Giant Cell Tumor of Bone Clinical Trial
Official title:
Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
NCT number | NCT03295981 |
Other study ID # | 28229 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 3, 2018 |
Est. completion date | January 2026 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | January 2026 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Centre | Montréal | Quebec |
India | All India Institute of Medical Science | New Delhi | |
United States | Johns Hopkins University Hospital | Baltimore | Maryland |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Indiana University | Indianapolis | Indiana |
United States | University of Iowa | Iowa City | Iowa |
United States | University of California - Los Angeles | Los Angeles | California |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
United States | University of Kansas | Overland Park | Kansas |
United States | Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Saint Louis University | Saint Louis | Missouri |
United States | Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
St. Louis University | All India Institute of Medical Science, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), American Academy of Orthopaedic Surgeons, Beth Israel Deaconess Medical Center, Boston Children's Hospital, Indiana University, Johns Hopkins University, Massachusetts General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre, Orthopedic Research and Education Foundation, The Cleveland Clinic, University of Iowa, University of Kansas, University of Oklahoma, Wake Forest University |
United States, Canada, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The endpoint for patient participation will be local recurrence | Local recurrence of giant cell tumor of bone | Followed for 2 years postoperatively for study end points | |
Secondary | MSTS Score | The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research | Followed for 2 years postoperatively for study end points | |
Secondary | Surgical site infection | 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. | 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. | |
Secondary | Wound healing | The surgical site will be assessed after surgery and during scheduled follow-up as outlined in time frame below for wound healing issues/concerns. | 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. | |
Secondary | Potential bisphosphonate complications related to systemic administration | Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw | Followed for 2 years postoperatively for study end points |
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