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临床试验/NCT06718985
NCT06718985已完成不适用

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

Istanbul Physical Medicine Rehabilitation Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Concordance Between FRAX Scores With and Without BMD

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Concordance Between FRAX Scores With and Without BMD

时间窗: 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).

次要结局

  • Treatment Threshold Exceedance Based on FRAX Calculations(0 day)

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fatma Nur Kesiktaş

Principle Investigator

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

研究点 (1)

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