Short Stature
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age: 3-18 years old children with GHD, ISS, SGA, TS, and PWS; (2)During screening, height is below 2 standard deviations (SD) of the average height for children of the same age and gender, or below the 3rd percentile (P3, -1.88 SD); (3)Has not previously received growth-promoting treatment and plans to undergo growth hormone therapy; (4)The guardian understands and signs the informed consent form. If the subject is already 8 years old or above, they must also sign the informed consent form. For subjects under 8 years old, when they are able to express consent, their agreement should be clearly documented.
Exclusion criteria
Exclusion criteria: Exclusion from the study was required if any of the following criteria were met: (1) known or suspected allergy to planned growth hormone; (2) The presence of any of the following diseases that are not suitable for growth hormone treatment: (3) history of malignant tumor; (4) diabetes mellitus; (5) abnormal liver and/or renal function (ALT> 2 times the upper limit of normal, and/or Cr > 2 times the upper limit of normal); (6) other diseases that are not suitable for growth hormone therapy, such as heart, liver, kidney and other important organ dysfunction, systemic infection or immune dysfunction; (7) complete closure of epiphysis; (8) congenital skeletal dysplasia or scoliosis or claudication; (9) participated in other interventional clinical trials within 3 months before screening; (10) any other conditions considered by the investigator to be not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Fat Percentage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fat-Free Mass;Growth Rate;Height Standard Deviation Score (HtSDS); | — |
Countries
China
Contacts
Beijing Jishuitan Hospital, Capital Medical University