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

March 2, 2017 updated by: Novartis Pharmaceuticals
Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Other protocol-defined inclusion / exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Zometa
Drug: zoledronic acid
Other Names:
  • ZOl446

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to assess the effectiveness of Zol in prevention of SREs in stratified groups (hormonal treatment)
Time Frame: at 15 months & at end of study
at 15 months & at end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
to assess the effectiveness of Zol in improving pain and QoL in prostate cancer patients with bone metastases
Time Frame: V1, V2, V3, V5
V1, V2, V3, V5
to assess the safety of ZOL treatment
Time Frame: V1, V2, V3, V5
V1, V2, V3, V5
to assess resources consumption
Time Frame: V1, V2, V3, V5
V1, V2, V3, V5
to assess BM
Time Frame: V1 et V5
V1 et V5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 17, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446EFR04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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