Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

Summary

This trial is conducted in Europe. The aim of this trial is to assess and compare the efficacy and safety of two dose levels of somatropin over a long period (till final height is reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial) and GHRETARD/BPD/20/NL (a 2-year extension trial).

Timeline

Start

1990-10

Primary completion

2005-05

Completion

2005-05

Publications

• Results Boonstra V, van Pareren Y, Mulder P, Hokken-Koelega A. Puberty in growth hormone-treated children born small for gestational age (SGA). J Clin Endocrinol Metab. 2003 Dec;88(12):5753-8. doi: 10.1210/jc.2003-030512.
• Results Sas T, de Waal W, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Growth hormone treatment in children with short stature born small for gestational age: 5-year results of a randomized, double-blind, dose-response trial. J Clin Endocrinol Metab. 1999 Sep;84(9):3064-70. doi: 10.1210/jcem.84.9.5942.
• Results Sas T, Mulder P, Hokken-Koelega A. Body composition, blood pressure, and lipid metabolism before and during long-term growth hormone (GH) treatment in children with short stature born small for gestational age either with or without GH deficiency. J Clin Endocrinol Metab. 2000 Oct;85(10):3786-92. doi: 10.1210/jcem.85.10.6917.
• Results Sas TC, Gerver WJ, De Bruin R, Mulder PG, Cole TJ, De Waal W, Hokken-Koelega AC. Body proportions during 6 years of GH treatment in children with short stature born small for gestational age participating in a randomised, double-blind, dose-response trial. Clin Endocrinol (Oxf). 2000 Dec;53(6):675-81. doi: 10.1046/j.1365-2265.2000.01155.x.
• Results Sas T, Mulder P, Aanstoot HJ, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Carbohydrate metabolism during long-term growth hormone treatment in children with short stature born small for gestational age. Clin Endocrinol (Oxf). 2001 Feb;54(2):243-51. doi: 10.1046/j.1365-2265.2001.01178.x.
• Results Van Pareren Y, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Adult height after long-term, continuous growth hormone (GH) treatment in short children born small for gestational age: results of a randomized, double-blind, dose-response GH trial. J Clin Endocrinol Metab. 2003 Aug;88(8):3584-90. doi: 10.1210/jc.2002-021172.
• Results van Pareren Y, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Effect of discontinuation of growth hormone treatment on risk factors for cardiovascular disease in adolescents born small for gestational age. J Clin Endocrinol Metab. 2003 Jan;88(1):347-53. doi: 10.1210/jc.2002-020458.

Drugs

Indications