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

Conditions

• Giant Cell Tumor of Bone

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

May 3, 2018

Status verified

Apr 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Control group
  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
  In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.

Primary Outcome Measure

The endpoint for patient participation will be local recurrence [ Time Frame: Followed for 2 years postoperatively for study end points ]

Central Contacts

• Allison Gruender, RN
  314-617-3406
  [email protected]
• Marsha Steffen, RN
  314-617-3410
  [email protected]

Locations (14)

Find similar trials in Los Angeles, CA

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