NCT00133354已完成2 期
Double-blind Trial Investigating the Safety and Efficacy of the Inhibitor Anastrozole (ARIMIDEX) in Delaying Epiphyseal Fusion and Increasing Height Potential of Adolescent Males With Growth Hormone (GH) Deficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.
研究概览
简要总结
The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay epiphyseal fusion and increase predicted adult height in boys who are growth hormone deficient, in puberty, and who are taking growth hormone. This is a double blind, placebo controlled 3 year trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Growth hormone deficient by formal testing with two provocative agents.
- •Treated with growth hormone for a minimum of 6 months prior to study entry.
- •Growth hormone doses must be maintained at 0.2-0.4mg/kg/wk while in protocol.
- •Stable organic pathology
- •Presence of puberty [genital Tanner Stage > II (>4cc testicular volume)]
- •Bone age (BA) > or = 11.5 years and < 15 years
排除标准
- •Participation in any other trial involving hormone therapy for at least 6 months prior.
- •Chronic illnesses requiring long term medication that impair growth. (Stable patients with occasional asthma, patients on Ritalin or Adderall or patients on topical acne medication may be included).
- •Hereditary disease diagnosed clinically.
- •Moderate to severe scoliosis.
研究组 & 干预措施
Arimidex and Growth Hormone
Active Comparator
干预措施: Arimidex (Anastrozole) (Drug)
Arimidex and Growth Hormone
Active Comparator
干预措施: Growth Hormone (Drug)
Placebo and Growth Hormone
Placebo Comparator
干预措施: Placebo (Drug)
Placebo and Growth Hormone
Placebo Comparator
干预措施: Growth Hormone (Drug)
结局指标
主要结局
The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.
时间窗: 12months, 24months, 36months
次要结局
- The secondary objective is to determine the effect of Arimidex® treatment in bone mineralization in pubertal GH deficient males treated concurrently with growth hormone.(12months, 24months, 36months)
研究者
Nelly Mauras
Chief, Division of Endocrinology, Diabetes & Metabolism
Nemours Children's Clinic
研究点 (1)
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