Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases

April 13, 2015 updated by: Novartis
The present study will give information about the course over time in skeletal-related events (SRE) in prostate cancer patients with bone metastases treated with zoledronic acid 4 mg administered as a 15-minute infusion every 4 weeks for a maximum of 15 infusions. The protocol will enroll patients with recent diagnosis of bone metastases from prostate cancer who are hormone-refractory, hormone-naïve or still hormone-sensitive, that represent the entire population of prostate cancer patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • Bologna

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

  • Patients aged ≥18 years
  • Written informed consent
  • Histologically-proven prostate carcinoma
  • ECOG performance status ≤ 2
  • Life expectancy > 6 months
  • Newly diagnosed (≤ 6 months prior to visit 1) bone metastases evidenced by bone scan or radiograph.
  • Patients on androgen deprivation therapy (medical therapy with LHRH analogues + antiandrogens or surgical castration) or going to start it
  • Patients with partners of childbearing potential should use a barrier method of contraception throughout the study

Exclusion Criteria

  • Patients without a history of metastatic disease to the bone
  • Prior treatment with bisphosphonates
  • SREs prior to visit 2
  • Prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to baseline
  • Corrected (adjusted for serum albumin - see Appendix 5 for the calculation) serum calcium concentration < 8.0 mg/dl (2.00 mmol/l)
  • Serum creatinine concentration > 265 micromol/l (3.0 mg/dl) or a calculated creatinine clearance < 30 ml/minute or serious underlying renal disease or prior renal transplantation
  • History of other malignant neoplasm within previous five years with exception of non-melanomatous skin cancer which has been satisfactorily treated
  • Other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future
  • Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days
  • Known hypersensitivity to zoledronic acid or other bisphosphonates
  • History of noncompliance to medical regimens and patients who are considered potentially unreliable (for example drug or alchohol abusers) or incapable of giving informed consent as judged by the investigator

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
occurence of skeletale related events (SREs) over time (time to first SRE,skeletal morbidity rate and proportion of patients experiencing SRE)

Secondary Outcome Measures

Outcome Measure
Bone pain
Use of analgesic medication and ECOG performance status every three months
Bone specific alkaline phosphatase, serum N-telopeptide and parathyroid hormone will be evaluated after one month of treatment and then every three months

Collaborators and Investigators

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

Sponsor

Novartis

Collaborators

Società Italiana di Urologia (SIU)

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

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446EIT04

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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