Status:
RECRUITING
Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
Lead Sponsor:
St. Louis University
Collaborating Sponsors:
Orthopedic Research and Education Foundation
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Conditions:
Giant Cell Tumor of Bone
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 lo...
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 cel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03295981
Start Date
May 3 2018
End Date
January 1 2028
Last Update
October 15 2025
Active Locations (16)
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1
University of California - Los Angeles
Los Angeles, California, United States, 90404
2
Indiana University
Indianapolis, Indiana, United States, 46202
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
University of Kansas
Overland Park, Kansas, United States, 66211