Impact of Bone Mineral Density on Fracture Risk Assessment in RA

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT06718985
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-04
• Primary Completion: 2023-04-04
• Study Completion: 2023-04-04
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance Between FRAX Scores With and Without BMD	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).

Secondary Outcome Measures

Name	Time	Method
Treatment Threshold Exceedance Based on FRAX Calculations	0 day	Proportion of patients exceeding treatment thresholds for MOF and HF risk based on FRAX calculations with and without BMD.

Trial Locations

Locations (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital; 🇹🇷 Istanbul, Bahcelievler, Turkey