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临床试验/NCT02785744
NCT02785744已完成不适用

Prevalence of Gaucher Among Patients With Osteopenia/Osteoporosis

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Population prevalence of Gaucher disease among patients with low bone mineral density

研究概览

简要总结

Gaucher disease is a most common genetic metabolic disease characterized by low platelet number, liver and spleen enlargement and various forms of bone diseases including low bone mineral density leading to brittle bones. Various treatment options are now available for this disease.

The purpose of this research study is to determine the prevalence of Gaucher disease in patients with low bone mineral density as observed by DEXA scan, which is a form of X-Ray of the bone.

详细描述

Gaucher disease is a potential secondary cause of low bone mineral density and it is prevalent among patients with low BMD. This cross sectional design study will measure point prevalence of Gaucher disease in patients with low bone mineral density (BMD).

研究设计

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

入排标准

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

入选标准

  • Patients > or equal to18 years and able to provide written consent.
  • Patients who have had a bone density test demonstrating T-score <-1.0 on a DEXA scan within the past year or those who are prospectively referred for DEXA scan and who are later identified by their physician to have a DEXA T-score < -1.0.

排除标准

  • Subject unable to read and sign consent form.
  • Terminally ill subjects or subjects with serious co-morbidities (malignancy), which would limit the ability of the patient to participate in the study.
  • Subjects with the following disorders or exposures
  • Underlying skeletal dysplasia
  • An endocrinologic/metabolic disease known to cause bone demineralization: including parathyroid dysfunction, hyperthyroidism, Cushing syndrome, hypogonadism, panhypopituitarism
  • Cystic Fibrosis
  • Exposure to medications that are known to cause low BMD including chemotherapy within past 2 years, chronic corticosteroid or phenytoin use within past 2 years
  • Radiation exposure within the past 5 years
  • Vitamin D deficiency is not an exclusion criteria as this is highly prevalent in the adult population under investigation as well as in patients with Gaucher disease. (9, 10)
  • Subjects previously diagnosed with Gaucher Disease

结局指标

主要结局

Population prevalence of Gaucher disease among patients with low bone mineral density

时间窗: 2 Years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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