Rheumatoid Arthritis and Osteosarcopenia: Associated Factors

NCT06889415 | Recruiting

• 1 other identifier: KBEAH-FTR-İK-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Our study is a cross-sectional study, and its aim is to compare and analyze the prevalence of sarcopenia and osteoporosis in patients with rheumatoid arthritis (RA) with a control group and to reveal the impact of sarcopenia on osteoporosis, fall risk, and fracture risk. This prospective cross-sectional study will include 100 rheumatoid arthritis patients and 100 healthy controls, matched for age and sex. Patients will be consecutively and meticulously enrolled based on inclusion and exclusion criteria. A detailed medical history and examination will be performed on the patients, and their clinical and sociodemographic characteristics will be recorded. Blood tests for RA (RF, Anti-Cyclic Citrullinated Peptide (anti-CCP), CRP, ESR) and disease activity levels (DAS28) will be recorded. The prevalence of osteosarcopenia will be assessed in both the RA and healthy control groups.These groups will be evaluated using various scales and tests (including power, performance tests) including musculoskeletal ultrasonographic measurements and clinical functional assessment tests. he sarcopenic group will be categorized based on the level of sarcopenia, according to the new ISarcoPRM criteria (non-sarcopenic, dynapenic, sarcopenic, and severe sarcopenic). Osteosarcopenia will be evaluated for both groups, and the collected data will be analyzed with primary and secondary outcomes. The analysis will explore the potential relationships between rheumatoid inflammation, sarcopenia, and osteoporosis.

Conditions

Osteosarcopenia; Rheumatoid Arthritis (RA); Sarcopenia

Keywords

osteosarcopenia; sarcopenia; Ultrasonography; rheumatoid arthritis

Outcome Measures

Primary Outcomes (3)

• Sarcopenia assessment

  According to the ISarcoPRM (2021) diagnostic algorithm and the reference values based on its threshold, participants were categorized into sarcopenia groups (no sarcopenia, dynapenia, sarcopenia, severe sarcopenia).

  baseline

• Osteoporosis assessment/dual-energy X-ray absorptiometry

  Dual-energy X-ray absorptiometry (DXA) measurements will be reviewed. In the lumbar spine, femoral neck, or total femur; a T score ≥ -1.0 is considered normal, -1 \> T score \> -2.5 is osteopenia, and T score ≤ -2.5 is defined as osteoporosis.

  baseline

• Balance and Gait Assessment Scale

  This scale is an important tool to evaluate the individual's functional status and daily living activities. The scale consists of a maximum of 16 points for balance and a maximum of 12 points for walking, for a total of 28 points. Individuals who score 26 or below on the scale are thought to have a problem; For those with scores of 19 or below, it is observed that the risk of self-falling increases fivefold compared to normal individuals.

  baseline

Secondary Outcomes (8)

• Fracture Risk Assessment Tool (FRAX)

  baseline

• Health Assessment Questionnaire, HAQ

  baseline

• Handgrip Strength Test

  baseline

• chair rise test

  baseline

• Anterior Thigh Muscle Thickness Measurement

  baseline

Study Arms (2)

rheumatoid arthritis grups

It includes females and males over the age of 50 who meet the RA diagnostic criteria according to the ACR/EULAR 2010 criteria.

Diagnostic Test: Osteosarcopenia in Patients with Rheumatoid Arthritis

healty control grups

It includes females and males over the age of 50 who do not meet the exclusion criteria.

Diagnostic Test: Osteosarcopenia in Healthy Control Group

Interventions

Osteosarcopenia in Patients with Rheumatoid Arthritis DIAGNOSTIC_TEST

The prevalence of osteosarcopenia will be examined in this group. Sarcopenia will be categorized into 4 groups. Both the prevalence of osteosarcopenia and the subgroups of sarcopenia will be compared with the healthy control group. Through this comparison, we will explain the relationship between sarcopenia and osteoporosis, the factors affecting this relationship, and the changes in fall and fracture risk using various questionnaires and tests.

rheumatoid arthritis grups

Osteosarcopenia in Healthy Control Group DIAGNOSTIC_TEST

The prevalence of osteosarcopenia will be examined in this group. Sarcopenia will be categorized into 4 groups. The relationship between sarcopenia and osteoporosis, the factors affecting this relationship, and the risk of falls and fractures will be evaluated using various questionnaires and tests.

healty control grups

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include consecutively 100 patients with RA aged 50 and over, who have been diagnosed according to the ACR/EULAR 2010 classification criteria (who have visited the Physical Medicine and Rehabilitation and Rheumatology outpatient clinics) and 100 age- and gender-matched healthy control subjects.

You may qualify if:

• Being diagnosed with RA according to the ACR/EULAR 2010 criteria
• Being a female or male over the age of 50
• Having the mental and physical capacity to complete the study questionnaires and tests
• Providing voluntary consent to participate in the study by signing the Informed Consent Form

You may not qualify if:

• Having an acute illness/disability or significant cognitive impairment that prevents understanding and performing the required tests
• Having thyroid or parathyroid disease, uncontrolled diabetes, Cushing's syndrome, anemia.
• History of malignancy
• Severe cardiovascular disease, enal failure, advanced-stage COPD, decompensated liver disease
• History of gastrointestinal (GIS) surgery
• Having another coexisting autoimmune/inflammatory rheumatic disease (e.g., SLE, Ankylosing Spondylitis, etc.), psoriatic arthritis, vasculitis, familial Mediterranean fever...)
• Having severe/symptomatic hand osteoarthritis and/or deformities
• Severe/symptomatic osteoarthritis in the knee, lumbar, hip, or ankle region
• Having Carpal Tunnel Syndrome, De Quervain, lateral epicondylitis, cubital tunnel syndrome or a history of traumatic hand injury
• Having a significant neurological disease, stroke, MS, myopathy, Parkinson's disease, radiculopathy/polyneuropathy/brachial plexopathy or others nerve root compressions
• History of surgical intervention on the upper and lower extremities or spine
• Having severe kyphosis or scoliosis
• Having any others disease causing balance disorders (neurological, orthopedic, metabolic, etc.)
• Having a major/significant psychiatric disorder (based on the medical history, and hospital records)
• Current use of androgens or estrogens

Sponsors & Collaborators

• Konya Beyhekim Training and Research Hospital: lead

Study Sites (1)

Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic

Konya, Selçuklu, 42000, Turkey (Türkiye)

RECRUITING

Related Publications (18)

• Kucukdeveci AA, Sahin H, Ataman S, Griffiths B, Tennant A. Issues in cross-cultural validity: example from the adaptation, reliability, and validity testing of a Turkish version of the Stanford Health Assessment Questionnaire. Arthritis Rheum. 2004 Feb 15;51(1):14-9. doi: 10.1002/art.20091.

  PMID: 14872450 BACKGROUND

• Çifçili S, Ünalan PC. Yaşlılarda fonksiyonel kayıplara yaklaşım. Turkish Journal of Family Practice. 2004;8(4):166-73

  BACKGROUND

• Ozcakar L, Kara M, Chang KV, Bayram Carli A, Hung CY, Tok F, Wu CH, Akkaya N, Hsiao MY, Tekin L, Wang TG, Ulasli AM, Chen WS, De Muynck M. EURO-MUSCULUS/USPRM. Basic Scanning Protocols for Ankle and foot. Eur J Phys Rehabil Med. 2015 Oct;51(5):647-53. Epub 2015 Sep 8.

  PMID: 26351106 BACKGROUND

• Chiu YH, Liao CL, Chien YH, Wu CH, Ozcakar L. Sonographic evaluations of the skeletal muscles in patients with Pompe disease. Eur J Paediatr Neurol. 2023 Jan;42:22-27. doi: 10.1016/j.ejpn.2022.12.002. Epub 2022 Dec 6.

  PMID: 36508847 BACKGROUND

• van Riel PL, Renskers L. The Disease Activity Score (DAS) and the Disease Activity Score using 28 joint counts (DAS28) in the management of rheumatoid arthritis. Clin Exp Rheumatol. 2016 Sep-Oct;34(5 Suppl 101):S40-S44. Epub 2016 Oct 18.

  PMID: 27762189 BACKGROUND

• Pinheiro PA, Passos TD, Coqueiro Rda S, Fernandes MH, Barbosa AR. [Motor performance of the elderly in northeast Brazil: differences with age and sex]. Rev Esc Enferm USP. 2013 Feb;47(1):128-36. doi: 10.1590/s0080-62342013000100016. Portuguese.

  PMID: 23515812 BACKGROUND

• Maggio M, Ceda GP, Ticinesi A, De Vita F, Gelmini G, Costantino C, Meschi T, Kressig RW, Cesari M, Fabi M, Lauretani F. Instrumental and Non-Instrumental Evaluation of 4-Meter Walking Speed in Older Individuals. PLoS One. 2016 Apr 14;11(4):e0153583. doi: 10.1371/journal.pone.0153583. eCollection 2016.

  PMID: 27077744 BACKGROUND

• 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 BACKGROUND

• Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.

  PMID: 34121127 BACKGROUND

• 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 BACKGROUND

• Adami G, Saag KG. Osteoporosis Pathophysiology, Epidemiology, and Screening in Rheumatoid Arthritis. Curr Rheumatol Rep. 2019 May 23;21(7):34. doi: 10.1007/s11926-019-0836-7.

  PMID: 31123839 BACKGROUND

• Torii M, Hashimoto M, Hanai A, Fujii T, Furu M, Ito H, Uozumi R, Hamaguchi M, Terao C, Yamamoto W, Uda M, Nin K, Morita S, Arai H, Mimori T. Prevalence and factors associated with sarcopenia in patients with rheumatoid arthritis. Mod Rheumatol. 2019 Jul;29(4):589-595. doi: 10.1080/14397595.2018.1510565. Epub 2018 Sep 11.

  PMID: 30092163 BACKGROUND

• Kanis JA. Diagnosis of osteoporosis and assessment of fracture risk. Lancet. 2002 Jun 1;359(9321):1929-36. doi: 10.1016/S0140-6736(02)08761-5.

  PMID: 12057569 BACKGROUND

• Cruz-Jentoft AJ, Landi F, Schneider SM, Zuniga C, Arai H, Boirie Y, Chen LK, Fielding RA, Martin FC, Michel JP, Sieber C, Stout JR, Studenski SA, Vellas B, Woo J, Zamboni M, Cederholm T. Prevalence of and interventions for sarcopenia in ageing adults: a systematic review. Report of the International Sarcopenia Initiative (EWGSOP and IWGS). Age Ageing. 2014 Nov;43(6):748-59. doi: 10.1093/ageing/afu115. Epub 2014 Sep 21.

  PMID: 25241753 BACKGROUND

• Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

  PMID: 20392703 BACKGROUND

• 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 BACKGROUND

• Haugeberg G, Uhlig T, Falch JA, Halse JI, Kvien TK. Bone mineral density and frequency of osteoporosis in female patients with rheumatoid arthritis: results from 394 patients in the Oslo County Rheumatoid Arthritis register. Arthritis Rheum. 2000 Mar;43(3):522-30. doi: 10.1002/1529-0131(200003)43:33.0.CO;2-Y.

  PMID: 10728744 BACKGROUND

• Aletaha D, Smolen JS. Diagnosis and Management of Rheumatoid Arthritis: A Review. JAMA. 2018 Oct 2;320(13):1360-1372. doi: 10.1001/jama.2018.13103.

  PMID: 30285183 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Sarcopenia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• İlhan ç KAYA

  Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ilhan ç KAYA

CONTACT

09005377889686; icaglar.kaya@gmail.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 21, 2025
• Study Start: August 15, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)