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

NCT ID: NCT00912938

Last Updated: 2010-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Zoledronic acid

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.

Group Type: EXPERIMENTAL

zoledronic acid

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

ZOMETA

Eligibility Criteria

Inclusion Criteria

1. 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)

2. Men or women aged ≥ 18 years

3. WHO (ECOG) performance status 0-2

4. Women of child-bearing potential must be using a reliable and appropriate method of contraception

5. Urine sample taken and sent to the central laboratory for baseline Ntx analysis

6. Written informed consent.

Exclusion Criteria

1. Bisphosphonate treatment within the 4 weeks prior to planned first study treatment

2. Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute

3. Poor venous access

4. Metabolic bone disease

5. Unable to comply with study procedures, especially the reliable collection of urine samples for bone resorption marker measurements

6. Estimated life expectancy of < 6 months

7. Treatment with systemic bone seeking radioisotopes within the 3 months prior to study entry

8. Wide field (hemi-body) radiotherapy within the 3 months prior to study entry

9. Concomitant medication with drugs known to affect bone metabolism

10. Pregnancy or breast-feeding

11. 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)

12. Recent (within 4 weeks of study entry*) or planned dental or jaw surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Korean Breast Cancer Study Group

OTHER

Sponsor Role: lead

Responsible Party

Korea University Guro Hospital

Principal Investigators

Jae Bok Lee, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Korea University Guro Hospital, South Korea

Locations

Department of Surgery, Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KBCSG001

Identifier Type: -

Identifier Source: org_study_id