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

18 Years
Not Enrolling
Osseous Lesions From Metastatic Breast Cancer

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Trial Information

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

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

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Evaluate whether routine clinical use of intravenous zoledronic acid therapy affects technetium methylidene diphosphonate (Tc-99 MDP) uptake in bone metastases.

Outcome Time Frame:

January 2009

Safety Issue:


Principal Investigator

Ravinder Grewal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

October 2008

Related Keywords:

  • Osseous Lesions From Metastatic Breast Cancer
  • osseous lesions
  • breast cancer
  • metastatic breast cancer
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Bone Marrow Diseases



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021