NCT03295981 Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
| NCT ID | NCT03295981 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | St. Louis University |
| Condition | Giant Cell Tumor of Bone |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2018-05-03 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 120 participants in total. It began in 2018-05-03 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03295981 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Giant Cell Tumor of Bone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03295981 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 120 participants.
Is NCT03295981 currently recruiting?
Yes, NCT03295981 is actively recruiting participants. Contact the research team at allison.gruender@health.slu.edu for enrollment information.
Where is the NCT03295981 trial being conducted?
This trial is being conducted at Los Angeles, United States, Indianapolis, United States, Iowa City, United States, Overland Park, United States and 11 additional locations.
Who is sponsoring the NCT03295981 clinical trial?
NCT03295981 is sponsored by St. Louis University. The trial plans to enroll 120 participants.