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Clinical Trials in India / NCT03295981
Recruiting Phase 3

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

NCT03295981 · tracked via the Priya Life Science India tracker
Sponsor
St. Louis University
Phase
Phase 3
Started
2018-05-03
Last updated
2026-04-22

Condition(s) studied

Giant Cell Tumor of Bone

Investigational drug(s) / intervention(s)

Zoledronic Acid →

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • The endpoint for patient participation will be local recurrence — Followed for 2 years postoperatively for study end points
    Local recurrence of giant cell tumor of bone

Trial sites (16)

FacilityCityRegionStatus
University of California - Los Angeles Los Angeles California Recruiting
Indiana University Indianapolis Indiana Recruiting
University of Iowa Iowa City Iowa Recruiting
University of Kansas Overland Park Kansas Completed
Johns Hopkins University Hospital Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Boston Children's Hospital Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Saint Louis University St Louis Missouri Recruiting
Wake Forest University Winston-Salem North Carolina Completed
Cleveland Clinic Cleveland Ohio Recruiting
University of Oklahoma Oklahoma City Oklahoma Recruiting
Allegheny-Singer Research Institute Pittsburgh Pennsylvania Recruiting
University of Washington Seattle Washington Completed
McGill University Health Centre Montreal Quebec Completed
All India Institute of Medical Science New Delhi India Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03295981 on ClinicalTrials.gov ↗ ← All trials in India