NCT07321795

Osteoporotic Vertebral Compression Fracture Cohort Study

Osteoporotic Vertebral Compression Fractures: A Multi-center Cohort Study Based on Disease and Syndrome Differentiation

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Wangjing Hospital, China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The study aims to construct an early warning model for Osteoporotic Vertebral Compression Fracture (OVCF) by integrating TCM syndrome patterns with modern risk factors. This is a multi-center cohort study on OVCF integrated with disease and syndrome differentiation in Traditional Chinese Medicine (TCM).

Detailed description

The subjects are selected according to the inclusion criteria and exclusion criteria. A total of 200 subjects will be recruited from four participating tertiary hospitals and categorized into four groups: individuals with normal bone mass, osteopenia, osteoporosis, and Osteoporotic Vertebral Compression Fracture (OVCF) . Data collection encompasses three levels: * Macro-level: Demographics, lifestyle, medical history, and physical metrics. * Meso-level: TCM syndrome diagnoses, bone mineral density (BMD), MRI assessments, and functional scores (VAS, ODI). * Micro-level: Serum biomarkers related to bone metabolism, lipids, inflammation, and muscle health. Strict quality control measures will be implemented, including researcher training and data monitoring. The integrated database and analytical framework are designed to develop a practical, population-specific risk prediction tool for OVCF.

Conditions

• OVCF Database
• Cohort Study

Timeline

• Start date: 2026-01-10
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2026-01-07
• Last updated: 2026-01-09

Locations

4 sites across 1 country: China