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Brief Title: Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
Official Title: Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
Study ID: NCT03295981
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.
Detailed Description: 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 (GCT) of bone. The investigators will evaluate whether bisphosphonate 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
University of California - Los Angeles, Los Angeles, California, United States
Indiana University, Indianapolis, Indiana, United States
University of Iowa, Iowa City, Iowa, United States
University of Kansas, Overland Park, Kansas, United States
Johns Hopkins University Hospital, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Boston Children's Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Saint Louis University, Saint Louis, Missouri, United States
Wake Forest University, Winston-Salem, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Oregon Health & Science University, Portland, Oregon, United States
Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
McGill University Health Centre, Montréal, Quebec, Canada
All India Institute of Medical Science, New Delhi, , India