Vertebral Compression FractureNCT06153576
The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures
An observational study of Vertebral Compression Fracture and Myeloma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Background : Vertebral fracture is the most common complication of osteoporosis. Vertebroplasty is a widespread treatment modality for osteoporotic vertebral fractures, providing consolidation, rapid pain relief and preventing secondary vertebral collapse. Read more about this study
- Who is it for?
- Ages 17 to 96 years
- Conditions the study is for
- Vertebral Compression Fracture, Myeloma, Bone Metastases
- How many people
- 1,120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 to 96 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who underwent a vertebroplasty with bone biopsy during the study period in the osteoarticular interventional radiology department of the Pasteur 2 hospital of the CHU of Nice
Who may be able to join
- all patients who underwent a vertebroplasty with bone biopsy
Who cannot join
- non-vertebral bone biopsies
- not performed during vertebroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Background : Vertebral fracture is the most common complication of osteoporosis. Vertebroplasty is a widespread treatment modality for osteoporotic vertebral fractures, providing consolidation, rapid pain relief and preventing secondary vertebral collapse. Performing a biopsy at the same time as the operation does not lengthen the procedure or increase the risk of complications. The question therefore arises as to whether it is cost-effective diagnostically: are non-osteoporotic vertebral lesions detected when biopsies are taken? Methods: The investigators carried out a single-centre retrospective study at Nice University Hospital.
From January 2016 to March 2022, 1729 biopsies were performed during 1439 vertebroplasty procedures on 1120 patients.
Read more
The pre-operative laboratory work-up included a blood count, a C-reactive protein assay and a coagulation test.
The imaging work-up systematically included MRI, unless contraindicated, in which case CT alone was performed.
Vertebroplasty was performed in an interventional CT suite under dual CT and fluoroscopic guidance. The systematic biopsy sample was then sent to the anatomopathology department for analysis.
Findings :
The samples detected cancer in 35 patients, including 5 (0.44%) for whom the pre-operative work-up had not raised any suspicion.
All the incidental findings were haemopathies, including 4 myelomas and one lymphoma.
Conclusion :
These results highlight the good performance of MRI in distinguishing osteoporotic vertebral fractures from solid tumour metastases.
However, an exhaustive pre-operative work-up does not seem to be able to formally rule out an underlying malignant lesion.
The investigators therefore recommend that biopsies be taken systematically when performing vertebroplasty.
- Conditions
- Vertebral Compression Fracture, Myeloma, Bone Metastases, Malignant Bone Tumour, Lymphoma, Plasmocytoma
- Medical subject headings
- Neoplasms, Plasma Cell, Lymphoma, Plasmacytoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incidental discovery of malignant lesions during systematic biopsies for the treatment of vertebral compression fractures
incidental findings of neoplasia during vertebroplasty for presumed osteoporotic fractures
Measured: 5 years and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Jan 2016
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Compression FractureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153576
- Sponsor's protocol ID
- 23Imagerie03
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures
- ClinicalTrials.gov ID
- NCT06153576
- Acronym / sponsor ID
- 23Imagerie03
- Conditions
- Vertebral Compression Fracture, Myeloma, Bone Metastases, Malignant Bone Tumour, Lymphoma, Plasmocytoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 1 Dec 2023 (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.
Background : Vertebral fracture is the most common complication of osteoporosis. Vertebroplasty is a widespread treatment modality for osteoporotic vertebral fractures, providing consolidation, rapid pain relief and preventing secondary vertebral collapse. Performing a biopsy at the same time as the operation does not lengthen the procedure or increase the risk of complications. The question therefore arises as to whether it is cost-effective diagnostically: are non-osteoporotic vertebral lesions detected when biopsies are taken? Methods: The investigators carried out a single-centre retrospective study at Nice University Hospital.
From January 2016 to March 2022, 1729 biopsies were performed during 1439 vertebroplasty procedures on 1120 patients.
The pre-operative laboratory work-up included a blood count, a C-reactive protein assay and a coagulation test.
The imaging work-up systematically included MRI, unless contraindicated, in which case CT alone was performed.
Vertebroplasty was performed in an interventional CT suite under dual CT and fluoroscopic guidance. The systematic biopsy sample was then sent to the anatomopathology department for analysis.
Findings :
The samples detected cancer in 35 patients, including 5 (0.44%) for whom the pre-operative work-up had not raised any suspicion.
All the incidental findings were haemopathies, including 4 myelomas and one lymphoma.
Conclusion :
These results highlight the good performance of MRI in distinguishing osteoporotic vertebral fractures from solid tumour metastases.
However, an exhaustive pre-operative work-up does not seem to be able to formally rule out an underlying malignant lesion.
The investigators therefore recommend that biopsies be taken systematically when performing vertebroplasty.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 17 to 96 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent a vertebroplasty with bone biopsy during the study period in the osteoarticular interventional radiology department of the Pasteur 2 hospital of the CHU of Nice
Key inclusion criteria (1 listed)
- all patients who underwent a vertebroplasty with bone biopsy
Key exclusion criteria (2 listed)
- non-vertebral bone biopsies
- not performed during vertebroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of incidental discovery of malignant lesions during systematic biopsies for the treatment of vertebral compression fractures
Time frame: 5 years and 2 months
incidental findings of neoplasia during vertebroplasty for presumed osteoporotic fractures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Compression Fracture and Myeloma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 11 Dec 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of incidental discovery of malignant lesions during systematic biopsies for the treatment of vertebral compression fractures (time frame: 5 years and 2 months). 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 11 Dec 2023.