NCT00434317

Brief Summary

This study will evaluate the safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or prostate cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

4 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

August 1, 2005

Completed
1.5 years 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
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.7 years

First QC Date

February 9, 2007

Last Update Submit

February 21, 2017

Conditions

Neoplasm Metastasis

Keywords

MetastasisNeoplasmpainbreast cancerprostate cancerbone metastasis

Outcome Measures

Primary Outcomes (1)

  • Measurement of pain assessed by a Visual Analogue Scale (VAS)

    throughout the study

Secondary Outcomes (1)

  • Quality of Life assessment at baseline and last visit

    throughout the study

Study Arms (1)

ZOL446

EXPERIMENTAL
Drug: Zoledronic acid

Interventions

Zoledronic acidDRUG
ZOL446

Eligibility Criteria

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

You may qualify if:

  • Ambulatory patients \>18 years
  • Proof of breast cancer or prostate cancer
  • Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening
  • Negative pregnancy test
  • ECOG performance status of 0,1 or 2

You may not qualify if:

  • Patients with abnormal renal function
  • Patients with clinically symptomatic brain metastases
  • Known hypersensitivity on zoledronic acid or other bisphosphonates
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Budapest, Hungary

Location

Novartis Investigative Site

Pécs, Hungary

Location

Novartis Investigative Site

Szeged, Hungary

Location

Novartis Investigative Site

Székesfehérvár, Hungary

Location

MeSH Terms

Conditions

Neoplasm MetastasisNeoplasmsPainBreast NeoplasmsProstatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 13, 2007

Study Start

August 1, 2005

Primary Completion

April 1, 2008

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

HU(4)