Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
Giant Cell Tumor of Bone
About this trial
This is an interventional treatment trial for Giant Cell Tumor of Bone
Eligibility Criteria
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
Sites / Locations
- University of California - Los Angeles
- Indiana UniversityRecruiting
- University of IowaRecruiting
- University of KansasRecruiting
- Johns Hopkins University HospitalRecruiting
- Massachusetts General HospitalRecruiting
- Boston Children's HospitalRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Saint Louis UniversityRecruiting
- Wake Forest UniversityRecruiting
- Cleveland ClinicRecruiting
- University of OklahomaRecruiting
- Oregon Health & Science University
- Allegheny-Singer Research InstituteRecruiting
- Medical College of Wisconsin
- McGill University Health CentreRecruiting
- All India Institute of Medical ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control group
Bisphosphonate group
The surgical procedure for all patients will include extensive curettage of the lesion to remove macroscopic tumor, high-speed burring of the residual cavity, adjuvant treatment to the residual cavity, followed by packing of the cavity with either polymethylmethacrylate (PMMA) bone cement (Simplex P; Stryker, Mahwah, New Jersey) alone or bone cement with subchondral allograft bone graft. The choice of cavity reconstruction will be at the discretion of the treating surgeon. Traditional local adjuvants (argon beam coagulation, phenol, ethanol, or cryotherapy) will be used depending on surgeon preference. In addition to the above standard treatment, the patients will be randomized into one of two study arms. In Arm 1, the control group, no additional local therapy will be utilized.
In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.