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

Phase 3

Recruiting

• Conditions: Giant Cell Tumor of Bone
• Interventions: Drug: Zoledronic Acid

• Registration Number: NCT03295981
• Lead Sponsor: St. Louis University

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.

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 Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-28
• Study Start: 2018-05-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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

Trial Locations

Locations (16)

University of Washington; 🇺🇸 Seattle, Washington, United States

University of California - Los Angeles; 🇺🇸 Los Angeles, California, United States

Johns Hopkins University Hospital; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of Kansas; 🇺🇸 Overland Park, Kansas, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Allegheny-Singer Research Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

All India Institute of Medical Science; 🇮🇳 New Delhi, India