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CompletedNCT00434447Updated Feb 27, 2017

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

A Phase 4 interventional study of Zoledronic acid in Bone Neoplasms, sponsored by Novartis Pharmaceuticals. Completed at 10 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-27.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
73
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Bone Neoplasms

Keywords

  • Prostate Cancer
  • Breast Cancer
  • Multiple Myeloma
  • Zoledronic acid
  • Bone metastases
  • Skeletal Related Events (SREs)
  • Renal Impairment
  • Osteonecrosis of the Jaw (ONJ)
  • Bone involvement
  • Multiple Myeloma (MM)
03

In context

Bone Neoplasms

330 studies on the registry are indexed under Bone Neoplasms; 82 are open to participants now.

This study's enrollment of 73 is above the median of 50 across 224 interventional studies indexed under Bone Neoplasms.

Browse Bone Neoplasms studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    Zoledronic Acid

    ZOL446

    Drug: Zoledronic acid

Interventions

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

10 sites
  • Novartis Investigative Site
    Canberra, Australian Capital Territory, Australia
  • Novartis Investigative Site
    Concord, New South Wales, Australia
  • Novartis Investigative Site
    Liverpool, New South Wales, Australia
  • Novartis Investigative Site
    Wagga Wagga, New South Wales, Australia
  • Novartis Investigative Site
    Redcliffe, Queensland, Australia
  • Novartis Investigative Site
    Townsville, Queensland, Australia
  • Novartis Investigative Site
    Woolloongabba, Queensland, Australia
  • Novartis Investigative Site
    Ballarat, Victoria, Australia
  • Novartis Investigative Site
    Box Hill, Victoria, Australia
  • Novartis Investigative Site
    Frankston, Victoria, Australia
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2006 and a primary completion of Sep 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2007
First posted
Feb 13, 2007
Start
Dec 2006
Primary completionActual
Sep 2009
Last update
Feb 27, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00434447
First posted
Feb 13, 2007
Start date
Dec 2006
Primary completion
Sep 2009
Last update
Feb 27, 2017

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmeceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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