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

Purpose

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

  • Giant Cell Tumor of Bone

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized controlled trial
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Kansas
Overland Park, Kansas 66211
Contact:
Sharon Bradshaw
sbradshaw2@kumc.edu

More Details

Status
Recruiting
Sponsor
St. Louis University

Study Contact

Allison Gruender, RN
314-617-3406
allison.gruender@health.slu.edu

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.