Idiopathic short stature
Conditions
Interventions
rhGH:None
PEG-rhGH:None
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
7 Years to 13 Years
Inclusion criteria
Inclusion criteria: (1) 2025.1-2026.1 Admitted to the pediatric clinic of the Second Hospital of Hebei Medical University aged 7-13 years old, boarding students; (2) Height below the 3rd percentile of height of normal healthy children of the same age and sex (-1.88SD); (3) Height growth rate (HV) =1 year; (5) No previous growth-promoting treatment, including but not limited to growth hormone, insulin-like growth factor, sex hormone, aromatase inhibitors; (6) The patient's parent or legal guardian must read, understand and sign the informed consent, and the patient with reading ability must read (or be read to) and sign the child's informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with complete closure of epiphysis; 2) Patients with potential tumors with any signs of progression and patients with diagnosed tumors; 3) Allergic to growth hormone or its protective agents; 4) In the 6 months prior to screening, the patient had received any growth hormone therapy other than the study drug; 5) Unable to provide complete medical records or expected to be unable to follow up or collect complete medical records; 6) Abnormal liver and kidney function (ALT> upper limit of normal value; Cr> upper limit of normal value); 7) A history or known presence of active hepatitis B or C (this exclusion criteria does not include the presence of antibodies as a result of vaccination against hepatitis B). 8) Other types of growth and development abnormalities have been diagnosed, such as Turner syndrome, Noonan syndrome, Laron syndrome, growth hormone receptor deficiency, growth and development delay caused by hypothyroidism, etc. Females with height = average height of normal children of the same age and sex -2.0SDS were not excluded from chromosome abnormalities; 9) Congenital abnormal bone development or scoliosis (scoliosis Angle >=15 degrees, or moderate and severe scoliosis need treatment), claudication; 10) For those diagnosed with diabetes, or laboratory tests/screening during screening - fasting blood glucose >=126mg/dL (7.0mmol/L) or -hemoglobin a1c (HbA1c) >=6.5%; 11)Any other conditions that the investigator deems unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stature;Drug compliance use proportion of days covered by prescription;Growth velocity;IGF-1;HT SDS;?BA/CA;?HtSDS_CA;?HtSDS_BA;Clinical results were evaluated including physical examination, hematology and imaging; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight;Bone age ;Collect and monitor adverse events; | — |
Countries
China
Contacts
Public ContactYuqian Li
The Second Hospital of Hebei Medical University
Outcome results
None listed