Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases

Novartis Pharmaceuticals73 enrolled

Overview

This study is designed to monitor the safety and efficacy of long-term treatment with zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Bone Neoplasms

Interventions

Zoledronic acidDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Documented bone metastases from breast cancer, prostate cancer or multiple myeloma * Prior treatment with zoledronic acid for 1-2 yrs * Life expectancy of at least 6 months Exclusion criteria: * Prior treatment with bisphosphonates other than zoledronic acid * Abnormal kidney function * Current or previous dental problems or planned dental surgery * Pregnant or likely to become pregnant during the study Other protocol-defined inclusion/exclusion criteria may apply

Locations (10)

Novartis Investigative Site

Canberra, Australian Capital Territory, Australia

Novartis Investigative Site

Concord, New South Wales, Australia

Novartis Investigative Site

Liverpool, New South Wales, Australia

Outcomes

Primary Outcomes

Safety assessed by incidence of renal impairment, osteonecrosis of the Jaw (ONJ), adverse events and serious adverse events. Efficacy assessed by incidence of skeletal related events (SREs).

Time frame: 52 weeks

Data from ClinicalTrials.gov

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