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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
Sponsor:
Information provided by (Responsible Party):
David Greenberg, MD;; Assistant Professor, St. Louis University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Giant Cell Tumor of Bone Drug: Zoledronic Acid Phase 3

Detailed 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 of bone. The investigators will evaluate whether bisphonsphonate 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Sarah Dawson, RN 314-577-8527 sarah.dawson@health.slu.edu
Contact: Marsha Steffen, RN 314-577-8904 marsha.steffen@health.slu.edu

Locations
United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David Greenberg, MD    314-577-8904    david.greenberg@health.slu.edu   
Contact: Sarah Dawson, RN    (314) 577-8527    sarah.dawson@health.slu.edu   
Sponsors and Collaborators
St. Louis University

Responsible Party: David Greenberg, MD;; Assistant Professor, Associate Professor Orthopaedic Surgery Saint Louis University, St. Louis University
ClinicalTrials.gov Identifier: NCT03295981     History of Changes
Other Study ID Numbers: 28229
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Bone Neoplasms
Giant Cell Tumor of Bone
Recurrence
Giant Cell Tumors
Disease Attributes
Pathologic Processes
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs