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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Giant Cell Tumor of Bone

Intervention / Treatment
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* Drug: Zoledronic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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<br>In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement. | Drug: Zoledronic Acid<br>* 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement<br>* Other names: zoledronate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| 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. | 
| 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 |