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Effect of Growth Hormone Therapy on Height Velocity in Korean Children with Idiopathic Short Stature: A Phase III Randomised Controlled Trial

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dc.contributor.authorChung, WY-
dc.contributor.authorYoo, HW-
dc.contributor.authorHwang, JS-
dc.contributor.authorKo, CW-
dc.contributor.authorKim, HS-
dc.contributor.authorJin, DK-
dc.contributor.authorLee, KH-
dc.contributor.authorHan, HS-
dc.contributor.authorParanchothy, P-
dc.contributor.authorSuh, BK-
dc.date.accessioned2019-11-13T00:20:59Z-
dc.date.available2019-11-13T00:20:59Z-
dc.date.issued2018-
dc.identifier.issn1663-2818-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/17302-
dc.description.abstractBACKGROUND/AIMS: The SYNERGY (Saizen(R) for Your New Life and Brighter Tomorrow without Growth Deficiency) study is the first randomised multi-centre, open-label study to assess the short-term efficacy and safety of this recombinant human growth hormone (r-hGH) preparation for prepubertal children with idiopathic short stature in South Korea.
METHODS: The SYNERGY study (ClinicalTrials.gov NCT01746862) was conducted at 9 centres throughout South Korea between December 2012 and March 2015. The primary endpoint was difference in height velocity from baseline to 6 months in the treatment and control arms.
RESULTS: 97 children were screened: 90 were randomly assigned: 60 children to 0.067 mg/kg/day r-hGH for 12 months (treatment) and 30 children to 6 months of no treatment followed by 0.067 mg/kg/day r-hGH for 6 months (control). The 6-month mean height velocity in the treatment group increased from 5.63 cm/year (SD 1.62) to 10.08 cm/year (SD 1.92) (p < 0.0001) and from 4.94 cm/year (SD 1.91) to 5.92 cm/year (SD 2.01) (p = 0.0938) in the control group (between-group difference 3.47 cm/year, 95% CI 2.17-4.78: p < 0.0001). Adherence was > 90% throughout the study. The safety profile was consistent with that already known for r-hGH.
CONCLUSION: Treatment with r-hGH in the SYNERGY study demonstrated a statistically significant increase in height velocity at 6 months.
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dc.language.isoen-
dc.subject.MESHBody Height/drug effects-
dc.subject.MESHChild-
dc.subject.MESHChild Development/drug effects-
dc.subject.MESHChild, Preschool-
dc.subject.MESHFemale-
dc.subject.MESHGrowth Disorders/drug therapy-
dc.subject.MESHGrowth Disorders/pathology-
dc.subject.MESHGrowth Disorders/physiopathology-
dc.subject.MESHHuman Growth Hormone/administration & dosage-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.titleEffect of Growth Hormone Therapy on Height Velocity in Korean Children with Idiopathic Short Stature: A Phase III Randomised Controlled Trial-
dc.typeArticle-
dc.identifier.pmid30110706-
dc.identifier.urlhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6214610/-
dc.subject.keywordIdiopathic short stature-
dc.subject.keywordRecombinant human growth hormone-
dc.subject.keywordHeight velocity-
dc.subject.keywordEfficacy-
dc.subject.keywordSafety-
dc.contributor.affiliatedAuthor황, 진순-
dc.type.localJournal Papers-
dc.identifier.doi10.1159/000491016-
dc.citation.titleHormone research in pædiatrics-
dc.citation.volume90-
dc.citation.number1-
dc.citation.date2018-
dc.citation.startPage44-
dc.citation.endPage53-
dc.identifier.bibliographicCitationHormone research in pædiatrics, 90(1). : 44-53, 2018-
dc.identifier.eissn1663-2826-
dc.relation.journalidJ016632818-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Pediatrics & Adolescent Medicine
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