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

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.

Conditions

• Giant Cell Tumor of Bone

Interventions

DRUG

Zoledronic Acid

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

Sponsors & Collaborators

• Orthopedic Research and Education Foundation

  collaborator OTHER

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Wake Forest University

  collaborator OTHER

• University of Kansas

  collaborator OTHER

• Indiana University

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• American Academy of Orthopaedic Surgeons

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• All India Institute of Medical Sciences

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of California

  collaborator OTHER

• St. Louis University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-05-03

Primary Completion

2027-01-31

Completion

2028-01-31

FDA Drug

Yes

Countries

• United States
• Canada
• India

Study Locations