Clinical trial NCT03295981: Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
Official title: Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Giant Cell Tumor of Bone
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: Orthopedic Research and Education Foundation
name: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: University of Iowa
name: Johns Hopkins University
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: The Cleveland Clinic
name: Wake Forest University
name: University of Kansas
name: Indiana University
name: University of Oklahoma
name: Beth Israel Deaconess Medical Center
name: Boston Children's Hospital
name: American Academy of Orthopaedic Surgeons
name: Massachusetts General Hospital
name: All India Institute of Medical Sciences
name: University of Washington
name: University of California
First posted: 2017-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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 (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.

Eligibility 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

Primary outcomes:
measure: The endpoint for patient participation will be local recurrence
timeFrame: Followed for 2 years postoperatively for study end points
Secondary outcomes:
measure: MSTS Score
timeFrame: Followed for 2 years postoperatively for study end points
measure: Surgical site infection
timeFrame: 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.
measure: Wound healing
timeFrame: 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.
measure: Potential bisphosphonate complications related to systemic administration
timeFrame: Followed for 2 years postoperatively for study end points
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Overland Park
country: United States
facility: University of Kansas
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: New Delhi
country: India
facility: All India Institute of Medical Science
Study officials:
References: