Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cancer Prostate
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 treatmen...
Eligibility Criteria
Inclusion
- All stages of prostate cancer without bone metastases
- No evidence of severe osteoporosis
- ECOG performance status 0, 1 or 2
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT00172055
Start Date
December 1 2004
End Date
July 1 2009
Last Update
March 6 2017
Active Locations (19)
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1
Novartis Investigative Site
Anderlecht, Belgium
2
Novartis Investigative Site
Antwerp, Belgium
3
Novartis Investigative Site
Bruges, Belgium
4
Novartis Investigative Site
Brussels, Belgium