Adolescents short or relatively short
Conditions
Interventions
PEG-rhGH+AI group:None
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Males with bone age ( BA)>=14 (G-P method) and Tanner IV-V; 2.Short male with HtSDS < -2SD or Ht< P10 compared to the height of normal, healthy children of the same age and gender treated with PEG-rhGH alone or combined with AI; 3.Birth weight = the 10th percentile compared to the same gender and gestational age; 4.Normal thyroid function, including FT4FT3 and TSH level within the normal range; 5.No rhGH, GnRHa or AI treatment in the past 2 years; 6.No contraindications to rhGH treatment as assessed by a doctor; 7.The physical evaluation and relevant examinations is completed;
Exclusion criteria
Exclusion criteria: 1.The epiphyse have completely closed; 2.Patients with active hepatitis B liver inflammation; 3.Patients with severe heart and lung diseases, blood system disorders, malignant tumors, diabetes or systemic infections, or with low immune function; 4.Diagnosed with other types of growth and development abnormalities, such as growth hormone deficiency, multiple pituitary hormone deficiency, Turner syndrome, Noonan syndrome, Laron syndrome, growth hormone receptor deficiency, small for gestational age combined with short stature, growth retardation caused by malnutrition, growth retardation caused by hypothyroidism, etc. 5.icrocephaly or with intellectual or developmental delays or with skeletal development abnormalities or with other congenital malformations; 6.Patients with known highly allergic constitution or allergic to the experimental drugs in this study; 7.Participated in other clinical trials related to growth and development within 3 months; 8.Other situations considered by the researchers not suitable for inclusion in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change between approximation adult final height or final height SDS and pre-treatment predicted final height SDS;Differences in the changes of the height Standard Deviation integral approximating adult final height or final height among different treatment groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in height Standard Deviation Score before and after treatment, and changes in annualized growth rate;Changes in glucose metabolism, lipid metabolism, thyroid function, levels, mean blood IGF-1 and IGF-1 SDS;Bone Maturity(BA/CA);Incidence of adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactXinyu Shao; Binmin Shi
The First Affiliated Hospital of Soochow University
Outcome results
None listed