CompletedNot Applicable

Impact of Bone Mineral Density on Fracture Risk Assessment in RA

Turkey (Türkiye)60 participantsStarted 2022-12-04

Plain-language 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. 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.

Who can participate

Age range

40 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Concordance Between FRAX Scores With and Without BMD

Timeframe: 0 day

Trial details

NCT IDNCT06718985

SponsorIstanbul Physical Medicine Rehabilitation Training and Research Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2023-04-04

View on ClinicalTrials.gov More Rheumatoid Arthritis trials