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NCT Number: NCT03295981

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

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.

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Key information

Conditions

Giant Cell Tumor of Bone Giant Cell Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

McGill University Health Centre, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronic acid

Drug

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

Other names: zoledronate

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Gruender, RN

CONTACT

[email protected]

314-617-3406

Marsha Steffen, RN

CONTACT

[email protected]

314-617-3410

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Collaborators

  • All India Institute of Medical Sciences
  • Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
  • American Academy of Orthopaedic Surgeons
  • Beth Israel Deaconess Medical Center
  • Boston Children's Hospital
  • Indiana University
  • Johns Hopkins University
  • Massachusetts General Hospital
  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Orthopedic Research and Education Foundation
  • The Cleveland Clinic
  • University of California
  • University of Iowa
  • University of Kansas
  • University of Oklahoma
  • University of Washington
  • Wake Forest University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Sep 28, 2017
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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