Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
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|ClinicalTrials.gov Identifier: NCT03295981|
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Giant Cell Tumor of Bone||Drug: Zoledronic Acid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Official Title:||Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial|
|Actual Study Start Date :||May 3, 2018|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2023|
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.
Drug: Zoledronic Acid
4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
Other Name: zoledronate
- The endpoint for patient participation will be local recurrence [ Time Frame: Followed for 2 years postoperatively for study end points ]Local recurrence of giant cell tumor of bone
- MSTS Score [ Time Frame: Followed for 2 years postoperatively for study end points ]The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research
- Surgical site infection [ 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. ]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.
- Wound healing [ 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. ]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 [ Time Frame: Followed for 2 years postoperatively for study end points ]Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295981
|Contact: Sarah Dawson, RNfirstname.lastname@example.org|
|Contact: Marsha Steffen, RNemail@example.com|
|United States, Missouri|
|Saint Louis University||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: David Greenberg, MD 314-577-8904 firstname.lastname@example.org|
|Contact: Sarah Dawson, RN (314) 577-8527 email@example.com|