Clinical trial Recruiting at 12 sites Phase 3 Interventional Ages 18 and up

Using bisphosphonate to reduce tumor recurrence in bone tumors

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

Run by St. Louis University · NCT03295981 · Data updated 2026-11-12

This study is testing if using a special bone cement with bisphosphonate during surgery can help prevent giant cell tumors in bones from coming back and improve recovery compared to regular surgery alone.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorSt. Louis University
Academic / other
Drugs / interventionsdenosumab
Locations16 sites (Los Angeles, California and 15 other locations)
StatusRecruiting
StartedMay 3, 2018
Main results expectedJanuary 2027
Study endsJanuary 2028
Registry record updatedApril 22, 2026
Trial IDNCT03295981 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals with primary benign giant cell tumors of bone located in an extremity that can be treated with intralesional curettage.

Probably not a fit

Patients with recurrent giant cell tumors, those with lesions in non-extremity locations, or individuals who have previously received systemic bisphosphonate or denosumab therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study investigates the effectiveness of local bisphosphonate delivery as a surgical adjuvant to reduce the recurrence rate of giant cell tumors of bone. The approach involves using bisphosphonate-loaded PMMA bone cement during surgery to enhance outcomes compared to traditional aggressive surgical removal. The study will also assess secondary outcomes such as pain relief, functional improvement, and complications related to the surgery. The hypothesis is that this localized treatment will lead to better results than standard intralesional curettage alone.

Why it matters

Potential benefit: If successful, this treatment could significantly lower the chances of giant cell tumors returning, improving patient outcomes and quality of life.

How similar studies have gone: While the use of bisphosphonates in other contexts has shown promise, this specific approach is novel and has not been extensively tested in the context of giant cell tumors of bone.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • University of California - Los Angeles
    Los Angeles, California, United States
    Recruiting
  • Indiana University
    Indianapolis, Indiana, United States
    Recruiting
  • University of Iowa
    Iowa City, Iowa, United States
    Recruiting
  • Johns Hopkins University Hospital
    Baltimore, Maryland, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Boston Children's Hospital
    Boston, Massachusetts, United States
    Recruiting
Show 10 more locations
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts, United States
    Recruiting
  • Saint Louis University
    St Louis, Missouri, United States
    Recruiting
  • Cleveland Clinic
    Cleveland, Ohio, United States
    Recruiting
  • University of Oklahoma
    Oklahoma City, Oklahoma, United States
    Recruiting
  • Allegheny-Singer Research Institute
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • All India Institute of Medical Science
    New Delhi, India
    Recruiting
  • University of Kansas
    Overland Park, Kansas, United States
    Completed
  • Wake Forest University
    Winston-Salem, North Carolina, United States
    Completed
  • University of Washington
    Seattle, Washington, United States
    Completed
  • McGill University Health Centre
    Montreal, Quebec, Canada
    Completed

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.