Rheumatoid Arthritis (RA)NCT06812481
Anticholinergic Burden and Osteoporosis in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis (RA) and Anticholinergic Adverse Reaction, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA), Anticholinergic Adverse Reaction, Fractures, Bone
- What is being tested?
- Anticholinergic load was calculated using anticholinergic cognitive load (ACB)
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 31 Dec 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with rheumatoid arthritis
Who may be able to join
- Patients diagnosed with rheumatoid arthritis
Who cannot join
- Kemik metabolizmasını etkileyen sistemik hastalıkları veya ilaçları kullanan hastalar,
- Kemik mineral yoğunluk ölçümünü etkileyen kalça veya lomber vertebralarda metalik materyalleri olan hastalar
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balikesir University Health Practice and Research Hospital
Balıkesir, 10145
About this study
Official title: 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.
Read the 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).
- Being tested
- Anticholinergic load was calculated using anticholinergic cognitive load (ACB)
- Keywords
- Rheumatoid arthritis, anticholinergic load, risk of fracture
- Medical subject headings
- Arthritis, Rheumatoid, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| group 1 | ACB risk score of 3 or more (high risk). Receives: Other: Anticholinergic load was calculated using anticholinergic cognitive load (ACB) | |
| group 2 | ACB risk score of less than 3 (low risk) Receives: Other: Anticholinergic load was calculated using anticholinergic cognitive load (ACB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 week after the start of the study
Secondary outcomes (1)
The Fracture Risk Assessment Tool (FRAX)
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).
Measured: 1 week after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start15 Sep 2025
- Primary completion28 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilal Uysal, Balikesir University
- Investigators
- Bilal UYSAL, assistant prof., Principal investigator, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812481
- Sponsor's protocol ID
- RA anticholinergic load
- Status last verified
- Nov 2026
- First submitted
- 2 Feb 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anticholinergic medication use and falls in postmenopausal women: findings from the women's health initiative cohort study
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticholinergic Drug Use in Patients With Rheumatoid Arthritis and Its Effects on Fracture Risk
- ClinicalTrials.gov ID
- NCT06812481
- Acronym / sponsor ID
- RA anticholinergic load
- Keywords
- Rheumatoid arthritis, anticholinergic load, risk of fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: Anticholinergic load was calculated using anticholinergic cognitive load (ACB)ACB risk score of 3 or more (high risk). |
| group 2 | – | Other: Anticholinergic load was calculated using anticholinergic cognitive load (ACB)ACB risk score of less than 3 (low risk) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with rheumatoid arthritis
Key inclusion criteria (1 listed)
- Patients diagnosed with rheumatoid arthritis
Key exclusion criteria (2 listed)
- Kemik metabolizmasını etkileyen sistemik hastalıkları veya ilaçları kullanan hastalar,
- Kemik mineral yoğunluk ölçümünü etkileyen kalça veya lomber vertebralarda metalik materyalleri olan hastalar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | group 1, group 2 |
Primary outcome
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.
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 secondary outcome
The Fracture Risk Assessment Tool (FRAX)
Time frame: 1 week after the start of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- BackgroundAnticholinergic medication use and falls in postmenopausal women: findings from the women's health initiative cohort study
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilal UYSAL, assistant prof. principal investigator
Balikesir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA) and Anticholinergic Adverse Reaction, run by Balikesir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Anticholinergic Cognitive Load (ACB) (time frame: 1 week after the start of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06812481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.