The GHD Reversal Trial
Research type
Research Study
Full title
The Growth Hormone Deficiency Reversal Trial: Effect on final height of discontinuation vs continuation of growth hormone treatment in pubertal children with isolated growth hormone deficiency – A non-inferiority randomised controlled trial
IRAS ID
281209
Contact name
Mehul Dattani
Contact email
Sponsor organisation
University College London
Eudract number
2020-001006-39
ISRCTN Number
ISRCTN12552768
Duration of Study in the UK
7 years, 5 months, 30 days
Research summary
Growth hormone (GH) is a hormone essential for normal growth and development. If a child doesn’t have enough GH, the speed of growth is slower and final adult height reduced. Growth hormone deficiency (GHD) is a condition where the pituitary gland doesn’t make enough growth hormone in childhood. GH treatment allows children with GHD to grow normally. GH is given as daily injections continued until the child reaches adult height. GH is usually given for 5-10 years and can cost £10,000-23,000 per patient per year.
Children are tested for GHD by measuring the highest amount of GH in the blood following a test. When GH production is checked after children reach their final height, some children are found to have normal levels of GH; these children therefore no longer have GHD. Some doctors think that this change occurs during puberty. Therefore, many pubertal children on GH therapy are assumed to no longer have GHD but doctors usually continue daily GH injections until the child reaches final adult height. Therefore some children continue to have potentially unnecessary, costly daily injections.
The aim of this ‘GHD reversal’ study is to find out whether certain children can stop their GH injections at puberty and still reach a similar final adult height to those children who continue to have daily GH injections. 138 children with GHD from 16 hospitals whose stimulated GH levels are found to be normal when tested after they have entered puberty, will take part in this study. After giving their consent, these children will be randomised (chosen by 50:50 chance by a computer) to either continue or stop their daily GH injections. The study will test whether the children who stop their GH injections reach a similar final adult height to those children that continue their injections.
REC name
Wales REC 3
REC reference
22/WA/0005
Date of REC Opinion
8 Mar 2022
REC opinion
Further Information Favourable Opinion