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Randomized Trial of Aromatase Inhibitors, Growth Hormone, or Combination in Pubertal Boys With Idiopathic, Short Stature

Nelly Mauras, Judith L Ross, Priscila Gagliardi, Y Miles Yu, Jobayer Hossain, Joseph Permuy, Ligeia Damaso, Debbie Merinbaum, Ravinder J Singh, Ximena Gaete, Veronica Mericq

J Clin Endocrinol Metab. 2016 Dec;101(12):4984-4993.

PMID: 27710241

Abstract:

Context:
Growth of short children in puberty is limited by the effect of estrogen on epiphyseal fusion.
Objectives:
To compare: 1) the efficacy and safety of aromatase inhibitors (AIs) vs GH vs AI/GH on increasing adult height potential in pubertal boys with severe idiopathic short stature (ISS); and 2) differences in body composition among groups.
Design:
Randomized three-arm open-label comparator.
Setting:
Outpatient clinical research.
Patients:
Seventy-six pubertal boys [mean (SE) age, 14.1 (0.1) years] with ISS [height SD score (SDS), -2.3 (0.0)].
Intervention:
Daily AIs (anastrozole or letrozole), GH, or AI/GH for 24-36 months.
Outcomes:
Anthropometry, bone ages, dual x-ray absorptiometry, spine x-rays, hormones, safety labs.
Results:
Height gain [mean (SE)] at 24 months was: AI, +14.0 (0.8) cm; GH, +17.1 (0.9) cm; AI/GH, +18.9 (0.8) cm (P < .0006, analysis of covariance). Height SDS was: AI, -1.73 (0.12); GH, -1.43 (0.14); AI/GH, -1.25 (0.12) (P < .0012). Those treated through 36 months grew more. Regardless of treatment duration, height SDS at near-final height [n = 71; age, 17.4 (0.2) years; bone age, 15.3 (0.1) years; height achieved, ∼97.6%] was: AI, -1.4 (0.1); GH, -1.4 (0.2); AI/GH, -1.0 (0.1) (P = .06). Absolute height change was: AI, +18.2 (1.6) cm; GH, +20.6 (1.5) cm; AI/GH, +22.5 (1.4) cm (P = .01) (expected height gain at -2.0 height SDS, +13.0 cm). AI/GH had higher fat free mass accrual. Measures of bone health, safety labs, and adverse events were similar in all groups. Letrozole caused higher T and lower estradiol than anastrozole.
Conclusions:
Combination therapy with AI/GH increases height potential in pubertal boys with ISS more than GH and AI alone treated for 24-36 months with a strong safety profile.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
AP75483044 AI-1 AI-1 75483-04-4 Price
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