NCT00406926已完成3 期
The Effect of Recombinant Human Growth Hormone Treatment on the Growth of Infants and Toddlers With Turner Syndrome
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Height at the end of two years in the study.
研究概览
简要总结
This study investigated the effect of growth hormone on the growth of infants and toddlers with Turner syndrome during 2 years of treatment with growth hormone. This was compared with the growth of infants and toddlers with Turner syndrome who did not receive any growth hormone treatment. The overall aim was to prevent the growth failure usually seen during this period. The study also looked at middle ear disease, hearing problems, and cognitive and behavioral development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 4 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Karyotype-proven Turner syndrome that included a documented abnormality of the short arm of an X chromosome.
- •At least 9 months of age and not greater than 4 years of age.
- •Normal values for age for hemoglobin, thyroid stimulating hormone (TSH) and urinalysis (office dipstick is adequate), performed prior to study entry.
- •If there was a known history of hypothyroidism, then adequate thyroid hormone replacement must have been taken for at least 6 months prior to study entry.
排除标准
- •Current or previous treatment with any therapy that may have directly influenced growth, including growth hormone, growth hormone-releasing hormone, estrogens and anabolic steroids such as oxandrolone. This included previous completion of, or withdrawal from, this study or any other study investigating therapeutic uses of growth hormone or growth hormone-releasing hormone.
- •Chronic treatment with systemic glucocorticoids in supra-physiological doses.
- •Treatment with potential growth-influencing medications such as methylphenidate (Ritalin), pemoline (Cylert), and amphetamines, at, or within 3 months prior to, study entry.
- •Presence of any Y chromosome component in the karyotype if gonads were in situ. Subjects whose karyotype contained Y chromatin, but who had undergone gonadectomy, were eligible to enter the study.
- •Presence of any additional known autosomal abnormality.
结局指标
主要结局
Height at the end of two years in the study.
次要结局
- Middle ear problems assessed every 4 months
- Hearing problems assessed annually
- Cognitive and behavioral development assessed annually
研究者
研究点 (11)
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