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
About this trial
This is an interventional treatment trial for Cancer Prostate focused on measuring Zoledronic acid, Zometa, prostate cancer, osteoporosis
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.
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
NCT ID
NCT00172055
First Posted
September 13, 2005
Last Updated
March 2, 2017
Sponsor
Novartis Pharmaceuticals
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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