Osteosarcopenia in Axial Spondyloarthritis
NCT Number: NCT06577350
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Axial Spondyloarthritis|Ankylosing Spondylitis|Axial Spondyloarthritis, Non-Radiographic|Osteoporosis|Sarcopenia|Osteosarcopenia
Sponsor: Ankara University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 97
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2025-04
Locations: Ankara University Hospitals, Department of Physical Medicine and Rehabilitation, Ankara, 06230, Turkey

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.

Primary Outcome Measures: Presence of osteosarcopenia, presence of osteoporosis and sarcopenia (probable, confirmed, severe), 16 months
Secondary Outcome Measures: 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., 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., 16 months
Other Outcome Measures: Bath Ankylosing Spondylitis Disease Activity Index, Disease activity. Scoring 0-10, higher score indicates higher disease activity, 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, 16 months|Bath Ankylosing Spondylitis Metrology Index, Spinal mobility. Scoring 0-10, higher score indicates worse spinal mobility., 16 months|Modified Stoke Ankylosing Spondylitis Spinal Score, Radiological involvement. Scoring 0-72, higher score indicates more advanced radiological involvement., 16 months|Bath Ankylosing Spondylitis Functional Index, Functional status. Scoring 0-10, higher score indicates more physical disability., 16 months|International Physical Activity Questionnaire-short form, Physical activity level. Scored as 3 categories: 1 inactive, 2 minimally active, 3 active, 16 months|Sonographic Thigh Adjustment Ratio, Regional muscle mass measurement, 16 months