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Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Patients With Metastatic Breast Cancer: Duration of Effect

NCT01344967 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-06-23

No results posted yet for this study

Summary

Bone is the most common site of spread of breast cancer and bone metastases will occur in roughly 70% of women with advanced disease. These patients are at risk of developing bone complications that cause significant impact on both patient morbidity and mortality. Close to two-thirds of women with bone metastases will go on to develop at least one of these complications, termed a skeletal related event (SRE), defined as 1) pathological fractures, 2) pain requiring radiation or surgical intervention, 3)spinal cord compression, and 4) hypercalcemia. In addition to SREs, most breast cancer patients with bone metastases have some degree of pain associated with their disease. Understandably these factors negatively impact their quality of life. Furthermore, the development of an SRE in this population has been shown to be associated with shorter overall survival. Prevention or delay in onset of these complications is therefore an important therapeutic goal.

Conditions

  • Metastatic Breast Cancer With Bone Involvement

Interventions

DRUG

Zoledronic acid

Zoledronic Acid at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline

Sponsors & Collaborators

  • Canadian Breast Cancer Foundation

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-08-31
Completion
2011-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01344967 on ClinicalTrials.gov