NCT00097526已完成不适用
Bone Mineral Density in Adolescent Subjects With Growth Hormone Deficiency Who Are Completing Treatment With Nutropin AQ, Nutropin, or Protropin in the National Cooperative Growth Study (NCGS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
研究概览
简要总结
This study is a multicenter, open-label, postmarketing surveillance study. The substudy will collect information on BMD in adolescents and young adults with GHD or Turner syndrome who are completing GH treatment for statural indications.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bone age of at least 15 years for girls or at least 16 years for boys within 6 months of obtaining the DXA scan
- •Previous enrollment in the NCGS core study, 85-036
- •Tanner Stage 4 or greater
- •Either spontaneous or induced puberty
- •Subjects who plan on terminating GH treatment for statural purposes for one or more of the following reasons: epiphyseal fusion, slowing growth rate indicates that near adult height has been reached, or satisfied with current height
排除标准
- •Current therapy with a non Genentech GH product
- •Pregnancy (to avoid exposure to low levels of radiation from DXA scanners)
- •Bilateral hip replacement
- •Weight >130 kg (286 lb.)
研究者
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