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This version published online on November 1, 2005
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2005-0891
A more recent version of this article appeared on January 1, 2006
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Submitted on April 25, 2005
Accepted on October 26, 2005

Effect of growth hormone dose on bone maturation and puberty in children with idiopathic short stature

Brenda J Crowe PhD*, Lyset TM Rekers-Mombarg PhD, Kristen Robling MSc, Anne M Wolka PhD, Gordon B Cutler Jr MD, Jan M Wit MD, PhD, and for the European Idiopathic Short Stature Group

Eli Lilly and Company, Indianapolis, USA (BJC, KR, AMW, GBC); Leiden University Medical Center, Leiden, Netherlands (LTMR-M, JMW)

* To whom correspondence should be addressed. E-mail: crowe_brenda_j{at}lilly.com.

Context: 0.22 mg/kg·wk GH has been shown to have no effect on pubertal onset or pace, while 0.5 mg/kg·wk GH has been shown to advance pubertal onset and bone maturation.

Objectives: Determine whether 0.37 mg/kg·wk GH advanced pubertal onset, pace, or bone maturation relative to 0.24 mg/kg·wk GH; whether 0.37 mg/kg·wk GH led to pubertal onset at an inappropriately early age; and whether age at start of GH therapy influenced pubertal onset

Design: Randomized, open-label, to final height

Patients: Children with ISS

Intervention: GH treatment: 0.24 mg/kg·wk; 0.24->0.37 mg/kg·wk; or 0.37 mg/kg·wk

Main Outcome Measures: 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·wk dose groups, median ages of pubertal onset (in years) were similar (13.7 vs. 13.5 [boys] and 11.7 vs. 11.4 [girls], respectively), 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·wk dose groups for either sex.

Conclusion: 0.37 mg/kg·wk GH does not appear to accelerate pubertal onset, pace, or bone maturation compared with 0.24 mg/kg·wk GH in patients with ISS. From a clinical standpoint, our results suggest that the approved dose range of up to 0.37 mg/kg·wk GH does not lead to pubertal onset at an inappropriately early age.

Parts of this work were presented at the Pediatric Academic Societies' Annual Meeting, May 1-4, 2004; San Francisco, CA (abstract: Cutler GB et al.; 2004; Pediatr Res 55(4): page 151A).
Key words: puberty • human growth hormone • bone age • idiopathic short stature




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