RECRUITING

Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone

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Conditions

Giant Cell Tumor of Bone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: a Prospective Randomized Controlled Trial

Quick Facts

Study Start:2018-05-03
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03295981

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary benign GCT of bone
  2. * Lesion located in an extremity
  3. * Lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal
  4. * No previous systemic bisphosphonate or denosumab therapy
  1. * Recurrent GCT of bone
  2. * Non-extremity location
  3. * Lesion too extensive for intralesional treatment, either due to bone loss, joint invasion, or large soft tissue component
  4. * Children and pregnancy
  5. * Previous systemic bisphosphonate or denosumab therapy

Contacts and Locations

Study Contact

Allison Gruender, RN
CONTACT
314-617-3406
allison.gruender@health.slu.edu
Marsha Steffen, RN
CONTACT
314-617-3410
marsha.steffen@slucare.ssmhealth.com

Study Locations (Sites)

University of California - Los Angeles
Los Angeles, California, 90404
United States
Indiana University
Indianapolis, Indiana, 46202
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University of Kansas
Overland Park, Kansas, 66211
United States
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Saint Louis University
Saint Louis, Missouri, 63110
United States
Wake Forest University
Winston-Salem, North Carolina, 27157
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104
United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: St. Louis University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-03
Study Completion Date2027-01

Study Record Updates

Study Start Date2018-05-03
Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

  • Giant Cell Tumor of Bone