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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 28, 2017
Last verified: May 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • To assess the activity of one year treatment with zoledronic acid [ Time Frame: 12 mos ]

Secondary Outcome Measures:
  • Three-year disease free survival [ Time Frame: 3 years ]
  • Change in bone mineral density at 12, 24 and 36 months versus baseline [ Time Frame: 12, 24 and 36 months ]
  • Changes in bone resorption markers at 12, 24 and 36 months versus baseline [ Time Frame: 12, 24 and 36 months ]
  • Safety and tolerability through abnormal values and AE reporting [ Time Frame: upto 36 mos ]

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)
Arms Assigned Interventions
Experimental: Zoledronic acid
4 mg IV infused over 15 minutes every 3 months
Drug: Zoledronic acid

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00219271     History of Changes
Other Study ID Numbers: CZOL446GGR01
Study First Received: September 13, 2005
Last Updated: May 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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

ClinicalTrials.gov processed this record on July 21, 2017