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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Korean Breast Cancer Study Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Korean Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00912938
First received: June 2, 2009
Last updated: February 14, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
 Drug: zoledronic acid
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korean Breast Cancer Study Group:

Primary Outcome Measures:
  • Urinary NTX and serum osteocalcin will be assessed at baseline, 3, 6, 9, and 12 months and when unexpected skeletal related events is detected. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 237
Study Start Date: December 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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 Name: ZOMETA

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912938

Locations
Korea, Republic of
Department of Surgery, Korea University Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korean Breast Cancer Study Group
Investigators
Principal Investigator: Jae Bok Lee, MD.PhD Department of Surgery, Korea University Guro Hospital, South Korea
  More Information

No publications provided

Responsible Party: Jae Bok Lee, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT00912938     History of Changes
Other Study ID Numbers: KBCSG001
Study First Received: June 2, 2009
Last Updated: February 14, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Breast Cancer Study Group:
metastatic breast cancer
bone remodeling markers
zoledronic acid

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013