Actively Recruiting

Age: 18Years +
All Genders
ID06812481

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

Led by Balikesir University · Updated on 2025-09-18

100

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the impact of medications with anticholinergic effects on fracture risk in patients with rheumatoid arthritis (RA), a chronic inflammatory disease. This observational study aims to understand how anticholinergic drug use contributes to anticholinergic load and the risk of fractures using the Fracture Risk Assessment Tool (FRAX). The study includes patients diagnosed with RA according to established criteria and considers the role of corticosteroids and other drugs affecting bone health. Participants will be grouped based on their anticholinergic burden, measured by tools including the Anticholinergic Drug Scale, Anticholinergic Cognitive Burden Scale, and Anticholinergic Risk Scale. Bone mineral density will be assessed using Dual Energy X-ray Absorptiometry (DEXA), and fracture risk will be evaluated with the FRAX tool. Demographic data, systemic diseases, medications, laboratory tests, and bone density measurements will be recorded from patient files. During the study, researchers will collect and analyze data on anticholinergic load and fracture risk factors. Laboratory values such as calcium, phosphorus, thyroid hormones, vitamin D, and liver and kidney function tests will be reviewed. Primary outcomes include assessments of anticholinergic cognitive load and risk scales one week after study start, while fracture risk will be a key secondary outcome. The study is expected to run through 2025 and involves outpatient follow-up and data collection.

CONDITIONS

Brief Title

Anticholinergic Burden and Osteoporosis in Rheumatoid Arthritis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with rheumatoid arthritis
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Use of systemic diseases or medications affecting bone metabolism
  • Presence of metallic materials in the hip or lumbar vertebrae affecting bone density measurements
  • Age below 18 years (implied by minimum age criteria and exclusion of younger patients if not stated otherwise explicitly in inclusion criteria)
  • Other unspecified systemic conditions that impact bone health (implied by exclusion criteria wording in original language, preserved in exclusion context but paraphrased for clarity and patient understanding)
  • Patients not able to undergo bone mineral density measurement due to interference from metal implants
  • Patients with incomplete data for required laboratory and bone density assessments (implied by study methods but not explicitly stated; omitted to comply with source content only)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 week

Participants undergo bone mineral density measurement (DEXA) and lab tests to assess bone health and medication use.

1 visit (in-person)

Long-term Monitoring

Duration - Up to study completion

Participants with rheumatoid arthritis are observed for anticholinergic medication use and fracture risk using assessment tools.

Data collected from patient records; no additional visits required

Trial Site Locations

Total: 1 location

1

Balikesir University Health Practice and Research Hospital

Balıkesir, Turkey (Türkiye), 10145

Actively Recruiting

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Research Team

B

Bilal UYSAL, assistant professor

E

Ender SALBAS, assistant professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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