Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
Phase 3 – large-scale trial before approval
Conditions:
Giant Cell Tumor of Bone
Sponsor: St. Louis University
trial.available_in:
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Overview
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.
Who can participate
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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