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临床试验/NCT04524481
NCT04524481Unknown不适用

Osteoporosis Screening in Adult Patients With Haemophilia and Influence of Physical Activity on the Prevalence of Osteoporosis

PD Dr. Andreas Strauß1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年8月19日最近更新:
适应症

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

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

发起方
PD Dr. Andreas Strauß
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

PD Dr. Andreas Strauß

specialist for orthopaedics and trauma surgery

University Hospital, Bonn

研究点 (1)

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