NCT01248416.

Trial name or 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
Methods	Type of study: efficacy Allocation: randomised Intervention model: parallel assignment Masking: open label Primary purpose: treatment
Participants	Condition: idiopathic short stature Enrolment: planned 77 Inclusion criteria: Males: aged 12‐18 years Bone age < 14.5 years at study initiation Presence of puberty Idiopathic short stature defined as a short child ≤ ‐2 SD for height, with normal GH responses to stimuli (≥ 5 ng/mL to at least 2 secretagogues) or a normal IGF‐I and IGFBP‐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
Interventions	Interventions AI: letrozole 2.5 mg daily or anastrozole 1 mg daily GH (somatotropin) 0.3 mg/kg/week in daily divided doses AI plus GH
Outcomes	Primary outcome(s): increasing adult height potential in adolescent boys with idiopathic short stature treated for 2 years (safety and efficacy of AIs alone versus GH alone versus AIs plus GH) Secondary outcome(s): To characterise bone density, bone turnover markers and 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 Other outcome(s): not reported
Starting date	November 2010
Contact information	Responsible party/principal investigator: Nelly Mauras, Nemours Childrens Clinic
Study identifier	NCT number: NCT01248416
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
Stated purpose of study	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
Notes

AI: aromatase inhibitors; GH: growth hormone; IGF‐1: insulin‐like growth factor‐1; IGFBP3: insulin‐like growth factor binding protein‐3; SD: standard deviation.