Prospective Evaluation of Bone Strength, Physical Activity, Falls, Subsequent Fractures and Mortality in Patients Presenting With a Recent Clinical Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Bone strength assessed with HRpQCT
研究概览
简要总结
The risk for a subsequent fracture is significantly higher in patients presenting with a fracture compared to individuals without a previous fracture and is highest within the first 2 years after the initial fracture. The risk for a subsequent fracture is not dependent of BMD as measured by conventional DXA. In recent studies, it has been shown that HRpQCT measurements provide information about bone structure, bone quality and bone strength in addition to BMD measurements. Diagnostic strategies should be focussed on bone quality and bone strength and fall prediction in the patients at high risk for falls, subsequent fracture and mortality such as patients with a recent fracture. Therefore, the investigators conduct a prospective observational study in 500 patients aged 50 years and older who present with a clinical fracture for evaluation of bone strength, physical activity, falls, subsequent fractures and mortality during a follow-up period of 3 years.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 50 years and older with a recent fracture that is being evaluated at the FLS at VieCuri MC.
- •Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical study procedures
- •Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.
排除标准
- •Patients with malignancy metastatic to the bone.
- •Patients with osteomyelitis.
- •Patients with fractures due to failure of a prosthesis.
- •Patients, who as judged by the Principal Investigator, are mentally incompetent. Patients who are compos mentis and understand the patient information, will not be considered mentally incompetent
结局指标
主要结局
Bone strength assessed with HRpQCT
时间窗: 3 years
Difference in bone strength, estimated by micro-finite element analyses, will be compared between patients with and without a subsequent fracture within 3 years of follow-up.
次要结局
- Subsequent falls within 3 years after a fracture(3 years)
- Mortality(3 years)
研究者
Joop P.W. van den Bergh
Clinical Professor
VieCuri Medical Centre