Extension to study of zoledronic acid in osteoporotic children

  • Research type

    Research Study

  • Full title

    A 1-year, multicenter, open-label extension to CZOL446H2337 to evaluate safety and efficacy of zoledronic acid twice yearly in osteoporotic children treated with glucocorticoids for chronic inflammatory conditions.

  • IRAS ID

    118039

  • Contact name

    Nick Shaw

  • Sponsor organisation

    Novartis Pharma Services AG

  • Eudract number

    2010-020399-41

  • Clinicaltrials.gov Identifier

    N/A

  • Research summary

    This is an extension to the ongoing paediatric study in which children with glucocorticoid-induced osteoporosis are treated with zoledronic acid. Patients entering this study will already have received treatment for one year in the core study and this study aims to extend the treatment and observation of the safety and efficacy of this drug for a further year.

  • REC name

    South Central - Oxford A Research Ethics Committee

  • REC reference

    13/SC/0079

  • Date of REC Opinion

    25 Mar 2013

  • REC opinion

    Further Information Favourable Opinion