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Artrite reumatoide e osteosarcopenia: fattori associati

2 ottobre 2026 aggiornato da: ilhan çağlar kaya, Konya Beyhekim Training and Research Hospital

La frequenza dell'osteosarcopenia nei pazienti con artrite reumatoide e i fattori che influenzano la relazione sarcopenia-osteoporosi

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Rheumatoid arthritis (RA) is a chronic, inflammatory joint disease that affects 5 out of 1,000 adults worldwide. The disease affects women 2 to 3 times more frequently than men and can occur at any age. The most common period for its onset is typically in the sixth decade (late 50s to 60s). In patients with rheumatoid arthritis, sarcopenia and osteopenia-osteoporosis are two commonly observed clinical conditions. Osteoporosis has been reported to be approximately twice as common in RA patients compared to the general population. The prevalence of osteoporosis in RA patients ranges from 6.3% to 36.3% in the hip region and from 12.3% to 38.9% in the spine region. Additionally, the prevalence of sarcopenia in RA patients is 21%.

Osteopenia/osteoporosis and sarcopenia are two commonly observed conditions in patients with rheumatoid arthritis (RA). Various factors increase the risk of sarcopenia in RA. These include reduced physical activity, increased levels of TNF-α and IL-1β, elevated energy expenditure at rest, increased CRP levels, and secondary immobility resulting from joint pain and stiffness.

Chronic inflammation in rheumatoid arthritis (RA) is known to increase osteoclast differentiation and suppress the osteogenesis process. In RA patients, the presence of antibodies against OPG, which inhibits RANKL, has been detected. Additionally, levels of Dickkopf-related protein 1 (DKK-1), which inhibits the Wnt signaling pathway, have been shown to be higher in the serum of RA patients compared to healthy controls. The prevalence of osteoporosis in rheumatoid arthritis patients has been reported to be more than twice that of the general population. For these reasons, the detection and prevention of osteosarcopenia in patients with rheumatoid arthritis should be considered an important comorbidity.

Sarcopenia is a syndrome characterized by the progressive and general loss of skeletal muscle mass and strength, carrying the risk of negative outcomes such as physical disability, low quality of life, and death. Although sarcopenia is typically associated with elderly individuals, it can also occur in younger individuals due to various diseases or conditions. Since its prevalence is higher in older adults compared to other age groups, it can also be referred to as a geriatric syndrome.

Various imaging methods such as computed tomography (CT), magnetic resonance imaging (MRI), dual-energy X-ray absorptiometry (DXA), bioimpedance analysis, and ultrasound can be used to determine muscle mass in the diagnosis of sarcopenia.

Osteoporosis is a systemic skeletal disease characterized by a decrease in bone mass and a deterioration of the structural integrity of bone tissue, which increases bone fragility and creates a risk of fractures. The World Health Organization (WHO) defines osteoporosis through measurements made using dual-energy X-ray absorptiometry (DXA). According to this definition, the T-score in the lumbar spine, femoral neck, or distal third of the radius is evaluated as follows: T-score ≥ -1.0 is normal, between -1.0 and -2.5 is osteopenia, and T-score ≤ -2.5 is considered osteoporosis. Additionally, if the T-score is below -2.5 and one or more osteoporotic fractures are present, this condition is referred to as established osteoporosis.

Sarcopenia is evaluated based on specific criteria. Although the information may change over time, it is important to consider muscle strength, muscle mass, and physical performance when diagnosing sarcopenia today.

Recently, the STAR study has been published, emphasizing the importance of regional muscle mass measurements in the diagnosis of sarcopenia. The study showed that the thickness of the anterior thigh muscle is the parameter that decreases the most with aging, and this measurement has a stronger correlation with height and BMI. In this regard, it is recommended to use the STAR value, obtained by dividing the anterior thigh muscle thickness measured by ultrasound by BMI, in the diagnosis of sarcopenia. The STAR threshold value has been set as <1.0 for women and <1.4 for men.

The formula is:

STAR = Anterior thigh muscle thickness (mm) / Body Mass Index (BMI) (kg/m²)

International Society of Physical and Rehabilitation Medicine, ISPRM (2021) has published a new sarcopenia diagnostic algorithm, which also includes the STAR study and ISarcoPRM recommends screening for all older adults and adults with RAS-associated disorders.

ISarcoPRM has set cut-off values of ≥12 seconds for the sit-to-stand test and <32 kg for grip strength in men and <19 kg in women to identify low muscle function. Initially, both tests are recommended. If low values are detected in either of these tests, the patient is considered to have "probable sarcopenia."

In individuals diagnosed with probable sarcopenia, it is recommended to measure the anterior thigh muscle thickness using ultrasound and calculate the STAR value. If the STAR value is below the threshold level determined by gender, the individual is classified as having "sarcopenia." Additionally, if the walking speed is ≤ 0.8 m/s and/or the individual cannot rise from a chair without support, this condition is defined as "severe sarcopenia."

If at least one of the patient's muscle function tests is low but the STAR value is normal, the patient is considered to have "dynapenia.

In our study, in addition to anterior thigh thickness, Achilles tendon thickness will also be measured. There is insufficient research explaining the relationship between Achilles tendon thickness and sarcopenia or osteoporosis. In this study, we will also investigate whether there is a relationship between Achilles tendon thickness and sarcopenia and/or osteoporosis.

There are few studies examining the relationship between RA, osteoporosis, and sarcopenia with heterogeneous methodologie. Therefore, the aim of this study is to evaluate the prevalence of osteosarcopenia in RA patients and control groups, and to investigate the impact of sarcopenia, along with the effects of inflammation, on osteoporosis, fall, and fracture risk. By evaluating sarcopenia according to the ISarcoPRM criteria, the study aims to address the gap in the literature with a unique and robust original methodologies.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

201

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Selçuklu
      • Konya, Selçuklu, Turchia (Türkiye), 42000
        • Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

Inclusion criteria:

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

Exclusion Criteria:

  1. Having an acute illness/disability or significant cognitive impairment that prevents understanding and performing the required tests
  2. Having thyroid or parathyroid disease, uncontrolled diabetes, Cushing's syndrome, anemia.
  3. History of malignancy
  4. Severe cardiovascular disease, enal failure, advanced-stage COPD, decompensated liver disease
  5. History of gastrointestinal (GIS) surgery

7-Having another coexisting autoimmune/inflammatory rheumatic disease (e.g., SLE, Ankylosing Spondylitis, etc.), psoriatic arthritis, vasculitis, familial Mediterranean fever...)

8-Having severe/symptomatic hand osteoarthritis and/or deformities

9-Severe/symptomatic osteoarthritis in the knee, lumbar, hip, or ankle region

10-Having Carpal Tunnel Syndrome, De Quervain, lateral epicondylitis, cubital tunnel syndrome or a history of traumatic hand injury

11-Having a significant neurological disease, stroke, MS, myopathy, Parkinson's disease, radiculopathy/polyneuropathy/brachial plexopathy or others nerve root compressions

12-History of surgical intervention on the upper and lower extremities or spine

13-Having severe kyphosis or scoliosis

14-Having any others disease causing balance disorders (neurological, orthopedic, metabolic, etc.)

15-Having a major/significant psychiatric disorder (based on the medical history, and hospital records)

16-Current use of androgens or estrogens

17-Having prostheses, being fully dependent, or immobilized

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: ECOLOGIC_OR_COMMUNITY
  • Prospettive temporali: CROSS_SECTIONAL

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.

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.

healty control grups

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

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sarcopenia assessment
Lasso di tempo: baseline

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
Lasso di tempo: baseline

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
Lasso di tempo: baseline

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fracture Risk Assessment Tool (FRAX)
Lasso di tempo: baseline

The Fracture Risk Assessment Tool (FRAX) will be calculated using the Turkish population version. The World Health Organization developed this web-based scoring system to assess the 10-year risk of hip fractures or major osteoporotic fractures based on fracture risk factors. According to the FRAX scoring system, treatment is recommended when the major osteoporotic fracture risk is 20% or higher, and the 10-year hip fracture risk is 3% or above.

baseline
Health Assessment Questionnaire, HAQ
Lasso di tempo: baseline

It can assess RA patients in all dimensions, such as disability and discomfort. It includes sections that evaluate disability with 20 questions, pain with one question, and global health status with one question. The disability index includes 8 areas that assess dressing and self-care, getting up, eating, walking, hygiene, reaching, grasping, and normal daily activities. Each section is scored individually, and the average of the 8 sections is recorded. This survey score ranges from 0 to 3. As the score increases, the health condition worsens.

baseline
Handgrip Strength Test
Lasso di tempo: baseline

According to the protocol recommended by the American Society of Hand Therapists in 1992, measurements will be taken while patients are seated, with the shoulder in neutral rotation and adduction, the elbow at 90° flexion, the forearm in a neutral position, and the wrist in 30 degrees of dorsiflexion. Patients will be instructed to squeeze the dynamometer with all their strength using similar words and tone. Grip strength will be measured for both hands. Measurements will be taken three times with 1-minute rest intervals, and the maximum value will be recorded. According to the ISarcoPRM (2021) diagnostic algorithm, values below <32 kg for men and <19 kg for women will be considered as reduced muscle strength.

baseline
chair rise test
Lasso di tempo: baseline

The five-time chair rise test is a measure used to assess lower extremity muscle strength. The patient will be asked to cross their arms over their chest and sit down and stand up from the chair five times as quickly as possible, with the time being recorded. If the time exceeds 12 seconds, it will be considered a reduction in muscle strength.

baseline
Anterior Thigh Muscle Thickness Measurement
Lasso di tempo: baseline

Participants will be evaluated while lying in a supine position, with their arms and legs extended and muscles relaxed. The measurement region will be selected as the midpoint between the anterior superior iliac spine and the upper pole of the patella. The ultrasound probe will be positioned in the axial plane at a 90-degree angle to the muscle extension. During imaging, measurements will be taken with a generous amount of gel applied, without any compression. The anterior thigh muscle thickness will be determined as the total thickness of the rectus femoris and vastus intermedius muscles, and the distance between the outer fascia of the rectus femoris and the femur periosteum will be used as the reference. Measurements will be repeated three times, and the average value will be recorded in mm. The noted muscle thickness will be divided by the participant's BMI to calculate the STAR value.

baseline
6-meter Walking Test
Lasso di tempo: baseline

The patient will be asked to walk a 6-meter distance at their normal walking speed, as in daily life. The time taken to complete the 6 meters will be recorded in seconds. The 6-meter walking speed will be calculated in meters per second (m/s), and speeds below 0.8 m/s will be considered as low walking speed.

baseline
Achilles tendon thickness measurement
Lasso di tempo: baseline

There is insufficient research explaining the relationship between Achilles tendon thickness and sarcopenia and osteoporosis. In this study, we will also examine whether there is a relationship between Achilles tendon thickness and sarcopenia and/or osteoporosis.

Participants will lie in a prone position with their feet hanging off the examination table. The tendon thickness will be measured axially (at the thickest point between the epitenons) at the level of the lateral malleolus.

baseline
VAS pain (pain intensity)
Lasso di tempo: baseline

A horizontal visual analog scale (VAS) will be used to assess the participants' pain levels. A 10 cm long line will be drawn on a blank paper, with the left end marked as "0" (no pain) and the right end marked as "10" (unbearable pain). Participants will be asked to indicate the intensity of their pain by marking an appropriate point on this line.

baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: İlhan ç KAYA, Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 agosto 2023

Completamento primario (Effettivo)

30 novembre 2025

Completamento dello studio (Effettivo)

30 novembre 2025

Date di iscrizione allo studio

Primo inviato

3 marzo 2025

Primo inviato che soddisfa i criteri di controllo qualità

16 marzo 2025

Primo Inserito (Effettivo)

21 marzo 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 ottobre 2026

Ultimo verificato

1 marzo 2025

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • KBEAH-FTR-İK-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .