RecruitingInterventionalPhase 3

Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial

NCT ID: NCT03295981Sponsor: St. Louis UniversityLast updated: 2026-04-22

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.

Arms & interventions

DrugZoledronic Acid
4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement

Outcome measures

Primary

The endpoint for patient participation will be local recurrence
Local recurrence of giant cell tumor of bone
Time frame: Followed for 2 years postoperatively for study end points

Secondary

MSTS Score
Time frame: Followed for 2 years postoperatively for study end points
Surgical site infection
Time frame: 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.
Wound healing
Time frame: 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.
Potential bisphosphonate complications related to systemic administration
Time frame: Followed for 2 years postoperatively for study end points

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

View on ClinicalTrials.gov

Conditions

Giant Cell Tumor of Bone

Study details

Enrollment: 120 participants

Start date: 2018-05-03

Est. completion: 2028-01

Collaborators: 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