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NCT03295981PHASE3RecruitingAccepts Healthy Volunteers

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

St. Louis University

Start Date

5/3/2018

Completion Date

1/1/2028

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.

Detailed Description

The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate (BP-loaded PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will evaluate whether bisphosphonate as a surgical adjuvant improves secondary outcomes, such as pain, function, fever, or wound complications. The hypothesis is that the local administration of bisphosphonate will decrease the recurrence rate of GCT compared to traditional aggressive intralesional curettage.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: * 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

Interventions

DRUG

Zoledronic Acid

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Conditions

Giant Cell Tumor of Bone

Locations

University of California - Los Angeles

Los Angeles, California 90404

United States

Indiana University

Indianapolis, Indiana 46202

United States

University of Iowa

Iowa City, Iowa 52242

United States

University of Kansas

Overland Park, Kansas 66211

United States

Johns Hopkins University Hospital

Baltimore, Maryland 21287

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Saint Louis University

St Louis, Missouri 63110

United States

Wake Forest University

Winston-Salem, North Carolina 27157

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

University of Oklahoma

Oklahoma City, Oklahoma 73104

United States

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania 15212

United States

University of Washington

Seattle, Washington 98195

United States

McGill University Health Centre

Montreal, Quebec H3G 1A4

Canada

All India Institute of Medical Science

New Delhi, 110029

India