Osteosarcopenia in Axial Spondyloarthritis

NCT06577350 | Recruiting

• 1 other identifier: I11-681-21
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Axial Spondyloarthritis; Ankylosing Spondylitis; Axial Spondyloarthritis, Non-Radiographic; Osteoporosis; Sarcopenia; Osteosarcopenia

Keywords

Axial Spondyloarthritis; Ankylosing Spondylitis; Non-Radiographic Axial Spondyloarthritis; Osteoporosis; Sarcopenia; Osteosarcopenia

Outcome Measures

Primary Outcomes (1)

• Presence of osteosarcopenia

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

  16 months

Secondary Outcomes (2)

• Presence of osteoporosis

  16 months

• Presence of sarcopenia

  16 months

Other Outcomes (7)

• Bath Ankylosing Spondylitis Disease Activity Index

  16 months

• Ankylosing Spondylitis Disease Activity Score

  16 months

• Bath Ankylosing Spondylitis Metrology Index

  16 months

Study Arms (1)

Axial Spondyloarthritis (AxSpA)

Participants with Axial Spondyloarthritis (AxSpA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)
• Psoriasis, inflammatory bowel disease
• Infection in the thigh area where ultrasonographic evaluation will be performed
• Body weight over 100 kg (contraindication to be positioned in the BMD device)
• Presence of malnutrition (individuals scoring 11 or below on the Mini Nutritional Assessment-Short Form (MNA))

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Hospitals, Department of Physical Medicine and Rehabilitation

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (16)

• Sieper J, Braun J, Dougados M, Baeten D. Axial spondyloarthritis. Nat Rev Dis Primers. 2015 Jul 9;1:15013. doi: 10.1038/nrdp.2015.13.

  PMID: 27188328 RESULT

• Kameda H, Kobayashi S, Tamura N, Kadono Y, Tada K, Yamamura M, Tomita T. Non-radiographic axial spondyloarthritis. Mod Rheumatol. 2021 Mar;31(2):277-282. doi: 10.1080/14397595.2020.1830512. Epub 2020 Oct 12.

  PMID: 32996809 RESULT

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

  PMID: 30312372 RESULT

• Zhao SS, Robertson S, Reich T, Harrison NL, Moots RJ, Goodson NJ. Prevalence and impact of comorbidities in axial spondyloarthritis: systematic review and meta-analysis. Rheumatology (Oxford). 2020 Oct 1;59(Suppl4):iv47-iv57. doi: 10.1093/rheumatology/keaa246.

  PMID: 33053193 RESULT

• Magrey MN, Lewis S, Asim Khan M. Utility of DXA scanning and risk factors for osteoporosis in ankylosing spondylitis-A prospective study. Semin Arthritis Rheum. 2016 Aug;46(1):88-94. doi: 10.1016/j.semarthrit.2016.03.003. Epub 2016 Mar 9.

  PMID: 27162010 RESULT

• Klingberg E, Lorentzon M, Mellstrom D, Geijer M, Gothlin J, Hilme E, Hedberg M, Carlsten H, Forsblad-d'Elia H. Osteoporosis in ankylosing spondylitis - prevalence, risk factors and methods of assessment. Arthritis Res Ther. 2012 May 8;14(3):R108. doi: 10.1186/ar3833.

  PMID: 22569245 RESULT

• Carter S, Lories RJ. Osteoporosis: a paradox in ankylosing spondylitis. Curr Osteoporos Rep. 2011 Sep;9(3):112-5. doi: 10.1007/s11914-011-0058-z.

  PMID: 21647573 RESULT

• Barone M, Viggiani MT, Anelli MG, Fanizzi R, Lorusso O, Lopalco G, Cantarini L, Di Leo A, Lapadula G, Iannone F. Sarcopenia in Patients with Rheumatic Diseases: Prevalence and Associated Risk Factors. J Clin Med. 2018 Dec 1;7(12):504. doi: 10.3390/jcm7120504.

  PMID: 30513782 RESULT

• El Maghraoui A, Ebo'o FB, Sadni S, Majjad A, Hamza T, Mounach A. Is there a relation between pre-sarcopenia, sarcopenia, cachexia and osteoporosis in patients with ankylosing spondylitis? BMC Musculoskelet Disord. 2016 Jul 11;17:268. doi: 10.1186/s12891-016-1155-z.

  PMID: 27401188 RESULT

• Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.

  PMID: 32941253 RESULT

• Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 1994 Dec;21(12):2286-91.

  PMID: 7699630 RESULT

• van der Heijde D, Lie E, Kvien TK, Sieper J, Van den Bosch F, Listing J, Braun J, Landewe R; Assessment of SpondyloArthritis international Society (ASAS). ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis. 2009 Dec;68(12):1811-8. doi: 10.1136/ard.2008.100826. Epub 2008 Dec 5.

  PMID: 19060001 RESULT

• Yanik B, Gursel YK, Kutlay S, Ay S, Elhan AH. Adaptation of the Bath Ankylosing Spondylitis Functional Index to the Turkish population, its reliability and validity: functional assessment in AS. Clin Rheumatol. 2005 Feb;24(1):41-7. doi: 10.1007/s10067-004-0968-6. Epub 2004 Sep 8.

  PMID: 15365877 RESULT

• van der Heijde D, Landewe R, Feldtkeller E. Proposal of a linear definition of the Bath Ankylosing Spondylitis Metrology Index (BASMI) and comparison with the 2-step and 10-step definitions. Ann Rheum Dis. 2008 Apr;67(4):489-93. doi: 10.1136/ard.2007.074724. Epub 2007 Aug 29.

  PMID: 17728332 RESULT

• Creemers MC, Franssen MJ, van't Hof MA, Gribnau FW, van de Putte LB, van Riel PL. Assessment of outcome in ankylosing spondylitis: an extended radiographic scoring system. Ann Rheum Dis. 2005 Jan;64(1):127-9. doi: 10.1136/ard.2004.020503. Epub 2004 Mar 29.

  PMID: 15051621 RESULT

• Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.

  PMID: 22018588 RESULT

Related Links

• Kanis, J. A. "Assessment of osteoporosis at the primary health-care level. Technical Report." http://www. shef. ac. uk/FRAX (2008).
• Wenker KJ, Quint JM. Ankylosing Spondylitis.

MeSH Terms

Conditions

Axial Spondyloarthritis; Spondylitis, Ankylosing; Non-Radiographic Axial Spondyloarthritis; Osteoporosis; Sarcopenia

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Bone Diseases, Metabolic; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Ayşe A Küçükdeveci, MD

  Ankara University, Medical Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe A Küçükdeveci, MD

CONTACT

+90 312 5082850; ayse.kucukdeveci@gmail.com

İsmail Aksu, MD

CONTACT

+90 312 5082822; draksuismail@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: September 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)