Using bisphosphonate to reduce tumor recurrence in bone tumors
Official title: Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
Run by St. Louis University · NCT03295981 · Data updated 2026-11-12
This study is testing if using a special bone cement with bisphosphonate during surgery can help prevent giant cell tumors in bones from coming back and improve recovery compared to regular surgery alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | St. Louis University Academic / other |
| Drugs / interventions | denosumab |
| Locations | 16 sites (Los Angeles, California and 15 other locations) |
| Status | Recruiting |
| Started | May 3, 2018 |
| Main results expected | January 2027 |
| Study ends | January 2028 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT03295981 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with primary benign giant cell tumors of bone located in an extremity that can be treated with intralesional curettage.
✕Probably not a fit
Patients with recurrent giant cell tumors, those with lesions in non-extremity locations, or individuals who have previously received systemic bisphosphonate or denosumab therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study investigates the effectiveness of local bisphosphonate delivery as a surgical adjuvant to reduce the recurrence rate of giant cell tumors of bone. The approach involves using bisphosphonate-loaded PMMA bone cement during surgery to enhance outcomes compared to traditional aggressive surgical removal. The study will also assess secondary outcomes such as pain relief, functional improvement, and complications related to the surgery. The hypothesis is that this localized treatment will lead to better results than standard intralesional curettage alone.
Why it matters
Potential benefit: If successful, this treatment could significantly lower the chances of giant cell tumors returning, improving patient outcomes and quality of life.
How similar studies have gone: While the use of bisphosphonates in other contexts has shown promise, this specific approach is novel and has not been extensively tested in the context of giant cell tumors of bone.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of California - Los Angeles
Los Angeles, California, United States Recruiting -
Indiana University
Indianapolis, Indiana, United States Recruiting -
University of Iowa
Iowa City, Iowa, United States Recruiting -
Johns Hopkins University Hospital
Baltimore, Maryland, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Show 10 more locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting -
Saint Louis University
St Louis, Missouri, United States Recruiting -
Cleveland Clinic
Cleveland, Ohio, United States Recruiting -
University of Oklahoma
Oklahoma City, Oklahoma, United States Recruiting -
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States Recruiting -
All India Institute of Medical Science
New Delhi, India Recruiting -
University of Kansas
Overland Park, Kansas, United States Completed -
Wake Forest University
Winston-Salem, North Carolina, United States Completed -
University of Washington
Seattle, Washington, United States Completed -
McGill University Health Centre
Montreal, Quebec, Canada Completed
Study contacts
- Study coordinator: Allison Gruender, RN
- Email: allison.gruender@health.slu.edu
- Phone: 314-617-3406
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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TRACP-5b test to help diagnose and monitor giant cell tumor of bone
This study tests whether a blood marker, TRACP-5b, can help diagnose and track giant cell tumor of bone in adults.
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Indocyanine green fluorescence to find leftover giant cell tumor tissue during surgery
We will try a dye called indocyanine green with near-infrared imaging during surgery to help surgeons spot any remaining giant cell tumor tissue in people having surgery for GCTB.
-
PROMIS questionnaires and smartphone mobility tracking after sarcoma surgery
This project tests whether PROMIS questionnaires together with a new smartphone app can track recovery and mobility in adults undergoing surgery for sarcoma or giant cell tumor of bone.
-
Using ICG imaging to improve surgery for giant cell tumors of bone
This study is testing if a special imaging technique can help surgeons find and remove all parts of giant cell tumors in the bone to reduce the chances of them coming back after surgery.
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Using zoledronic acid-loaded bone cement to reduce recurrence of giant cell bone tumors after surgery
This study tests if using a special bone cement with a drug can help prevent giant cell bone tumors from coming back after surgery, compared to regular bone cement.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.