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

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ClinicalTrials.gov Identifier: NCT01248416
Recruitment Status : Completed
First Posted : November 25, 2010
Results First Posted : June 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
Thrasher Research Fund
Genentech, Inc.
Novartis
AstraZeneca
Pfizer
Information provided by (Responsible Party):
Nelly Mauras, Nemours Children's Clinic

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Idiopathic Short Stature Drug: Aromatase Inhibitor Drug: Growth Hormone Drug: Aromatase Inhibitor and Growth Hormone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2010
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism Hormones

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Aromatase Inhibitor
Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years
 Drug: Aromatase Inhibitor
Other Names:
  • Arimidex (Anastrozole)
  • Femara (Letrozole)
Active Comparator: Growth Hormone
Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years
 Drug: Growth Hormone
Other Names:
  • Nutropin (Somatropin)
  • Genotropin (Somatropin)
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
 Drug: Aromatase Inhibitor
Other Names:
  • Arimidex (Anastrozole)
  • Femara (Letrozole)

Drug: Growth Hormone
Other Names:
  • Nutropin (Somatropin)
  • Genotropin (Somatropin)

Drug: Aromatase Inhibitor and Growth Hormone
Other Names:
  • Arimidex (Anastrozole)
  • Femara (Letrozole)
  • Nutropin (Somatropin)
  • Genotropin (Somatropin)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248416


Locations
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United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Nemours Children's Clinic
Orlando, Florida, United States, 32801
United States, Pennsylvania
Nemours Children's Clinic- Jefferson
Philadelphia, Pennsylvania, United States, 19107
Chile
Veronica Mericq, MD
Santiago, Chile
Sponsors and Collaborators
Nemours Children's Clinic
Thrasher Research Fund
Genentech, Inc.
Novartis
AstraZeneca
Pfizer
Investigators
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Principal Investigator: Nelly Mauras, MD Nemours Children's Clinic Jacksonville
More Information
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Publications of Results:

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Responsible Party: Nelly Mauras, Chief, Division of Endocrinology, Diabetes & Metabolism, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01248416    
Other Study ID Numbers: 180984
First Posted: November 25, 2010    Key Record Dates
Results First Posted: June 7, 2018
Last Update Posted: August 7, 2018
Last Verified: July 2018
Keywords provided by Nelly Mauras, Nemours Children's Clinic:
Aromatase
Growth
Letrozole
Anastrozole
 GH
Children
Puberty
Additional relevant MeSH terms:
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Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Letrozole
Anastrozole
Hormones
Aromatase Inhibitors
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal