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

Phase 3RecruitingNCT03295981

St. Louis University120 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Giant Cell Tumor of Bone

Interventions

Zoledronic AcidDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (16)

University of California - Los Angeles

Los Angeles, California, United States

NOT_YET_RECRUITING

Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

The endpoint for patient participation will be local recurrence

Local recurrence of giant cell tumor of bone

Time frame: Followed for 2 years postoperatively for study end points

Secondary Outcomes

MSTS Score

The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research

Time frame: Followed for 2 years postoperatively for study end points

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.

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.

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.

Potential bisphosphonate complications related to systemic administration

Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw

Time frame: Followed for 2 years postoperatively for study end points

Central Contacts

Allison Gruender, RN

CONTACT

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

Marsha Steffen, RN

CONTACT

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

Data from ClinicalTrials.gov

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