A double-blind, placebo-controlled comparison of letrozole to oxandrolone effects upon growth and puberty of children with constitutional delay of puberty and idiopathic short stature.
OBJECTIVE
Constitutional delay of growth and puberty (CDGP) with short stature is one of the most common problems in pediatrics. We compared the effects of letrozole with that of oxandrolone on predicted adult height (PAH), puberty, bone mineral density, serum insulin-like growth factor 1 (IGF-1) and blood lipoproteins.


METHODS
In a prospective, double-blind, randomized, placebo-controlled clinical trial, 91 CDGP boys (12.6-14.6 years old) with predicted short stature were treated with letrozole (2.5 mg/day), oxandrolone (2.5 mg/day), or placebo, at the outpatient pediatric endocrine clinic of Mofid Children's Hospital in Tehran for 2 years.


RESULTS
Letrozole differed from oxandrolone and placebo in significantly increasing PAH (p < 0.05), and slightly but significantly decreasing HDL-cholesterol. Oxandrolone, and to a lesser degree letrozole, significantly increased the height standard deviation score and bone age compared to placebo.


CONCLUSIONS
This first randomized controlled clinical trial in CDGD teenage boys with predicted short stature shows that letrozole increases PAH more than oxandrolone and advances pubertal stage and bone mineralization less.
Salehpour
Shadab
S
Mofid Children's Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran. shadab.salehpour @ gmail.com
Alipour
Parvin
P
Razzaghy-Azar
Maryam
M
Ardeshirpour
Laleh
L
Shamshiri
Alireza
A
Monfared
Mahtab Farahmand
MF
Gharib
Atoosa
A
D000293:Adolescent; D000728:Androgens / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000627:therapeutic use*; D001827:Body Height / Q000187:drug effects; D015519:Bone Density / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006130:Growth Disorders / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D000077289:Letrozole; D008297:Male; D009570:Nitriles / Q000627:therapeutic use*; D010074:Oxandrolone / Q000627:therapeutic use*; D011446:Prospective Studies; D011628:Puberty, Delayed / Q000097:blood / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D013739:Testosterone / Q000097:blood; D014230:Triazoles / Q000627:therapeutic use*; D014280:Triglycerides / Q000097:blood
D000728:Androgens; D047072:Aromatase Inhibitors; D009570:Nitriles; D014230:Triazoles; D014280:Triglycerides; D013739:Testosterone; D007334:Insulin-Like Growth Factor I; D010074:Oxandrolone; D000077289:Letrozole; D002784:Cholesterol