Osteoporosis Screening in Adult Patients With Haemophilia and Influence of Physical Activity on the Prevalence of Osteoporosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- blood sample (Vit. D/Calcium)
研究概览
简要总结
The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia.
详细描述
The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia. Subsequently, the ascertained prevalence of osteoporosis in patients with haemophilia will be compared to the latest published data of osteoporosis in Germany. Furthermore, the impact of severity of haemophilia, comorbidities as well as the role of both physical activity and individual joint condition as influencing factors on the presence of osteoporosis will be analysed by this study.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years of age) suffering from mild (FVIII or IX >5 %), moderate (FVIII or IX 1-5 %) or severe (FVIII or IX <1 %) haemophilia A or B
- •Submitted written consent to participate in the study
排除标准
- •Patients suffering from other bleeding diseases
- •PWH without written consent
- •PWH < 18 years of age
- •Secondary osteoporosis
结局指标
主要结局
blood sample (Vit. D/Calcium)
时间窗: 10 minutes
The blood samples of all patients with haemophilia will be tested according to the guidelines of the confederation of osteology (DVO). These blood samples are necessary to assess the osteoporosis by measuring the Vitamin-D and Calcium level.
bone mass/bone density maesurement
时间窗: 15 minutes
All patients with haemophilia of this study will receive a standardised bone density measurement by using the same dual energy X-ray absorptiometry (DXA) device.
次要结局
- haemophilia related clinical data(10 minutes)
- level of physical activity(non determinable)
- orthopaedic joint status(45 minutes)
- pain condition(15 minutes)
- subjective quality of life and subjective physical performance(10 minutes)
研究者
PD Dr. Andreas Strauß
specialist for orthopaedics and trauma surgery
University Hospital, Bonn
