Impact of Bone Mineral Density on Fracture Risk Assessment in RA

NCT06718985 | Completed

• 1 other identifier: IstPRMTRH55
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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).

  0 day

Secondary Outcomes (1)

• Treatment Threshold Exceedance Based on FRAX Calculations

  0 day

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Rheumatoid arthritis patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Bahcelievler, 34180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 4, 2022
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)