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

Saint Louis University (SLU)

Status and phase: Enrolling; Phase 3

Conditions: Giant Cell Tumor of Bone

Treatments: Drug: Zoledronic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03295981

28229

Details and patient eligibility

About

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 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Control group

No Intervention group

Description:

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.

Bisphosphonate group

Experimental group

Description:

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

Treatment:

Drug: Zoledronic Acid