Short stature
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: Girls aged 3-12 years and boys aged 3-13 years (inclusive of the boundary values); 2. At the time of screening, the child's height must be 2 standard deviations (SD) or more below the average height for normal children of the same age and gender, or below the 3rd percentile (P3, -1.88 SD), and must be diagnosed as a short child; 3. Children must be before the peak of puberty, specifically in Tanner Stage I; 4. The child must not have received growth-promoting treatment previously and must be planning to undergo growth hormone treatment; 5. The guardian must understand and sign the informed consent form. For subjects aged 8 years or older, the informed consent form must also be signed by them. For subjects under 8 years old who are capable of expressing consent, their consent should be clearly documented.
Exclusion criteria
Exclusion criteria: Any of the following conditions will disqualify a participant from this study: 1. Patients with contraindications or allergies to the study drug or its components; 2. Patients with any of the following conditions that render them unsuitable for growth hormone treatment: (1) A history of malignant tumors; (2) Other endocrine system diseases such as diabetes and hypothyroidism; (3) Liver or kidney dysfunction (ALT > 2 times the upper limit of normal, and/or Cr > 2 times the upper limit of normal); (4) Other conditions that are unsuitable for growth hormone treatment, including Turner syndrome, pubertal delay due to constitutional factors, Laron syndrome, and growth hormone receptor deficiency; 3. Complete closure of the epiphysis; 4. Congenital skeletal abnormalities, scoliosis, or limping; 5. Participation in other interventional clinical studies within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height standard deviation score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Height growth rate;Insulin-like growth factor-1;Bone age; | — |
Countries
China
Contacts
The Second Hospital of Tianjin Medical University