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
18 Years
N/A
Both
Cancer Prostate
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
at 6 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmeceuticals
Authority:
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study ID:
CZOL446GBE03
NCT ID:
NCT00172055
Start Date:
December 2004
Completion Date:
Related Keywords:
- Cancer Prostate
- Zoledronic acid
- Zometa
- prostate cancer
- osteoporosis
- Bone Resorption
- Neoplasm Metastasis
- Prostatic Neoplasms
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