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
1 other identifier
interventional
218
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2004
Longer than P75 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedMarch 6, 2017
March 1, 2017
4.6 years
September 13, 2005
March 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at 6 months
Secondary Outcomes (1)
If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases
at 6 months
Study Arms (1)
ZOL446 (zoledronic acid)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- All stages of prostate cancer without bone metastases
- No evidence of severe osteoporosis
- ECOG performance status 0, 1 or 2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Novartis Investigative Site
Anderlecht, Belgium
Novartis Investigative Site
Antwerp, Belgium
Novartis Investigative Site
Bruges, Belgium
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Charleroi, Belgium
Novartis Investigative Site
Edegem, Belgium
Novartis Investigative Site
Ghent, Belgium
Novaris Investigative Site
Gosselies, Belgium
Novartis Investigative Site
Kortrijk, Belgium
Novartis Investigative Site
Leper, Belgium
Novartis Investigative Site
Leuven, Belgium
Novaris Investigative Site
Libramont, Belgium
Novartis Investigative Site
Mont-Godinne, Belgium
Novartis Investigative Site
Roeselare, Belgium
Novartis Investigative Site
Tongeren, Belgium
Novartis Investigative Site
Tournai, Belgium
Novartis Investigative Site
Turnhout, Belgium
Novartis Investigative Site
Wilrijk, Belgium
Novartis Investigative Site
Woluwe-Saint-Lambert, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmeceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
December 1, 2004
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
March 6, 2017
Record last verified: 2017-03