Anticholinergic Drug Use in Patients With Rheumatoid Arthritis and Its Effects on Fracture Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Anticholinergic Cognitive Load (ACB)
研究概览
简要总结
Background: Rheumatoid arthritis (RA) is a chronic, progressive, inflammatory rheumatological disease. Use of corticosteroids for more than 3 months in RA treatment is considered an important risk factor in terms of developing secondary osteoporosis and increasing the risk of fracture. The cumulative effect of taking one or more drugs with anticholinergic properties is called anticholinergic load. It is stated that anticholinergic load also increases the risk of fracture in individuals. The aim of this study is to investigate the effects of drugs used by patients with Rheumatoid Arthritis (RA) on anticholinergic load and fracture risk. The Fracture Risk Assessment Tool (FRAX) will be used to assess fracture risk in patients.
Materials and methods: The study was planned as a prospective cohort study. The study will included 100 patients who were followed up as outpatients with rheumatoid arthritis diagnosis in the physical medicine and rehabilitation clinic between 2024-2025. Patients of both genders and over 18 years of age diagnosed with rheumatoid arthritis will be included in the study. Patients with systemic diseases or medications affecting bone metabolism and those with metallic materials in the hip or lumbar vertebrae affecting bone mineral density measurement will be excluded from the study. Demographic characteristics, systemic diseases, medications used, bone density measurement and blood test values of the patients will be recorded.
Patients taking multiple medications with anticholinergic effects create an anticholinergic burden. The Anticholinergic Drug Scale, Anticholinergic Cognitive Burden Scale and Anticholinergic Risk Scale will be used to measure anticholinergic burden in the study.
详细描述
It will be conducted in Balıkesir University, Faculty of Medicine, Health Practice and Research Hospital, Department of Physical Medicine and Rehabilitation.
The study planned to include patients with rheumatoid arthritis classified according to the 2010 American College of Rheumatology/European League Against Rheumatology (ACR/EULAR) criteria. The study will be conducted on patients diagnosed with rheumatoid arthritis and followed up in physical medicine and rehabilitation outpatient clinics.
Bone mineral density measurement (DEXA), urea, creatinine, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, calcium, phosphorus, thyroid stimulating hormone, free thyroxine, parathyroid hormone and 25-OH vitamin D levels in routine examinations of the patients within the last year and the medications used will be obtained from the patient files and recorded.
Patients taking multiple medications with anticholinergic effects create an anticholinergic burden. Several tools have been developed to estimate the cumulative effects of drugs with anticholinergic effects in individuals. They are based on either expert consensus, serum anticholinergic activity or pharmacological principles. The Anticholinergic Drug Scale, Anticholinergic Cognitive Burden Scale and Anticholinergic Risk Scale, which are widely used to measure anticholinergic burden, will be used in the study.
The Fracture Risk Assessment Tool (FRAX) will be used to assess fracture risk in patients. The University of Sheffield launched the FRAX tool in 2008 (Center for Metabolic Bone Diseases, University of Sheffield, UK).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with rheumatoid arthritis
排除标准
- •Kemik metabolizmasını etkileyen sistemik hastalıkları veya ilaçları kullanan hastalar,
- •Kemik mineral yoğunluk ölçümünü etkileyen kalça veya lomber vertebralarda metalik materyalleri olan hastalar
结局指标
主要结局
The Anticholinergic Cognitive Load (ACB)
时间窗: 1 week after the start of the study
The ACB score is a score that determines the impact of anticholinergic medications. ACB is a scale that was introduced in 2008 and is widely used to estimate anticholinergic burden and its relationship with cognitive impairment. ACB is the most easily accessible and most frequently used scale in practice. The scale scores between 0 and 3 according to the affinity of the drugs to muscarinic receptors and their effects on cognition. 0 is no burden; a score of 3 or above is considered high risk. The anticholinergic burden of 88 drugs is calculated in the ACB score.
The Anticholinergic Risk Scale (ARS)
时间窗: 1 week after the start of the study
The Anticholinergic Risk Scale (ARS) is used to estimate the extent to which a patient may be at risk for anticholinergic side effects that can lead to cognitive dysfunction and delirium. The ARS ranks medications for anticholinergic potential on a 3-point scale (0, no or low risk; 3, high anticholinergic potential). The ARS score for a patient is the sum of points for his or her number of medications.
次要结局
- The Fracture Risk Assessment Tool (FRAX)(1 week after the start of the study)
研究者
Bilal Uysal
Assistant professor
Balikesir University