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临床试验/NCT05517070
NCT05517070已完成不适用

Association of Vitamin D Deficiency, Sarcopenia, Body Composition, Osteoporosis and Hemophilic Arthropathy in the Patients With Hemophilia

Tsung-Ying Li1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Vitamin D

研究概览

简要总结

Hemophilia is associated with osteoporosis and increased prevalence of low bone mineral density (BMD). Many clinical risk factors have been reported, such as hemophilic arthropathy, reduced physical activity, decreased sun exposure, hepatitis C virus infections, vitamin D deficiency, and low body mass index (BMI). There is no data on the prevalence of vitamin D deficiency and low BMD in hemophilia patients in Taiwan or Asia. To the best of our knowledge, no previous studies have reported the prevalence of sarcopenia and correlation with osteoporosis in hemophilia adult patients. The purpose of this study will evaluate the prevalence of vitamin D deficiency, low BMD, sarcopenia and body composition in a cohort of patients with hemophilia in Taiwan.

详细描述

Hemophilia is associated with osteoporosis and increased prevalence of low bone mineral density (BMD). Soucek et al. reported sarcopenia and low trabecular BMD at the radius in the boys with hemophilia by CT.The severity of hemophilic arthropathy associated with lower BMD, muscle atrophy and obesity has been shown by some studies.

This is a single-center, cross-sectional, observational study. All participants will sign informed consent that fully disclosed the risks and benefits of study participation. The study will be performed at the Hemophilia Care and Research Center. Sixty adult patients (age ≥ 20) with hemophilia and 20 healthy subjects will be enrolled for scanning of the lean tissue, appendicular skeletal muscle mass (ASM), fat mass, lumbar spine and hip BMD by dual-energy X-ray absorptiometry (DXA) and assess serum vitamin D level. We will collect other clinically relevant information, including age, body mass index (BMI), hemophilia type and severity, inhibitor titer, Pettersson score by x-ray, HJHS, handgrip strength, history of HCV or HIV infection and history of fracture.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Hemophilia patients

排除标准

  • Severe diseases affecting bone metabolism (such as primary hyperparathyroidism, hypogonadism),
  • History of total hip arthroplasty
  • History of instrumentation in lumbar spine

结局指标

主要结局

Vitamin D

时间窗: one day

serum vitamin D

次要结局

  • Bone marrow density(one day)
  • Body composition(one day)
  • Pettersson score(one day)
  • Hemophilia Joint Health Score(one day)
  • Handgrip strength(one day)

研究者

发起方
Tsung-Ying Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tsung-Ying Li

Attending Physician

Tri-Service General Hospital

研究点 (1)

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