Placebo controlled study of zoledronic acid in osteoporotic children

• Research type

  Research Study

• Full title

  A multicentre, randomised, double-blind, placebo controlled efficacy and safety trial of intravenous zoledronic acid twice yearly compared to placebo in osteoporotic children treated with glucocorticoids for chronic inflammatory conditions

• Contact name

  Nick Shaw

• Sponsor organisation

  PPD

• Eudract number

  2008-001252-52

• ISRCTN Number

  N/A

• Research summary

  Long-term systemic treatment of children with glucocorticoids can result in reduced bone mineral density (BMD) and osteoporosis, which in turn leads to an increased incidence of fractures. There is no licensed treatment for osteoporosis in children at present. Zoledronic acid has previously been shown to improve the BMD and reduce fractures in adults with osteoporosis and other bone diseases, and appears to have a good safety profile. Novartis have recently completed a study in children with osteogenesis imperfecta in which zoledronic acid was seen to increase BMD significantly. This study aims to show that zoledronic acid can safely be administered to children with osteoporosis. Children between the ages of 5 and 17 will be included in the study and will be dosed twice with zoledronic acid at six monthly intervals. Patients will be followed up for one year. BMD will be measured by DXA scans and fractures will be assessed by X-rays. In addition, key bone markers will be measured. Safety will be assessed via monitoring of blood and urine samples, collection of adverse events and concomitant medication use details.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  08/H0604/170

• Date of REC Opinion

  12 Mar 2009

• REC opinion

  Further Information Favourable Opinion