Osteoporotic Vertebral FractureNCT06172179
Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty
An observational study of Osteoporotic Vertebral Fracture and Prediction Model, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
"Retrospectively collecting clinical data from post-PVA (Percutaneous Vertebroplasty) patients, recording incidences of secondary vertebral fractures, and conducting statistical analysis to create a risk prediction model for recurrent fractures." Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporotic Vertebral Fracture, Prediction Model
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Older population with osteoporosis, who have undergone vertebral augmentation procedures due to osteoporotic vertebral fractures.
Who may be able to join
- Meets the diagnostic criteria for primary osteoporosis as per the Osteoporosis Diagnosis and Treatment Guidelines (2022);
- No history of high-energy trauma;
- Patient complains of pain in the lumbar region, confirmed by MRI showing a newly developed vertebral fracture from T5 to L5 (i.e., MRI shows low signal on T1 and high or slightly high signal on T2);
- Has undergone Percutaneous Vertebroplasty (PVA) treatment.
Who cannot join
- Incomplete imaging or medical record data;
- History of spinal surgeries other than PVA;
- Pre-existing symptoms of spinal cord compression or nerve root injury;
- Patients undergoing PVA treatment due to conditions such as tumors, vascular malformations, infections, or symptomatic Schmorl's nodes;
- Chronic conditions like Kummell's disease or non-union of old fractures;
- Concurrent vertebral burst fractures;
- Diagnosis of central nervous system diseases such as dementia or stroke before or during the follow-up period post-PVA procedure;
- History of violent trauma after PVA procedure.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen memorial hospital
Guangzhou, Guangdong, 510000
Chunhai Li, MD, 18602079796, lichhai@mail.sysu.edu.cn
hanwen cheng, Master, 19541080926, chenghw3@mail2.sysu.edu.cn
About this study
"Retrospectively collecting clinical data from post-PVA (Percutaneous Vertebroplasty) patients, recording incidences of secondary vertebral fractures, and conducting statistical analysis to create a risk prediction model for recurrent fractures."
- Conditions
- Osteoporotic Vertebral Fracture, Prediction Model
- Being tested
- No interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
All procedures are observation. No intervention in this study.
| Study group | Role | What they receive |
|---|---|---|
| Sun Yat-sen memorial hospital | Not described Receives: Other: No interventions | |
| Second People's Hospital of Foshan City | Not described Receives: Other: No interventions | |
| The Fifth People's Hospital of Nanhai District, Foshan City | Not described Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
secondary vertebral fractures
Recording the secondary vertebral fractures
Measured: 2 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Dec 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic Vertebral FractureStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunhai Li, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172179
- Sponsor's protocol ID
- SYSKY-2023-1155-01
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty
- ClinicalTrials.gov ID
- NCT06172179
- Acronym / sponsor ID
- SYSKY-2023-1155-01
- Conditions
- Osteoporotic Vertebral Fracture, Prediction Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 15 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.
"Retrospectively collecting clinical data from post-PVA (Percutaneous Vertebroplasty) patients, recording incidences of secondary vertebral fractures, and conducting statistical analysis to create a risk prediction model for recurrent fractures."
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sun Yat-sen memorial hospital | – | Other: No interventions |
| Second People's Hospital of Foshan City | – | Other: No interventions |
| The Fifth People's Hospital of Nanhai District, Foshan City | – | Other: No interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Older population with osteoporosis, who have undergone vertebral augmentation procedures due to osteoporotic vertebral fractures.
Key inclusion criteria (4 listed)
- Meets the diagnostic criteria for primary osteoporosis as per the Osteoporosis Diagnosis and Treatment Guidelines (2022);
- No history of high-energy trauma;
- Patient complains of pain in the lumbar region, confirmed by MRI showing a newly developed vertebral fracture from T5 to L5 (i.e., MRI shows low signal on T1 and high or slightly high signal on T2);
- Has undergone Percutaneous Vertebroplasty (PVA) treatment.
Key exclusion criteria (8 listed)
- Incomplete imaging or medical record data;
- History of spinal surgeries other than PVA;
- Pre-existing symptoms of spinal cord compression or nerve root injury;
- Patients undergoing PVA treatment due to conditions such as tumors, vascular malformations, infections, or symptomatic Schmorl's nodes;
- Chronic conditions like Kummell's disease or non-union of old fractures;
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 |
|---|---|---|
| No interventionsAll procedures are observation. No intervention in this study. | Other | Second People's Hospital of Foshan City, Sun Yat-sen memorial hospital, The Fifth People's Hospital of Nanhai District, Foshan City |
Primary outcome
secondary vertebral fractures
Time frame: 2 years post-operative
Recording the secondary vertebral fractures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 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. This study is not recruiting at the moment.
Chunhai Li, MD principal investigator
Sun Yat-Sen Memorial 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?
An observational study of Osteoporotic Vertebral Fracture and Prediction Model, run by Sun Yat-Sen Memorial 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunhai Li, MD (18602079796, lichhai@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
secondary vertebral fractures (time frame: 2 years post-operative). 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 Dec 2023.