Evaluation of Bone Markers as Diagnostic Tools for Early Detection of Bone Metastases in Patients With High Risk Prostate Cancer

Novartis1 site in 1 country99 target enrollmentFebruary 2006

ConditionsProstate Cancer

DrugsZoledronic acid

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Novartis
Enrollment: 99
Locations: 1
Primary Endpoint: • To assess the relationship between change in bone parameters and bone scan with respect to bone metastases
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

It is the aim of this prospective, single-group, clinical study to assess whether bone parameters can be used as diagnostic tools for early detection of bone metastases in patients with high risk prostate cancer. The usefulness in monitoring zoledronic acid therapy in patients who have developed bone metastases will also be assessed.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

December 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

• To assess the relationship between change in bone parameters and bone scan with respect to bone metastases

Time Frame: Every 3 months

Secondary Outcomes

Assessment of course of bone parameters (PINP, amino-terminal propeptide of procollagen type 1) and (ICTP, Pyridinoline cross-linked carboxyterminal telopeptide of type I collagen)(Every 3 months)
Assessment of course of Prostate-specific antigen (PSA)(Every 3 months)
Assessment of correlation of bone parameters and PSA(Every 3 months)
Assessment of optimal intervals for bone scans based on serum markers(Every 3 months)
Assessment of time to rise in bone markers PINP and ICTP(Every 3 months)
• Time to detection of bone metastases in bone scan(Every 3 months)