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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

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ClinicalTrials.gov Identifier: NCT00172055
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Prostate Drug: Zoledronic acid Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2004
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ZOL446 (zoledronic acid) Drug: Zoledronic acid



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00172055     History of Changes
Other Study ID Numbers: CZOL446GBE03
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Zoledronic acid
Zometa
prostate cancer
osteoporosis

Additional relevant MeSH terms:
Prostatic Neoplasms
Bone Resorption
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hormones
Zoledronic acid
Diphosphonates
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents