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Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy

Primary Purpose

Cancer Prostate

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Prostate focused on measuring Zoledronic acid, Zometa, prostate cancer, osteoporosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All stages of prostate cancer without bone metastases No evidence of severe osteoporosis ECOG performance status 0, 1 or 2 Exclusion Criteria: Surgery / fracture at the lumbosacral spine, bilateral hip implants Evidence of metabolic bone diseases, Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment Abnormal kidney or liver function Other cancers within the last 5 years Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novaris Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novaris Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ZOL446 (zoledronic acid)

Arm Description

Outcomes

Primary Outcome Measures

If and to what extent rising levels of the bone resorption marker CTX can be used as an indicator for the development of bone metastases, diagnosed via bone scintigraphy.

Secondary Outcome Measures

If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases

Full Information

First Posted
September 13, 2005
Last Updated
March 2, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00172055
Brief Title
Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy
Official Title
Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Prostate
Keywords
Zoledronic acid, Zometa, prostate cancer, osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZOL446 (zoledronic acid)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Primary Outcome Measure Information:
Title
If and to what extent rising levels of the bone resorption marker CTX can be used as an indicator for the development of bone metastases, diagnosed via bone scintigraphy.
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All stages of prostate cancer without bone metastases No evidence of severe osteoporosis ECOG performance status 0, 1 or 2 Exclusion Criteria: Surgery / fracture at the lumbosacral spine, bilateral hip implants Evidence of metabolic bone diseases, Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment Abnormal kidney or liver function Other cancers within the last 5 years Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmeceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Anderlecht
Country
Belgium
Facility Name
Novartis Investigative Site
City
Antwerpen
Country
Belgium
Facility Name
Novartis Investigative Site
City
Brugge
Country
Belgium
Facility Name
Novartis Investigative Site
City
Bruxelles
Country
Belgium
Facility Name
Novartis Investigative Site
City
Charleroi
Country
Belgium
Facility Name
Novartis Investigative Site
City
Edegem
Country
Belgium
Facility Name
Novartis Investigative Site
City
Gent
Country
Belgium
Facility Name
Novaris Investigative Site
City
Gosselies
Country
Belgium
Facility Name
Novartis Investigative Site
City
Kortrijk
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leper
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
Country
Belgium
Facility Name
Novaris Investigative Site
City
Libramont
Country
Belgium
Facility Name
Novartis Investigative Site
City
Mont-Godinne
Country
Belgium
Facility Name
Novartis Investigative Site
City
Roeselare
Country
Belgium
Facility Name
Novartis Investigative Site
City
Tongeren
Country
Belgium
Facility Name
Novartis Investigative Site
City
Tournai
Country
Belgium
Facility Name
Novartis Investigative Site
City
Turnhout
Country
Belgium
Facility Name
Novartis Investigative Site
City
Wilrijk
Country
Belgium
Facility Name
Novartis Investigative Site
City
Woluwe-Saint-Lambert
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy

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