PMID- 25667132
OWN - NLM
STAT- MEDLINE
DCOM- 20160323
LR  - 20181202
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 32
IP  - 2
DP  - 2015 Feb
TI  - A follow-up study to monitor adult height among Spanish children with growth 
      hormone deficiency who received biosimilar human recombinant growth hormone 
      (Omnitrope(R)) during a phase III clinical trial.
PG  - 148-56
LID - 10.1007/s12325-015-0181-9 [doi]
AB  - INTRODUCTION: An initial Phase III clinical trial has evaluated the efficacy and 
      safety of biosimilar recombinant human growth hormone (rhGH; Omnitrope((R)), 
      Sandoz) in Spanish children with growth hormone deficiency (GHD). At the end of 
      the study, those patients still growing were offered to remain on treatment (as 
      in usual clinical practice), and continued to be monitored. The aim of this study 
      was to determine the adult height achieved by the Spanish children who 
      participated in the initial Phase III clinical trial, and to evaluate the 
      long-term safety of rhGH treatment. METHODS: This study was a multicenter, 
      observational, retrospective follow-up study of patients who participated in the 
      Phase III clinical trial (70 patients recruited). Auxological parameters 
      [including height, height velocity, and their associated height standard 
      deviation scores (HSDS)] were obtained from 39 patients. Safety was assessed by 
      recording any adverse events (AEs). RESULTS: In total, 27 men and 12 women 
      provided auxological data. At the start of the follow-up study, the mean age of 
      the patients was 12.5 +/- 2.7 years, mean height was 144.8 +/- 13.9 cm and mean HSDS 
      was -1.16 +/- 0.63. By the end of the follow-up period, mean height had increased 
      to 163.1 +/- 7.6 cm (n = 36; men 165.5 +/- 7.8 cm, women 157.6 +/- 3.2 cm) and mean 
      HSDS also increased to -1.01 +/- 0.59 (n = 36; men -1.07 +/- 0.52, women -0.86 +/- 
      0.72). In terms of safety, no treatment-related AEs were reported during the 
      study. CONCLUSION: This cohort of Spanish patients with GHD showed a positive 
      response to rhGH treatment, achieving adult height within the local normal 
      ranges. In addition, rhGH treatment was well tolerated, with no new or additional 
      safety concerns.
FAU - Borras Perez, Victoria
AU  - Borras Perez V
AD  - Hospital General de Granollers, Barcelona, Spain.
FAU - Lopez-Siguero, Juan Pedro
AU  - Lopez-Siguero JP
FAU - Martinez, Gabriela
AU  - Martinez G
FAU - Corripio, Raquel
AU  - Corripio R
FAU - Fernandez, Juan Manuel
AU  - Fernandez JM
FAU - Labarta, Jose Ignacio
AU  - Labarta JI
FAU - Ferrer, Marta
AU  - Ferrer M
FAU - Cabrinety, Nuria
AU  - Cabrinety N
FAU - Prieto, Pablo
AU  - Prieto P
FAU - Ramon-Krauel, Marta
AU  - Ramon-Krauel M
FAU - Bosch, Jordi
AU  - Bosch J
FAU - Espino, Rafael
AU  - Espino R
FAU - Palla Garcia, Margarida
AU  - Palla Garcia M
FAU - Rebollo, Francisco Jose
AU  - Rebollo FJ
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150211
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 12629-01-5 (Human Growth Hormone)
MH  - Adolescent
MH  - Biosimilar Pharmaceuticals/*therapeutic use
MH  - *Body Height
MH  - Child
MH  - Female
MH  - Follow-Up Studies
MH  - Growth Disorders/*drug therapy
MH  - Human Growth Hormone/*therapeutic use
MH  - Humans
MH  - Male
MH  - Retrospective Studies
PMC - PMC4349959
EDAT- 2015/02/11 06:00
MHDA- 2016/03/24 06:00
PMCR- 2015/02/11
CRDT- 2015/02/11 06:00
PHST- 2014/11/24 00:00 [received]
PHST- 2015/02/11 06:00 [entrez]
PHST- 2015/02/11 06:00 [pubmed]
PHST- 2016/03/24 06:00 [medline]
PHST- 2015/02/11 00:00 [pmc-release]
AID - 181 [pii]
AID - 10.1007/s12325-015-0181-9 [doi]
PST - ppublish
SO  - Adv Ther. 2015 Feb;32(2):148-56. doi: 10.1007/s12325-015-0181-9. Epub 2015 Feb 
      11.