Anastrozole plus leuprorelin in early maturing girls with compromised growth: the -GAIL- studyReportar como inadecuado

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Journal of Endocrinological Investigation

, Volume 39, Issue 4, pp 439–446

First Online: 27 October 2015Received: 30 August 2015Accepted: 07 October 2015DOI: 10.1007-s40618-015-0399-z

Cite this article as: Papadimitriou, D.T., Dermitzaki, E., Papagianni, M. et al. J Endocrinol Invest 2016 39: 439. doi:10.1007-s40618-015-0399-z


PurposeAromatase inhibitors have been used to increase predicted adult height PAH in boys but in girls only in McCune-Albright syndrome. We investigated whether anastrozole combined with leuprorelin for up to 2 years is safe and effective in improving PAH in girls with early puberty and compromised growth, compared to leuprorelin alone.

MethodsThe -GAIL- study: girls treated with an aromatase inhibitor and an LHRH analogue, ISRCTN11469487, was a 7-year prospective phase IIa study with parallel design, performed at Athens Medical Center C-A, and Attikon University Hospital, Athens, Greece C-B. Forty girls, consecutively referred for early puberty onset 7.5–9 years with a PAH <−2 or >1.5 SD lower than their target height TH, were included. Twenty started on leuprorelin sc-im 0.3 mg-kg-month plus anastrozole 1 mg-d p.o. group-A, C-A and 20 on leuprorelin group-B, C-B for 2 years or until the age of 10 years. Groups did not differ in age, height, BMI, bone age advancement BAA, and distance of PAH from TH. Follow-up was at 6, 12, 18, and 24 m.

ResultsReduction in BAA was significantly higher in group-A compared to group-B already by 6 m. Despite the transiently significant decrease in height velocity in group-A, gain in PAH SD was almost double by 12 and 18 m vs group-B and reached the maximum of +1.21 ± 0.45 7.51 cm vs +0.31 ± 0.37 1.92 cm, p = 0.001 in group-B at 24 m. Group-A had no clinical or biochemical hyperandrogenism, unchanged normal bone density, and lumbar spine X-rays.

ConclusionThe co-administration of anastrozole with leuprorelin safely improves PAH in girls with compromised growth.

KeywordsAromatase inhibitors Anastrozole LHRH analogues Early puberty Girls  Download fulltext PDF

Autor: D. T. Papadimitriou - E. Dermitzaki - M. Papagianni - G. Papaioannou - V. Papaevangelou - A. Papadimitriou


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