When treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty, increase height potential, but leave children sexually infantile at a critical time in development. Human and animal data show that estrogen, in females and males, is a principal regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs), which block testosterone to estrogen conversion, in boys with different growth disorders, we have shown that AIs may have beneficial effects enhancing height potential in growth-retarded males, without affecting their puberty. However, no direct comparison of the effect of AIs alone vs. conventional GH treatment has been done to date. This study will assess the effect of AIs alone, GH alone and combination treatment in enhancing height potential in adolescent boys with idiopathic short stature.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Nemours Children's Clinic
Jacksonville, Florida, United States
Nemours Children's Clinic
Orlando, Florida, United States
Nemours Children's Clinic- Jefferson
Philadelphia, Pennsylvania, United States
Veronica Mericq, MD
Santiago, Chile
Change in Height
Differences in height gains
Time frame: 0 to 24 months
Change in Predicted Height
Primary efficacy end point: change in predicted height (cm) from baseline at 24 months based on change in bone age (years)
Time frame: 0 to 24 months
Change in Bone Density z Score Adjusted for Height
Time frame: 0 to 24 months
Change in Lean Body Mass
Time frame: 0 to 24 months
Change in Body Mass Index
Time frame: 0 to 24 months
Change in IGF-I Concentrations
Time frame: 0 to 24 months
Change in Testosterone
Time frame: 0 to 24 months
Change in Estradiol
Those taking AI alone or AI/GH combined were grouped by type, either anastrozole or letrozole.
Time frame: 0 to 24 months
Change in Estrone
Time frame: 0 to 24 months
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