Individualizing the Dose of Growth Hormone (GH) to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children Within TR 98-0198-003
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 主要终点
- The Proportion of Children Maintaining Normal Growth Velocity
研究概览
简要总结
The objective was to study whether normal growth velocity can be maintained with adapted GH dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled catch up growth (=difference to target height reached, less than - 0.6 SDS).
详细描述
The aim of the trial is to study the effect of adapted GH treatment in order to find an individualized GH dose maintaining normal growth velocity close to target height SDS and normal metabolism after fulfilled catch up growth in prepubertal children treated with individual doses of GH within the trial 98-0198-003 (1). The overall aim is to find for the individual the lowest effective GH dose during maintenance period, maintaining normal growth velocity and metabolism, i.e. a satisfactory biological active dose.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in the 'GH-dose catch-up study' 98- 0198-
- •Midparental height reached (difference less than 0.6 SDS)
- •Prepubertal at start of the study (girls =B 1, boys: testes :<; 3ml).
- •Signed written informed consent from the patient's parents (and the child if old enough)
排除标准
- •Disease affecting growth other than correctly treated hypothyroidism.
- •Incapable of following the study protocol (i.e. bad compliance in the previous study).
- •Puberty (> breast stage 2, or testes > 4ml).
- •Poor compliance.
研究组 & 干预措施
Interventional
Unchanged dose Genotropin
干预措施: Genotropin (Drug)
Interventional 2
reduced dose 50% Genotropin
干预措施: Genotropin (Drug)
结局指标
主要结局
The Proportion of Children Maintaining Normal Growth Velocity
时间窗: twelve months
The proportion of children in the intervention 1 group (=reduced dose) that maintained an individual ΔheightSDS within ±0.3 during the first year of the Maintenance trial, compared to the proportion of children in the intervention 2 group (non-reduced dose)
次要结局
- IGF-I(start of study to two years after start in the trial)
- Height SDS at Start of Puberty(1-7 years in the trial)