Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00172055
First received: September 13, 2005
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss.


Condition Intervention Phase
Cancer Prostate
Drug: Zoledronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • If and to what extent rising levels of the bone resorption marker CTX can be used as an indicator for the development of bone metastases, diagnosed via bone scintigraphy. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Enrollment: 218
Study Start Date: December 2004
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZOL446 (zoledronic acid) Drug: Zoledronic acid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All stages of prostate cancer without bone metastases
  • No evidence of severe osteoporosis
  • ECOG performance status 0, 1 or 2

Exclusion Criteria:

  • Surgery / fracture at the lumbosacral spine, bilateral hip implants
  • Evidence of metabolic bone diseases,
  • Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment
  • Abnormal kidney or liver function
  • Other cancers within the last 5 years

Other protocol-defined 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: NCT00172055

Locations
Belgium
Novartis Investigative Site
Anderlecht, Belgium
Novartis Investigative Site
Antwerpen, Belgium
Novartis Investigative Site
Brugge, Belgium
Novartis Investigative Site
Bruxelles, Belgium
Novartis Investigative Site
Charleroi, Belgium
Novartis Investigative Site
Edegem, Belgium
Novartis Investigative Site
Gent, Belgium
Novaris Investigative Site
Gosselies, Belgium
Novartis Investigative Site
Kortrijk, Belgium
Novartis Investigative Site
Leper, Belgium
Novartis Investigative Site
Leuven, Belgium
Novaris Investigative Site
Libramont, Belgium
Novartis Investigative Site
Mont-Godinne, Belgium
Novartis Investigative Site
Roeselare, Belgium
Novartis Investigative Site
Tongeren, Belgium
Novartis Investigative Site
Tournai, Belgium
Novartis Investigative Site
Turnhout, Belgium
Novartis Investigative Site
Wilrijk, Belgium
Novartis Investigative Site
Woluwe-Saint-Lambert, Belgium
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00172055     History of Changes
Other Study ID Numbers: CZOL446GBE03
Study First Received: September 13, 2005
Last Updated: June 15, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Novartis:
Zoledronic acid
Zometa
prostate cancer
osteoporosis

Additional relevant MeSH terms:
Bone Resorption
Neoplasm Metastasis
Prostatic Neoplasms
Bone Diseases
Musculoskeletal Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014