Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
ConditionGiant Cell Tumor of Bone
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Louis University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Zoledronic Acid
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
St. Louis University
Lead sponsor
Orthopedic Research and Education Foundation
Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborator
University of Iowa
Collaborator
Johns Hopkins University
Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
The Cleveland Clinic
Collaborator
Wake Forest University
Collaborator
University of Kansas
Collaborator
Indiana University
Collaborator
University of Oklahoma
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Boston Children's Hospital
Collaborator
American Academy of Orthopaedic Surgeons
Collaborator
Massachusetts General Hospital
Collaborator
All India Institute of Medical Sciences
Collaborator
University of Washington
Collaborator
University of California
Collaborator
Source ClinicalTrials.gov