NCT00912938

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
237

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

Enrollment Period

3 years

First QC Date

June 2, 2009

Last Update Submit

February 14, 2010

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancerbone remodeling markerszoledronic acid

Outcome Measures

Primary Outcomes (1)

  • Urinary NTX and serum osteocalcin will be assessed at baseline, 3, 6, 9, and 12 months and when unexpected skeletal related events is detected.

    one year

Study Arms (1)

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.

Drug: zoledronic acid

Interventions

zoledronic acidDRUG

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.

Also known as: ZOMETA
Zoledronic acid

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jae Bok Lee, MD.PhD

    Department of Surgery, Korea University Guro Hospital, South Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 3, 2009

Study Start

December 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 17, 2010

Record last verified: 2010-02

Locations

KR(1)