NCT00473187Unknown1 期
Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets
University of Rostock2 个研究点 分布在 1 个国家开始时间: 2004年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 2
- 主要终点
- change of body proportion and final height
研究概览
简要总结
X-linked hypophosphatemic rickets (XLH) is characterized by rickets, disproportionate short stature, impaired renal phosphate reabsorption and vitamin D metabolism. Despite oral phosphate and vitamin D treatment, most children with XLH demonstrate reduced adult height. The main objective of the study is to determine the beneficial effects of recombinant human growth hormone (rhGH) therapy on body proportions after 36 month in these patients. Secondary objective is to monitor side effects of the therapy.
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
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tanner stages of puberty B1, G1
- •body height < 2,5 SDS
- •growth velocity < 75%
- •confirmed diagnosis of XLHR
- •conservative treatment for at least 1 year (phosphate, vitamin D)
- •informed consent, written agreement
排除标准
- •growth hormone deficiency
- •hypothyreosis
- •severe rickets
- •severe physical deformities
- •severe hyperparathyreoidism
- •chronic renal failure
- •complex syndrome involving failure to thrive
- •chronic disease with failure to thrive
- •impairment of glucose tolerance
- •Tanner stages of puberty greater than B1, G1
- •medical history of malignancy
- •therapy with growth hormone, glucocorticoides, anabolica
- •attending another clinical trial
结局指标
主要结局
change of body proportion and final height
时间窗: within 5 years
次要结局
- side effects of therapy with rhGH(within 5 years)
研究者
研究点 (2)
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