Short Stature
Conditions
Brief summary
This study is dedicated to addressing the lack of research on the most effective dosage of long-acting growth hormone for children with short stature. By employing clinical trial design, we are committed to investigating the therapeutic benefits and safety profiles associated with varying doses of long-acting growth hormone. Our ultimate goal is to offer clinicians more precise treatment guidance and assist patients in attaining optimal growth and developmental outcomes.
Interventions
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with short stature or a genetic target height below 2 standard deviations; 2. Individuals who are pre-pubertal (Tanner stage I) and pubertal (Tanner stages II-IV). 3. Legal guardians consenting to participate in the study and signing informed consent forms.
Exclusion criteria
1. Known or suspected hypersensitivity reactions to the investigational product or related products; 2. Presence of severe systemic diseases; 3. Patients with malignant tumors; 4. Participation in any other clinical trial and receipt of drug or non-drug interventions within the 3 months prior to screening; 5. Patients unable to adhere to follow-up or receive treatment as scheduled; 6. Other circumstances in which the investigator deems the patient unsuitable for inclusion in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| height growth rate | 2 years | Measure the height and observe how many centimeters it grows each month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual development status | two years | Evaluate Tanner staging, The Tanner Staging, also known as Sexual Maturity Rating (SMR), is a classification system that healthcare providers use to document and track the development of secondary sex characteristics of children during puberty. It's a tool that outlines the stages of puberty for children and when they're likely to occur. |
| IGF-1 | two years | IGF-1, known as insulin-like growth factor, is utilized to evaluate the efficacy of growth hormone therapy. By measuring IGF-1 levels, doctors can determine the effectiveness of the treatment and whether the patient's growth falls within the normal range |
Other
| Measure | Time frame | Description |
|---|---|---|
| bone age | 2 years | Bone age assessment |
Contacts
Primary ContactXiaoou Shan
Backup ContactMengjie Yang
Outcome results
None listed