Anticholinergic Burden and Osteoporosis in Rheumatoid Arthritis

NCT06812481 | Recruiting

• 1 other identifier: RA anticholinergic load
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis (RA); Anticholinergic Adverse Reaction; Fractures, Bone

Keywords

Rheumatoid arthritis; anticholinergic load; risk of fracture

Outcome Measures

Primary Outcomes (2)

• 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.

  1 week after the start of the study

• 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.

  1 week after the start of the study

Secondary Outcomes (1)

• The Fracture Risk Assessment Tool (FRAX)

  1 week after the start of the study

Study Arms (2)

group 1

ACB risk score of 3 or more (high risk).

Other: Anticholinergic load was calculated using anticholinergic cognitive load (ACB)

group 2

ACB risk score of less than 3 (low risk)

Other: Anticholinergic load was calculated using anticholinergic cognitive load (ACB)

Interventions

Anticholinergic load was calculated using anticholinergic cognitive load (ACB) OTHER

Bone mineral density was measured using a Dual Energy X-ray Absorptiometry (DEXA) device. Fracture Risk Assessed with Fracture Risk Assessment Tool (FRAX).

group 1; group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with rheumatoid arthritis

You may qualify if:

• Patients diagnosed with rheumatoid arthritis

You may not qualify if:

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

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Balikesir University Health Practice and Research Hospital

Balıkesir, 10145, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Anticholinergic medication use and falls in postmenopausal women: findings from the women's health initiative cohort study

  BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Fractures, Bone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Wounds and Injuries

Study Officials

• Bilal UYSAL, assistant prof.

  Balikesir University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bilal UYSAL, assistant professor

CONTACT

2666121010; bilaluysal@gmail.com

Ender SALBAS, assistant professor

CONTACT

2666121010

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: September 15, 2025
• Primary Completion: November 28, 2025
• Study Completion: December 31, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)