Giant Cell Tumor of BonePhase 2NCT05595603
Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage
A Phase 2 study testing 4mg ZOL loaded gentamicin PMMA and gentamicin PMMA in people with Giant Cell Tumor of Bone, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to investigate whether zoledronic acid-loaded bone cement (4mg ZOL+ gentamicin PMMA ) as adjuvant method can decrease local recurrence in patients with giant cell bone tumor following intralesional curettage surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Giant Cell Tumor of Bone
- What is being tested?
- 4mg ZOL loaded gentamicin PMMA and gentamicin PMMA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- Mar 2023to 1 Dec 2026
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with primary resectable GCT of bone
- 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
- with expected longer than 18 months of survival time
- sign the informed consent form
Who cannot join
- patients with recurrent GCT or extensive GCT which is impossible or inappropriate to use curettage surgery due to its "unresectable" nature.
- conduct unexpected surgery at other center
- the primary goal for surgery is revision
- patient conduct en-bloc/wide resection instead of curettage surgery
- patient can not conduct self-assessment during follow up
- difficulty in complete postoperative follow-up
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- previous use of bisphosphonate/ZOL or denosumab drug
- patients have participated in similar research projects
- refused to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou, 311200
Meng Liu, 13515711791, liumeng80@163.com
About this study
Official title: Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage: a Prospective, Multicenter, Single Blinded, Randomized Control Trial.
The purpose of this study is to investigate whether zoledronic acid-loaded bone cement (4mg ZOL+ gentamicin PMMA ) as adjuvant method can decrease local recurrence in patients with giant cell bone tumor following intralesional curettage surgery. The hypothesis is that patients with local administration of zoledronic acid to the bone cement has lower relapse rate compared those with traditional bone cement(gentamicin PMMA ).
Read the detailed description
The purpose of the clinical study is to investigate whether the local delivery of zoledronic acid (4mg ZOL-loaded gentamicin PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will also evaluate whether patients with zoledronic acid as a surgical adjuvant improves secondary outcomes, including function (MSTS and TESS), surgery related complications (henderson's failure mode) and ZOL-related complications.
- Conditions
- Giant Cell Tumor of Bone
- Being tested
- 4mg ZOL loaded gentamicin PMMA, gentamicin PMMA
- Keywords
- Zoledronic Acid, intralesional curettage
- 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.
4mg ZOL loaded gentamicin PMMAProcedure or surgery
During surgery, 4mg ZOL will be mixed with gentamicin (1000mg) PMMA cement (40g) by surgeon under sterile conditions to prepare ZOL loaded bone cement, and then it will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.
gentamicin PMMAProcedure or surgery
During surgery, gentamicin (1000mg) PMMA (40g) was prepared by surgeon under sterile conditions and will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic Acid loaded bone cement | Experimental | 4mg zoledronic acid-loaded gentamicin bone cement (PMMA) Receives: Procedure: 4mg ZOL loaded gentamicin PMMA |
| conventional gentamicin bone cement | Active comparator | gentamicin bone cement (PMMA) Receives: Procedure: gentamicin PMMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first local recurrence
Time to first local recurrence will be reported during postoperative 18-month follow up period
Measured: All patients will be followed for this endpoint until 18 months postoperatively
Secondary outcomes (4)
MSTS score
The Musculoskeletal Tumor Society (MSTS) scoring system is a disease-specific instrument to determine the physical and mental health for patients underwent limb-salvage surgery after tumor resection and is a validated and well-accepted functional scoring system used in orthopaedic oncology research
Measured: Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up
TESS score
The Toronto Extremity Salvage Score (TESS) is a physical disability measure developed specifically for patients undergoing surgery for extremity tumours and has been shown to have superior measurement properties compared with other commonly used sc
Measured: Patients will be asked to fill this survey 3 months, 9 months, 12 months, 18 months postoperatively
postoperative complication
Including wound healing problem, mechanical failure, infection and any tumor progression issues
Measured: Patients will be asked to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively during follow up
Potential ZOL-related complications
Patients will be followed for atypical bone fractures and avascular necrosis (AVN) of jaw, one of the most severe complication of ZOL
Measured: Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study startMar 2023 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595603
- Sponsor's protocol ID
- 2022_LM1020
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage: a Prospective, Multicenter, Single Blinded, Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05595603
- Acronym / sponsor ID
- 2022_LM1020
- Conditions
- Giant Cell Tumor of Bone
- Keywords
- Zoledronic Acid, intralesional curettage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Oct 2022 (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 this study is to investigate whether zoledronic acid-loaded bone cement (4mg ZOL+ gentamicin PMMA ) as adjuvant method can decrease local recurrence in patients with giant cell bone tumor following intralesional curettage surgery. The hypothesis is that patients with local administration of zoledronic acid to the bone cement has lower relapse rate compared those with traditional bone cement(gentamicin PMMA ).
Detailed description
The purpose of the clinical study is to investigate whether the local delivery of zoledronic acid (4mg ZOL-loaded gentamicin PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will also evaluate whether patients with zoledronic acid as a surgical adjuvant improves secondary outcomes, including function (MSTS and TESS), surgery related complications (henderson's failure mode) and ZOL-related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoledronic Acid loaded bone cement | Experimental | Procedure: 4mg ZOL loaded gentamicin PMMA4mg zoledronic acid-loaded gentamicin bone cement (PMMA) |
| conventional gentamicin bone cement | Active comparator | Procedure: gentamicin PMMAgentamicin bone cement (PMMA) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- patients with primary resectable GCT of bone
- 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
- with expected longer than 18 months of survival time
- sign the informed consent form
Key exclusion criteria (9 listed)
- patients with recurrent GCT or extensive GCT which is impossible or inappropriate to use curettage surgery due to its "unresectable" nature.
- conduct unexpected surgery at other center
- the primary goal for surgery is revision
- patient conduct en-bloc/wide resection instead of curettage surgery
- patient can not conduct self-assessment during follow up
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 |
|---|---|---|
| 4mg ZOL loaded gentamicin PMMADuring surgery, 4mg ZOL will be mixed with gentamicin (1000mg) PMMA cement (40g) by surgeon under sterile conditions to prepare ZOL loaded bone cement, and then it will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage. | Procedure or surgery | Zoledronic Acid loaded bone cement |
| gentamicin PMMADuring surgery, gentamicin (1000mg) PMMA (40g) was prepared by surgeon under sterile conditions and will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage. | Procedure or surgery | conventional gentamicin bone cement |
Primary outcome
time to first local recurrence
Time frame: All patients will be followed for this endpoint until 18 months postoperatively
Time to first local recurrence will be reported during postoperative 18-month follow up period
4 secondary outcomes
MSTS score
Time frame: Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up
TESS score
Time frame: Patients will be asked to fill this survey 3 months, 9 months, 12 months, 18 months postoperatively
postoperative complication
Time frame: Patients will be asked to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively during follow up
Potential ZOL-related complications
Time frame: Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively.
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 15 Mar 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4mg ZOL loaded gentamicin PMMA and gentamicin PMMA in people with Giant Cell Tumor of Bone, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 5 inclusion and 9 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Meng Liu, MD (13515711791, liumeng80@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first local recurrence (time frame: All patients will be followed for this endpoint until 18 months postoperatively). 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 15 Mar 2023.