Clinical Trial: Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase IV Study of Zoledronic Acid Therapy in Patients With Bone Metastases From Breast Cancer or Hormone Resistant Prostate Cancer, or Bone Involvement From Multiple Myeloma, Assessing Long-term Eff
Brief Summary: This study is designed to monitor the safety and efficacy of long-term treatment with zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Safety assessed by incidence of renal impairment, osteonecrosis of the Jaw (ONJ), adverse events and serious adverse events. Efficacy assessed by incidence of skeletal related events (SREs). [ Time Frame: 52 weeks ]
Original Primary Outcome: Safety assessed by incidence of renal impairment, osteonecrosis of the Jaw (ONJ), adverse events and serious adverse events. Efficacy assessed by incidence of skeletal related events (SREs).
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: February 9, 2007
Date Started: December 2006
Date Completion:
Last Updated: February 23, 2017
Last Verified: October 2010