Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
Completed · Phase 3
Conditions studied: Idiopathic Short Stature
In brief
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.
Key facts
- Study ID
- NCT01248416
- Run by
- Nemours Children's Clinic
- People needed
- 76
- Starts
- 2010-11-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2018-08-07
Who can join
Age: 12 and older, up to 18. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- 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
Full record on ClinicalTrials.gov
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