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临床试验/NCT06804252
NCT06804252进行中(未招募)不适用

Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients: a Prospective Observational Study

University of Palermo1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
1
主要终点
Evaluating the Incidence of Osteoporosis and Fragility Fractures in Chronic Stroke Patients

研究概览

简要总结

Stroke is a known risk factor for the development of osteoporosis, leading to an increased risk of falls and fractures. Several international studies have associated stroke with hip fractures, showing an odds ratio ranging between 1.5 and 4. The literature frequently indicates a lack of management for bone metabolism in patients following cerebrovascular events. This study aims to evaluate the incidence of osteoporosis and fragility fractures in patients with chronic stroke. A secondary aim is to assess whether patients have been adequately screened for bone metabolism following a cerebrovascular event. This study is designed as a prospective observational study. Patients aged over 65 years with chronic stroke are assessed at the U.O.C. of "Functional Recovery and Rehabilitation" at A.O.U.P. "P. Giaccone," Palermo. During the assessment, clinical and demographic data are collected, including details of the cerebrovascular event (location, hemorrhagic/ischemic, date), pre-event and post-event disability/autonomy (Rankin scale), presence of fractures (location and date) in the patient's medical history (pre and post-event), femoral and lumbar DEXA for osteoporosis evaluation, and DeFRA for assessing the 10-year risk of fragility fractures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 65 years and older
  • Diagnosed with chronic stroke
  • Able to provide informed consent
  • Willing to participate in follow-up assessments
  • Stable medical condition that allows participation in the study

排除标准

  • Patients with acute stroke
  • Severe cognitive impairment that prevents informed consent
  • Other major illnesses affecting bone metabolism (e.g., severe renal disease)
  • Patients already undergoing treatment for osteoporosis
  • Patients with conditions that contraindicate DEXA scan

结局指标

主要结局

Evaluating the Incidence of Osteoporosis and Fragility Fractures in Chronic Stroke Patients

时间窗: From enrollment to the end of treatment at 6 months

The primary objective of this study is to evaluate the incidence of osteoporosis and fragility fractures in patients with chronic stroke.

次要结局

  • Proper screening for bone metabolism in patients after cerebrovascular event(From enrollment to the end of treatment at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof.ssa Giulia Letizia Mauro

Professor

University of Palermo

研究点 (1)

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