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

Phase 3CompletedNCT00172055

Novartis Pharmaceuticals218 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

218

Conditions

Cancer Prostate

Interventions

Zoledronic acidDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (19)

Novartis Investigative Site

Anderlecht, Belgium

Novartis Investigative Site

Antwerp, Belgium

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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