Phase 3
Completed N=76
Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
Source: ClinicalTrials.gov NCT01248416 ↗Enrolled (actual)
76
Serious AEs
10.5%
Results posted
Jun 2018
Primary outcomePrimary: Change in Height — 14; 17.1; 18.9 Centimeters — p=<0.006
◆ Published Evidence
Established
99citations · ~10 / year
Randomized Trial of Aromatase Inhibitors, Growth Hormone, or Combination in Pubertal Boys with Idiopathic, Short Stature.
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.
Linked Publications
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Randomized Trial of Aromatase Inhibitors, Growth Hormone, or Combination in Pubertal Boys with Idiopathic, Short Stature.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Height |
14; 17.1; 18.9 | <0.006 sig |
| PRIMARY Change in Predicted Height |
0.5; 4.9; 7.4 | — |
| SECONDARY Change in Bone Density z Score Adjusted for Height |
-1.061; -0.586; -0.605 | 0.906 |
| SECONDARY Change in Lean Body Mass |
42.2; 42.0; 46.5 | 0.015 sig |
| SECONDARY Change in Body Mass Index |
2.5; 1.7; 2.5 | — |
| SECONDARY Change in IGF-I Concentrations |
158; 280; 303 | <0.0001 sig |
| SECONDARY Change in Testosterone |
737; 372; 668 | <0.0001 sig |
| SECONDARY Change in Estradiol |
8; 4 | 0.0003 sig |
| SECONDARY Change in Estrone |
0.0; 6.1; -0.9 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT01248416) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.