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

Overview

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.

Full Title of Study: “Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 2024

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 of bone. The investigators will evaluate whether bisphonsphonate 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.

Interventions

  • Drug: Zoledronic Acid
    • 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The endpoint for patient participation will be local recurrence
    • Time Frame: Followed for 2 years postoperatively for study end points
    • Local recurrence of giant cell tumor of bone

Secondary Measures

  • MSTS Score
    • Time Frame: 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
    • 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.
    • 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
    • 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.
    • 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
    • Time Frame: Followed for 2 years postoperatively for study end points
    • Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • St. Louis University
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Greenberg, MD;; Assistant Professor, Associate Professor Orthopaedic Surgery Saint Louis University – St. Louis University
  • Overall Contact(s)
    • Sarah Dawson, RN, 314-577-8527, sarah.dawson@health.slu.edu

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