Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
NCT ID: NCT03295981
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2018-05-03
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
The surgical procedure for all patients will include extensive curettage of the lesion to remove macroscopic tumor, high-speed burring of the residual cavity, adjuvant treatment to the residual cavity, followed by packing of the cavity with either polymethylmethacrylate (PMMA) bone cement (Simplex P; Stryker, Mahwah, New Jersey) alone or bone cement with subchondral allograft bone graft. The choice of cavity reconstruction will be at the discretion of the treating surgeon. Traditional local adjuvants (argon beam coagulation, phenol, ethanol, or cryotherapy) will be used depending on surgeon preference. In addition to the above standard treatment, the patients will be randomized into one of two study arms. In Arm 1, the control group, no additional local therapy will be utilized.
No interventions assigned to this group
Bisphosphonate group
In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.
Zoledronic Acid
4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
Interventions
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Zoledronic Acid
4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Orthopedic Research and Education Foundation
OTHER
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
OTHER
University of Iowa
OTHER
Johns Hopkins University
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
The Cleveland Clinic
OTHER
Wake Forest University
OTHER
University of Kansas
OTHER
Indiana University
OTHER
University of Oklahoma
OTHER
Beth Israel Deaconess Medical Center
OTHER
Boston Children's Hospital
OTHER
American Academy of Orthopaedic Surgeons
OTHER
Massachusetts General Hospital
OTHER
All India Institute of Medical Sciences
OTHER
University of Washington
OTHER
University of California
OTHER
St. Louis University
OTHER
Responsible Party
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David Greenberg, MD;; Associate Professor
Professor Orthopaedic Surgery Saint Louis University
Locations
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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
St 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
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
McGill University Health Centre
Montreal, Quebec, Canada
All India Institute of Medical Science
New Delhi, , India
Countries
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Central Contacts
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Facility Contacts
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Alexander Christ
Role: primary
Shah Alam Khan
Role: primary
Other Identifiers
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28229
Identifier Type: -
Identifier Source: org_study_id
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