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临床试验/NCT00591162
NCT00591162终止2 期

Bone Disease in Severely Burned Children

The University of Texas Medical Branch, Galveston1 个研究点 分布在 1 个国家目标入组 254 人开始时间: 1992年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
254
试验地点
1
主要终点
Determine Bone Health(bone growth,strength,and content) in burn injured patients.

研究概览

简要总结

Bone metabolism is adversely affected by severe burns in children for a period of time.

详细描述

More closely monitored biochemical and radiologic parameters of bone and mineral metabolism will increase the likelihood of earlier detection of abnormalities and possible therapeutic interventions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Children age 5-18 years old with at least 40% or more of their body burned.

排除标准

  • Anyone with a burn covering less than 40% of the body or whose burn covers the front of both hipbones.
  • Anyone younger than 5 years old, anyone with a history of cancer or other metabolic disease process, or anyone who is pregnant or has an allergy to Tetracycline will also be excluded.
  • Anyone who has participated in an investigational drug trial within the past 60 days from date of admission will be excluded from this study.

研究组 & 干预措施

1

Active Comparator

Compare bone density of severly burned children to normal non-burned population

干预措施: Tetracycline (Drug)

1

Active Comparator

Compare bone density of severly burned children to normal non-burned population

干预措施: Duel Energy X-Ray Absorptiometry (DEXA) (Radiation)

1

Active Comparator

Compare bone density of severly burned children to normal non-burned population

干预措施: Bone Biopsy (Procedure)

结局指标

主要结局

Determine Bone Health(bone growth,strength,and content) in burn injured patients.

时间窗: Admission to Burn Unit up to eighteen years old.

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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Bone Disease in Severely Burned Children | 临床试验