Giant Cell Tumor of BonePhase 3NCT03295981
Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
A Phase 3 study testing Zoledronic Acid in people with Giant Cell Tumor of Bone, run by St. Louis University at 16 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Giant Cell Tumor of Bone
- What is being tested?
- Zoledronic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 3 May 2018to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 3 countries
United States14 sites, 11 recruiting
- Recruiting
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
Vaishali Laljani, vparikh2@jhmi.edu
Adam Levin, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Emily Berner, EABERNER@mgh.harvard.edu
Santiago Lozano Calderon, MD
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Saurav Pandey, Saurav.Pandey@childrens.harvard.edu
Megan Anderson, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Katiri Wagner, kwagner@bidmc.harvard.edu
Megan Anderson, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Heather Keaney, MPH, keaneyh@ccf.org
Lukas Nystrom, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Charalampos Lyssikatos, clyssika@iu.edu
L.Daniel Wurtz, MD
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Abigail Grothe, abigail-grothe@uiowa.edu
Benjamin Miller, MD
- Recruiting
University of California - Los Angeles
Los Angeles, California, 90404
Alexander Christ
Alexander Christ, MD
- Recruiting
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Kathy Edge, Kathy-edge@ouhsc.edu
Jeremy White, MD
- Completed
University of Kansas
Overland Park, Kansas, 66211
- Recruiting
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
Myles Forsyth, myles.forsyth@ahn.org
Lisa Ercolano, MD
- Completed
University of Washington
Seattle, Washington, 98195
- Recruiting
Saint Louis University
St Louis, Missouri, 63110
David Greenberg, MD, 314-617-3410, david.greenberg@slucare.ssmhealth.com
Allison Gruender, RN, (314) 617-3406, allison.gruender@health.slu.edu
- Completed
Wake Forest University
Winston-Salem, North Carolina, 27157
Canada1 site
- Completed
McGill University Health Centre
Montreal, Quebec, H3G 1A4
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Science
New Delhi, 110029
Shah Alam Khan
About this study
Official title: Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Giant Cell Tumor of Bone
- Being tested
- Zoledronic Acid
- Medical subject headings
- Giant Cell Tumor of Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic AcidDrug
Also called zoledronate
4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Bisphosphonate group | Experimental | In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement. Receives: Drug: Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The endpoint for patient participation will be local recurrence
Local recurrence of giant cell tumor of bone
Measured: Followed for 2 years postoperatively for study end points
Secondary outcomes (4)
MSTS Score
The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research
Measured: Followed for 2 years postoperatively for study end points
Surgical site infection
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.
Measured: 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
The surgical site will be assessed after surgery and during scheduled follow-up as outlined in time frame below for wound healing issues/concerns.
Measured: 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
Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw
Measured: Followed for 2 years postoperatively for study end points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start3 May 2018
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell Tumor of BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), University of Iowa, Johns Hopkins University, McGill University Health Centre/Research Institute of the McGill University Health Centre, The Cleveland Clinic, Wake Forest University, University of Kansas, Indiana University, University of Oklahoma, Beth Israel Deaconess Medical Center, Boston Children's Hospital, American Academy of Orthopaedic Surgeons, Massachusetts General Hospital, All India Institute of Medical Sciences, University of Washington, University of California
- Responsible party
- Principal investigator, David D. Greenberg, MD; Professor, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295981
- Sponsor's protocol ID
- 28229
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2017
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03295981
- Acronym / sponsor ID
- 28229
- Conditions
- Giant Cell Tumor of Bone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), University of Iowa, Johns Hopkins University, McGill University Health Centre/Research Institute of the McGill University Health Centre, The Cleveland Clinic, Wake Forest University, University of Kansas, Indiana University, University of Oklahoma, Beth Israel Deaconess Medical Center, Boston Children's Hospital, American Academy of Orthopaedic Surgeons, Massachusetts General Hospital, All India Institute of Medical Sciences, University of Washington, University of California
- Study start
- 3 May 2018 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Bisphosphonate group | Experimental | Drug: Zoledronic AcidIn Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic AcidAlso: zoledronate4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement | Drug | Bisphosphonate group |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic Acid in people with Giant Cell Tumor of Bone, run by St. Louis University at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Gruender, RN (314-617-3406, allison.gruender@health.slu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The endpoint for patient participation will be local recurrence (time frame: Followed for 2 years postoperatively for study end points). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.