About this trial
This study looks at whether using a medication called bisphosphonate during surgery can help lower the chance of a giant cell tumor of bone coming back. Doctors will compare this method to traditional surgery alone. They hope that adding bisphosphonate will lead to better results for patients.
The trial ID is NCT03295981. This is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. The trial is FDA-regulated and aims to include about 120 participants.
Who can join
The trial is open to adults aged 18 and older, including both men and women. Participants should have a primary giant cell tumor in an arm or leg that can be treated with surgery. Those who have had previous treatments with certain medications or who have recurrent tumors cannot join. The trial team will check who is eligible before enrollment.
Condition
Giant Cell Tumor of Bone
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into two groups. One group will receive traditional surgery with no medication added. The other group will get the same surgery, but with a medication called zoledronic acid added to the bone cement used in the procedure. Everyone will have their progress monitored for up to two years after surgery.
Where
This trial is running at 14 locations in the United States. 11 of them are currently recruiting.
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Boston Children's Hospital
Boston, Massachusetts
Cleveland Clinic
Cleveland, Ohio
Indiana University
Indianapolis, Indiana
Johns Hopkins University Hospital
Baltimore, Maryland
Massachusetts General Hospital
Boston, Massachusetts
Saint Louis University
St Louis, Missouri
The first 8 of 14 sites are listed here. The registry record has the full list.