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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name ThrasherAI

NCTNCT01248416 (opens ClinicalTrials.gov in a new tab)Other id180984
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
76 participants (actual)
Sponsor
Nemours Children's Clinic · Other
Design
Randomized · Open label (no masking)
Countries
2 countries

United States, Chile

Start
Nov 2010
Primary completion
Sept 2016
Completion
Sept 2016
First posted
25 Nov 2010 (estimated)
Last update posted
7 Aug 2018
Conditions
Idiopathic Short Stature

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201220142016
  1. Ph 3

    ThrasherAI

    NCT01248416

    Nov 2010 to Sept 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Aromatase InhibitorDrug
  • Growth HormoneDrug
  • Aromatase Inhibitor and Growth HormoneDrug

Arms3

  • Active comparator

    Aromatase Inhibitor

    Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years

  • Active comparator

    Growth Hormone

    Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years

  • Active comparator

    Aromatase Inhibitor and Growth Hormone

    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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Height

    Time frame · 0 to 24 months

    Registry description

    Differences in height gains

  2. Change in Predicted Height

    Time frame · 0 to 24 months

    Registry description

    Primary efficacy end point: change in predicted height (cm) from baseline at 24 months based on change in bone age (years)

Secondary outcomes(7)

  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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 0 to 24 months

Change in Height

GroupValue (Centimeters)Spread
Aromatase Inhibitor140.8
Growth Hormone17.10.9
Aromatase Inhibitor and Growth Hormone18.90.8
Primary outcomeLeast squares mean· 0 to 24 months

Change in Predicted Height

GroupValue (centimeters)Spread
Aromatase Inhibitor0.51.0
Growth Hormone4.90.9
Aromatase Inhibitor and Growth Hormone7.40.9
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· 0 to 24 months

Change in Bone Density z Score Adjusted for Height

GroupValue (z-score)Spread
Aromatase Inhibitor-1.0610.313
Growth Hormone-0.5860.244
Aromatase Inhibitor and Growth Hormone-0.6050.257
Secondary outcomeMean· 0 to 24 months

Change in Lean Body Mass

GroupValue (kg)Spread
Aromatase Inhibitor42.21.6
Growth Hormone42.01.3
Aromatase Inhibitor and Growth Hormone46.51.2
Secondary outcomeMean· 0 to 24 months

Change in Body Mass Index

GroupValue (kg/m^2)Spread
Aromatase Inhibitor2.50.3
Growth Hormone1.70.4
Aromatase Inhibitor and Growth Hormone2.50.4
Secondary outcomeMean· 0 to 24 months

Change in IGF-I Concentrations

GroupValue (ng/mL)Spread
Aromatase Inhibitor15814
Growth Hormone28016
Aromatase Inhibitor and Growth Hormone30327
Secondary outcomeMean· 0 to 24 months

Change in Testosterone

GroupValue (ng/dL)Spread
Aromatase Inhibitor73779
Growth Hormone37233
Aromatase Inhibitor and Growth Hormone66837
Secondary outcomeMean· 0 to 24 months

Change in Estradiol

GroupValue (pg/mL)Spread
Anastrozole81
Letrozole41

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Aromatase InhibitorAnastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years Aromatase Inhibitor0 / 254 / 250 / 25
Growth HormoneSomatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years Growth Hormone0 / 252 / 250 / 25
Aromatase Inhibitor and Growth HormoneAnastrozole 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 Aromatase Inhibitor Growth Hormone Aromatase Inhibitor and Growth Hormone0 / 262 / 260 / 26

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultMauras N, Ross JL, Gagliardi P, Yu YM, Hossain J, Permuy J, Damaso L, Merinbaum D, Singh RJ, Gaete X, Mericq V. Randomized Trial of Aromatase Inhibitors, Growth Hormone, or Combination in Pubertal Boys with Idiopathic, Short Stature. J Clin Endocrinol Metab. 2016 Dec;101(12):4984-4993. doi: 10.1210/jc.2016-2891. Epub 2016 Oct 6. PMID 27710241

Eligibility

Who could join, as posted.

Sex
Male
Age
from 12 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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