A Phase 3 interventional study of Zoledronic Acid in Giant Cell Tumor of Bone, sponsored by St. Louis University. Recruiting at 16 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by St. Louis University · Phase 3, Interventional, and Treatment
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.
23 studies on the registry are indexed under Giant Cell Tumor of Bone; 7 are open to participants now.
This study's planned enrollment of 120 is above the median of 43 across 16 interventional studies indexed under Giant Cell Tumor of Bone.
Browse Giant Cell Tumor of Bone studies →St. Louis University is the lead sponsor of 156 studies on the registry; 17 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Exclusion Criteria:
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.
In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.
Drug: Zoledronic Acid
4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
Also known as: zoledronate
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
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.
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.
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
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Plan to share: No
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Studies of the drug tested here: Zoledronic Acid