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

NCT01248416 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2018-08-07

Study results available
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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.

Conditions

  • Idiopathic Short Stature

Interventions

DRUG

Aromatase Inhibitor

DRUG

Growth Hormone

DRUG

Aromatase Inhibitor and Growth Hormone

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Nelly Mauras, MD · Nemours Children's Clinic Jacksonville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States
  • Chile

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01248416 on ClinicalTrials.gov