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Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
University of Athens
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00219271
First received: September 13, 2005
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

The objective of this study is to assess the effect Of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer


Condition Intervention Phase
Prostate Cancer
 Drug: Zoledronic acid
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To assess the activity of one year treatment with zoledronic acid

Secondary Outcome Measures:
  • Three-year disease free survival
  • Change in bone mineral density at 12, 24 and 36 months versus baseline
  • Changes in bone resorption markers at 12, 24 and 36 months versus baseline
  • Safety and tolerability through abnormal values and AE reporting

Enrollment: 60
Study Start Date: September 2003
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Prostate cancer
  • Radical prostatectomy or external beam irradiation therapy within 6 months before study entry.
  • No bone metastases according to bone scan

Exclusion Criteria

  • Metastatic prostate cancer
  • Hormone ablation therapy for more than 3 months before/after radical prostatectomy and external beam irradiation therapy
  • Treatment with bisphosphonates or other drugs known to affect the skeleton within the past year.

Other protocol-defined inclusion / exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219271

Locations
Greece
Novartis Investigative Site
Athens, Greece
Sponsors and Collaborators
Novartis Pharmaceuticals
University of Athens
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00219271     History of Changes
Other Study ID Numbers: CZOL446GGR01
Study First Received: September 13, 2005
Last Updated: May 21, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Novartis:
Prostate cancer
molecular staging
antitumor potential

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013