An observational study in Axial Spondyloarthritis, Ankylosing Spondylitis and Axial Spondyloarthritis, Non-Radiographic, sponsored by Ankara University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by Ankara University · Observational
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.
Ankylosing Spondylitis (AS) is a chronic inflammatory disease of unknown etiology that affects the spine, sacroiliac joints, entheses regions, and sometimes peripheral joints. Its typical findings include inflammatory back pain, limited spinal mobility, and radiographic sacroiliitis. The term axial spondyloarthritis (AxSpA) describes a chronic inflammatory disease affecting the axial skeleton, including the spine and sacroiliac joints. It encompasses both patients with definite AS diagnosis with radiographic (X-ray) sacroiliitis, and patients with non-radiographic AxSpA whose sacroiliitis detected by MRI. Osteoporosis is among the clinical findings of AS. Similarly, sarcopenia may develop in AS patients due to both inflammation and immobilization. Osteosarcopenia is a clinical syndrome that includes both osteoporosis and sarcopenia. Osteosarcopenia may be a significant cause of morbidity and mortality in AxSpA patients.
This study aims to determine the frequency of osteosarcopenia in patients with AxSpA and to investigate its relationship with demographic and various clinical parameters. To determine the presence of osteoporosis, bone mineral density (BMD) measurement will be performed using Dual-energy X-ray absorptiometry (DXA). WHO definition for the diagnosis of osteoporosis will be used. A T score at or below -2.5 at the lumbal and/or hip region is defined as osteoporosis. Subsequently, to determine the presence of sarcopenia, patients will be assessed according to the European Working Group on Sarcopenia in Older People (EWGSOP2) algorithm through measurements of muscle strength, muscle mass quantity or quality, and physical performance. Skeletal muscle mass or quality will be measured by appendicular skeletal muscle mass (ASM) using both DXA, and bioelectrical impedance analysis (BIA). Skeletal muscle strength will be measured by grip strength and physical performance by gait speed. EWGSOP2 cut-off points will be used for low muscle strength (grip strength), low muscle quantity (ASM/height2) and low physical performance (gait speed). Then the sarcopenia diagnosis (probable, confirmed, severe) will be made according to the 2018 operational definition of sarcopenia by EWGSOP2. A healthy control group with similar age and gender distribution will be recruited to evaluate osteosarcopenia and compare with the patient group. After determining the presence of osteosarcopenia in AxSpA, the relationship between osteosarcopenia (sarcopenia and osteoporosis) and demographic/clinical parameters including age, gender, physical activity, disease duration, medications used (biological vs. non-biological), disease activity, spinal mobility, radiological involvement, and functional status will be investigated.
There has been no prior study on investigating osteosarcopenia in AxSpA. We expect a higher frequency osteosarcopenia in the AxSpA group compared to the control group. Additionally, the relationship between osteosarcopenia and clinical parameters will be demonstrated, thus increasing the attention and awareness of patients at high risk for developing osteosarcopenia, and facilitating early steps in treatment.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's planned enrollment of 97 is below the median of 202 across 256 observational studies indexed under Spondylitis.
Browse Spondylitis studies →Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.
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The study will include participants with AxSpA aged 18-65 years who are being followed at the Department of Physical Medicine and Rehabilitation and the Division of Rheumatology at Ankara University Faculty of Medicine.
Age- and gender-matched healthy participants for control group will also be included. Control group will be selected from the relatives of outpatients or inpatients visiting the same clinic and from the hospital staff.
Before the study, all participants will be asked to read the study protocol and provide written informed consent to participate in the study.
Patient group:
Healthy control group:
Exclusion Criteria:
Participants with Axial Spondyloarthritis (AxSpA)
Presence of osteosarcopenia
presence of osteoporosis and sarcopenia (probable, confirmed, severe)
Time frame: 16 months
Presence of osteoporosis
Presence of osteoporosis will be determined by bone mineral density (BMD) measurement using Dual-energy X-ray absorptiometry (DXA). WHO definition for the diagnosis of osteoporosis will be used. A T score at or below -2.5 at the lumbal and/or hip region is defined as osteoporosis.
Time frame: 16 months
Presence of sarcopenia
Presence of sarcopenia will be determined by EWGSOP2 algorithm through measurements of muscle strength, muscle mass quantity or quality, and physical performance. Skeletal muscle mass or quality will be measured by appendicular skeletal muscle mass (ASM) using both DXA, and bioelectrical impedance analysis (BIA). Skeletal muscle strength will be measured by grip strength and physical performance by gait speed. EWGSOP2 cut-off points will be used for low muscle strength (grip strength), low muscle quantity (ASM/height2) and low physical performance (gait speed). Then the sarcopenia diagnosis (probable, confirmed, severe) will be made according to the 2018 operational definition of sarcopenia by EWGSOP2.
Time frame: 16 months
Bath Ankylosing Spondylitis Disease Activity Index
Disease activity. Scoring 0-10, higher score indicates higher disease activity
Time frame: 16 months
Ankylosing Spondylitis Disease Activity Score
Disease activity. Scored as 4 categories: 1 inactive, 2 low disease activity, 3 high disease activity, 4 very high disease activity
Time frame: 16 months
Bath Ankylosing Spondylitis Metrology Index
Spinal mobility. Scoring 0-10, higher score indicates worse spinal mobility.
Time frame: 16 months
Modified Stoke Ankylosing Spondylitis Spinal Score
Radiological involvement. Scoring 0-72, higher score indicates more advanced radiological involvement.
Time frame: 16 months
Bath Ankylosing Spondylitis Functional Index
Functional status. Scoring 0-10, higher score indicates more physical disability.
Time frame: 16 months
International Physical Activity Questionnaire-short form
Physical activity level. Scored as 3 categories: 1 inactive, 2 minimally active, 3 active
Time frame: 16 months
Sonographic Thigh Adjustment Ratio
Regional muscle mass measurement
Time frame: 16 months
Plan to share: No
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