Giant Cell Tumor of Bone
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGZoledronic Acid
4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
Sponsors
St. Louis University
Orthopedic Research and Education Foundation
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
University of Iowa
Johns Hopkins University
McGill University Health Centre/Research Institute of the McGill University Health Centre
The Cleveland Clinic
Wake Forest University
University of Kansas
Indiana University
University of Oklahoma
Beth Israel Deaconess Medical Center
Boston Children's Hospital
American Academy of Orthopaedic Surgeons
Massachusetts General Hospital
All India Institute of Medical Sciences
University of Washington
University of California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The endpoint for patient participation will be local recurrence | Followed for 2 years postoperatively for study end points | Local recurrence of giant cell tumor of bone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MSTS Score | Followed for 2 years postoperatively for study end points | The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research |
| Surgical site infection | Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery. | The surgical site will be assessed for a surgical site infection (SSI) as defined by CDC guidelines after surgery and during scheduled follow-up as outlined in time frame below. |
| Wound healing | Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery. | The surgical site will be assessed after surgery and during scheduled follow-up as outlined in time frame below for wound healing issues/concerns. |
| Potential bisphosphonate complications related to systemic administration | Followed for 2 years postoperatively for study end points | Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw |
Countries
Canada, India, United States
Contacts
CONTACTAllison Gruender, RN
CONTACTMarsha Steffen, RN
Outcome results
None listed