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

Sponsor

St. Louis University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03295981

Collaborator

Orthopaedic Research and Education Foundation (Other), Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (Other), University of Iowa (Other), Johns Hopkins University (Other), McGill University Health Centre/Research Institute of the McGill University Health Centre (Other), The Cleveland Clinic (Other), Medical College of Wisconsin (Other), Wake Forest University (Other), Oregon Health and Science University (Other), University of Kansas (Other), University of California, Los Angeles (Other), Indiana University (Other), University of Oklahoma (Other)

120

Enrollment

Locations

Arms

Anticipated Duration (Months)

9.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized 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

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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 Names: zoledronate

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 Names:

zoledronate

Outcome Measures

Primary Outcome Measures

The endpoint for patient participation will be local recurrence [Followed for 2 years postoperatively for study end points]
Local recurrence of giant cell tumor of bone

Secondary Outcome Measures

MSTS Score [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
Surgical site infection [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.
Wound healing [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.
Potential bisphosphonate complications related to systemic administration [Followed for 2 years postoperatively for study end points]
Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California - Los Angeles	Los Angeles	California	United States	90404
2	Indiana University	Indianapolis	Indiana	United States	46202
3	University of Iowa	Iowa City	Iowa	United States	52242
4	University of Kansas	Overland Park	Kansas	United States	66211
5	Johns Hopkins University Hospital	Baltimore	Maryland	United States	21287
6	Saint Louis University	Saint Louis	Missouri	United States	63110
7	Wake Forest University	Winston-Salem	North Carolina	United States	27157
8	Cleveland Clinic	Cleveland	Ohio	United States	44195
9	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
10	Oregon Health & Science University	Portland	Oregon	United States	97239
11	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania	United States	15212
12	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
13	McGill University Health Centre	Montréal	Quebec	Canada	H3G 1A4

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Sep 28, 2017

Last Update Posted:

Oct 25, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Giant Cell Tumors

Bone Neoplasms

Giant Cell Tumor of Bone

Recurrence

Zoledronic Acid

Study Results

No Results Posted as of Oct 25, 2021