Impact of Bone Mineral Density on Fracture Risk Assessment in RA

December 2, 2024 updated by: Fatma Nur Kesiktaş, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bahcelievler
      • Istanbul, Bahcelievler, Turkey, 34180
        • Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Rheumatoid arthritis patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance Between FRAX Scores With and Without BMD
Time Frame: 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).
0 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Threshold Exceedance Based on FRAX Calculations
Time Frame: 0 day
Proportion of patients exceeding treatment thresholds for MOF and HF risk based on FRAX calculations with and without BMD.
0 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2022

Primary Completion (Actual)

April 4, 2023

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPRMTRH55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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