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

NCT00582920 | Completed Phase 1

• 1 other identifier: 05-133
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osseous Lesions From Metastatic Breast Cancer

Keywords

osseous lesions; breast cancer; metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

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

  January 2009

Interventions

Zometa™ RADIATION

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.

Also known as: Zoledronic acid

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ravinder Grewal, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: January 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

US (1)