Study on Local Bisphosphonate Treatment to Prevent Recurrence of Giant Cell Tumor in Arm or Leg Bones

Sponsor: St. Louis University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03295981

Provider View

This clinical trial is exploring whether applying bisphosphonate directly to the bone during surgery can reduce the chances of a giant cell tumor returning in the same spot. The study compares this method to the traditional approach of removing the tumor aggressively.

Patient Parameters

Program Overview

The aim of this study is to find out if using bisphosphonate, a type of medication, directly on the bone during surgery can lower the risk of a giant cell tumor coming back in the same area. Researchers will also look at whether this treatment helps with pain, movement, fever, or wound healing compared to the usual method of removing the tumor.

Description

This study is testing whether applying bisphosphonate directly to the bone during surgery can help prevent giant cell tumors from returning in the arms or legs. Bisphosphonate is mixed with a special bone cement and used during surgery to see if it can lower the chances of the tumor coming back. Researchers will also check if this treatment helps with other issues like pain, how well the limb works, fever, or problems with the surgical wound. The study compares this new method to the traditional way of removing the tumor more aggressively.

Eligibility Criteria

Inclusion Criteria

  • Have a primary benign giant cell tumor in a bone.
  • The tumor is located in an arm or leg.
  • The tumor can be treated with a specific type of surgery that leaves some bone intact.
  • Have not received bisphosphonate or denosumab treatments before.

Exclusion Criteria

  • Have a giant cell tumor that has come back.
  • The tumor is not in an arm or leg.
  • The tumor is too large or has spread to joints or soft tissues, making it unsuitable for the specific surgery.
  • Are a child or pregnant.
  • Have had bisphosphonate or denosumab treatments before.

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