RecruitingPhase 3NCT03295981

Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone

Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial


Sponsor

St. Louis University

Enrollment

120 participants

Start Date

May 3, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Primary benign GCT of bone
  • Lesion located in an extremity
  • Lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal
  • No previous systemic bisphosphonate or denosumab therapy

Exclusion Criteria5

  • Recurrent GCT of bone
  • Non-extremity location
  • Lesion too extensive for intralesional treatment, either due to bone loss, joint invasion, or large soft tissue component
  • Children and pregnancy
  • Previous systemic bisphosphonate or denosumab therapy

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Interventions

DRUGZoledronic Acid

4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement


Locations(16)

University of California - Los Angeles

Los Angeles, California, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas

Overland Park, Kansas, United States

Johns Hopkins University Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Saint Louis University

St Louis, Missouri, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, United States

University of Washington

Seattle, Washington, United States

McGill University Health Centre

Montreal, Quebec, Canada

All India Institute of Medical Science

New Delhi, India

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NCT03295981


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