Delayed Puberty in Boys; Clinical and Biochemical Characteristics and Effect of Testosterone Treatment - Retrospective Experience From a Single Tertiary Referral Centre 1990-2013
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 1
- 主要终点
- Age at diagnosis in boys with delayed puberty.
研究概览
简要总结
To evaluate the phenotype and biochemical characteristics of boys referred for delayed puberty, to describe the frequency of associated co-morbidities and diseases, to evaluate the diagnostic criteria and the effect of testosterone treatment.
详细描述
Delayed Puberty in Boys; Clinical and biochemical characteristics and effect of testosterone treatment, is a retrospective study in a large case series of Danish boys with delayed puberty.
All boys were referred to the Department of Growth and Reproduction to be evaluated for delayed puberty.
Medical history: Birth length, birth weight, gestational age at birth, medical history (including cryptorchidism and hypospadias), family history of delayed puberty in mother, father and possible siblings.
Physical examination: Pubertal staging according to Tanners classification of boys, genitalia development (G1-G5), pubic hair development (PH1-PH6), axillary hair (yes/no), axillary sweat (yes/no), gynecomastia (yes/no), micropenis (yes/no), height, mother height, father height, target height, weight, BMI, bone age and predicted adult height.
Blood sampling for measurement of hormone levels: Follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol, anti-mullerian hormone, sex hormone-binding globulin, testosterone, dehydroepiandrosterone-sulfate, androstenedione, inhibin A, inhibin B, growth hormone, insulin like growth factor-1 and insulin like growth factor binding protein-3.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All boys identified in the period from January 1990 to February 2013
排除标准
- •Misclassified (other diagnoses)
- •Insufficient data
- •Lost to follow up
结局指标
主要结局
Age at diagnosis in boys with delayed puberty.
时间窗: At first evaluation
We will evaluate the mean age at diagnosis as well as the age distribution of newly diagnosed boys. These data are compared to age at onset and progression of normal puberty in contemporary healthy Danish boys.
次要结局
- Selected secondary outcomes include clinical, auxological and biochemical parameters and association to specific genetic polymorphisms(At first evaluation and during first 12 months of observation / treatment)
研究者
Anders Juul
PhD, DMSc
Rigshospitalet, Denmark