Status:

COMPLETED

Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Bone Neoplasms

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Documented bone metastases from breast cancer, prostate cancer or multiple myeloma
  • Prior treatment with zoledronic acid for 1-2 yrs
  • Life expectancy of at least 6 months
  • Exclusion criteria:
  • Prior treatment with bisphosphonates other than zoledronic acid
  • Abnormal kidney function
  • Current or previous dental problems or planned dental surgery
  • Pregnant or likely to become pregnant during the study
  • Other protocol-defined inclusion/exclusion criteria may apply

Exclusion

    Key Trial Info

    Start Date :

    December 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    73 Patients enrolled

    Trial Details

    Trial ID

    NCT00434447

    Start Date

    December 1 2006

    Last Update

    February 27 2017

    Active Locations (10)

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    Page 1 of 3 (10 locations)

    1

    Novartis Investigative Site

    Canberra, Australian Capital Territory, Australia

    2

    Novartis Investigative Site

    Concord, New South Wales, Australia

    3

    Novartis Investigative Site

    Liverpool, New South Wales, Australia

    4

    Novartis Investigative Site

    Wagga Wagga, New South Wales, Australia