Titre Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
Protocole ID 28229
ClinicalTrials.gov ID NCT03295981
Type(s) de cancer Sarcome
Phase Phase III
Type étude Traitement
Médicament Acide Zolédronique
Institution CENTRE UNIVERSITAIRE DE SANTE MCGILL
   HOPITAL GENERAL DE MONTREAL
      1650 Avenue Cedar, Montréal, QC, H3G 1A4
Ville Montréal
Investigateur(trice) principal(e) Dr Robert Turcotte
Coordonnateur(trice) Mireille Dessureault
514-934-1934 poste 43022
Statut Actif en recrutement
Critètes d'éligibilité
  • Primary benign GCT of bone
  • Lesion located in an extremity
  • Lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal
  • No previous systemic bisphosphonate or denosumab therapy
  • Serum creatinine level less than 3.5 mg/dL
  • Corrected total serum calcium level of 8.0 mg/dL or greater
Critètes d'exclusion
  • Recurrent GCT of bone
  • Non-extremity location
  • Lesion too extensive for intralesional treatment, either due to bone loss, joint invasion, or large soft tissue component
  • Children and pregnancy
  • Previous systemic bisphosphonate or denosumab therapy
  • Hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation
  • Patients with severe renal impairment (drug excreted by the kidney)
  • Patients with hypocalcaemia