Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
- Conditions
- Idiopathic Short Stature
- Interventions
- Registration Number
- NCT01248416
- Lead Sponsor
- Nemours Children's Clinic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 76
- Males: Ages: 12 - less than 18 years.
- Bone age less than 14 ½ years at study initiation.
- Presence of puberty.
- Idiopathic short stature will be defined as a short child equal or less than -2SD for height, with normal GH responses to stimuli (> or = 5ng/ml to at least 2 secretagogues) or a normal IGF-I and BP-3, normal body proportions and no other identifiable growth pathology.
- Accurate growth data for at least 6 months at baseline is available.
- Chronic illnesses.
- Chronic use of glucocorticosteroids.
- Previous use of hormonal treatment with AIs, sex steroids or GH in the preceding 6 months.
- Birth weight small for gestational age (SGA).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aromatase Inhibitor Aromatase Inhibitor Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years Aromatase Inhibitor and Growth Hormone Aromatase Inhibitor Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years Aromatase Inhibitor and Growth Hormone Aromatase Inhibitor and Growth Hormone Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years Growth Hormone Growth Hormone Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years Aromatase Inhibitor and Growth Hormone Growth Hormone Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years
- Primary Outcome Measures
Name Time Method Change in Height 0 to 24 months Differences in height gains
Change in Predicted Height 0 to 24 months Primary efficacy end point: change in predicted height (cm) from baseline at 24 months based on change in bone age (years)
- Secondary Outcome Measures
Name Time Method Change in Testosterone 0 to 24 months Change in IGF-I Concentrations 0 to 24 months Change in Bone Density z Score Adjusted for Height 0 to 24 months Change in Lean Body Mass 0 to 24 months Change in Body Mass Index 0 to 24 months Change in Estradiol 0 to 24 months Those taking AI alone or AI/GH combined were grouped by type, either anastrozole or letrozole.
Change in Estrone 0 to 24 months
Trial Locations
- Locations (3)
Veronica Mericq, MD
🇨🇱Santiago, Chile
Nemours Children's Clinic
🇺🇸Orlando, Florida, United States
Nemours Children's Clinic- Jefferson
🇺🇸Philadelphia, Pennsylvania, United States