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Clinical Study on Osteoporosis Assessment Based on Artificial Intelligence Trabecular Bone Score (TBS)

Clinical Study on Osteoporosis Assessment Based on Artificial Intelligence Trabecular Bone Score (TBS)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093219
Enrollment
Unknown
Registered
2024-11-29
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoporosis, compression fracture

Interventions

5. Parathyroid hormone testing
6. Detection of bone turnover markers.
Gold Standard:The T value detected by DXA is the gold standard, and a T value less than -2.5 is considered osteoporosis.
Index test:1. DXA inspection: BMD-T value, TBS value
2. X-ray and/or QCT examination
3. Blood routine, liver and kidney function
4. Serum calcium and vitamin D testing

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Suspects male patients with osteoporosis (aged over 50 years old) in clinical practice; 2.Female menopausal patients; 3.Regular pattern of renal failure in hemodialysis patients; 4.Patients meet the diagnostic criteria for diabetes; 5.Long term hormone therapy patients; 6.The image quality meets the standards and specifications;

Exclusion criteria

Exclusion criteria: 1.Lumbar compression fracture; 2.Serious hematological diseases such as multiple myeloma, leukemia, lymphoma; 3.Those who do not accept CT or X-ray examinations for other reasons; 4.Severe Malnutrition; 5.There are implants in the research area (lumbar spine or hip);

Design outcomes

Primary

MeasureTime frame
T value of DXA;trabecular bone score(TBS) value;Accuracy;Sensitivity;Specificity;

Secondary

MeasureTime frame
Probability of fracture occurrence;Probability of adverse events (such as poor therapeutic effect, fracture occurrence);

Countries

China

Contacts

Public Contactyijie fang

Fifth Affiliated Hospital, Sun Yat-Sen University

fangyj5@mail.sysu.edu.cn+86 756 2528320

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026