NCT03295981

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
19mo left

Started May 2018

Longer than P75 for phase_3

Geographic Reach
3 countries

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
May 2018Jan 2028

First Submitted

Initial submission to the registry

September 18, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

May 3, 2018

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

8.7 years

First QC Date

September 18, 2017

Last Update Submit

April 17, 2026

Conditions

Giant Cell Tumor of Bone

Outcome Measures

Primary Outcomes (1)

  • The endpoint for patient participation will be local recurrence

    Local recurrence of giant cell tumor of bone

    Followed for 2 years postoperatively for study end points

Secondary Outcomes (4)

  • MSTS Score

    Followed for 2 years postoperatively for study end points

  • 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.

  • 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.

  • Potential bisphosphonate complications related to systemic administration

    Followed for 2 years postoperatively for study end points

Study Arms (2)

Control group

NO INTERVENTION

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.

Bisphosphonate group

EXPERIMENTAL

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

Drug: Zoledronic Acid

Interventions

Zoledronic AcidDRUG

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

Also known as: zoledronate
Bisphosphonate group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of California - Los Angeles

Los Angeles, California, 90404, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas

Overland Park, Kansas, 66211, United States

COMPLETED

Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Saint Louis University

St Louis, Missouri, 63110, United States

RECRUITING

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

COMPLETED

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

COMPLETED

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

COMPLETED

All India Institute of Medical Science

New Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Giant Cell Tumor of Bone

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Giant Cell TumorsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone Tissue

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Allison Gruender, RN

CONTACT

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

Marsha Steffen, RN

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Orthopaedic Surgery Saint Louis University

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 28, 2017

Study Start

May 3, 2018

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(14)IN(1)