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Growth response to an individualized versus fixed dose GH treatment in short children born small for gestational age: the OPTIMA study

Heike Jung, Christof Land, Claudia Nikolay, Jean De Schepper UGent, Werner F Blum and Eckhard Schönau (2009) EUROPEAN JOURNAL OF ENDOCRINOLOGY. 160(2). p.149-156
abstract
Objective: Initial GH-induced catch up growth is highly variable in short children born small for gestational age (SGA) and mainly influenced by age at start of therapy and GH dose. This study compared the first year growth-promoting effect of an individually adjusted GH dose (IAD) versus a fixed high GH dose (FHD) in pre-pubertal children born SGA with severe short stature. Design: This was a randomized, open-label, multi-center study. Methods: The FHD group received 0.067 mg/kg per day GH throughout the 12-month study. The IAD group initially received 0.035 mg/kg per day GH; at 3 months the Cologne growth-prediction model for first year change in height SDS was applied; if predicted change was <0.75, GH was increased to 0.067 mg/kg per day for the remaining 9 months, otherwise the initial dose was continued. Results: fit the IAD group, 38 out of the 80 patients required the higher GH dose from month 3. From an ANCOVA for non-inferiority, mean difference in change in height SIDS between IAD and FHD groups was -0.24 (95%, confidence interval (CI) -0.35: -0.12), the Cl for height SDS being above the pre-defined non-inferiority margin of -0.5. GH dose reductions due to IGF-I SDS > 0.5 and IGFBP-3 SDS < - 0.5 were performed in 4/99 FHD patients, but none of the IAD group patients. Safety data were similar between groups. Conclusion: With a mean treatment group difference of 1 cm in 12-month growth response, although statistically significant, the IAD group was considered non-inferior compared with the FHD group. Early growth prediction can be used to tailor the dose to the individual patient's needs. resulting in lower overall GH dose.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
HORMONE TREATMENT, IDIOPATHIC SHORT STATURE, INTRAUTERINE GROWTH, FINAL HEIGHT, DOUBLE-BLIND, PREDICTION, WEIGHT, BIRTH, VELOCITY, SOCIETY
journal title
EUROPEAN JOURNAL OF ENDOCRINOLOGY
Eur. J. Endocrinol.
volume
160
issue
2
pages
149 - 156
Web of Science type
Article
Web of Science id
000263355100004
JCR category
ENDOCRINOLOGY & METABOLISM
JCR impact factor
3.539 (2009)
JCR rank
36/104 (2009)
JCR quartile
2 (2009)
ISSN
0804-4643
DOI
10.1530/EJE-08-0301
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
1017623
handle
http://hdl.handle.net/1854/LU-1017623
date created
2010-08-04 12:17:14
date last changed
2010-08-05 08:47:45
@article{1017623,
  abstract     = {Objective: Initial GH-induced catch up growth is highly variable in short children born small for gestational age (SGA) and mainly influenced by age at start of therapy and GH dose. This study compared the first year growth-promoting effect of an individually adjusted GH dose (IAD) versus a fixed high GH dose (FHD) in pre-pubertal children born SGA with severe short stature.
Design: This was a randomized, open-label, multi-center study.
Methods: The FHD group received 0.067 mg/kg per day GH throughout the 12-month study. The IAD group initially received 0.035 mg/kg per day GH; at 3 months the Cologne growth-prediction model for first year change in height SDS was applied; if predicted change was {\textlangle}0.75, GH was increased to 0.067 mg/kg per day for the remaining 9 months, otherwise the initial dose was continued.
Results: fit the IAD group, 38 out of the 80 patients required the higher GH dose from month 3. From an ANCOVA for non-inferiority, mean difference in change in height SIDS between IAD and FHD groups was -0.24 (95\%, confidence interval (CI) -0.35: -0.12), the Cl for height SDS being above the pre-defined non-inferiority margin of -0.5. GH dose reductions due to IGF-I SDS {\textrangle} 0.5 and IGFBP-3 SDS {\textlangle} - 0.5 were performed in 4/99 FHD patients, but none of the IAD group patients. Safety data were similar between groups.
Conclusion: With a mean treatment group difference of 1 cm in 12-month growth response, although statistically significant, the IAD group was considered non-inferior compared with the FHD group. Early growth prediction can be used to tailor the dose to the individual patient's needs. resulting in lower overall GH dose.},
  author       = {Jung, Heike and Land, Christof and Nikolay, Claudia and De Schepper, Jean and Blum, Werner F and Sch{\"o}nau, Eckhard},
  issn         = {0804-4643},
  journal      = {EUROPEAN JOURNAL OF ENDOCRINOLOGY},
  keyword      = {HORMONE TREATMENT,IDIOPATHIC SHORT STATURE,INTRAUTERINE GROWTH,FINAL HEIGHT,DOUBLE-BLIND,PREDICTION,WEIGHT,BIRTH,VELOCITY,SOCIETY},
  language     = {eng},
  number       = {2},
  pages        = {149--156},
  title        = {Growth response to an individualized versus fixed dose GH treatment in short children born small for gestational age: the OPTIMA study},
  url          = {http://dx.doi.org/10.1530/EJE-08-0301},
  volume       = {160},
  year         = {2009},
}

Chicago
Jung, Heike, Christof Land, Claudia Nikolay, Jean De Schepper, Werner F Blum, and Eckhard Schönau. 2009. “Growth Response to an Individualized Versus Fixed Dose GH Treatment in Short Children Born Small for Gestational Age: The OPTIMA Study.” European Journal of Endocrinology 160 (2): 149–156.
APA
Jung, H., Land, C., Nikolay, C., De Schepper, J., Blum, W. F., & Schönau, E. (2009). Growth response to an individualized versus fixed dose GH treatment in short children born small for gestational age: the OPTIMA study. EUROPEAN JOURNAL OF ENDOCRINOLOGY, 160(2), 149–156.
Vancouver
1.
Jung H, Land C, Nikolay C, De Schepper J, Blum WF, Schönau E. Growth response to an individualized versus fixed dose GH treatment in short children born small for gestational age: the OPTIMA study. EUROPEAN JOURNAL OF ENDOCRINOLOGY. 2009;160(2):149–56.
MLA
Jung, Heike, Christof Land, Claudia Nikolay, et al. “Growth Response to an Individualized Versus Fixed Dose GH Treatment in Short Children Born Small for Gestational Age: The OPTIMA Study.” EUROPEAN JOURNAL OF ENDOCRINOLOGY 160.2 (2009): 149–156. Print.