Clinical trial NCT06812481: Anticholinergic Burden and Osteoporosis in Rheumatoid Arthritis
Official title: Anticholinergic Drug Use in Patients With Rheumatoid Arthritis and Its Effects on Fracture Risk
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rheumatoid Arthritis (RA)
Anticholinergic Adverse Reaction
Fractures, Bone
Keywords: Rheumatoid arthritis
anticholinergic load
risk of fracture
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with rheumatoid arthritis

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with rheumatoid arthritis

Exclusion Criteria:

* Kemik metabolizmasını etkileyen sistemik hastalıkları veya ilaçları kullanan hastalar,
* Kemik mineral yoğunluk ölçümünü etkileyen kalça veya lomber vertebralarda metalik materyalleri olan hastalar

Primary outcomes:
measure: The Anticholinergic Cognitive Load (ACB)
timeFrame: 1 week after the start of the study
measure: The Anticholinergic Risk Scale (ARS)
timeFrame: 1 week after the start of the study
Secondary outcomes:
measure: The Fracture Risk Assessment Tool (FRAX)
timeFrame: 1 week after the start of the study
Other outcomes:
Locations:
city: Balikesir
country: Turkey
facility: Balikesir University Health Practice and Research Hospital
Study officials:
affiliation: Balikesir University
name: Bilal UYSAL, assistant professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anticholinergic medication use and falls in postmenopausal women: findings from the women's health initiative cohort study