Limited Efficacy of Growth Hormone (GH) during Transition of GH-Deficient Patients from Adolescence to Adulthood: A Phase III Multicenter, Double-Blind, Randomized Two-Year Trial

Mauras, Nelly; Pescovitz, Ora Hirsch; Allada, Vivekanand; Messig, Michael; Wajnrajch, Michael; Lippe, Barbara M.

doi:10.1210/jc.2005-0208

Cited by 96 publications

(90 citation statements)

References 48 publications

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“…23 Four patients had untreated primary hypogonadism, one of whom had concomitant low bone mass. In contrast, levels of 25(OH) vitamin D were lower in the patient group and were positively correlated with BMD total both in univariate and multivariate analyses.…”

Section: Discussionmentioning

confidence: 99%

Decreased bone mineral density in young adults treated with SCT in childhood: the role of 25-hydroxyvitamin D

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Arvidson

Ljunggren

et al. 2011

Bone Marrow Transplant

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We measured bone mineral density (BMD) with dualenergy X-ray absorptiometry in the total body, at the lumbar spine, at the femoral neck and in the total hip, in 18 young adults with a median of 18.2 years after SCT. Fifteen patients had undergone auto-SCT and all patients had received TBI. The patients had significantly lower BMD in the total body, at the femoral neck, and in the total hip compared with age-and sex-matched controls. Six of 18 patients (33%) had low bone mass (z-score oÀ1) at one or more measurement sites, as opposed to two of the controls (11%, P ¼ 0.29). We found no significant influence of growth hormone levels or of untreated hypogonadism on BMD variables. Levels of 25-hydroxy (25(OH)) vitamin D were lower among the patients (35.2 vs 48.8 nmol/L, P ¼ 0.044) and were significantly correlated with total body BMD in the patient group (r ¼ 0.55, P ¼ 0.021). All six patients with low bone mass had hypovitaminosis D (p37 nmol/L as opposed to 4 of the 11 (36%) patients without low bone mass (P ¼ 0.035). In conclusion, we found decreased BMD in SCT survivors, which may in part be caused by 25(OH) vitamin D deficiency.

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Section: Discussionmentioning

confidence: 99%

Decreased bone mineral density in young adults treated with SCT in childhood: the role of 25-hydroxyvitamin D

Frisk

Arvidson

Ljunggren

et al. 2011

Bone Marrow Transplant

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“…No increase in total body BMD was detected in our study. Several recent studies have assessed the effects of GH replacement on BMD at completion of linear growth in children (36)(37)(38)(39). Consistent with our findings, in a smaller study involving 24 adolescents with severe GHD, 12 months' GH therapy was associated with a 4.7% increase in mean lumbar spine BMD from baseline compared with a 2.7% change in those who discontinued treatment, while the median whole body BMC increased by 6% in GH-treated patients and remained unchanged in untreated patients (36).…”

Section: Discussionmentioning

confidence: 99%

Treatment for 24 months with recombinant human GH has a beneficial effect on bone mineral density in young adults with childhood-onset GH deficiency

Conway

Szarras‐Czapnik

Rácz

et al. 2009

European Journal of Endocrinology

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Objective: Discontinuation of growth hormone (GH) therapy on completion of linear growth may adversely affect bone mineral density (BMD) in young adults with childhood-onset GH-deficiency (GHD). In the present study, we analyzed the impact of GH treatment on bone in young adults with GHD. Methods: BMD at the lumbar spine (L2-L4), total hip, and total body was measured at baseline and after 24 months in a cohort of young adults (18-25 years; nZ160) with severe GHD treated with GH during childhood who were randomized to GH (nZ109) or no treatment (nZ51) in a multicenter, multinational, open-label study. GH starting doses (0.2 mg/day (males), 0.4 mg/day (females)) were increased after 1 month to 0.6 mg/day (males) and 0.9 mg/day (females) and then to 1.0 mg/day (males) and 1.4 mg/day (females) at 3 months for the remainder of the study. Results: After 24 months, lumbar spine BMD had increased significantly more in GH-treated patients than in controls (6 vs 2%; estimated treatment difference; 3.5% (95% confidence interval, 1.52-5.51) P!0.001). GH also had a significant positive effect on total hip BMD (PZ0.015). Total body BMD was unchanged from baseline (PZ0.315). Conclusions: In young adults treated for childhood-onset GHD, there is a beneficial effect of continued GH treatment on BMD in adult life. Twenty-four months of GH treatment in these young adults was associated with an estimated 3.5% greater increase in BMD of the lumbar spine compared with controls.

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“…• GHD No additional RCTs were reported for GHD although an additional one is included in the SHTAC MTA (Mauras 2005 • CRI Three RCTs (de Graaf 2003;Fine 2002;Sanchez 2002). Two of these (de Graaf and Fine) are not included in the SHTAC MTA review because they do not meet our inclusion criteria.…”

Section: Searches Identifiedmentioning

confidence: 99%

Recombinant human growth hormone for the treatment of growth disorders in children: a systematic review and economic evaluation

Takeda

Cooper²,

Bird³

et al. 2010

Health Technol Assess

108

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How to obtain copies of this and other HTA programme reports An electronic version of this title, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable DVD is also available (see below).Printed copies of HTA journal series issues cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our despatch agents.Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per issue and for the rest of the world £3 per issue. How to order:-fax (with credit card details) -post (with credit card details or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you to either print out your order or download a blank order form. Contact details are as follows:Synergie UK (HTA Department) Digital House, The Loddon Centre Wade Road Basingstoke Hants RG24 8QW Email: orders@hta.ac.uk Tel: 0845 812 4000 -ask for 'HTA Payment Services' (out-of-hours answer-phone service) Fax: 0845 812 4001 -put 'HTA Order' on the fax header Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to University of Southampton and drawn on a bank with a UK address. Paying by credit cardYou can order using your credit card by phone, fax or post. SubscriptionsNHS libraries can subscribe free of charge. Public libraries can subscribe at a reduced cost of £100 for each volume (normally comprising 40-50 titles). The commercial subscription rate is £400 per volume (addresses within the UK) and £600 per volume (addresses outside the UK). Please see our website for details. Subscriptions can be purchased only for the current or forthcoming volume. How do I get a copy of HTA on DVD?Please use the form on the HTA website (www.hta.ac.uk/htacd/index.shtml). HTA on DVD is currently free of charge worldwide.The website also provides information about the HTA programme and lists the membership of the various committees. NIHR Health Technology Assessment programmeT he Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'. The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projects. F...

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Limited Efficacy of Growth Hormone (GH) during Transition of GH-Deficient Patients from Adolescence to Adulthood: A Phase III Multicenter, Double-Blind, Randomized Two-Year Trial

Cited by 96 publications

References 48 publications

Decreased bone mineral density in young adults treated with SCT in childhood: the role of 25-hydroxyvitamin D

Decreased bone mineral density in young adults treated with SCT in childhood: the role of 25-hydroxyvitamin D

Treatment for 24 months with recombinant human GH has a beneficial effect on bone mineral density in young adults with childhood-onset GH deficiency

Recombinant human growth hormone for the treatment of growth disorders in children: a systematic review and economic evaluation

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