Anticholinergic Burden and Osteoporosis in Rheumatoid Arthritis

September 16, 2025 updated by: Bilal Uysal, Balikesir University

Anticholinergic Drug Use in Patients With Rheumatoid Arthritis and Its Effects on Fracture Risk

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ender SALBAS, assistant professor
  • Phone Number: 4450 2666121010

Study Locations

  • Turkey (Türkiye)
      • Balıkesir, Turkey (Türkiye), 10145
        • Recruiting
        • Balikesir University Health Practice and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed with rheumatoid arthritis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
ACB risk score of 3 or more (high risk).
Other: Anticholinergic load was calculated using anticholinergic cognitive load (ACB)

Bone mineral density was measured using a Dual Energy X-ray Absorptiometry (DEXA) device.

Fracture Risk Assessed with Fracture Risk Assessment Tool (FRAX).
group 2
ACB risk score of less than 3 (low risk)
Other: Anticholinergic load was calculated using anticholinergic cognitive load (ACB)

Bone mineral density was measured using a Dual Energy X-ray Absorptiometry (DEXA) device.

Fracture Risk Assessed with Fracture Risk Assessment Tool (FRAX).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Anticholinergic Cognitive Load (ACB)
Time Frame: 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.
1 week after the start of the study
The Anticholinergic Risk Scale (ARS)
Time Frame: 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.
1 week after the start of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Fracture Risk Assessment Tool (FRAX)
Time Frame: 1 week after the start of the study

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).
1 week after the start of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balikesir University

Investigators

  • Principal Investigator: Bilal UYSAL, assistant prof., Balikesir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

November 28, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA anticholinergic load

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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