Adolescent children in the middle and late stages of puberty with impaired predicted final adult height
Conditions
Interventions
GnRHa Treatment Group:None
Control Group:None
GH Monotherapy Treatment Group:None
GH and AI Combination Treatment Group:None
GH and GnRHa Combination Treatment Group:None
Sponsors
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Children entering adolescence: Tanner stage >= 2; boys with testicular volume >= 4 mL; girls with breast development. 2.Children with impaired predicted adult height (PAH): Those whose PAH is below the 3rd percentile of the growth curve for normal children (-1.88 SD), or below the genetic target height minus 2 standard deviations (-2 SD); 3.Children with no prior history of GH-, GnRHa-, or AI-related therapies. 4.Parents/legal guardians have provided consent for the children’s participation in this study and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with completely closed epiphyses; 2.Patients allergic to growth hormone (GH) or its protective agents; 3.Patients who have received any growth hormone therapy other than the study drugs within 6 months prior to screening; 4.Patients with severe cardiopulmonary diseases, hematological diseases, malignant tumors, diabetes mellitus, or systemic infections, as well as those with hypoimmunity; 5. Any other circumstances that the researcher deems unsuitable for inclusion in the study; 5.Other conditions that are considered inappropriate for enrollment in the study by any investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Final adult height minus predicted adult height (FAH–PAH); | — |
Secondary
| Measure | Time frame |
|---|---|
| FAH improvements with different GH-related treatments;PAH improvements at 1-year post-treatment;GV improvements at 1-year post-treatment;Body Mass Index Standard Deviation Score (BMI SDS);Height standard deviation score,Ht SDS;FAH benefits from different initiation times of GH-related treatment;Incidence of serious adverse events;Adverse event incidence; | — |
Countries
China
Contacts
Public ContactPan Hui
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Outcome results
None listed