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

Completed · Phase 1

Conditions studied: Osseous Lesions From Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT00582920

Run by

Memorial Sloan Kettering Cancer Center

People needed

10

Starts

2006-01-01

Expected to finish

2008-10-01

Last updated by the study team

2015-12-24

Who can join

Age: 18 and older, up to 110. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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