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Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT03295981.
Locations matching your search criteria
United States
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Beth Israel Deaconess Medical Center
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available
North Carolina
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Name Not Available
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available
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.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationSSM Health Saint Louis University Hospital
