Efficacy and safety of a new ready-to-use recombinant human growth hormone solution Results from the First 2 Years of a Clinical Trial with Recombinant DNA‐derived Human Growth Hormone (Somatrem) in Turner's Syndrome Growth Hormone Improves Body Composition and Motor Development in Infants with Prader-Willi Syndrome After Six Months Intuitiveness, ease of use, and preference of a prefilled growth hormone injection pen: a noninterventional, randomized, open-label, crossover, comparative usability study of three delivery devices in growth hormone-treated pediatric patients. Growth hormone treatment of children with Prader‐Willi syndrome affects linear growth and body composition favourably Growth hormone therapy in Turner's syndrome. Impact of injection frequency and initial bone age. Absence of growth hormone effects on cognitive function in girls with Turner syndrome. Growth hormone improves mobility and body composition in infants and toddlers with Prader-Willi syndrome. Growth Hormone Treatment in Short Children with Intrauterine Growth Retardation Growth promotion and Turner-specific bone age after therapy with growth hormone and in combination with oxandrolone: when should therapy be started in Turner syndrome? Effects of growth hormone treatment on growth and body composition in Prader-Willi syndrome: a preliminary report. The Swedish National Growth Hormone Advisory Group. Psychological aspects of the Canadian randomized controlled trial of human growth hormone and low-dose ethinyl oestradiol in children with Turner syndrome. The Canadian Growth Hormone Advisory Group. History and organization of the Growth Failure in Children with Renal Diseases Study. Methionyl human growth hormone and oxandrolone in Turner syndrome: preliminary results of a prospective randomized trial. Treatment with human growth hormone in patients with Prader-Labhart-Willi syndrome reduces body fat and increases muscle mass and physical performance Patient preference for a new growth hormone injection device: results of an open-label study in Japanese pediatric patients Three-year results of treatment with growth hormone, alone or associated with oxandrolone, in girls with Turner syndrome. The Kabi Collaborative Study Group.
We report 24-month interim results of two multicenter phase III studies in previously untreated children with growth failure secondary to GH deficiency ( GHD ) that were paramount to the development of a new recombinant human GH ( rhGH , somatropin ) , approved as the first ‘ biosimilar ’ in Europe . Study 1 consisted of 3 parts performed in 89 children . The objective was to compare efficacy and safety of the lyophilized formulation of the new somatropin [ Somatropin Powder ( S and oz ) ] with a licensed reference rhGH preparation and the liquid formulation of the new somatropin [ Somatropin Solution ( S and oz ) ] and to assess long-term efficacy and safety of this ready-to-use Somatropin Solution . Study 2 was performed in 51 children and design ed to demonstrate efficacy and safety of Somatropin Powder and to confirm its low immunogenic potential ; rhGH was given sc at a daily dose of 0.03 mg/kg . Primary [ body height , height SD score ( HSDS ) , height velocity , and height velocity ( HV ) SD score ( HVSDS ) ] and secondary [ IGF-I and IGF binding protein 3 ( IGFBP-3 ) ] efficacy end-points and safety parameters were assessed regularly . In study 1 , all treatments showed comparable increases in growth . The baseline-adjusted difference between Somatropin Powder and the reference rhGH product in mean HV was −0.20 cm/yr ( 95 % confidence interval ( CI ) [ −1.34;0.94 ] ) and in mean HVSDS was 0.76 ( 95 % CI [ −0.57;2.10 ] ) after 9 months . These very small differences demonstrate comparable therapeutic efficacy between the two treatments . The results of study 2 were consistent with those seen in study 1 . Equivalent therapeutic efficacy and clinical comparability in terms of safety and immunogenicity between Somatropin Powder and the reference rhGH product and between Somatropin Powder and Somatropin Solution was demonstrated . The safety and immunogenicity profiles were similar and as expected from experience with rhGH preparations A total of 70 subjects with Turner 's syndrome from 11 centres were enrolled in a study of somatrem . After an initial observation period , they were r and omly assigned to one of four groups , receiving no treatment ( Group 1 , control ) ; ox and rolone , 0.125 mg/kg/day ( Group 2 ) ; somatrem , 0.125 mg/kg 3 times/week ( Group 3 ) ; or a combination of somatrem and ox and rolone on the above dose regimens ( Group 4 ) . After 12–20 months , Groups 1 ( control ) , 2 ( ox and rolone ) and 4 ( combination ) were treated with somatrem , 0.125 mg/kg 3 times/week , and ox and rolone , 0.0625 mg/kg/day ; Group 3 remained on somatrem , 0.125 mg/kg 3 times/week . All three treatment groups showed a statistically significant increase during year 1 in growth velocity over both their pretreatment growth rates and the control group growth rate . These increases were slightly less in year 2 for the somatrem and combination therapy groups , but remained significantly higher than the year 1 control group growth rate . Plasma IGF‐1 levels were elevated in years 1 and 2 in the somatrem and combination groups . Adverse events were few with the somatrem group , though mild virilization occurred with ox and rolone , alone or in combination . Bone age advancement was observed with all treatments but was greater with combination therapy ; it was accompanied by height age advancement . The effect of this therapy on predicted adult height was also evaluated BACKGROUND Infants with Prader-Willi syndrome ( PWS ) show abnormalities of body composition .  Children with PWS treated with growth hormone ( GH ) demonstrate improved body composition and motor skills . OBJECTIVE To assess body composition and motor changes in infants with PWS following 6 months GH therapy . METHODS Twenty-five infants with PWS ( mean age 15.5 mo ) underwent dual energy X-ray absorptiometry ( DEXA ) assessment of body composition , and motor assessment with the Toddler Infant Motor Evaluation ( TIME ) . Patients were then r and omized to treatment ( Genotropin , 1 mg/m2/day ) or control , with re assessment at 6 months . RESULTS GH treatment significantly increased lean body mass ( 6.4 + /- 2.4 kg to 8.9 + /- 2.7 kg ) and decreased body fat ( 27.6 + /- 9.9 % to 22.4 + /- 10.3 % ) . Age equivalent motor scores improved 4 months in the treated group vs 2 months in controls ( p < 0.01 ) . CONCLUSIONS Infants with PWS show significant body composition and motor development improvement following 6 months GH therapy . We are investigating whether this improvement leads to long-term reductions in obesity BACKGROUND Growth hormone ( GH ) is used to treat pediatric and adult GH deficiency ( GHD ) and growth failure in , among others , patients with Turner syndrome or children born small for gestational age . To improve treatment adherence , self-injection devices should be easy to learn , easy to use , and well accepted , especially in pediatric patients . Several GH pen devices are available , each with distinct features design ed for specific patient needs . OBJECTIVES This study compared injection time and intuitiveness of a prefilled test injection device ( Norditropin FlexPro , Novo Nordisk A/S , Bagsværd , Denmark ) with those of 2 commercially available durable injection devices ( easypod , Merck Serono SA , Geneva , Switzerl and ; and Genotropin , Pfizer Inc , New York , New York ) in GH-treated pediatric patients .  Dose accuracy , application errors , intuitiveness , usability , device features , ease of learning , ease of use , and overall preference were also assessed . METHODS This noninterventional , r and omized , open-label , crossover study enrolled patients aged ≥10 to < 18 years who were diagnosed with GHD or Turner syndrome or were born small for gestational age . Patients were allocated to an intuitiveness group ( without instruction ) or an instruction group and assigned to 1 of 3 sequences of device testing . For each device , time taken to deliver a mock injection of test medium ( FlexPro ) or GH ( easypod and Genotropin ) into an Eppendorf tube and the delivered dose were measured . Dose accuracy and application errors were assessed by a health care professional . Patients assessed the intuitiveness ( intuitiveness group only ) , device features , ease of learning , ease of use , and overall preference of the devices using question naires . RESULTS Included in the study were 56 patients ( mean [ SD ] age , 13.6 [ 2.1 ] years ; 63 % male ; GHD , 44 patients ; Turner syndrome , 3 ; born small for gestational age , 9 ) : 30 in the intuitiveness group and 26 in the instruction group . In the intuitiveness group , the mean ( SD ) mock injection time was significantly shorter with FlexPro ( 47.0 [ 49.0 ] seconds ) than with the easypod ( 219.2 [ 72.6 ] seconds ; P < 0.001 ) or the Genotropin pen ( 95.1 [ 78.4 ] seconds ; P < 0.01 ) . In the instruction group , injection time was also shortest with FlexPro ( 30.7 [ 10.8 ] seconds vs 59.6 [ 13.1 ] with easypod and 40.7 [ 18.6 ] with the Genotropin pen ; both , P < 0.001 ) . Most patients ( 70 % ) ranked FlexPro as the most intuitive device ( easypod , 0 % ; Genotropin , 30 % ) . In both the intuitiveness and instruction groups , a significantly greater proportion of patients considered FlexPro easiest to learn compared with the easypod and Genotropin devices ( both , P < 0.001 ) , although more patients preferred the easypod or Genotropin devices than FlexPro with regard to appearance ( intuitiveness group : FlexPro , 8 patients ; easypod , 9 ; and Genotropin , 13 ; instruction group : FlexPro , 4 ; easypod , 10 ; and Genotropin , 12 ) and quality ( intuitiveness group : FlexPro , 6 patients ; easypod , 10 ; and Genotropin , 14 ; instruction group : FlexPro , 8 ; easypod , 12 ; and Genotropin , 6 ) , and easy- pod 's delivery feedback feature was preferred by more patients ( intuitiveness group : FlexPro , 8 patients ; easypod , 14 ; Genotropin , 8 ; instruction group : FlexPro , 8 ; easypod , 14 ; and Genotropin , 4 ) . Dose accuracies ( as assessed by weighing the delivered dose and calculating variation in the delivered dose by device ) were 4.6 % with FlexPro , 14.6 % with easypod , and 20.6 % with the Genotropin pen in the intuitiveness group , and 2.7 % with FlexPro , 5.8 % with easypod , and 24.4 % with the Genotropin pen in the instruction group . CONCLUSION In this study , Norditropin FlexPro was associated with shorter injection times , higher dose accuracy , and greater intuitiveness , and was rated as easier to learn compared with the easypod and Genotropin devices We have compared the growth and the body composition in children with Prader‐Willi syndrome ( PWS ) with and without growth hormone treatment ( recombinant GH 0.1 IU/kg/day ) after a 1‐y period . Twenty‐nine prepubertal children with PWS , with mean body mass index ( BMI ) SDS of 2.2 , and 10 ( control ) healthy obese children with mean BMI SDS of 5.6 , underwent 24‐h frequent blood sampling . Both PWS and control obese children had low and similar GH levels ( 0.7 /ng/l ± 0.4 SD ) . Serum IGF‐I levels , however , were significantly lower in children with PWS ( ‐1.5 SDS ± 0.8 SD vs ‐0.2 SDS ±0.8 SD ) . The 29 PWS children were r and omized into 2 groups of 15 and 14 subjects for GH treatment and no treatment  , respectively . Height velocity increased from ‐1.9 SDS to + 6.0 SDS in the treated group ( p < 0:001 ) and decreased from ‐0.1 SDS to ‐1.4 SDS in the control PWS group during the study year . BMI decreased significantly for the treated group ( + 3.0 SDS to + 2.0 SDS ) . Relative fat mass decreased significantly , while fat‐free mass increased ( p < 0:001 ) for the treated group . No significant changes were noticed in body composition in the control PWS group . In conclusion , the low spontaneous 24‐h GH secretion , regardless of body weight , and the exceptional response to growth hormone treatment together with the finding of low IGF‐I levels suggest that growth hormone deficiency is a common feature of PWS , as a result of hypothalamic dysfunction . Treatment with growth hormone is beneficial for the majority of PWS children STUDY OBJECTIVE To determine the influence of the injection frequency and the initial bone age on the efficacy of treatment with biosynthetic growth hormone in Turner 's syndrome . DESIGN R and omized study . SETTING Referral-based pediatric endocrinology departments of seven university medical centers . PATIENTS Fifty-two patients with Turner 's syndrome confirmed with chromosomal analysis . TREATMENT Somatotropin recombinant DNA ( 24 IU/m2 of body surface area ) subcutaneously administered in three or six injections per week for 2 years . Patients who were older than 12 years at the beginning of the study received low doses of estrogen . RESULTS The following statistically significant findings supported the use of six injections per week compared with three injections per week : the mean ( + /- SD ) increment in height during 2 years was 11.3 cm ( 3.8 cm ) with six injections vs 8.6 cm ( 3.4 cm ) with three injections ; the increment in height st and ard deviation score was 0.9 cm ( 0.5 cm ) vs 0.6 cm ( 0.3 cm ) ; the growth velocity was 6.6 cm/y ( 2.0 cm/y ) vs 5.2 cm/y ( 1.7 cm/y ) in year 1 and 4.7 cm/y ( 2.0 cm/y ) vs 3.4 cm/y ( 1.7 cm/y ) in year 2 ; and the increment in height st and ard deviation score for bone age was 0.8 cm ( 0.5 cm ) vs 0.4 cm ( 0.6 cm ) . For patients whose initial bone age was more than 13 years , growth velocity increased by 1 to 2 cm in year 1 ; in year 2 no increment was observed . We did not observe adverse effects . CONCLUSIONS Biosynthetic growth hormone in a higher-frequency regimen in Turner 's syndrome is more efficient in terms of increment in height , growth velocity , and height st and ard deviation score for bone age than treatment in a lower-frequency regimen . In patients with an initial bone age of more than 13 years , the response was poor . Longer follow-up is necessary to assess the effect on final height Turner syndrome ( TS ) is a genetic disorder characterized by short stature , gonadal dysgenesis , and a particular neurocognitive profile of normally developed language abilities ( particularly verbal IQ ) and impaired visual-spatial and /or visual-perceptual abilities . We have followed a large sample of girls with Turner syndrome who were enrolled in a long-term , double-blind , placebo-controlled trial of the effects of growth hormone ( GH ) treatment on final adult height . This study provides a unique opportunity to prospect ively evaluate the effects of GH treatment on neurocognitive function in this population of girls with Turner syndrome . The GH- and placebo-treated Turner syndrome subjects were well matched for age , treatment duration , race , karyotype , and socioeconomic status . Treatment ( GH or placebo ) duration s ranged from 1 - 7 yr . Whether GH deficiency and /or treatment in childhood and adolescence influences cognitive outcome in short children or GH-children is controversial . The major result of this study was the absence of GH treatment effects on cognitive function in girls with Turner syndrome . Our findings are in agreement with most of the previous studies that found no apparent growth hormone treatment effects on cognitive function in growth-hormone deficient children . We conclude that this study does not support a role for growth hormone in influencing childhood brain development in girls with Turner syndrome . Their characteristic nonverbal neurocognitive deficits were not altered with GH treatment into early adolescence OBJECTIVES To determine the effect of growth hormone ( GH ) on body composition and motor development in infants and toddlers with Prader-Willi syndrome ( PWS ) . STUDY DESIGN Twenty-nine subjects with PWS ( 4 - 37 months of age ) were r and omized to GH treatment ( 1mg/m 2 /day ) or observation for 12 months . Percent body fat , lean body mass , and bone mineral density were measured by dual x-ray absorptiometry ; energy expenditure was measured by deuterium dilution ; and motor constructs of mobility ( M ) and stability ( S ) were assessed using the Toddler Infant Motor Evaluation ( TIME ) . RESULTS GH-treated subjects , compared with controls , demonstrated decreased percent body fat ( mean , 22.6 % + /- 8.9 % vs 28.5 % + /- 7.9 % ; P < .001 ) , increased lean body mass ( mean , 9.82 + /- 1.9 kg vs 6.3 + /- 1.9 kg ; P < .001 ) , and increased height velocity Z scores ( mean , 5 . 0 + /- 1.8 vs 1.4 + /- 1.0 ; P < .001 ) . Patients who began GH before 18 months of age showed higher mobility skill acquisition compared with controls within the same age range ( mean increase in raw score , 284 + /- 105 vs 206 + /- 63 ; P < .05 ) . CONCLUSIONS GH treatment of infants and toddlers with PWS for 12 months significantly improves body composition and when begun before 18 months of age increases mobility skill acquisition . These results suggest that GH therapy instituted early in life may lessen deterioration of body composition in PWS while also accelerating motor development The aim of this prospect i ve controlled study was to assess the effect of rhGH in short prepubertal children with intrauterine growth retardation and normal growth hormone status . Twenty-six children were r and omized into treatment ( 12F , 4 M ) and control ( 6F , 4 M ) groups . Mean ages were 5.3 ( 1.3 ) yr and 4.3 ( 1.7 ) yr , respectively .  rhGH ( Genotropin ) was used at a dose of 0.2 IU/kg/day as daily s.c . injections for two years . In the treated group , mean height SDS increased from -3.0 ( 0.5 ) to -1.9 ( 0.7 ) and height velocity SDS showed a significant increase from -1.3 ( 2.0 ) to 3.7 ( 1.8 ) in the first year ( p < 0.001 ) and 1.6 ( 1.8 ) ( p < 0.01 ) in the second year of treatment . In the controls , height SDS , initially -2.7 ( 1.4 ) , and height velocity SDS , initially -0.9 ( 1.1 ) , remained essentially the same during two years of follow-up . Height SDS for bone age changed by 0.6 in the treated group and 0.4 in the control group . Target height SDS -- initial height SDS in the treated group improved by 1.1 SD but declined in the control group . IGF-I levels increased from 9.5 ( 4.2 ) nmol/l ( 72 [ 31.8 ] ng/ml ) to 32.5 ( 27.0 ) nmol/l ( 244.4 [ 202.8 ] ng/ml ) ( p = 0.004 ) in the treated group while no change was observed in the controls . No adverse effects were encountered during rhGH therapy . It was concluded that rhGH treatment induces a significant increase in growth velocity in the short term . This outcome , as opposed to the unchanged indices in the control group over the same period , may be indicative of an improved height prognosis in short children born with intrauterine growth retardation treated with rhGH The aims of this comparative multicenter study of 67 girls with Turner syndrome ( TS ) on three different therapeutical regimens were , first , to evaluate the effect of either recombinant human growth hormone ( GH ) alone or in combination with the anabolic steroid ox and rolone ( Oxa ) on height velocity and on Turner-specific bone age ( BA'TS ) and , second , to estimate the gain in final height taking the age at the onset of treatment into account . The mean advancement of BA'TS in 2 years of treatment was 2.5 years/2 years in group 1 ( low dose GH : 16 IU/m2/week ) , 2.8 years/2 years in group 2 ( high dose GH : 28 IU/m2/week ) and 3.3 years/2 years in group 3 ( GH : 24 IU/m2/week + Oxa : 0.06 mg/kg/day ) instead of the expected 2 years/2 years advancement in untreated girls with TS . On all treatment regimens the advancement of BA'TS was more pronounced in the younger girls . In many girls with a BA'TS below 9 years at the onset of treatment the increase in height did not outweigh the advancement in BA'TS , suggesting that starting growth-promoting treatment before 9 years would not be the best way to improve final height . In our opinion , the optimal age for starting growth-promoting therapy is at 9 years . A start at a younger age might have no advantage in regard of an ultimate gain in final height . On the other h and , therapy should not be delayed much after the age of 9 years giving the girls with TS the possibility to catch up substantially before estrogen treatment is initiated A controlled , r and omized study was conducted to assess the effect of growth hormone ( GH ) treatment on growth , body composition and behaviour in prepubertal children ( 3 - 12 years of age ) with Prader-Willi syndrome .  GH treatment was given to one group of 15 patients ( group A ) at a dose of 0.1 IU/kg/day for 2 years . The second group ( group B ; n = 12 ) was not treated for the first year and was then given GH at a dose of 0.2 IU/kg/day for the second year . All patients had low 24-hour levels of GH and insulin-like growth factor I before GH treatment .  Height velocity SDS increased from -1.9 + /- 2.0 to 6.0 + /- 3.2 during the first year of GH treatment in group A , and from -1.4 + /- 1.2 to 10.1 + /- 3.9 in the second year of the study in group B. When GH treatment was stopped , height velocity declined dramatically . Height SDS followed a similar pattern . GH treatment reduced the percentage body fat and increased the muscle area of the thigh . Isometric muscle strength was also increased . In addition , GH treatment appeared to have psychological and behavioural benefits , which were reversed after cessation of treatment . It was concluded that GH treatment improves growth , body composition and behaviour in children with Prader-Willi syndrome Preliminary results are presented after 2 years of the Canadian long-term multicentre study on the impact of hormone therapy on the final height , sexual development and psychological status of girls with Turner syndrome . Girls entering the study were r and omized either to be treated with recombinant human growth hormone or to act as controls . Both groups received oestrogen replacement therapy in the same dose and format at the age of 13 years . However , for the purpose s of the psychological study at this time , children receiving oestrogen were excluded from analysis . Girls treated with GH for a period of 2 years showed a significant increase in growth rate , which declined with continued treatment , while the growth rate in the control group remained constant throughout . There was a correlation between the higher growth rate and the girls ' perceptions of themselves as more intelligent , more attractive , having more friends , greater popularity and experiencing less teasing than the untreated group . Growth rate was not correlated with family or school functioning The Growth Failure in Children With Renal Diseases ( GFRD ) Study was funded by the National Institutes of Health ( NIH ) in mid-1983 to test the efficacy of treating early childhood renal osteodystrophy with either 1,25dihydroxyvitamin D 3 or dihydrotachysterol to determine which promotes the best linear growth and nutrient consumption and results in the least deterioration of renal function . In addition , the study was design ed to evaluate the anthropometric , biochemical , and nutritional status of children with moderate renal insufficiency Seventy girls with Turner syndrome , 4 to 12 years of age , were r and omly assigned to receive either no treatment ( control ) or methionyl human growth hormone ( 0.125 mg/kg three times per week ) , ox and rolone ( 0.125 mg/kg/day ) , or combination hGH plus ox and rolone therapy .  Baseline growth rates averaged 4.3 cm/yr , and all were within 2 SD of mean growth velocity for age in girls with Turner syndrome . Sixty-seven girls remained in the study for a minimum of 1 year . Growth rates and growth velocity ( in st and ard deviations for age in girls with Turner syndrome ) were control 3.8 cm/yr ( -0.1 SD ) , hGH 6.6 cm/yr ( + 2.3 SD ) , ox and rolone 7.9 cm/yr ( + 3.7 SD ) , and combination therapy 9.8 cm/yr ( + 5.4 SD ) . Mean bone ages advanced 1.0 years ( hGH ) , 1.3 years ( ox and rolone ) , and 1.6 years ( combination ) . However , median increments in height age/bone age ( delta HA/delta BA ) ratios ranged from 1.0 to 1.1 for treatment groups , compared with 0.8 for the controls . Predicted adult height by the method of Bayley-Pinneau increased 2.5 cm for hGH or ox and rolone alone , and 3.2 cm for combination treatment . These data indicate that both hGH and ox and rolone can significantly stimulate short-term skeletal growth in patients with Turner syndrome , and potentially increase final adult height Twelve children with documented Prader-Labhart-Willi syndrome were treated with human growth hormone ( 24 U/m2/week ) during 1 year . The children were divided into three groups : group 1 : overweight and prepubertal ( n = 6 , age 3.8–7.0 years ) ; group 2 : underweight and prepubertal ( n = 3 , age 0.6–4.1 years ) ; group 3 : pubertal ( n = 3 , age 9.2–14.6 years ) . In group 1 , height increased from -1.7 SD to -0.6 SD , while weight decreased from 1.1 SD to 0.4 SD , with a dramatic drop in weight for height from 3.8 SD to 1.2 SD . H and length increased from -1.5 SD to -0.4 SD and foot length from -2.5 SD to -1.4 SD . Body fat , measured by dual X-ray energy absorptiometry , dropped by a third , whereas muscle mass increased by a fourth . Physical capability ( Wingate test ) improved considerably . The children were reported to be much more active and capable . In group 2 , similar changes were seen , but weight for height increased , probably because muscle mass increase exceeded fat mass decrease . Changes in group 3 were similar as in group 1 , even though far less distinct . Conclusion Growth hormone treatment in Prader-Labhart-Willi syndrome led to dramatic changes : distinct increase in growth velocity , height and muscle mass , as well as an improvement in physical performance . Fat mass and weight for height decreased in the initially overweight children , and weight for height increased in underweight children Abstract Background : Growth hormone deficiency ( GHD ) in children is treated with daily subcutaneous injections of GH . Poor adherence , result ing in suboptimal treatment outcomes , is common due to long-term treatment . Injection devices that are considered easy to use by patients or guardians could improve adherence . Objective : This study assessed the usability of the Norditropin ® FlexPro ® pen injector and NovoTwist ® needles ( both Novo Nordisk A/S , Bagsvaerd , Denmark ) in Japanese children and adolescents with GHD . Methods : This open-label , uncontrolled usability test included patients aged 6 to ≤18 years with GHD currently receiving daily injections of GH with pen injectors . Patients performed repeated injections of test medium into a foam cushion . Patients or guardians completed a question naire on pen h and ling . Results : A total of 73/74 patients ( 99 % ) rated Norditropin ® FlexPro  ® easy to h and le , reporting no technical complaints . In total , 60 ( 81 % ) preferred Norditropin ® FlexPro ® over their current device , with 12 % preferring their current device and 7 % not sure . Conclusions : Norditropin ® FlexPro ® was perceived as easy to use and reliable , and was well accepted and preferred over the current device for the administration of GH in children and adolescents . Patients were more confident that Norditropin ® FlexPro ® delivered the right dose compared with their current device 22 girls with Turner syndrome aged 10.8 + /- 2.4 years with bone age 8.58 + /- 1.32 years , r and omized in two groups , were treated for 3 years with either growth hormone ( GH ) , 0.1 U/kg daily ( group A ) , or GH , 0.1 U/kg , plus ox and rolone , 0.06 mg/kg ( group B ) . This result ed in a sharp increase in growth rate for the first year of treatment , followed in the second and third years by a growth rate near to the normal mean for age . The growth velocity was better in group B , the difference being significant during the first year only . After 3 years , the predicted adult height had increased by 2.1 cm as a mean in group A and by 4.5 cm in group B , with important individual variations , result ing in a gain of at least 3 cm in 3/10 patients of group A and 9/12 of group B. No metabolic or other side effects occurred . These 3-year data confirm that GH improves the predictable height in Turner girls . They suggest that it may be useful for at least 3 years and that adding a small dose of ox and rolone for 2 years in girls aged more than 8 years could be of good practice . However , earlier and more protracted treatment with GH has to be studied with the hope to better improve the predictable adult height
This SR highlights the lack of long-term RCTs reporting final height data and other important qualitative outcomes , such as quality of life .
ABSTRACT Genotropin ( somatropin ) is licensed for the treatment of children with growth hormone deficiency , Prader-Willi syndrome , Turner syndrome , chronic renal insufficiency and in children born small for gestational age .
This systematic review ( SR ) evaluated the clinical efficacy and effectiveness of Genotropin in these conditions to inform a NICE Technology Appraisal of growth hormone for the treatment of growth failure in children .