What this study is
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.
What's being tested
- Zoledronic Acid
Intervention · DRUG
4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
Study details
- Official title
- Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
- Sponsor
- St. Louis University
- Conditions
- Giant Cell Tumor of Bone
- Enrolling
- 120 people
- Starts
- 2018-05-03
- Est. completion
- 2028-01
- Design
- Single-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (16)
12 openUniversity of California - Los Angeles
Los Angeles, California, United States
- Alexander Christ · Contact
- Alexander Christ, MD · Principal investigator
RecruitingIndiana University
Indianapolis, Indiana, United States
- Charalampos Lyssikatos · Contactclyssika@iu.edu
- L.Daniel Wurtz, MD · Principal investigator
- Christopher Collier, MD · Principal investigator
RecruitingUniversity of Iowa
Iowa City, Iowa, United States
- Abigail Grothe · Contactabigail-grothe@uiowa.edu
- Benjamin Miller, MD · Principal investigator
RecruitingJohns Hopkins University Hospital
Baltimore, Maryland, United States
- Vaishali Laljani · Contactvparikh2@jhmi.edu
- Adam Levin, MD · Principal investigator
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
- Emily Berner · ContactEABERNER@mgh.harvard.edu
- Santiago Lozano Calderon, MD · Principal investigator
RecruitingBoston Children's Hospital
Boston, Massachusetts, United States
- Saurav Pandey · ContactSaurav.Pandey@childrens.harvard.edu
- Megan Anderson, MD · Principal investigator
RecruitingBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
- Katiri Wagner · Contactkwagner@bidmc.harvard.edu
- Megan Anderson, MD · Principal investigator
RecruitingSaint Louis University
St Louis, Missouri, United States
- David Greenberg, MD · Contact314-617-3410david.greenberg@slucare.ssmhealth.com
- Allison Gruender, RN · Contact(314) 617-3406allison.gruender@health.slu.edu
RecruitingCleveland Clinic
Cleveland, Ohio, United States
- Heather Keaney, MPH · Contactkeaneyh@ccf.org
- Lukas Nystrom, MD · Principal investigator
RecruitingUniversity of Oklahoma
Oklahoma City, Oklahoma, United States
- Kathy Edge · ContactKathy-edge@ouhsc.edu
- Jeremy White, MD · Principal investigator
RecruitingAllegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
- Myles Forsyth · Contactmyles.forsyth@ahn.org
- Lisa Ercolano, MD · Principal investigator
RecruitingUniversity of Kansas
Overland Park, Kansas, United States
CompletedWake Forest University
Winston-Salem, North Carolina, United States
CompletedUniversity of Washington
Seattle, Washington, United States
Completed
2 sites outside the US
All India Institute of Medical Science
New Delhi, India
- Shah Alam Khan · Contact
RecruitingMcGill University Health Centre
Montreal, Quebec, Canada
Completed
Study team
Sponsor
St. Louis University
Study ID 28229
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.