Recruiting

Phase 3

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

Sponsor:

St. Louis University

Code:

NCT03295981

Conditions

Giant Cell Tumor of Bone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Zoledronic Acid

Study Details

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.

Conditions

Giant Cell Tumor of Bone

Study ID

NCT03295981

Start date

May 3, 2018

Status verified date

Apr, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Zoledronic Acid

4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement

Primary outcome measure

The endpoint for patient participation will be local recurrence [ Time Frame: Followed for 2 years postoperatively for study end points ]

Central Contacts and Locations

Central contacts

Allison Gruender, RN

314-617-3406 allison.gruender@health.slu.edu

Marsha Steffen, RN

314-617-3410 marsha.steffen@slucare.ssmhealth.com

Locations

University of California - Los Angeles

Recruiting

Los Angeles, California, United States, 90404

Principal Investigator:

Alexander Christ, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Charalampos Lyssikatos

clyssika@iu.edu

Principal Investigator:

L.Daniel Wurtz, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Abigail Grothe

abigail-grothe@uiowa.edu

Principal Investigator:

Benjamin Miller, MD

Johns Hopkins University Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Vaishali Laljani

vparikh2@jhmi.edu

Principal Investigator:

Adam Levin, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Emily Berner

EABERNER@mgh.harvard.edu

Principal Investigator:

Santiago Lozano Calderon, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Saurav Pandey

Saurav.Pandey@childrens.harvard.edu

Principal Investigator:

Megan Anderson, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Katiri Wagner

kwagner@bidmc.harvard.edu

Principal Investigator:

Megan Anderson, MD

Saint Louis University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

David Greenberg, MD

314-617-3410 david.greenberg@slucare.ssmhealth.com

Allison Gruender, RN

(314) 617-3406 allison.gruender@health.slu.edu

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Heather Keaney, MPH

keaneyh@ccf.org

Principal Investigator:

Lukas Nystrom, MD

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Kathy Edge

Kathy-edge@ouhsc.edu

Principal Investigator:

Jeremy White, MD

Allegheny-Singer Research Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Myles Forsyth

myles.forsyth@ahn.org

Principal Investigator:

Lisa Ercolano, MD

More Information

Sponsor

St. Louis University

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Louis University on 2026-04-22.