NCT03295981

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: St. Louis University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Giant Cell Tumor of Bone

Interventions

Type	Name	Description
DRUG	Zoledronic Acid	4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement

Timeline

• Start date: 2018-05-03
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2017-09-28
• Last updated: 2025-10-15

Locations

16 sites across 3 countries: United States, Canada, India

Regulatory

• FDA-regulated drug study