Randomization to Letrozole vs. Anastrozole in Short Pubertal Males
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Predicted Adult Height at Year 3
研究概览
简要总结
The purpose of the study is to determine if there are differences in the final height or hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now routinely used to increase stature: Anastrozole and Letrozole. It also should determine if there are differences in the side effect profiles of the two drugs to be used.
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
- 10 Years 至 17 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Current height less than 5th percentile AND/OR
- •Predicted adult height (based on bone age) more than 10 cm below target height (mid parental height)
- •Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl
排除标准
- •Bone age reading more than 14.0 years
- •Follicle stimulating hormone > 20 IU/L
研究组 & 干预措施
Letrozole
Letrozole 2.5 mg daily
干预措施: Letrozole (Drug)
Anastrozole
Anastrozole 1 mg daily
干预措施: Anastrozole (Drug)
结局指标
主要结局
Predicted Adult Height at Year 3
时间窗: Year 3
Heights will be obtained by physical exam every 6 months during treatment. Skeletal maturation will be assessed from an x-ray by the method of Greulich and Pyle at baseline and every 12 months until the end of treatment. Predicted adult height will be calculated at baseline and at the end of treatment based upon measured height and skeletal maturation (bone age).
次要结局
- Estrone(Baseline, year 3)
- Follicle Stimulating Hormone(Baseline, year 3)
- Serum Testosterone(Baseline, year 3)
- Androstenedione(Baseline, year 3)
- Dihydrotestosterone(Baseline, year 3)
- Luteinizing Hormone(Baseline, year 3)
- Estradiol(Baseline, year 3)
- Number of Adverse Events Related to Acne or Bone Fracture(3 years)
- Insulin-like Growth Factor Type 1(Baseline, year 3)
- Inhibin B(Baseline, year 3)
研究者
Laura K Bachrach
Professor of Pediatrics
Stanford University