A Randomized Controlled Trial Of The Use Of Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Change in Height
研究概览
简要总结
When treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty, increase height potential, but leave children sexually infantile at a critical time in development. Human and animal data show that estrogen, in females and males, is a principal regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs), which block testosterone to estrogen conversion, in boys with different growth disorders, we have shown that AIs may have beneficial effects enhancing height potential in growth-retarded males, without affecting their puberty. However, no direct comparison of the effect of AIs alone vs. conventional GH treatment has been done to date. This study will assess the effect of AIs alone, GH alone and combination treatment in enhancing height potential in adolescent boys with idiopathic short stature.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males: Ages: 12 - less than 18 years.
- •Bone age less than 14 ½ years at study initiation.
- •Presence of puberty.
- •Idiopathic short stature will be defined as a short child equal or less than -2SD for height, with normal GH responses to stimuli (> or = 5ng/ml to at least 2 secretagogues) or a normal IGF-I and BP-3, normal body proportions and no other identifiable growth pathology.
- •Accurate growth data for at least 6 months at baseline is available.
排除标准
- •Chronic illnesses.
- •Chronic use of glucocorticosteroids.
- •Previous use of hormonal treatment with AIs, sex steroids or GH in the preceding 6 months.
- •Birth weight small for gestational age (SGA).
研究组 & 干预措施
Aromatase Inhibitor
Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years
干预措施: Aromatase Inhibitor (Drug)
Growth Hormone
Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years
干预措施: Growth Hormone (Drug)
Aromatase Inhibitor and Growth Hormone
Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years
干预措施: Aromatase Inhibitor (Drug)
Aromatase Inhibitor and Growth Hormone
Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years
干预措施: Growth Hormone (Drug)
Aromatase Inhibitor and Growth Hormone
Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years
干预措施: Aromatase Inhibitor and Growth Hormone (Drug)
结局指标
主要结局
Change in Height
时间窗: 0 to 24 months
Differences in height gains
Change in Predicted Height
时间窗: 0 to 24 months
Primary efficacy end point: change in predicted height (cm) from baseline at 24 months based on change in bone age (years)
次要结局
- Change in Testosterone(0 to 24 months)
- Change in IGF-I Concentrations(0 to 24 months)
- Change in Bone Density z Score Adjusted for Height(0 to 24 months)
- Change in Lean Body Mass(0 to 24 months)
- Change in Body Mass Index(0 to 24 months)
- Change in Estradiol(0 to 24 months)
- Change in Estrone(0 to 24 months)
研究者
Nelly Mauras
Chief, Division of Endocrinology, Diabetes & Metabolism
Nemours Children's Clinic