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Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone

RECRUITINGPhase 3Sponsored by St. Louis University
Actively Recruiting
PhasePhase 3
SponsorSt. Louis University
Started2018-05-03
Est. completion2027-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations14 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerGiant Cell Tumor of Bone

Locations14 sites

University of California - Los Angeles
Los Angeles, California, 90404
Alexander Christ
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
University of Kansas
Overland Park, Kansas, 66211
Sharon Bradshawsbradshaw2@kumc.edu
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
Vaishali Laljanivparikh2@jhmi.edu

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