Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Brief Summary

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Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.

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Detailed Description

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Conditions

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Prostate Cancer With Bone Metastasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zometa

Group Type OTHER

zoledronic acid

Intervention Type DRUG

Interventions

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zoledronic acid

Intervention Type DRUG

Other Intervention Names

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ZOl446

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No