Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03295981
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295981
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : October 25, 2021
Sponsor:
Collaborators:
Orthopaedic Research and Education Foundation
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
University of Iowa
Johns Hopkins University
McGill University Health Centre/Research Institute of the McGill University Health Centre
The Cleveland Clinic
Medical College of Wisconsin
Wake Forest University
Oregon Health and Science University
University of Kansas
University of California, Los Angeles
Indiana University
University of Oklahoma
Information provided by (Responsible Party):
David Greenberg, MD;; Associate Professor, St. Louis University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Giant Cell Tumor of Bone Drug: Zoledronic Acid Phase 3

Detailed Description:
The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate (BP-loaded PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will evaluate whether bisphosphonate as a surgical adjuvant improves secondary outcomes, such as pain, function, fever, or wound complications. The hypothesis is that the local administration of bisphosphonate will decrease the recurrence rate of GCT compared to traditional aggressive intralesional curettage.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Arm Intervention/treatment
No Intervention: 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.
Experimental: Bisphosphonate group
In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.
Drug: Zoledronic Acid
4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
Other Name: zoledronate




Primary Outcome Measures :
  1. The endpoint for patient participation will be local recurrence [ Time Frame: Followed for 2 years postoperatively for study end points ]
    Local recurrence of giant cell tumor of bone


Secondary Outcome Measures :
  1. MSTS Score [ Time Frame: Followed for 2 years postoperatively for study end points ]
    The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research

  2. Surgical site infection [ Time Frame: Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery. ]
    The surgical site will be assessed for a surgical site infection (SSI) as defined by CDC guidelines after surgery and during scheduled follow-up as outlined in time frame below.

  3. Wound healing [ Time Frame: Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery. ]
    The surgical site will be assessed after surgery and during scheduled follow-up as outlined in time frame below for wound healing issues/concerns.

  4. Potential bisphosphonate complications related to systemic administration [ Time Frame: Followed for 2 years postoperatively for study end points ]
    Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295981


Contacts
Layout table for location contacts
Contact: Sarah Dawson, RN 314-577-8527 sarah.dawson@health.slu.edu
Contact: Marsha Steffen, RN 314-577-8904 marsha.steffen@health.slu.edu

Locations
Layout table for location information
United States, California
University of California - Los Angeles Recruiting
Los Angeles, California, United States, 90404
Contact: Brooke Crawford       BrookeCrawford@mednet.ucla.edu   
Principal Investigator: Brooke Crawford, MD         
United States, Indiana
Indiana University Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Julian Dilley       jedilley@indiana.edu   
Principal Investigator: L.Daniel Wurtz, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Tammy Smith       tammy-smith@uiowa.edu   
Principal Investigator: Benjamin Miller, MD         
United States, Kansas
University of Kansas Recruiting
Overland Park, Kansas, United States, 66211
Contact: Sharon Bradshaw       sbradshaw2@kumc.edu   
Principal Investigator: Kyle Sweeney, MD         
United States, Maryland
Johns Hopkins University Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Vaishali Laljani       vparikh2@jhmi.edu   
Principal Investigator: Adam Levin, MD         
United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David Greenberg, MD    314-577-8904    david.greenberg@health.slu.edu   
Contact: Sarah Dawson, RN    (314) 577-8527    sarah.dawson@health.slu.edu   
United States, North Carolina
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Ariel Brotherton, MA       abrother@wakehealth.edu   
Principal Investigator: Cynthia Emory, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Heather Keaney, MPH       keaneyh@ccf.org   
Contact: Kierstyn Hayden       haydenk2@ccf.org   
Principal Investigator: Lukas Nystrom, MD         
United States, Oklahoma
University of Oklahoma Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kathy Edge       Kathy-edge@ouhsc.edu   
Principal Investigator: Jeremy White, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Rebecca Wetzel       wetzelr@ohsu.edu   
Principal Investigator: Kenneth Gundle, MD         
United States, Pennsylvania
Allegheny-Singer Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Angela Finamore, MS       angela.finamore@ahn.org   
Principal Investigator: Lisa Ercolano, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Karen Gonzalez       kgonzalez@mcw.edu   
Principal Investigator: John Neilson, MD         
Canada, Quebec
McGill University Health Centre Recruiting
Montréal, Quebec, Canada, H3G 1A4
Contact: Clinical Research Coordinator, Sarcoma    514-934-1934 ext 43022      
Principal Investigator: Robert Turcotte, MD         
Sponsors and Collaborators
St. Louis University
Orthopaedic Research and Education Foundation
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
University of Iowa
Johns Hopkins University
McGill University Health Centre/Research Institute of the McGill University Health Centre
The Cleveland Clinic
Medical College of Wisconsin
Wake Forest University
Oregon Health and Science University
University of Kansas
University of California, Los Angeles
Indiana University
University of Oklahoma
Layout table for additonal information
Responsible Party: David Greenberg, MD;; Associate Professor, Associate Professor Orthopaedic Surgery Saint Louis University, St. Louis University
ClinicalTrials.gov Identifier: NCT03295981    
Other Study ID Numbers: 28229
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Giant Cell Tumors
Bone Neoplasms
Giant Cell Tumor of Bone
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs