Skip to main content
OpenTrials
Completed

NCT Number: NCT01248416

Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Idiopathic Short Stature

Age range

12 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Veronica Mericq, MD, Santiago, Chile

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Aromatase Inhibitor

Drug

Other names: Arimidex (Anastrozole), Femara (Letrozole)

growth hormone

Drug

Other names: Nutropin (Somatropin), Genotropin (Somatropin)

Aromatase Inhibitor and Growth Hormone

Drug

Other names: Arimidex (Anastrozole), Femara (Letrozole), Nutropin (Somatropin), Genotropin (Somatropin)

Primary outcomes

  1. Change in Height

    Time frame: 0 to 24 months

    Differences in height gains

  2. 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)

Secondary outcomes

  1. Change in Bone Density z Score Adjusted for Height

    Time frame: 0 to 24 months

  2. Change in Lean Body Mass

    Time frame: 0 to 24 months

  3. Change in Body Mass Index

    Time frame: 0 to 24 months

  4. Change in IGF-I Concentrations

    Time frame: 0 to 24 months

  5. Change in Testosterone

    Time frame: 0 to 24 months

  6. Change in Estradiol

    Time frame: 0 to 24 months

    Those taking AI alone or AI/GH combined were grouped by type, either anastrozole or letrozole.

  7. Change in Estrone

    Time frame: 0 to 24 months

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • AstraZeneca
  • Genentech, Inc.
  • Novartis
  • Pfizer
  • Thrasher Research Fund

Registry information

Official study title

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

Acronym: ThrasherAI

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Nov 25, 2010
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.