Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582920
First received: December 21, 2007
Last updated: November 3, 2008
Last verified: November 2008
  Purpose

The purpose of this study is to examine for changes in the bone scan after treating with zoledronic acid (Zometa™). This study is designed to show if intravenous (IV) bisphosphonates, which are infused by vein, such as pamidronate (Aredia™) or zoledronic acid (Zometa™), cause changes in the result of bone scans in women with metastatic breast cancer. Both bone scans and the IV bisphosphonates are components of routine care of women with breast cancer that has spread to the bone.


Condition Intervention
Osseous Lesions From Metastatic Breast Cancer
Radiation: Zometa™

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Evaluate whether routine clinical use of intravenous zoledronic acid therapy affects technetium methylidene diphosphonate (Tc-99 MDP) uptake in bone metastases. [ Time Frame: January 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Zometa™
    Patients who will be receiving zoledronic acid therapy and are scheduled for an extent of disease evaluation with bone scan would undergo a second bone scan within 1 day of zoledronic acid therapy to assess changes in imaging.
    Other Name: Zoledronic acid
Detailed Description:

Presently, intravenous bisphosphonates are routinely used every 3 to 4 weeks in patients with osseous metastases from breast cancer. However, there is no data addressing the effects of intravenous bisphosphonate therapy on the results of bone scan imaging. Therefore, the first step in the collaboration between MSKCC Breast Cancer Medicine Service and Nuclear Medicine Service is to define whether or not intravenous bisphosphonate therapy affects the results of bone imaging with the standard technetium, Tc-99m MDP. Women receiving intravenous bisphosphonate therapy for breast cancer metastases involving bone at MSKCC are eligible for this diagnostic clinical is no therapeutic intent in this study.

Bone Scan performed before intravenous bisphosphonate therapy (baseline as clinically indicated). Ideally, the bone scan will be performed immediately before to, bisphosphonate therapy.

Zoledronic acid, intravenous bisphosphonate therapy (as clinically indicated)

Bone Scan performed within 1 day after intravenous bisphosphonate therapy (study test).

Number of lesions seen in the baseline and study test will be counted and compared for changes in imaging results induced by intravenous bisphosphonate therapy.

The number of lesions detected by bone scan pre and post therapy will be recorded and the difference will be calculated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receiving intravenous biphosphonate therapy (zoledronic acid 4 mg or renal dose equivalent) as part of their treatment regimen, who are diagnosed with metastatic breast cancer involving surrounding bone.
  • Patients must have had prior treatment zoledronic acid (4 mg or adjusted dose for renal function) within 8 weeks.
  • The patients clinical status as assessed by a treating physician must be deemed appropriate for continuing treatment with zoledronic acid
  • The patient's clinical status, as assessed by a treating physician, must be deemed appropriate for an evaluation with a bone scan
  • The patient's medical status as assessed by a treating physician must be medically appropriate to receive zoledronic acid within the study time frame and in association with the study bone scan

Exclusion Criteria:

  • No evidence of bone metastases, or less than 3 osseous lesions felt to be consistent with bone metastases, on most recent bone scan performed for clinical indications prior to study entry.
  • Patients with illnesses, or conditions that would prevent them from understanding the nature of the study and complying with the protocol requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582920

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Ravinder Grewal, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ravinder Grewal, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582920     History of Changes
Other Study ID Numbers: 05-133
Study First Received: December 21, 2007
Last Updated: November 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
osseous lesions
breast cancer
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014