A Multiple Center, Prospective Study Targeting the Secondary Prevention of Fractures in Greece: Evaluation of the Fracture Liaison Service in Multiple Hospital Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 397
- 试验地点
- 4
- 主要终点
- Participation rate in the FLS program
研究概览
简要总结
This is multiple center, prospective study aiming to investigate the tracking and outcome of patients attending Greek General hospitals with low-trauma fractures. Secondary end-points were to facilitate the implementation of coordinated, multi-disciplinary models of care for secondary fracture prevention, and to monitor osteoporosis treatment initiation, osteoporosis treatment persistence at 12 months, compliance, and subsequent fractures.
详细描述
This study includes 5 different hospitals in 4 cities of Greece. The responsible party in each hospital is an orthopedic department which will organize a fracture liaison service (FLS) for both Hospitalized patients over 50 years old with low energy fractures and Outpatients over 50 years old with low energy fractures (low energy fracture is defined as a fracture resulting from minimal trauma such as falling from standing height or less).
This action targets to improve patient care and to reduce secondary osteoporotic fractures, along with collateral healthcare cost.
Prerequisite for patients' enrollment in the FLS program is the voluntary signed acceptance of the program's terms and conditions (signed Inform Consent Forms).
Program Services for eligible patients include the following steps:
- The FLS personnel informs patient about the program, its services and provides him/her with the relevant, informative, printed material. After obtaining patient's signed informed consent, the competent personnel in cooperation with treating physicians:
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients and Outpatients over 50 years old with low energy fractures (low energy fracture is defined as a fracture resulting from minimal trauma such as falling from standing height or less).
排除标准
- •Presence of osteomalacia and/or other clinical entities predisposing to low energy fractures, apart from osteoporosis, such as primary or secondary hyperparathyroidism, Paget's disease of bone, osteogenesis imperfecta and paraplegia.
研究组 & 干预措施
patients with low-energy fracture(s)
The study will include patients from pre-defined groups of individuals (postmenopausal, perimenopausal, male, and steroid induced osteoporosis) who would be anyway eligible to receive treatment for their condition according to standard medical practice and Greek treatment guidelines.
Drug: anti-osteoporotic medication (bisphosphonates, denosumab, strontium ranelate, teriparatide, SERMs)
干预措施: anti-osteoporotic medication (Drug)
结局指标
主要结局
Participation rate in the FLS program
时间窗: 2 years
Participation rate in the FLS program of patients with low-trauma fractures
次要结局
- osteoporosis treatment adherence at 24 months [measured by Medication Possession Ratio (MPR)](2 years)
- Percentage of patients initiating osteoporosis treatment(2 years)
- percentage of patients experiencing subsequent fractures(2 years)