DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Nemours Children's Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Short Stature

Intervention: Aromatase Inhibitor (Drug); Growth Hormone (Drug); Aromatase Inhibitor and Growth Hormone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Nemours Children's Clinic

Official(s) and/or principal investigator(s):
Nelly Mauras, MD, Principal Investigator, Affiliation: Nemours Children's Clinic Jacksonville


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To assess the safety and efficacy of AIs alone, vs. GH alone, vs. AIs and GH increasing adult height potential in adolescent boys with idiopathic short stature treated for 2 years.

Secondary outcome:

To characterize bone density and bone turnover markers as well as bone morphology in all 3 groups.

To investigate if the combination of GH with an AI has additive effects increasing lean body mass in puberty as compared to each compound alone.

To assess the degree of suppression of aromatase using letrozole vs anastrozole using highly sensitive LCMSMS assays.


Minimum age: 12 Years. Maximum age: 18 Years. Gender(s): Male.


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


- Birth weight small for gestational age (SGA).

Locations and Contacts

Veronica Mericq, MD, Santiago, Chile

Nemours Children's Clinic, Jacksonville, Florida 32207, United States

Nemours Children's Clinic, Orlando, Florida 32801, United States

Nemours Children's Clinic- Jefferson, Philadelphia, Pennsylvania 19107, United States

Additional Information

Starting date: November 2010
Last updated: May 17, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017