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Recruiting NCT03295981

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

Phase III Interventional Giant Cell Tumor of Bone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zoledronic Acid.
Who it may be relevant to
Registry conditions: Giant Cell Tumor of Bone. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial

Overview

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.

Interventions

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

Primary outcome measures

  • The endpoint for patient participation will be local recurrence [Time frame: Followed for 2 years postoperatively for study end points]
Secondary outcome measures (4)
  • MSTS Score [Time frame: Followed for 2 years postoperatively for study end points]
  • 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.]
  • 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.]
  • Potential bisphosphonate complications related to systemic administration [Time frame: Followed for 2 years postoperatively for study end points]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 14 centers
  • University of California - Los Angeles — Los Angeles
  • Indiana University — Indianapolis
  • University of Iowa — Iowa City
  • University of Kansas — Overland Park
  • Johns Hopkins University Hospital — Baltimore
  • Massachusetts General Hospital — Boston
  • Boston Children's Hospital — Boston
  • Beth Israel Deaconess Medical Center — Boston
  • … and 6 more centers
Canada · 1 center
  • McGill University Health Centre — Montreal
India · 1 center
  • All India Institute of Medical Science — New Delhi

Identifiers

NCT: NCT03295981 · 28229

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗