Retrospective Multicenter Study in Patients With Osteoporosis and Fragility Fractures to Estimate the Extent and Impact of Delayed Administration of Anti-fracture Therapy
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
- 否
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
Maurizio Mazzantini
MD
Azienda Ospedaliero, Universitaria Pisana
