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

Giant Cell Tumor of Bone Clinical Trial

Official title:

Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03295981
• Other study ID #: 28229
• Status: Recruiting
• Phase: Phase 3
• Start date: May 3, 2018
• Est. completion date: January 2026

Study information

• Verified date: October 2023
• Source: St. Louis University
• Contact: Allison Gruender, RN
• Phone: 314-617-3406
• Email: allison.gruender[@]health.slu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasms
• Giant Cell Tumor of Bone
• Giant Cell Tumors
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montréal	Quebec
India	All India Institute of Medical Science	New Delhi
United States	Johns Hopkins University Hospital	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of California - Los Angeles	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	University of Kansas	Overland Park	Kansas
United States	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Saint Louis University	Saint Louis	Missouri
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (16)

Lead Sponsor

Collaborator

St. Louis University

All India Institute of Medical Science, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), American Academy of Orthopaedic Surgeons, Beth Israel Deaconess Medical Center, Boston Children's Hospital, Indiana University, Johns Hopkins University, Massachusetts General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre, Orthopedic Research and Education Foundation, The Cleveland Clinic, University of Iowa, University of Kansas, University of Oklahoma, Wake Forest University

Countries where clinical trial is conducted

United States,  Canada,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MSTS Score	The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research	Followed for 2 years postoperatively for study end points
Secondary	Surgical site infection	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.	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.
Secondary	Wound healing	The surgical site will be assessed after surgery and during scheduled follow-up as outlined in time frame below for wound healing issues/concerns.	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.
Secondary	Potential bisphosphonate complications related to systemic administration	Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw	Followed for 2 years postoperatively for study end points