Osteosarcopenia in Axial Spondyloarthritis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAnkara University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Age- and gender-matched healthy participants (age 18-65)

Disqualifiers

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)

Trial population

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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

97 Participants
are grouped into 1 trial group
Group A: Axial Spondyloarthritis (AxSpA)

Trial outcomes

Primary outcomes

1

Presence of osteosarcopenia

presence of osteoporosis and sarcopenia (probable, confirmed, severe)

Time frame
16 months

Secondary outcomes

1

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
2

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

Other outcomes

1

Bath Ankylosing Spondylitis Disease Activity Index

Disease activity. Scoring 0-10, higher score indicates higher disease activity

Time frame
16 months
2

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
3

Bath Ankylosing Spondylitis Metrology Index

Spinal mobility. Scoring 0-10, higher score indicates worse spinal mobility.

Time frame
16 months
4

Modified Stoke Ankylosing Spondylitis Spinal Score

Radiological involvement. Scoring 0-72, higher score indicates more advanced radiological involvement.

Time frame
16 months

Sponsors and contacts

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