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関節リウマチと骨肉骨骨:関連因子

2026年10月2日 更新者:ilhan çağlar kaya、Konya Beyhekim Training and Research Hospital

関節リウマチ患者における骨肉球減少症の頻度と、サルコペニア腫症の関係に影響する要因

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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (実際)

201

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Selçuklu
      • Konya、Selçuklu、トルコ(Türkiye)、42000
        • Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:ECOLOGIC_OR_COMMUNITY
  • 時間の展望:CROSS_SECTIONAL

コホートと介入

グループ/コホート
介入・治療
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Sarcopenia assessment
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Fracture Risk Assessment Tool (FRAX)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:İlhan ç KAYA、Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年8月15日

一次修了 (実際)

2025年11月30日

研究の完了 (実際)

2025年11月30日

試験登録日

最初に提出

2025年3月3日

QC基準を満たした最初の提出物

2025年3月16日

最初の投稿 (実際)

2025年3月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月5日

QC基準を満たした最後の更新が送信されました

2026年10月2日

最終確認日

2025年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • KBEAH-FTR-İK-01

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