Anticholinergic Burden and Osteoporosis in Rheumatoid Arthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBalikesir University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with rheumatoid arthritis
Disqualifiers
Kemik metabolizmasını etkileyen sistemik hastalıkları veya ilaçları kullanan hastalar,
Kemik mineral yoğunluk ölçümünü etkileyen kalça veya lomber vertebralarda metalik materyalleri olan hastalar
Trial population
Patients diagnosed with rheumatoid arthritis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Anticholinergic load was calculated using anticholinergic cognitive load (ACB)
Other interventionBone mineral density was measured using a Dual Energy X-ray Absorptiometry (DEXA) device. Fracture Risk Assessed with Fracture Risk Assessment Tool (FRAX).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: group 11 intervention
Group B: group 21 intervention
Trial outcomes
Primary outcomes
1
The Anticholinergic Cognitive Load (ACB)
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.
Time frame
1 week after the start of the study2
The Anticholinergic Risk Scale (ARS)
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.
Time frame
1 week after the start of the studySecondary outcomes
1
The Fracture Risk Assessment Tool (FRAX)
The 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). It was developed by the FRAX® tool to assess fracture risk in patients. It is based on individual patient models combining fracture risk associated with clinical risk factors and femoral neck bone mineral density (BMD) measurement. FRAX® models were developed based on population-based cohort studies conducted in Europe, North America, Asia and Australia. FRAX® algorithms provide the 10-year probability of fracture. The result indicates the 10-year probability of having a hip fracture and a major osteoporotic fracture (clinical vertebral, forearm, hip or shoulder fracture).
Time frame
1 week after the start of the studySponsors and contacts
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Source ClinicalTrials.gov