Osteosarcopenia in Axial Spondyloarthritis

August 28, 2024 updated by: Ayşe A Küçükdeveci, MD, Ankara University

The Frequency of Osteosarcopenia and Its Relationship With Demographic and Clinical Factors in Axial Spondyloarthritis

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Ankara University Hospitals, Department of Physical Medicine and Rehabilitation
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ayşe A Küçükdeveci, MD
        • Sub-Investigator:
          • İsmail Aksu, MD
        • Sub-Investigator:
          • Aysun Genç, MD
        • Sub-Investigator:
          • Atilla Elhan, PhD
        • Sub-Investigator:
          • Metin Kır, MD
        • Sub-Investigator:
          • Şebnem Ataman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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))

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Axial Spondyloarthritis (AxSpA)
Participants with Axial Spondyloarthritis (AxSpA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of osteosarcopenia
Time Frame: 16 months
presence of osteoporosis and sarcopenia (probable, confirmed, severe)
16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of osteoporosis
Time Frame: 16 months
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
Time Frame: 16 months
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

Outcome Measure
Measure Description
Time Frame
Bath Ankylosing Spondylitis Disease Activity Index
Time Frame: 16 months
Disease activity. Scoring 0-10, higher score indicates higher disease activity
16 months
Ankylosing Spondylitis Disease Activity Score
Time Frame: 16 months
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
Time Frame: 16 months
Spinal mobility. Scoring 0-10, higher score indicates worse spinal mobility.
16 months
Modified Stoke Ankylosing Spondylitis Spinal Score
Time Frame: 16 months
Radiological involvement. Scoring 0-72, higher score indicates more advanced radiological involvement.
16 months
Bath Ankylosing Spondylitis Functional Index
Time Frame: 16 months
Functional status. Scoring 0-10, higher score indicates more physical disability.
16 months
International Physical Activity Questionnaire-short form
Time Frame: 16 months
Physical activity level. Scored as 3 categories: 1 inactive, 2 minimally active, 3 active
16 months
Sonographic Thigh Adjustment Ratio
Time Frame: 16 months
Regional muscle mass measurement
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Ayşe A Küçükdeveci, MD, Ankara University, Medical Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I11-681-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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