ESPE Yearbook of Paediatric Endocrinology

ESPE Yearbook of Paediatric Endocrinology

ISSN 1662-4009 (online)

Published by BioScientifica

Page 1 of about 6 results

ey0021.7-4 | Clinical Guidance and Studies | ESPEYB21

7.4. Unstimulated luteinizing hormone for assessment of suppression during treatment of central precocious puberty with 6-month subcutaneous leuprolide acetate: correlations with clinical response

KO Klein , BS Miller , N Mauras

Brief Summary: This prospective study of 62 children with Central Precocious Puberty (CPP) concluded that measuring unstimulated luteinizing hormone (LH) may be adequate to assess effective pubertal suppression.Pubertal stages, growth velocity and bone age maturation are considered as key clinical markers to evaluate adequate pubertal suppression in patients treated for CPP. Basal LH concentrations levels also seem to be effective1. This study...
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ey0018.4-5 | Growth Hormone Therapy: Safety | ESPEYB18

4.5. Long-term safety of growth hormone treatment in childhood: two Large observational studies: nordiNet IOS and ANSWER

L Savendahl , M Polak , P Backeljauw , JC Blair , BS Miller , TR Rohrer , A Hokken-Koelega , A Pietropoli , N Kelepouris , J Ross

J Clin Endocrinol Metab. 2021 May 13;106(6):1728–1741. doi: 10.1210/clinem/dgab080. PMID: 33571362This report gathered data from two large observational studies (NordiNet International Outcome Study and ANSWER Program) aimed at assessing the incidence of adverse drug reactions (ADRs), serious adverse events (SAEs), and their relation with rhGH dose. The whole study cohort included 37,7...
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ey0018.7-3 | Clinical Guidance | ESPEYB18

7.3. Phase 3 trial of a small-volume subcutaneous 6-month duration leuprolide acetate treatment for central precocious puberty

KO Klein , A Freire , MG Gryngarten , GB Kletter , M Benson , BS Miller , TS Dajani , EA Eugster , N Mauras

J Clin Endocrinol Metab. 2020 Oct 1;105(10):e3660–71. 10.1210/clinem/dgaa479. https://academic.oup.com/jcem/article/105/10/e3660/5879679In brief: This phase 3 multi-centre, open-label, single-arm study explores the efficacy, pharmacokinetics and safety of 6-monthly 45-mg subcutaneous leuprolide acetate in 59 pati...
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ey0020.2-7 | Long-Acting Growth Hormone (LAGH) | ESPEYB20

2.7. Weekly somapacitan is effective and well tolerated in children with GH deficiency: The randomized phase 3 REAL4 trial

BS Miller , JC Blair , MH Rasmussen , A Maniatis , RJ Kildemoes , J Mori , M Polak , RB Bang , V Bottcher , S Stagi , R Horikawa

Brief summary: This multicenter, randomized, controlled, phase 3 study compared the effects of long-acting GH (Somapacitan; 0.16 mg/kg/wk) with daily GH (Norditropin; 0.034 mg/kg/d), in GHD children. The trial was conducted over 52 weeks, followed by an ongoing 3-year single-group extension period. Similar efficacy and safety for somapacitan compared to daily GH was demonstrated over 52 weeks of treatment.Long-acting growth hormone (LAGH) formulations ha...
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ey0020.2-8 | Long-Acting Growth Hormone (LAGH) | ESPEYB20

2.8. Efficacy and safety of weekly somatrogon vs daily somatropin in children with growth hormone deficiency: A phase 3 study

CL Deal , J Steelman , E Vlachopapadopoulou , R Stawerska , LA Silverman , M Phillip , HS Kim , C Ko , O Malievskiy , JF Cara , CL Roland , CT Taylor , SR Valluri , MP Wajnrajch , A Pastrak , BS Miller

Brief summary: This 12-months randomized, controlled, phase 3 study compared the efficacy and safety of once-weekly Somatrogon 0.66 mg/kg/week with once-daily somatropin in prepubertal children with GHD. The efficacy of once-weekly Somatrogon was noninferior to once-daily somatropin, with similar safety and tolerability profiles.Somatrogon (MOD-4023) is a long-acting rhGH recently approved by the European Medicines Agency for the treatment of children wi...
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ey0017.4-1 | Important for clinical practice | ESPEYB17

4.1. Diagnosis, genetics, and therapy of short stature in children: A growth hormone research society international perspective

PF Collett-Solberg , G Ambler , PF Backeljauw , M Bidlingmaier , BMK Biller , MCS Boguszewski , PT Cheung , CSY Choong , LE Cohen , P Cohen , A Dauber , CL Deal , C Gong , Y Hasegawa , AR Hoffman , PL Hofman , R Horikawa , AAL Jorge , A Juul , P Kamenicky , V Khadilkar , JJ Kopchick , B Kristrom , MdLA Lopes , X Luo , BS Miller , M Misra , I Netchine , S Radovick , MB Ranke , AD Rogol , RG Rosenfeld , P Saenger , JM Wit , J Woelfle

To read the full abstract: Horm Res Paediatr. 2019;92:1–14In March 2019, 46 international experts from 14 countries across 5 continents attended a 3-day workshop organized by the Growth Hormone Research Society (GRS) and produced this perspective on the diagnosis, management and therapy in children with short stature. In this context, this expert panel tackled almost all aspects related to the management of children with short stature, prov...
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ESPE Yearbook of Paediatric Endocrinology
ISSN 1662-4009 (Online)
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