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临床试验/NCT00420251
NCT00420251已完成3 期

Recombinant Human Growth Hormone Treatment in Juvenile Idiopathic Arthritis: Controlled Study on the Effect on Growth and Bone Development

Ludwig-Maximilians - University of Munich2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 1996年3月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Final height

研究概览

简要总结

Growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. Especially those who were under additional treatment with glucocorticoids for high disease activity. The hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. In a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. Additionally, we are interested in bone density development in those treated with growth hormone.

详细描述

Growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. Especially those who were under additional treatment with glucocorticoids for high disease activity. This is the case in patients with a polyarticular and a systemic form of juvenile idiopathic arthritis. The permanent consequence is short stature at final height. Up to 30% of these patients will have a final height below the 3rd percentile, even after discontinuation of glucocorticoid treatment. The hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. In a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. From safety aspects we were interested in the effect of growth hormone on the disease activity. Additionally, we are interested in bone density development in those treated with growth hormone up to final height.

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
4 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Polyarticular or systemic juvenile idiopathic arthritis,
  • Growth velocity below the 25th percentile and or short stature ,
  • Treatment with glucocorticoids for at least the previous 6 months before inclusion,
  • Prepubertal stage,
  • Bone age below 10 in girls and 12 in boys,
  • Growth hormone levels after stimulation with clonidine or arginine above 10 ng/ml

排除标准

  • Previous treatment with growth hormone,
  • Endocrinopathy,
  • Additional chronic disease beside juvenile idiopathic arthritis,
  • Malignant disase,
  • Chromosomal aberration or othe syndromal disease,
  • Previous treatment with Oxandrolone,
  • Small for gestational age,
  • Elevated fasting glucose level

结局指标

主要结局

Final height

次要结局

  • Bone geometry and density

研究者

申办方类型
Other

研究点 (2)

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