Re-treatment of relapsed patients with Paget's disease with Aclasta
An open label, Reclast®/Aclasta®, re-treatment of relapsed patients with Paget’s disease of bone who participated in the CZOL446K2304 and CZOL446K2305 Core Registration studies
Novartis Pharma Services AG
Paget's disease is a raredisease that causes brittle and abnormally structured bones, which in turnleads to weakened bones and an increased incidence of fractures. Zoledronicacid (ZOL, a bisphosphonate), has previously been shown to be an effectivetreatment in reducing bone turnover which allows improved bone structure andtherefore increased strength. Serum Alkaline Phosphatase has been shown to bean effective marker for bone activity and is used to assess relapse in thesepatients. Patients eligible for this study have previously responded tozoledronic acid in studies CZOL446K2304 and CZOL446K2305 and have been followedup every 6 months for up to four years. The purpose of this open labelled studyis to show that patients who's Paget disease has relapsed can be successfulre-treated. Patients will be treated with ZOL and then followed up for sixmonths. The study aims to collect information about relapse diagnosis bypracticing physicians and to determine the adverse events profile afterre-treatment in these patients.
South West - Cornwall & Plymouth Research Ethics Committee
Date of REC Opinion
13 Oct 2008
Further Information Favourable Opinion