Internet Archive Scholar

Efficacy and Safety of Oxandrolone in Growth Hormone-Treated Girls with Turner Syndrome

Leonie A. Menke, Theo C. J. Sas, Sabine M. P. F. de Muinck Keizer-Schrama, Gladys R. J. Zandwijken, Maria A. J. de Ridder, Roelof J. Odink, Maarten Jansen, Henriëtte A. Delemarre-van de Waal, Wilhelmina H. Stokvis-Brantsma, Johan J. Waelkens, Ciska Westerlaken, H. Maarten Reeser (+7 others)
2010 Journal of Clinical Endocrinology and Metabolism  

Preserved Fulltext

fulltext thumbnail
Web Archive Capture PDF (247.4 kB)
https://web.archive.org/web/20160402020322/http://www.stefvanbuuren.nl/publications/2010%20Efficacy%20Oxandrolone%20-%20JECM.pdf

A copy of this work was available on the public web and has been preserved in the Wayback Machine. The capture dates from 2016; you can also visit the original URL. The file type is application/pdf.

Context and Objective: GH therapy increases growth and adult height in Turner syndrome (TS). The benefit to risk ratio of adding the weak androgen oxandrolone (Ox) to GH is unclear. Design and Participants: A randomized, placebo-controlled, double-blind, dose-response study was performed in 10 centers in The Netherlands. One hundred thirty-three patients with TS were included in age group 1 (2-7.99 yr), 2 (8 -11.99 yr), or 3 (12-15.99 yr). Patients were treated with GH (1.33 mg/m 2 ⅐ d) from
more » ... eline, combined with placebo (Pl) or Ox in low (0.03 mg/kg ⅐ d) or conventional (0.06 mg/kg ⅐ d) dose from the age of 8 yr and estrogens from the age of 12 yr. Adult height gain (adult height minus predicted adult height) and safety parameters were systematically assessed. Results: Compared with GHϩPl, GHϩOx 0.03 increased adult height gain in the intention-to-treat analysis (mean Ϯ SD, 9.5 Ϯ 4.7 vs. 7.2 Ϯ 4.0 cm, P ϭ 0.02) and per-protocol analysis (9.8 Ϯ 4.9 vs. 6.8 Ϯ 4.4 cm, P ϭ 0.02). Partly due to accelerated bone maturation (P Ͻ 0.001), adult height gain on GHϩOx 0.06 was not significantly different from that on GHϩPl (8.3 Ϯ 4.7 vs. 7.2 Ϯ 4.0 cm, P ϭ 0.3). Breast development was slower on GHϩOx (GHϩOx 0.03, P ϭ 0.02; GHϩOx 0.06, P ϭ 0.05), and more girls reported virilization on GHϩOx 0.06 than on GHϩPl (P Ͻ 0.001). Conclusions: In GH-treated girls with TS, we discourage the use of the conventional Ox dosage (0.06 mg/kg ⅐ d) because of its low benefit to risk ratio. The addition of Ox 0.03 mg/kg ⅐ d modestly increases adult height gain and has a fairly good safety profile, except for some deceleration of breast development. (J Clin Endocrinol Metab 95:
doi:10.1210/jc.2009-1821 pmid:20061421 fatcat:bnbxso77mreg5oojhvtfaluicm
Citation

Leonie A. Menke, Theo C. J. Sas, Sabine M. P. F. de Muinck Keizer-Schrama, Gladys R. J. Zandwijken, Maria A. J. de Ridder, Roelof J. Odink, Maarten Jansen, Henriëtte A. Delemarre-van de Waal, Wilhelmina H. Stokvis-Brantsma, Johan J. Waelkens, Ciska Westerlaken, H. Maarten Reeser, A. S. Paul van Trotsenburg, Evelien F. Gevers, Stef van Buuren, Philippe H. DeJonckere, Anita C. S. Hokken-Koelega, Barto J. Otten, Jan M. Wit. "Efficacy and Safety of Oxandrolone in Growth Hormone-Treated Girls with Turner Syndrome." Journal of Clinical Endocrinology and Metabolism 95.3 (2010) 1151-1160