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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

June 15, 2011

Start Date ^ICMJE

December 2004

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00172055 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cancer Prostate

Intervention ^ICMJE

Drug: Zoledronic acid

Study Arm (s)

Experimental: ZOL446 (zoledronic acid)

Intervention: Drug: Zoledronic acid

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

218

Completion Date

Not Provided

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00172055

Other Study ID Numbers ^ICMJE

CZOL446GBE03

Has Data Monitoring Committee

Not Provided

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Novartis Pharmeceuticals

Information Provided By

Novartis

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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