Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome

Summary

The aim of this study is to study the effects of GH on body composition, lipid and glucose metabolism, physical performance and safety aspects in adults with PWS.The patients are randomized to either GH or placebo the first year of the study, subsequently followed by two years of GH treatment. the study is performed in Norway, Sweden and Denmark.

Timeline

Start

2005-04

Primary completion

2010-03

Completion

2010-03

Publications

• Shukur HH, Hussain-Alkhateeb L, Farholt S, Norregaard O, Jorgensen AP, Hoybye C. Effects of Growth Hormone Treatment on Sleep-Related Parameters in Adults With Prader-Willi Syndrome. J Clin Endocrinol Metab. 2021 Aug 18;106(9):e3634-e3643. doi: 10.1210/clinem/dgab300.
• Olarescu NC, Jorgensen AP, Godang K, Jurik AG, Froslie KF, Bollerslev J. Dual-energy X-ray absorptiometry is a valid method to estimate visceral adipose tissue in adult patients with Prader-Willi syndrome during treatment with growth hormone. J Clin Endocrinol Metab. 2014 Sep;99(9):E1727-31. doi: 10.1210/jc.2014-2059. Epub 2014 Jun 23.
• Jorgensen AP, Ueland T, Sode-Carlsen R, Schreiner T, Rabben KF, Farholt S, Hoybye C, Christiansen JS, Bollerslev J. Glucose homeostasis in adults with Prader-Willi syndrome during treatment with growth hormone: results from a 12-month prospective study. Growth Horm IGF Res. 2014 Feb;24(1):16-21. doi: 10.1016/j.ghir.2013.11.002. Epub 2013 Dec 4.
• Jorgensen AP, Ueland T, Sode-Carlsen R, Schreiner T, Rabben KF, Farholt S, Hoybye C, Christiansen JS, Bollerslev J. Two years of growth hormone treatment in adults with Prader-Willi syndrome do not improve the low BMD. J Clin Endocrinol Metab. 2013 Apr;98(4):E753-60. doi: 10.1210/jc.2012-3378. Epub 2013 Feb 22.

Drugs

Indications