Trial | NCT00912938  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    237
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.
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
Study Started
Dec 31
2007
Primary Completion
Dec 31
2010
Anticipated
Study Completion
Dec 31
2010
Anticipated
Last Update
Feb 17
2010
Estimate

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.

  • Other names: ZOMETA

Zoledronic acid Experimental

Patients with advanced breast cancer with radiographic confirmation of bone metastases. This arm will be receiving zoledronic acid administration. The primary endpoint is to find the correlation between bone turnover markers and the frequency of skeletal-related-events for one year. Skeletal related events are defined as pathologic fractures, the need for radiation therapy, orthopaedic surgery, hypercalcemia of malignancy and spinal cord compression. A total of 237 patients will be included.

Criteria 

Inclusion Criteria:

Patients with advanced breast cancer with radiographic confirmation of bone metastases (minimum of one bone scan lesion must be confirmed as metastatic on plain radiographs or CT/MR imaging)
Men or women aged ≥ 18 years
WHO (ECOG) performance status 0-2
Women of child-bearing potential must be using a reliable and appropriate method of contraception
Urine sample taken and sent to the central laboratory for baseline Ntx analysis
Written informed consent.

Exclusion Criteria:

Bisphosphonate treatment within the 4 weeks prior to planned first study treatment
Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute
Poor venous access
Metabolic bone disease
Unable to comply with study procedures, especially the reliable collection of urine samples for bone resorption marker measurements
Estimated life expectancy of < 6 months
Treatment with systemic bone seeking radioisotopes within the 3 months prior to study entry
Wide field (hemi-body) radiotherapy within the 3 months prior to study entry
Concomitant medication with drugs known to affect bone metabolism
Pregnancy or breast-feeding
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular), or a current or prior diagnosis of osteonecrosis of the jaw (ONJ)
Recent (within 4 weeks of study entry*) or planned dental or jaw surgery
No Results Posted