Efficacy and Safety of a 4 Year Combination Therapy of Growth Hormone and Gonadotropin- Releasing Hormone Agonist in Children With a Short Predicted Height.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- height
研究概览
简要总结
Estrogens are responsible for the disappearance of growth cartilage in the long bones at the end of the pubertal growth spurt both in boys and in girls. It is therefore hypothesized that stopping pubertal development and hence estrogen production, will prolong and increase the pubertal growth spurt, especially when growth hormone is given concommitantly.
Boys in early puberty, with a bone age between 11 and 13 years and a predicted adult height below 163 cm or girls in early puberty with a bone age between 10 and 12 years and a predicted height under 151 cm will be treated with triptorelin 3.75 mg and Zomacton growth hormone for 4 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult height prediction below -2.5 SD : 151 cm for girls and 164 cm for boys based on the vlaamse groeicurve 2004 (vub.ac.be/groeicurven)
- •Pubertal: breast development at least M2 for girls and at least 4 ml of testicular volume for boys
- •Bone age >10 years but < 12 years for girls and > 11 but < 13 years for boys
- •Signed informed consent
排除标准
- •Adopted children ( different genetic background, lack of data on birth parameters and parents)
- •Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al (see appendix)
- •Chronic use of glucocorticoids
- •Previous growth promoting therapy such as GH, sex steroids, oxandrolone,
- •Known GH deficiency
- •Chronic infectious disease
- •Active rheumatic disease
- •Previously diagnosed or currently suspected malignancy
- •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 30 days before the moment of inclusion.
研究组 & 干预措施
ZOMATRIP
GnRH agonist triptorelin plus somatropin
干预措施: somatropin (Drug)
ZOMATRIP
GnRH agonist triptorelin plus somatropin
干预措施: triptorelin (Drug)
结局指标
主要结局
height
时间窗: 6 - 8 years
Difference between predicted height at start of treatment and adult height
次要结局
- bone density(6 - 8 years)
研究者
Hilde Dotremont
MD
Belgian Study Group for Pediatric Endocrinology