Skip to main content
OpenTrials
Completed

NCT Number: NCT00219271

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Athens, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

  1. To assess the activity of one year treatment with zoledronic acid

    Time frame: 12 mos

Secondary outcomes

  1. Three-year disease free survival

    Time frame: 3 years

  2. Change in bone mineral density at 12, 24 and 36 months versus baseline

    Time frame: 12, 24 and 36 months

  3. Changes in bone resorption markers at 12, 24 and 36 months versus baseline

    Time frame: 12, 24 and 36 months

  4. Safety and tolerability through abnormal values and AE reporting

    Time frame: upto 36 mos

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

  • University of Athens

Registry information

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2005
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.