Creating a model to predict the risk of new vertebral fractures in osteoporosis patients after treatment
Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty
This study is trying to see if it can predict the risk of new spine fractures in patients with osteoporosis who have already had treatment for previous fractures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06172179 on ClinicalTrials.gov |
What this trial studies
This observational study collects clinical data from patients who have undergone Percutaneous Vertebroplasty (PVA) for osteoporotic vertebral compression fractures. It aims to record the incidence of secondary vertebral fractures and analyze this data statistically to develop a risk prediction model for future fractures. The study focuses on patients diagnosed with primary osteoporosis and evaluates their lumbar pain and MRI results to ensure they meet specific inclusion criteria. No interventions are administered as the study is retrospective in nature.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with primary osteoporosis who have experienced a vertebral compression fracture and have undergone PVA treatment.
Not a fit: Patients with incomplete medical records, prior spinal surgeries, or those with certain chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this model could help identify patients at high risk for secondary vertebral fractures, allowing for targeted preventive measures.
How similar studies have performed: Other studies have explored risk prediction models in osteoporosis, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meets the diagnostic criteria for primary osteoporosis as per the Osteoporosis Diagnosis and Treatment Guidelines (2022); 2. No history of high-energy trauma; 3. 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); 4. Has undergone Percutaneous Vertebroplasty (PVA) treatment. Exclusion Criteria: 1. Incomplete imaging or medical record data; 2. History of spinal surgeries other than PVA; 3. Pre-existing symptoms of spinal cord compression or nerve root injury; 4. Patients undergoing PVA treatment due to conditions such as tumors, vascular malformations, infections, or symptomatic Schmorl's nodes; 5. Chronic conditions like Kummell's disease or non-union of old fractures; 6. Concurrent vertebral burst fractures; 7. Diagnosis of central nervous system diseases such as dementia or stroke before or during the follow-up period post-PVA procedure; 8. History of violent trauma after PVA procedure.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen memorial hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Chunhai Li, MD — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Chunhai Li, MD
- Email: lichhai@mail.sysu.edu.cn
- Phone: 18602079796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.