NCT00434447

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

February 27, 2017

Status Verified

October 1, 2010

Enrollment Period

2.8 years

First QC Date

February 9, 2007

Last Update Submit

February 23, 2017

Conditions

Bone Neoplasms

Keywords

Prostate CancerBreast CancerMultiple MyelomaZoledronic acidBone metastasesSkeletal Related Events (SREs)Renal ImpairmentOsteonecrosis of the Jaw (ONJ)Bone involvementMultiple Myeloma (MM)

Outcome Measures

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).

    52 weeks

Study Arms (1)

Zoledronic Acid

EXPERIMENTAL

ZOL446

Drug: Zoledronic acid

Interventions

Zoledronic acidDRUG
Also known as: ZOL446
Zoledronic Acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Novartis Investigative Site

Canberra, Australian Capital Territory, Australia

Location

Novartis Investigative Site

Concord, New South Wales, Australia

Location

Novartis Investigative Site

Liverpool, New South Wales, Australia

Location

Novartis Investigative Site

Wagga Wagga, New South Wales, Australia

Location

Novartis Investigative Site

Redcliffe, Queensland, Australia

Location

Novartis Investigative Site

Townsville, Queensland, Australia

Location

Novartis Investigative Site

Woolloongabba, Queensland, Australia

Location

Novartis Investigative Site

Ballarat, Victoria, Australia

Location

Novartis Investigative Site

Box Hill, Victoria, Australia

Location

Novartis Investigative Site

Frankston, Victoria, Australia

Location

MeSH Terms

Conditions

Bone NeoplasmsProstatic NeoplasmsBreast NeoplasmsMultiple MyelomaRenal Insufficiency

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmeceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 13, 2007

Study Start

December 1, 2006

Primary Completion

September 1, 2009

Last Updated

February 27, 2017

Record last verified: 2010-10

Locations

AU(10)