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

Primary Purpose

Giant Cell Tumor of Bone

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zoledronic Acid
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Giant Cell Tumor of Bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California - Los Angeles
  • Indiana UniversityRecruiting
  • University of IowaRecruiting
  • University of KansasRecruiting
  • Johns Hopkins University HospitalRecruiting
  • Massachusetts General HospitalRecruiting
  • Boston Children's HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Saint Louis UniversityRecruiting
  • Wake Forest UniversityRecruiting
  • Cleveland ClinicRecruiting
  • University of OklahomaRecruiting
  • Oregon Health & Science University
  • Allegheny-Singer Research InstituteRecruiting
  • Medical College of Wisconsin
  • McGill University Health CentreRecruiting
  • All India Institute of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Bisphosphonate group

Arm Description

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.

In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.

Outcomes

Primary Outcome Measures

The endpoint for patient participation will be local recurrence
Local recurrence of giant cell tumor of bone

Secondary Outcome Measures

MSTS Score
The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research
Surgical site infection
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.
Wound healing
The surgical site will be assessed after surgery and during scheduled follow-up as outlined in time frame below for wound healing issues/concerns.
Potential bisphosphonate complications related to systemic administration
Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw

Full Information

First Posted
September 18, 2017
Last Updated
October 2, 2023
Sponsor
St. Louis University
Collaborators
Orthopedic 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, Wake Forest University, University of Kansas, Indiana University, University of Oklahoma, Beth Israel Deaconess Medical Center, Boston Children's Hospital, American Academy of Orthopaedic Surgeons, Massachusetts General Hospital, All India Institute of Medical Science
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1. Study Identification

Unique Protocol Identification Number
NCT03295981
Brief Title
Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
Official Title
Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
Collaborators
Orthopedic 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, Wake Forest University, University of Kansas, Indiana University, University of Oklahoma, Beth Israel Deaconess Medical Center, Boston Children's Hospital, American Academy of Orthopaedic Surgeons, Massachusetts General Hospital, All India Institute of Medical Science

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Tumor of Bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Bisphosphonate group
Arm Type
Experimental
Arm Description
In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Other Intervention Name(s)
zoledronate
Intervention Description
4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
Primary Outcome Measure Information:
Title
The endpoint for patient participation will be local recurrence
Description
Local recurrence of giant cell tumor of bone
Time Frame
Followed for 2 years postoperatively for study end points
Secondary Outcome Measure Information:
Title
MSTS Score
Description
The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research
Time Frame
Followed for 2 years postoperatively for study end points
Title
Surgical site infection
Description
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.
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.
Title
Wound healing
Description
The surgical site will be assessed after surgery and during scheduled follow-up as outlined in time frame below for wound healing issues/concerns.
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.
Title
Potential bisphosphonate complications related to systemic administration
Description
Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw
Time Frame
Followed for 2 years postoperatively for study end points

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allison Gruender, RN
Phone
314-617-3406
Email
allison.gruender@health.slu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marsha Steffen, RN
Phone
314-617-3410
Email
marsha.steffen@health.slu.edu
Facility Information:
Facility Name
University of California - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Christ
First Name & Middle Initial & Last Name & Degree
Alexander Christ, MD
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julian Dilley
Email
jedilley@indiana.edu
First Name & Middle Initial & Last Name & Degree
L.Daniel Wurtz, MD
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Grothe
Email
abigail-grothe@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Miller, MD
Facility Name
University of Kansas
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Bradshaw
Email
sbradshaw2@kumc.edu
First Name & Middle Initial & Last Name & Degree
Kyle Sweeney, MD
Facility Name
Johns Hopkins University Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vaishali Laljani
Email
vparikh2@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Adam Levin, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alisha Sodhi
Email
asodhi1@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Santiago Lozano Calderon, MD
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernanda Canizares
Email
maria.canizares@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Megan Anderson, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katiri Wagner
Email
kwagner@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Megan Anderson, MD
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Greenberg, MD
Phone
314-617-3410
Email
david.greenberg@health.slu.edu
First Name & Middle Initial & Last Name & Degree
Allison Gruender, RN
Phone
(314) 617-3406
Email
allison.gruender@health.slu.edu
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel Brotherton, MA
Email
abrother@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Cynthia Emory, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Keaney, MPH
Email
keaneyh@ccf.org
First Name & Middle Initial & Last Name & Degree
Kierstyn Hayden
Email
haydenk2@ccf.org
First Name & Middle Initial & Last Name & Degree
Lukas Nystrom, MD
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Edge
Email
Kathy-edge@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Jeremy White, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Withdrawn
Facility Name
Allegheny-Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myles Forsyth
Email
myles.forsyth@ahn.org
First Name & Middle Initial & Last Name & Degree
Lisa Ercolano, MD
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Withdrawn
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadine Zablith
Email
nadine.zablith@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Robert Turcotte, MD
Facility Name
All India Institute of Medical Science
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shah Alam Khan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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