NCT06812481

Anticholinergic Burden and Osteoporosis in Rheumatoid Arthritis

StatusCompleted

PhaseNot specified

SponsorBalikesir University

Primary completionNov 28, 2025

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Minor Nov 2, 2026 Trial completed Show 5 more changesShow less
- Final enrollment: 120 participants (planned 100)
- Secondary endpoints: details revised at 1 of 1 entry
- Site details revised
- Publications: details revised at 1 of 1 entry
- Eligibility criteria expanded, about 3 words
Notable Sep 16, 2025 Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
- Primary completion date: Apr 30, 2025 to Nov 28, 2025
- Start date changed from estimate of Mar 3, 2025 to Sep 15, 2025
- Study completion date: May 30, 2025 to Dec 31, 2025
- Site details revised
Feb 2, 2025 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

The Anticholinergic Cognitive Load (ACB)

Timeframe: 1 week after the start of the study

The Anticholinergic Risk Scale (ARS)

Timeframe: 1 week after the start of the study

Secondary (1)

The Fracture Risk Assessment Tool (FRAX)

Arms and interventions

group 1

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

group 2

ACB risk score of less than 3 (low risk)

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

Sites

1 site in 1 country

Balikesir University Health Practice and Research HospitalBalıkesir, Turkey (Türkiye)

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.

Trial details

Enrollment: 120 participants (actual)
Started: Sep 15, 2025
Study completion: Dec 31, 2025
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: Arthritis, Rheumatoid, Fractures, Bone, Rheumatoid Arthritis (RA), Anticholinergic Adverse Reaction
Official title: Anticholinergic Drug Use in Patients With Rheumatoid Arthritis and Its Effects on Fracture Risk
First posted: Feb 6, 2025
Registry updated: Nov 3, 2026
Last verified: Nov 2026

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