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NCT Number: NCT06812481

Anticholinergic Burden and Osteoporosis in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis (RA) Anticholinergic Adverse Reaction Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Fractures, Bone Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Balikesir University Health Practice and Research Hospital

Balıkesir, 10145, Turkey (Türkiye)

Location status: Recruiting

Location contact

Bilal UYSAL, assistant professor

CONTACT

[email protected]

+902666121010 ext. 4450

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Bilal UYSAL, assistant professor

CONTACT

[email protected]

2666121010 ext. 4450

Ender SALBAS, assistant professor

CONTACT

2666121010 ext. 4450

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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