A randomized, multicenter, multinational trial to evaluate the safety and efficacy of Growth Hormone treatment at varying doses in short children born SGA

Design An open multicenter study Aim of study To evaluate changes in short and long term growth, body composition and insulin sensitivity at different GH doses (low, high and IGF-I titrated dose). Study population 300 short children born SGA aged 4-8.99 years (4-9.99 years in boys) from 7 European centres. GH doses Year 1 67 μg Norditropin /kg bodyweight/day Year 2 and thereafter, patients randomized to receive: 35 μg Norditropin /kg bodyweight/day 67 μg Norditropin /kg bodyweight/day Variable dose (IGF-I titrated) Duration of treatment 3 years

Investigations Every 3 months: Clinical exam Auxology IGF-I IGFBP-3 HbA1C At baseline, 1 yr and 3 yr: IVGTT DEXA scanning At baseline and 2 yr: OGTT (WHO standard) Annually: Bone age Thyroid hormones Lipids Investigators Anders Juul, Copenhagen, Denmark (principal investigator) Olle Söder, Stockholm, Sweden Sten Ivarsson, Malmø, Sweden David Dunger, Cambridge, UK Jeremy Kirk, Birmingham, UK Malcolm Donaldson, Glasgow, Scotland Hillary Hoey, Dublin, Ireland

If you require any help, please contact: Anders Juul Email: anders.juul@rh.hosp.dk

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