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临床试验/NCT04861142
NCT04861142招募中不适用

Osteoporosis Treatment Protocol in Patients With Fragility Fractures: Application and Efficacy

University General Hospital of Heraklion1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2021年4月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
350
试验地点
1
主要终点
Adherence to the prescribed anti-osteoporotic medication

研究概览

简要总结

Osteoporosis and osteoporotic fractures, especially hip fractures, have a significant impact on public healthcare. Despite the fact that the patients that have suffered an osteoporotic fracture have 86% increased risk of sustaining a second osteoporotic fracture, the efforts to prevent these fractures remain inadequate. The in-hospital initiation of antiosteoporotic treatment in patients that have been admitted due to hip fracture has shown to improve treatment rates and contribute to second fracture prevention. For this purpose the Arbeitsgemeinschaft für Osteosynthesefragen (AO) Foundation has introduced an algorithm that can be used by Orthopedic surgeons for the prevention of second fracture in patients that have already suffered an osteoporotic fracture. The purpose of this thesis is to study the efficacy of this algorithm in preventing the second fracture in the greek population. The study will include patients that have been admitted in the Orthopedics department of the University Hospital of Heraklion due to hip fracture. Bone density measurement will be performed using the DXA method and antiosteoporotic treatment will be administered according to the algorithm. These patients will be included in the hip registry of the Orthopedics department and the follow-up will last for 2 years .The primary aims of the study are: a)evaluation of the adherence to the antiosteoporotic medication b)the efficacy of the adherence to the aforementioned clinical algorithm in the secondary fracture prevention in the greek population.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with hip fractures after low-energy falls(fragility fractures)

排除标准

  • Patients with hip fractures after high energy falls

研究组 & 干预措施

Patients adherent to the anti-osteoporotic medication

干预措施: Anti-osteoporotic medication( alendronate or denosumab) (Drug)

Patients non-adherent to the anti-osteoporotic medication

干预措施: Anti-osteoporotic medication( alendronate or denosumab) (Drug)

结局指标

主要结局

Adherence to the prescribed anti-osteoporotic medication

时间窗: 1 year

Secondary fracture incidence

时间窗: 1 year

次要结局

  • Morbidity and mortality of operatively treated hip fractures in our department(1 year)

研究者

发起方
University General Hospital of Heraklion
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ioannis Daskalakis

Orthopaedic surgery resident

University General Hospital of Heraklion

研究点 (1)

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