Conditions: Idiopathic Short Stature
Keywords: Aromatase Growth Letrozole Anastrozole GH Children Puberty
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 76
Healthy volunteers: no

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:

Arms:
arm 1: Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years arm 2: Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years arm 3: 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

Interventions: intervention 1: Aromatase Inhibitor intervention 2: Growth Hormone intervention 3: Aromatase Inhibitor and Growth Hormone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: