Children with Idiopathic Short Stature (ISS)
Conditions
Interventions
Doctor-patient shared decision-making group:None
Conventional patient management group:None
Sponsors
General Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
5 Years to 11 Years
Inclusion criteria
Inclusion criteria: (1) Age: Girls aged 5 to 10 years old, and boys aged 5 to 11 years old. (2) At the time of screening, the height is lower than the 3rd percentile (-1.88 SD) of normal children of the same chronological age and the same gender. (3) Prepubertal children (Tanner I stage). (4) For any growth hormone provocation test within three months before screening, the peak concentration of serum growth hormone is >= 10 µg/L (ng/ml). (5) At the time of screening, the bone age (BA) is <= the actual chronological age. (6) Having never received growth-promoting treatments before, including but not limited to growth hormone, insulin-like growth factor, sex hormone, and aromatase inhibitors. (7) Participants and their guardians are willing and able to cooperate to complete the scheduled visits, treatment plans, laboratory tests and other trial procedures. The guardians or the participants themselves voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Known or suspected hypersensitivity to the study intervention products or related products; (2) Those with abnormal liver and kidney functions (ALT > upper limit of normal value; Cr > upper limit of normal value); (3) Those with a history of hepatitis B or hepatitis C or known to have active hepatitis B or hepatitis C (this exclusion criterion does not include the situation where antibodies exist due to hepatitis B vaccination); (4) Patients with currently or previously diagnosed malignant tumors; (5) Those already diagnosed with other types of growth and development abnormalities, such as Turner syndrome, Noonan syndrome, Laron syndrome, growth hormone receptor deficiency (GHD), short stature combined with small for gestational age (SGA), growth retardation caused by malnutrition, growth retardation caused by hypothyroidism, SHOX gene deletion and other etiologies of short stature, Prader-Willi syndrome (PWS); (6) Those with congenital skeletal dysplasia or scoliosis (the angle of scoliosis >= 15 degrees, or those with moderate to severe scoliosis requiring treatment), limping; (7) Those diagnosed with diabetes, or with laboratory tests/screening: fasting blood glucose >= 126 mg/dL (7.0 mmol/L) or glycated hemoglobin (HbA1c) >= 6.5% at the time of screening; (8) Those using other treatments that may affect growth in combination, for example, but not limited to, using methylphenidate to treat attention deficit hyperactivity disorder (ADHD), receiving systemic corticosteroid treatment for current inflammatory diseases for more than 2 consecutive weeks within 3 months before screening, or children receiving inhaled budesonide greater than (400 µg/day) or an equivalent dose of inhaled glucocorticoids for more than 4 consecutive weeks within 12 months before screening; (9) Children with hypothyroidism and/or adrenal insufficiency who have not received sufficient and stable replacement treatment for at least 90 days before randomization; (10) Those who have participated in any other clinical trials and have already received drug or non-drug interventions within 3 months before screening; (11) Other situations that investigators consider not suitable for enrollment in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in Ht SDS between the doctor-patient shared decision-making group and the routine patient management group at the 12th, 26th, 39th and 52nd weeks of treatment;Differences in IGF-1 between the doctor-patient shared decision-making group and the routine patient management group at the 12th, 26th, 39th and 52nd weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in growth rate between the doctor-patient shared decision-making group and the routine patient management group at the 12th, 26th, 39th and 52nd weeks of treatment;Differences in height between the doctor- patient shared decision- making group and the routine patient management group at the 12th, 26th, 39th and 52nd weeks of treatment;Drug dosage and adjustment time;Patient satisfaction (Decision Regret Scale, Shared Decision-Making Questionnaire for patients and for doctors);Patient compliance (Medication Possession Ratio);Safety Analysis: The changes in blood glucose metabolic indicators of children in both groups at each follow- up visit point during the study period; The occurrence of adverse events among children in both groups during the study period; | — |
Countries
China
Contacts
Public ContactRongxiu Zheng
General Hospital of Tianjin Medical University
Outcome results
None listed