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Published on: January 7, 2016
Two-Year Data from a Long-Term Phase IV Study of Recombinant Human Growth Hormone in Short Children Born Small for
Hans-Peter Schwarz1, Mieczysław Walczak2, Dorota Birkholz-Walerzak3
1Department of Endocrinology, von Haunersches Kinderspital, University Hospital Munich, Munich, Germany.
Insights
Recombinant human growth hormone (rhGH) treatment effectively improved growth in short children born small for gestational age (SGA) over two years. The study found rhGH treatment was safe, with no cases of diabetes or adverse body mass changes.
Area of Science:
- Pediatric Endocrinology
- Growth Hormone Therapy
- Metabolic Disorders
Background:
- Small for gestational age (SGA) children often experience growth disturbances.
- Recombinant human growth hormone (rhGH) is used to treat short stature in children.
- Long-term safety and efficacy data in SGA populations are crucial.
Purpose of the Study:
- To evaluate the safety and efficacy of rhGH (Omnitrope) in short children born SGA.
- To assess the impact of rhGH treatment on carbohydrate metabolism and body mass.
- To monitor adverse events and malignancies during rhGH therapy.
Main Methods:
- Prospective, open-label, multicenter phase IV study.
- Inclusion of prepubertal children born SGA with defined growth disturbances.
- 2-year follow-up for safety (diabetes, adverse events) and efficacy (height standard deviation score, height velocity).
Main Results:
- 249 children completed 2 years of rhGH treatment.
- No cases of diabetes mellitus or adverse changes in body mass were observed.
- Significant improvements in mean height standard deviation score and height velocity standard deviation score were noted.
Conclusions:
- Two-year rhGH treatment in short SGA children is safe and effective.
- Omnitrope did not adversely affect carbohydrate metabolism or body mass.
- rhGH therapy demonstrated positive effects on growth parameters in this cohort.
Introduction:
This ongoing, prospective, open-label, non-comparative, multicenter phase IV study is evaluating the safety and efficacy of recombinant human growth hormone (rhGH; Omnitrope(®), Sandoz GmbH) in short children born small for gestational age (SGA). Here we report data from patients who have completed 2 years' treatment.
Methods:
Eligibility criteria included prepubertal children born SGA with growth disturbances defined as current height standard deviation score (HSDS) <-2.5 and parental adjusted SDS <-1; birth weight and/or length <-2 SDS; and failure of catch-up growth [height velocity (HV) SDS <0 during the last year] by 4 years of age or later. The primary study objective is to assess the long-term effect of Omnitrope treatment on the development of diabetes in short children born SGA. Secondary objectives include evaluation of efficacy, incidence and severity of adverse events (AEs), occurrence of malignancies during treatment, and detection of anti-rhGH antibodies during treatment.
Results:
In total, 278 children have been enrolled and received study medication; 249 have completed 2 years of treatment. No child has developed diabetes mellitus during the first 2 years; no fasting glucose or 2-h oral glucose tolerance test value exceeded the pre-defined limits of >126 or >200 mg/dL, respectively. No adverse alterations in body mass were noted. Treatment-emergent AEs were experienced by 211 (76.2%) children; most of these were of mild-to-moderate intensity (99.3%) and considered unrelated to study medication (97.6%). Treatment with Omnitrope was effective; mean HSDS was -3.39 at baseline, -2.57 at 1 year and -2.15 at 2 years of treatment. Mean HVSDS (peak-centered) also improved, from -2.13 at baseline to +4.16 at 1 year and +2.23 at 2 years.
Conclusion:
In this second interim analysis, short children born SGA were safely and effectively treated with rhGH (Omnitrope), and 2 years' treatment had no major adverse impact on carbohydrate metabolism or body mass.
Funding:
Sandoz.
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