Impact of Bone Mineral Density on Fracture Risk Assessment in RA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-04

Study Completion Date

2023-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fatma Nur Kesiktaş

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Bahcelievler, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IstPRMTRH55

Identifier Type: -

Identifier Source: org_study_id