2024-519935-41-00招募中3 期
Efficacy and safety of a 4 year pubertal therapy with growth hormone (Omnitrope) or growth hormone and an aromatase inhibitor (Letrozole) in boys with a short predicted height.
Universitair Ziekenhuis Antwerpen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adult height gain = Final height minus predicted adult height
研究概览
简要总结
The primary objective of this study is to test the hypothesis that in boys with a low predicted adult height , adult height gain (height attained minus predicted height) is higher after a 4 year combination therapy with GH (Omnitrope ®) and the aromatase inhibitor (Letrozole®), started at the beginning of puberty, than in patients that receive only GH.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male gender
- •Adult height prediction below or equal to –2.5 SD : < 164.0 cm based on the Vlaamse groeicurve 2004 (vub.ac.be/groeicurven) using the Greulich and Pyle Bayley Pinneau prediction method
- •Pubertal: at least 4 ml of testicular volume for boys
- •Bone age ≥ 11 but ≤ 13 years for boys
- •Signed informed consent
排除标准
- •Children for whom data on birth length, weight and height of one of the parents are lacking
- •Sex steroid therapy
- •Diabetes mellitus
- •Renal insufficiency (serum creatinine > 1.5 mg/dl)
- •Hepatic disease ( liver test > 4 fold upper limit of normality)
- •Current congestive heart failure
- •Inability to follow the study protocol
- •Treatment with a non-registered drug during the last 90 days before the moment of inclusion.
- •Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al (see appendix)
- •Vertebral anomalies
- •Chronic use of glucocorticoids
- •Previous growth promoting therapy such as GH, sex steroids, oxandrolone, aromatase inhibitors
- •Known GH deficiency
- •Chronic infectious disease
- •Active rheumatic disease
- •Previously diagnosed or currently suspected malignancy
结局指标
主要结局
Adult height gain = Final height minus predicted adult height
Adult height gain = Final height minus predicted adult height
次要结局
未报告次要终点
研究者
Universitair Ziekenhuis Antwerpen
Scientific
Universitair Ziekenhuis Antwerpen
研究点 (1)
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