The Influence of Growth Hormone (GH) Therapy on Short Stature Related Distress a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Psychological Distress score
研究概览
简要总结
The research aims to provide data on gender-related psychological impact of GH (Growth Hormone)treatment. Implicit measurable psychological metrics of the therapy outcome on males are to be evaluated in a Prospective Randomized Controlled Trial. As a secondary axis of the study, the investigators aim to provide descriptive documentation of the unique distress signal manifestation implicitly shown by Idiopathic Short Stature (ISS) boys and suggest methods of early detection and measurement of such manifestations that can be used to cement guidelines for the treatment in GH.
详细描述
Study Design:
A prospective randomized, double blind, placebo controlled trial design, comparing four research groups, with 4 repeated psychological measures (before treatment, after 3 months,after 1 year, and at the end of treatment, after 4 years).
The study will be divided into two segments:
Segment 1:double blind, placebo controlled, will include the first 60 ISS (Idiopathic Short Stature)recruited patients. Patients in this segment will be randomized to one of the growth hormone treatment groups in a ratio of 2:1. 40 patients will be treated 4 years with GH and 20 patients will be treated with placebo at the first year of the study and will have the option to start GH treatment after one year, for a duration of 3 years.
Segment 2:after the enrollment to segment 1 will end, enrollment to segment 2 will begin.Participants in segment 2 (patients with ISS and short stature) will serve as control groups and therefore will not be treated with growth hormone. Patients in Segment 2 will be evaluated only once.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1 Segment 1 :Boys at the age range of 8-13 years
- •Segment 2: Boys at the age range of 12-17 years
- •Tanner stage 1 (segment 1 only)
- •more than 2 SD's (standard deviation) below the average height
排除标准
- •Mental retardation,
- •Psychiatric illness,
- •Lack of informed consent\assent.
- •Health status that required chronic treatment with steroids
研究组 & 干预措施
GH treatment
4 years of GH treatment
干预措施: GH treatment (Genotropin) (Drug)
Placebo
1 year treatment with placebo followed by optional 3 years of GH treatment
干预措施: 1 year treatment with placebo followed by optional 3 years of GH treatment (Drug)
结局指标
主要结局
Psychological Distress score
时间窗: After 4 years of treatment
short stature related distress score as measured by Silhouette Apperception Technique questionnaire
次要结局
- Perceived self image score(After 4 years of treatment)