跳至主要内容
临床试验/NCT01970800
NCT01970800撤回不适用

The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature

Maimonides Medical Center1 个研究点 分布在 1 个国家开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Primary Efficacy Outcome measurement

研究概览

简要总结

The purpose of the study is to evaluate the predictive value of IGF-1 generation test for growth velocity during GH treatment for 12 months.

研究设计

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

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ability to provide written informed consent
  • Prepubertal males and females form 5- 11years old
  • Bone age <11 years in males and <9 years in females
  • Height SD score<-2.25SD in males and females
  • IGF-1SD score <-1SD in both males and females
  • Peak GH level after stimulation >10ng/ml

排除标准

  • History of prior chemotherapy and or radiation
  • Active neoplasm
  • Pediatric patients with closed epiphyses
  • Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly
  • Treatment with inhaled or systemic steroids
  • BMI <5th percentile or >95th percentile
  • Tanner 2 at clinical or biochemical examination by ultrasensitive LH and FSH

研究组 & 干预措施

Growth hormone, injections

Experimental

Growth hormone injection 0.3mg/kg/week dailY

干预措施: Growth Hormone (Drug)

结局指标

主要结局

Primary Efficacy Outcome measurement

时间窗: one year

Growth velocity after treatment with appropriate growth hormone doses

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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