Effect of growth hormone dose on bone maturation and puberty in children with idiopathic short stature.
BACKGROUND
GH at 0.22 mg/kg.wk has been shown to have no effect on pubertal onset or pace, whereas GH at 0.5 mg/kg x wk has been shown to advance pubertal onset and bone maturation.


OBJECTIVE
Our objectives were to determine whether 0.37 mg/kg x wk GH advanced pubertal onset, pace, or bone maturation relative to 0.24 mg/kg x wk GH; whether 0.37 mg/kg x wk GH led to pubertal onset at an inappropriately early age; and whether age at start of GH therapy influenced pubertal onset.


METHODS
We conducted a randomized, open-label study to final height.


METHODS
We studied children with idiopathic short stature.


METHODS
Patients were treated with 0.24 mg/kg x wk, 0.24 increasing to 0.37 mg/kg x wk, or 0.37 mg/kg x wk.


METHODS
We assessed age at pubertal onset and rates of bone maturation, Tanner stage development, and increase in testicular volume (boys only).


RESULTS
For the primary comparison between the 0.24 and 0.37 mg/kg x wk dose groups, median ages of pubertal onset (in years) were similar (13.7 vs. 13.5 for boys and 11.7 vs. 11.4 for girls) and were greater than those for the general population for each sex. Age at start of GH therapy did not appear to influence pubertal onset for either sex. Rates of pubertal pace and bone maturation were not significantly different between the 0.24 and 0.37 mg/kg x wk dose groups for either sex.


CONCLUSIONS
GH at 0.37 mg/kg x wk does not appear to accelerate pubertal onset, pace, or bone maturation compared with GH at 0.24 mg/kg x wk in patients with idiopathic short stature. From a clinical standpoint, our results suggest that the approved dose range of up to 0.37 mg/kg x wk GH does not lead to pubertal onset at an inappropriately early age.
Crowe
Brenda J
BJ
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA. crowe_brenda_j@lilly.com
Rekers-Mombarg
Lyset T M
LT
Robling
Kristen
K
Wolka
Anne M
AM
Cutler
Gordon B
GB
Wit
Jan M
JM
D000293:Adolescent; D000365:Age Determination by Skeleton; D000375:Aging / Q000502:physiology; D001827:Body Height / Q000502:physiology*; D001846:Bone Development / Q000187:drug effects*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D013006:Growth Hormone / Q000008:administration & dosage* / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D007236:Infant, Small for Gestational Age; D008297:Male; D011627:Puberty / Q000187:drug effects*
D013006:Growth Hormone