Study procedures
GHD
ADVERSE EVENT, GHD
Routine retesting in established puberty is routine clinical practice in all trial sites. Children with GHD persistence at retesting will restart GH; those with GHD reversal will be offered study participation. Following consent, participants will be randomised to GH + (25–35 µg/kg/day) and GH − groups and followed in routine endocrine clinics until ‘Near FH’ (growth rate < 2 cm/year) is reached. In the GH − group, any unexpected decrease in IGF-1 concentrations below − 2 SD (lower limit of normal) at 6 months would trigger a repeat GH stimulation test and recommencement of GH if deficient.The baseline visit for all patients will include confirmation of inclusion and exclusion criteria, informed consent/assent, randomisation and allocation of trial number, prescription of growth hormone (if randomised to continue treatment), a record of the preparation and dose prescribed, a record of concomitant medication and relevant medical history. Height, weight and Tanner stage will also be measured at baseline. All patients will have 6-monthly visits to measure height, weight, Tanner stage, serum IGF-1 (at 6 months and annually thereafter) as well as checking compliance with GH therapy and any concomitant medication and adverse event reporting. HRQoL will be measured using the CHU9D questionnaire at baseline and at each 6-monthly visit. A left hand X-ray will be conducted at enrolment and near FH, for central analysis using the BoneXpert software. Fasting lipids will be measured at baseline and near FH.At near FH, all subjects will have a GH stimulation test to reconfirm GH status. Given the usual duration of pubertal growth until near FH is achieved, we have allowed for 3 years follow-up.The information captured at the randomisation and subsequent visits are shown in Fig. 