a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,800
- 试验地点
- 2
- 主要终点
- Number of patients with osteoporotic fractures
研究概览
简要总结
BACKGROUND Recent evidence has been published about the effectiveness for the secondary prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.
AIM To assess the effectiveness of a primary care based intervention in the secondary prevention of OF.
METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT) level. Total study follow-up 3 years. Sample size 1800 patients.
DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up in the intervention PCT vs treatment as usual in the control branch.
ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will be analyzed through Cox proportional hazard regression model stratified by age groups.
Outcomes :
- new OF ratio in intervention vs control areas.
- maintenance of the adherence to the pharmacological and non pharmacological interventions proposed
- assessment of cost-effectivity of the intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major OF (distal forearm, vertebral, hip, pelvis and humerus
- •Caused by a low impact mechanism
排除标准
- •High impact mechanism of impact or secondary to other diseases (cancer, Paget disease ...)
- •Patients not residing in the area of the targeted primary care practices
- •Patients with an invalidating disease (dementia ...)
结局指标
主要结局
Number of patients with osteoporotic fractures
时间窗: 24 months
次要结局
- economic cost(24 months)