Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
St. Louis University
120 participants
May 3, 2018
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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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Interventions
4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
Locations(16)
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NCT03295981