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

Idiopathic Short Stature Clinical Trial

— ThrasherAI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248416
• Other study ID #: 180984
• Status: Completed
• Phase: Phase 3
• Start date: November 2010
• Est. completion date: September 2016

Study information

• Verified date: July 2018
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dwarfism
• Idiopathic Short Stature

Intervention

Drug:
• Aromatase Inhibitor

• Growth Hormone

• Aromatase Inhibitor and Growth Hormone

Locations

Country	Name	City	State
Chile	Veronica Mericq, MD	Santiago
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	Nemours Children's Clinic	Orlando	Florida
United States	Nemours Children's Clinic- Jefferson	Philadelphia	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
Nemours Children's Clinic	AstraZeneca, Genentech, Inc., Novartis, Pfizer, Thrasher Research Fund

Countries where clinical trial is conducted

United States,  Chile, 

References & Publications (1)

Mauras 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 Met — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Height	Differences in height gains	0 to 24 months
Primary	Change in Predicted Height	Primary efficacy end point: change in predicted height (cm) from baseline at 24 months based on change in bone age (years)	0 to 24 months
Secondary	Change in Bone Density z Score Adjusted for Height		0 to 24 months
Secondary	Change in Lean Body Mass		0 to 24 months
Secondary	Change in Body Mass Index		0 to 24 months
Secondary	Change in IGF-I Concentrations		0 to 24 months
Secondary	Change in Testosterone		0 to 24 months
Secondary	Change in Estradiol	Those taking AI alone or AI/GH combined were grouped by type, either anastrozole or letrozole.	0 to 24 months
Secondary	Change in Estrone		0 to 24 months