Using bisphosphonate to reduce tumor recurrence in bone tumors
Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
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 |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Louis University Academic / other |
| Drugs / interventions | denosumab |
| Locations | 16 sites (Los Angeles, California and 15 other locations) |
| Trial ID | NCT03295981 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Los Angeles, California and 15 other locations
- 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)
- University of Kansas — Overland Park, Kansas, United States (Completed)
- 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)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Saint Louis University — St Louis, Missouri, United States (Recruiting)
- Wake Forest University — Winston-Salem, North Carolina, United States (Completed)
- 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)
- University of Washington — Seattle, Washington, United States (Completed)
- McGill University Health Centre — Montreal, Quebec, Canada (Completed)
- All India Institute of Medical Science — New Delhi, India (Recruiting)
Study contacts
- Study coordinator: Allison Gruender, RN
- Email: allison.gruender@health.slu.edu
- Phone: 314-617-3406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.