Osteoporosis FractureNCT06379243
Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures
A study testing PVP/PKP in people with Osteoporosis Fracture and Osteoporosis Vertebral, run by The Seventh Affiliated Hospital of Sun Yat-sen University at 1 site in China.
Trial summary
In this project, IDEAL-IQ technology and PDFF and R2* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoporosis Fracture, Osteoporosis Vertebral, Compression Fracture
- What is being tested?
- PVP/PKP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Dec 2027
- Phase
- Interventional
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with osteoporotic vertebral fractures of the thoracic and lumbar level with reference to the 2022 edition of the Osteoporotic Fractures Guidelines (2022 edition);
- The presence of bone marrow edema or hemorrhage (acute fracture) in the fractured vertebrae is clearly defined by MR examination, and the responsible vertebrae is treated with PVP / PKP;
- Number of fractured vertebrae: 1-3 vertebral compression fractures (including old fractures).
Who cannot join
- History of severe scoliosis, vertebroplasty, or internal spinal fixation;
- Presence of spinal infection and malignant neoplastic disease;
- Presence of mental disease, cognitive impairment, or critical illness (e.g., severe cardiac or cerebrovascular disease).
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 Seventh Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Kuiqing Lu, 0755-81207263, lukq@mail.sysu.edu.cn
About this study
Official title: Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study
In this project, IDEAL-IQ technology and PDFF and R2* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP / PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP / PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP/ PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year).
- Conditions
- Osteoporosis Fracture, Osteoporosis Vertebral, Compression Fracture, Perform PVP / PKP Treatment
- Being tested
- PVP/PKP
- Keywords
- osteoporosis, spinal vertebral fractures, PVP / PKP treatment
- Medical subject headings
- Osteoporotic Fractures, Fractures, Compression, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVP/PKPProcedure or surgery
PVP or PKP surgery in patients with osteoporotic vertebral compression fractures
| Study group | Role | What they receive |
|---|---|---|
| non-operative vertebra refracture | Experimental | observe non-operative vertebra refracture after PVP/PKP surgery. Receives: Procedure: PVP/PKP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-operative vertebral re-fracture within 1 year after PVP / PKP
Non-operative vertebral re-fracture within 1 year after PVP / PKP, confirmed by follow-up spinal MRI
Measured: 1 year
Secondary outcomes (2)
Visual Analog Score (VAS) at 1 year after PVP/ PKP
Visual Analog Score (VAS) at 1 year after PVP / PKP were obtained by completing the appropriate questionnaires on-site at the time of the 1-year postoperative spinal MRI review.
Measured: 1 year
Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP
Oswestry Dysfunction Index (ODI) at 1 year after PVP / PKP were obtained by completing the appropriate questionnaires on-site at the time of the 1-year postoperative spinal MRI review.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis FractureStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Seventh Affiliated Hospital of Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Medical University, Huizhou Municipal Central Hospital, Dongguan Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Qingyu Liu, The Seventh Affiliated Hospital of Sun Yat-sen University
- Investigators
- qingyu liu, Principal investigator, The Seventh Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379243
- Sponsor's protocol ID
- KY-2023-008-02
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06379243
- Acronym / sponsor ID
- KY-2023-008-02
- Conditions
- Osteoporosis Fracture, Osteoporosis Vertebral, Compression Fracture, Perform PVP / PKP Treatment
- Keywords
- osteoporosis, spinal vertebral fractures, PVP / PKP treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- The Seventh Affiliated Hospital of Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Medical University, Huizhou Municipal Central Hospital, Dongguan Hospital of Traditional Chinese Medicine
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Apr 2024 (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.
In this project, IDEAL-IQ technology and PDFF and R2* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP / PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP / PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP/ PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-operative vertebra refracture | Experimental | Procedure: PVP/PKPobserve non-operative vertebra refracture after PVP/PKP surgery. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with osteoporotic vertebral fractures of the thoracic and lumbar level with reference to the 2022 edition of the Osteoporotic Fractures Guidelines (2022 edition);
- The presence of bone marrow edema or hemorrhage (acute fracture) in the fractured vertebrae is clearly defined by MR examination, and the responsible vertebrae is treated with PVP / PKP;
- Number of fractured vertebrae: 1-3 vertebral compression fractures (including old fractures).
Key exclusion criteria (3 listed)
- History of severe scoliosis, vertebroplasty, or internal spinal fixation;
- Presence of spinal infection and malignant neoplastic disease;
- Presence of mental disease, cognitive impairment, or critical illness (e.g., severe cardiac or cerebrovascular disease).
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 |
|---|---|---|
| PVP/PKPPVP or PKP surgery in patients with osteoporotic vertebral compression fractures | Procedure or surgery | non-operative vertebra refracture |
Primary outcome
Non-operative vertebral re-fracture within 1 year after PVP / PKP
Time frame: 1 year
Non-operative vertebral re-fracture within 1 year after PVP / PKP, confirmed by follow-up spinal MRI
2 secondary outcomes
Visual Analog Score (VAS) at 1 year after PVP/ PKP
Time frame: 1 year
Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP
Time frame: 1 year
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 23 Apr 2024.
- 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.
qingyu liu principal investigator
The Seventh Affiliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVP/PKP in people with Osteoporosis Fracture and Osteoporosis Vertebral, run by The Seventh Affiliated Hospital of Sun Yat-sen University 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 3 inclusion and 3 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 23 Apr 2024. 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.
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 jinhui cai (+86 18002299663, caijinhui123456@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-operative vertebral re-fracture within 1 year after PVP / PKP (time frame: 1 year). 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 23 Apr 2024.