Status:
COMPLETED
Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer With Bone Metastasis
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.
Eligibility Criteria
Inclusion
- Aged ≥18 years.
- Written informed consent.
- With histologically-proven prostate carcinoma.
- ECOG performance status ≤ 2
- Life expectancy \> 12 months
- Current or previously documented diagnosis of at least 1 bone metastasis due to prostate cancer (patient could be hormono naif, Hormono sensible or hormono refractory)
- Patients with partners of childbearing potential should use a barrier method of contraception throughout the study.
Exclusion
- ECOG performans status \>3
- Prior treatment with bisphosphonates IV within the last 3 month to the study
- Renal insufficiency (serum creatinine \> 265 micromol/L or \> 3.0 mg/dL)
- Liver function tests \> 2.5 ULN
- Patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol.
- History of concomitant disease with influence on bone metabolism such as Paget's disease or primary hyperparathyroidism
- Disabling or non controlled concomitant disease likely to alter the quality of life
- Patient unable to fill in a questionnaire: senile dementia, psychiatric or neurological disease, illiterate or partially sighted patient
- Known hypersensitivity to zoledronic acid or other bisphosphonates
- Other protocol-defined inclusion / exclusion criteria may apply.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00241111
Start Date
September 1 2003
Last Update
March 6 2017
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