Rheumatoid ArthritisNCT06718985
Impact of Bone Mineral Density on Fracture Risk Assessment in RA
An observational study of Rheumatoid Arthritis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study investigates whether incorporating bone mineral density (BMD) into FRAX calculations changes fracture risk assessment and influences treatment decisions in rheumatoid arthritis (RA) patients. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2022to 4 Apr 2023
- How long will I take part?
- 1 Day
- 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 40 to 90 years
- All sexes
- Adult, Older adult
Study population: Rheumatoid arthritis patients
Who may be able to join
- Diagnosis of rheumatoid arthritis (RA) based on ACR/EULAR criteria.
- Age between 40-90 years.
- Dual-energy X-ray absorptiometry (DXA) results obtained within the past six months.
- Availability of complete clinical and demographic data for fracture risk assessment.
- Patients who provide informed consent for the study.
Who cannot join
- Patients with secondary causes of osteoporosis (e.g., hyperparathyroidism, Cushing's syndrome).
- Use of medications affecting bone metabolism (e.g., glucocorticoids >7.5 mg/day, bisphosphonates, denosumab) within the past year.
- History of metabolic bone diseases other than osteoporosis (e.g., osteomalacia, Paget's disease).
- Patients with a history of malignancy, except for non-melanoma skin cancer.
- Incomplete or missing data required for FRAX or DXA analysis.
- Any condition or comorbidity likely to affect fracture risk assessment, as determined by the clinician.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Istanbul, Bahcelievler, 34180
About this study
Official title: Does Incorporating Bone Mineral Density Change Fracture Risk Assessment and Influence Treatment Decisions in Rheumatoid Arthritis Patients?
This study investigates whether incorporating bone mineral density (BMD) into FRAX calculations changes fracture risk assessment and influences treatment decisions in rheumatoid arthritis (RA) patients. Analyzing 60 RA patients, FRAX scores for 10-year major osteoporotic and hip fractures were calculated with and without BMD. While no significant differences were found between the two methods, discrepancies in treatment recommendations were identified, particularly for hip fractures. The findings emphasize the importance of combining BMD and FRAX for a more comprehensive fracture risk assessment and informed treatment decision-making in RA patients.
- Conditions
- Rheumatoid Arthritis
- Being tested
- No intervention
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance Between FRAX Scores With and Without BMD
The agreement between 10-year fracture risk calculations for major osteoporotic fractures (MOF) and hip fractures (HF) using FRAX with and without bone mineral density (BMD).
Measured: 0 day
Secondary outcomes (1)
Treatment Threshold Exceedance Based on FRAX Calculations
Proportion of patients exceeding treatment thresholds for MOF and HF risk based on FRAX calculations with and without BMD.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start4 Dec 2022
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Nur Kesiktaş, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718985
- Sponsor's protocol ID
- IstPRMTRH55
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Incorporating Bone Mineral Density Change Fracture Risk Assessment and Influence Treatment Decisions in Rheumatoid Arthritis Patients?
- ClinicalTrials.gov ID
- NCT06718985
- Acronym / sponsor ID
- IstPRMTRH55
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 4 Dec 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 5 Dec 2024 (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.
This study investigates whether incorporating bone mineral density (BMD) into FRAX calculations changes fracture risk assessment and influences treatment decisions in rheumatoid arthritis (RA) patients. Analyzing 60 RA patients, FRAX scores for 10-year major osteoporotic and hip fractures were calculated with and without BMD. While no significant differences were found between the two methods, discrepancies in treatment recommendations were identified, particularly for hip fractures. The findings emphasize the importance of combining BMD and FRAX for a more comprehensive fracture risk assessment and informed treatment decision-making in RA patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis patients
Key inclusion criteria (5 listed)
- Diagnosis of rheumatoid arthritis (RA) based on ACR/EULAR criteria.
- Age between 40-90 years.
- Dual-energy X-ray absorptiometry (DXA) results obtained within the past six months.
- Availability of complete clinical and demographic data for fracture risk assessment.
- Patients who provide informed consent for the study.
Key exclusion criteria (6 listed)
- Patients with secondary causes of osteoporosis (e.g., hyperparathyroidism, Cushing's syndrome).
- Use of medications affecting bone metabolism (e.g., glucocorticoids >7.5 mg/day, bisphosphonates, denosumab) within the past year.
- History of metabolic bone diseases other than osteoporosis (e.g., osteomalacia, Paget's disease).
- Patients with a history of malignancy, except for non-melanoma skin cancer.
- Incomplete or missing data required for FRAX or DXA analysis.
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Concordance Between FRAX Scores With and Without BMD
Time frame: 0 day
The agreement between 10-year fracture risk calculations for major osteoporotic fractures (MOF) and hip fractures (HF) using FRAX with and without bone mineral density (BMD).
1 secondary outcome
Treatment Threshold Exceedance Based on FRAX Calculations
Time frame: 0 day
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 5 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 5 inclusion and 6 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 5 Dec 2024. 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?
Concordance Between FRAX Scores With and Without BMD (time frame: 0 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2024.