NCT00912938

Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients

A Phase IV, Multi-center, Open Label, Single Arm Clinical Trial to Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 237 (estimated)
• Sponsor: Korean Breast Cancer Study Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

to evaluate whether bone marker can provide the valuable predictor of skeletal complications and whether regular assessing of NTX(N-telopeptide of type I collagen) and osteocalcin can be useful in advanced breast cancer patients with bone metastasis receiving zoledronic acid.

Detailed description

to evaluate the efficacy and safety of zoledronic acid by measuring changes in bone turnover markers * the incidence of skeletal-related events * time to skeletal-related events * time to bone metastases progression * overall survival * the incidence of each adverse event including osteonecrosis

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	zoledronic acid	Intravenous zoledronic acid 4mg over a minimum of 15 minutes in at least 100mls of calcium free infusion solution (0.9% sodium chloride or 5% glucose solution) every 4 weeks.

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-06-03
• Last updated: 2010-02-17

Locations

1 site across 1 country: South Korea