Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/15/2019 |
| Start Date: | May 3, 2018 |
| End Date: | January 2023 |
| Contact: | Sarah Dawson, RN |
| Email: | sarah.dawson@health.slu.edu |
| Phone: | 314-577-8527 |
Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
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.
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.
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 of bone. The investigators will evaluate whether
bisphonsphonate 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.
bisphosphonate (BP-loaded PMMA bone cement) as a surgical adjuvant can decrease the local
recurrence rate of giant cell tumor of bone. The investigators will evaluate whether
bisphonsphonate 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.
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
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