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Clinical experience with authentic recombinant somatropin--German Collaborative Study.

M B Ranke, J R Bierich

    Acta Paediatrica Scandinavica. Supplement
    |January 1, 1987
    PubMed
    Summary
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    Recombinant somatropin significantly increased height velocity in children with human growth hormone (hGH) deficiency. This new treatment showed good tolerance and no antibody formation in a multicentre trial.

    Area of Science:

    • Pediatric Endocrinology
    • Biotechnology
    • Clinical Trials

    Background:

    • Human growth hormone (hGH) deficiency impacts growth in children.
    • Previous treatments utilized pituitary-derived hGH.
    • Recombinant somatropin offers a new therapeutic option.

    Purpose of the Study:

    • To evaluate the efficacy and safety of recombinant somatropin in treating hGH deficiency.
    • To assess growth responses in both treatment-naïve and previously treated patients.

    Main Methods:

    • A multicentre clinical trial involving 41 treatment-naïve and 28 previously treated patients.
    • Administration of recombinant somatropin at 12 IU/m2/week subcutaneously, divided into six doses.
    • Monitoring of height velocities before and during treatment at 3 and 6 months.

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    Main Results:

    • Naïve patients showed a dramatic increase in height velocity from 3.5 cm/year to 15.0 cm/year at 3 months.
    • Previously treated patients experienced an increase in height velocity from 5.8 cm/year to 9.2 cm/year at 3 months.
    • Recombinant somatropin was well-tolerated, with no anti-hGH antibodies detected.

    Conclusions:

    • Recombinant somatropin is an effective treatment for improving growth in children with hGH deficiency.
    • The new therapy demonstrates a favorable safety profile.
    • This study supports the use of recombinant somatropin in pediatric growth disorders.