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

  • STATUS
    Recruiting
  • End date
    Jan 3, 2025
  • participants needed
    120
  • sponsor
    St. Louis University
Updated on 26 February 2022
Accepts healthy volunteers

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.

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.

Details
Condition Giant Cell Tumor of Bone
Treatment Zoledronic Acid
Clinical Study IdentifierNCT03295981
SponsorSt. Louis University
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

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
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