Form (MNA))
Contact & Investigator
Ayşe A Küçükdeveci, MD
PRINCIPAL INVESTIGATOR
Ankara University, Medical Faculty
Frequently Asked Questions
Who can join the NCT06577350 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Axial Spondyloarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06577350 currently recruiting?
Yes, NCT06577350 is actively recruiting participants. Contact the research team at ayse.kucukdeveci@gmail.com for enrollment information.
Where is the NCT06577350 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT06577350 clinical trial?
NCT06577350 is sponsored by Ankara University. The principal investigator is Ayşe A Küçükdeveci, MD at Ankara University, Medical Faculty. The trial plans to enroll 97 participants.