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OpenTrials
Completed

NCT Number: NCT06718985

Impact of Bone Mineral Density on Fracture Risk Assessment in RA

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.

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Key information

Conditions

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

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Bahcelievler, 34180, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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