2022-502008-62-00已完成3 期
The Growth Hormone Deficiency Reversal Trial: Effect on final height of discontinuation vs continuation of growth hormone treatment in pubertal children with isolated growth hormone deficiency – A non-inferiority randomised controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Final Height in Standard Deviation Score (FH SDS)
研究概览
简要总结
To compare near Final Height Standard Deviation Score (FH SDS) in the GH+ and GH- groups, Mid-parental Target Height (TH) (estimated from parental heights[1]), and TH-FH (in cm and SDS from FH reference data).
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children (8-15 years of age for girls, 9-17 years of age for boys) with reversed Isolated Growth Hormone Deficiency (I-GHD) in established puberty (Tanner stages B2/3 in girls & 6-12ml testes in boys) and normal brain Magnetic Resonance Imaging (MRI) scan result (incl. small anterior pituitary). Children will need to have completed a minimum 6-week period of discontinuation of GH medication prior to a GH re-test. Children demonstrating GHD reversal (defined as a peak stimulated GH equal to or greater than 6.7 μg/L using arginine or insulin tolerance test) will be eligible to participate in this trial. Written informed consent must be obtained.
排除标准
- •Hypopituitarism with or without additional pituitary hormone supplementation, a known genetic cause for I-GHD, organic GHD, ectopic posterior pituitary, other indications for GH therapy, pregnancy or lactation, any malignancy, current participation in another CTIMP, receipt of prednisolone or dexamethasone during the (minimum) 6-week discontinuation period before GH re-test
结局指标
主要结局
Final Height in Standard Deviation Score (FH SDS)
Final Height in Standard Deviation Score (FH SDS)
次要结局
- Growth Related: The proportion of children reaching normal adult height (- 2SD) The proportion reaching mid-parental Target Height (- 2SD) Difference in child's Target Height minus Final Height (in Standard Deviation Score and centimetres) Bone Related: Bone age delay at Final Height Bone age acceleration between enrolment and Final Height Bone health index at Final Height Biochemistry: Serum IGF-1 and lipid profiles (fasting lipids - serum triglyceride and total serum cholesterol) at Final Heig
研究者
Mehul Tulsidas Dattani
Scientific
University College London
研究点 (5)
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