NCT01248416: ThrasherAI

A Randomized Controlled Trial Of The Use Of Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature

Completed Phase 3 Results posted Last updated 9 July 2018

What this trial tests

Phase 3 trial testing Aromatase Inhibitor in Idiopathic Short Stature in 76 participants. Completed in 1 September 2016.

Timeline

1 November 2010

Primary endpoint
1 September 2016

1 September 2016

Quick facts

Lead sponsor	Nemours Children's Clinic
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	76
Start date	1 November 2010
Primary completion	1 September 2016
Estimated completion	1 September 2016
Sites	4 locations across United States, Chile

Drugs / interventions tested

• Aromatase Inhibitor (aromatase-inhibitor) — full drug profile →
• Growth Hormone — full drug profile →
• Aromatase Inhibitor and Growth Hormone — full drug profile →

Conditions studied

• Idiopathic Short Stature — all drugs for Idiopathic Short Stature →

Sponsor

Nemours Children's Clinic

Who can join

Adults 12 to 18, male only, with Idiopathic Short Stature. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Height
  Time frame: 0 to 24 months
  Differences in height gains
• Change in Predicted Height
  Time frame: 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)

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized Trial of Aromatase Inhibitors, Growth Hormone, or Combination in Pubertal Boys with Idiopathic, Short Stature.
   Mauras N, Ross JL, Gagliardi P, Yu YM, et al · · 2016 · cited 67× · PMID 27710241 · DOI 10.1210/jc.2016-2891
2. Aromatase inhibitors for short stature in male children and adolescents.
   McGrath N, O'Grady MJ. · · 2015 · cited 23× · PMID 26447646 · DOI 10.1002/14651858.cd010888.pub2