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Impact of Bone Mineral Density on Fracture Risk Assessment in RA

Does Incorporating Bone Mineral Density Change Fracture Risk Assessment and Influence Treatment Decisions in Rheumatoid Arthritis Patients?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06718985
Enrollment
60
Registered
2024-12-05
Start date
2022-12-04
Completion date
2023-04-04
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Concordance Between FRAX Scores With and Without BMD0 dayThe 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

MeasureTime frameDescription
Treatment Threshold Exceedance Based on FRAX Calculations0 dayProportion of patients exceeding treatment thresholds for MOF and HF risk based on FRAX calculations with and without BMD.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026