Short Stature
Conditions
Keywords
IGF-1, Short Stature, GH
Brief summary
The purpose of the study is to evaluate the predictive value of IGF-1 generation test for growth velocity during GH treatment for 12 months.
Interventions
DRUGGrowth Hormone
Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months
Sponsors
Maimonides Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This study was changed to a retrospective chart review. There was no prospective component.
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* ability to provide written informed consent * Prepubertal males and females form 5- 11years old * Bone age \<11 years in males and \<9 years in females * Height SD score\<-2.25SD in males and females * IGF-1SD score \<-1SD in both males and females * Peak GH level after stimulation \>10ng/ml
Exclusion criteria
* History of prior chemotherapy and or radiation * Active neoplasm * Pediatric patients with closed epiphyses * Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly * Treatment with inhaled or systemic steroids * BMI \<5th percentile or \>95th percentile * Tanner 2 at clinical or biochemical examination by ultrasensitive LH and FSH
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Outcome measurement | one year | Growth velocity after treatment with appropriate growth hormone doses |
Countries
United States
Outcome results
None listed