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临床试验/NCT07512453
NCT07512453尚未招募不适用

Retrospective Multicenter Study in Patients With Osteoporosis and Fragility Fractures to Estimate the Extent and Impact of Delayed Administration of Anti-fracture Therapy

Azienda Ospedaliero, Universitaria Pisana1 个研究点 分布在 1 个国家目标入组 8,000 人开始时间: 2026年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
8,000
试验地点
1
主要终点
Objective and primary endpoint

研究概览

简要总结

Osteoporosis (OP) and fragility fractures are a significant problem that leads to morbidity, mortality, and high costs for the National Health System. The treatment of fragility fractures includes numerous anti-resorptive and anabolic drugs, and its goal is the secondary prevention of new fractures. It is well known that the risk of a new fracture following a fracture event is highest in the months immediately following the first fracture. However, recent data clearly show a dramatic global delay in the administration of anti-osteoporotic therapy following a fragility fracture. It has been estimated that in Italy, 71% of patients with fragility fractures eligible for anti-fracture treatment did not receive timely treatment (a problem defined as a "treatment gap"), and that in 2034, the incidence of new fragility fractures will increase compared to 2019 [1]. However, there is a lack of real-life Italian data on the extent of the treatment gap in osteoporotic patients with fragility fractures and its impact in terms of the incidence of subsequent fragility fractures: this study therefore aims to fill this gap by collecting data from a large population of patients attending several centers throughout the country.

详细描述

Italian real-life study in patients with osteoporosis and fragility fractures to assess the extent and impact of delays in the administration of anti-fracture therapy.

研究设计

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

入排标准

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

入选标准

  • adult patients of both sexes;
  • patients with osteoporosis and/or previous fragility fractures (fragility fractures are defined as those that occur spontaneously, i.e., not resulting from trauma, even of low intensity, or those caused by a fall from standing height.
  • willingness to sign the consent form

排除标准

  • patients under the age of 18
  • no previous fragility fractures - failure to sign the consent form Exit criteria

结局指标

主要结局

Objective and primary endpoint

时间窗: From enrollment to the end of data records 1 year

the number of months elapsed between the first fragility (osteoporotic) fracture and the initiation of anti-osteoporotic therapy.

次要结局

  • Objective and secondary endpoint(From enrollment to the end of data records 1 year)

研究者

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

Maurizio Mazzantini

MD

Azienda Ospedaliero, Universitaria Pisana

研究点 (1)

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