Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Louis University
• Collaborators: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute); Indiana University; Johns Hopkins University; McGill University Health Centre/Research Institute of the McGill University Health Centre; Medical College of Wisconsin; Oregon Health and Science University; Orthopaedic Research and Education Foundation; The Cleveland Clinic; University of California, Los Angeles; University of Iowa; University of Kansas; University of Oklahoma; Wake Forest University
• Treatments: Diphosphonates; Zoledronic Acid

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