Examining Osteosarcopenia in Patients with Axial Spondyloarthritis
The Frequency of Osteosarcopenia and Its Relationship With Demographic and Clinical Factors in Axial Spondyloarthritis
This study looks at how common osteosarcopenia is in people with axial spondyloarthritis and checks if it relates to different health factors by measuring bone strength and muscle strength.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 97 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Ankara) |
| Trial ID | NCT06577350 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the prevalence of osteosarcopenia, which is the combination of osteoporosis and sarcopenia, in patients diagnosed with axial spondyloarthritis (AxSpA). It aims to explore the relationship between osteosarcopenia and various demographic and clinical factors in these patients. Participants will undergo bone mineral density measurements using Dual-energy X-ray absorptiometry (DXA) to assess osteoporosis, while sarcopenia will be evaluated through grip strength assessments. A control group of age- and gender-matched healthy individuals will also be included for comparison.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-65 with a diagnosis of axial spondyloarthritis, either ankylosing spondylitis or non-radiographic spondyloarthritis.
Not a fit: Patients with systemic high-dose steroid use or other conditions causing secondary sarcopenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of osteosarcopenia in AxSpA patients, potentially leading to improved management strategies for these conditions.
How similar studies have performed: While the specific combination of osteosarcopenia in AxSpA is less commonly studied, related research on osteoporosis and sarcopenia in inflammatory diseases has shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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))
Where this trial is running
Ankara
- Ankara University Hospitals, Department of Physical Medicine and Rehabilitation — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Ayşe A Küçükdeveci, MD — Ankara University, Medical Faculty
- Study coordinator: Ayşe A Küçükdeveci, MD
- Email: ayse.kucukdeveci@gmail.com
- Phone: +90 312 5082850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.