Osteoporotic Vertebral Compression Fracture Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: OVCF Database, Cohort Study. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Osteoporotic Vertebral Compression Fractures: A Multi-center Cohort Study Based on Disease and Syndrome Differentiation
Overview
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.
Primary outcome measures
- Bone Mineral Density (BMD) [Time frame: Baseline]
Secondary outcome measures (12)
- Muscle Strength [Time frame: Baseline]
- The bone marrow fat fraction (FF) [Time frame: Baseline]
- Paravertebral muscle area [Time frame: Baseline]
- Fatty infiltration [Time frame: Baseline]
- Vertebral bone quality (VBQ) score [Time frame: Baseline]
- Visual Analogue Scale (VAS) Score [Time frame: Baseline]
- Lumbar Oswestry Disability Index (ODI) Score [Time frame: Baseline]
- OP TCM Syndrome Information [Time frame: Baseline]
- OVCF TCM Syndrome Information [Time frame: Baseline]
- Total Type I Procollagen N-terminal Propeptide (P1NP)、β-Cross-linked C-telopeptide of Type I Collagen (β-CTX) [Time frame: Baseline]
- Serum bone glaprotein (BGP) [Time frame: Baseline]
- 25-Hydroxyvitamin D (25(OH)D) [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
1.50 years ≤ age < 80 years; gender includes both male and female. 2.Meet the diagnostic criteria for new-onset osteoporotic vertebral compression fracture.
3.Voluntarily participate in this clinical study and sign the informed consent form.
Subjects meeting only criteria (1) and (3) with a T-score ≥ -1.0 can be included in the normal bone mass group. Subjects meeting criteria (1) and (3) with -2.5 < T-score < -1.0 can be included in the osteopenia group. Subjects meeting criteria (1) and (3) with T-score ≤ -2.5, meeting the diagnostic criteria for osteoporosis, can be included in the OP group. Subjects meeting all criteria (1), (2), and (3) will be included in the OVCF patient group.
Exclusion criteria
- Patients with serious concomitant cardiovascular/cerebrovascular diseases, liver/kidney diseases, malignant tumors, or other wasting diseases, and patients with infectious diseases.
- Patients with other endocrine system diseases, such as Cushing's syndrome, hyperthyroidism, hypothyroidism, etc.
- Patients who have participated in other clinical trials within the past 3 months.
- Patients with concomitant Alzheimer's disease, mental illnesses or depression, or those unable to cooperate to complete the trial.
- Patients with poor compliance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 4 centers
- The First Affiliated Hospital of Hunan University of Chinese Medicine — Hunan
- Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine — Suzhou
- Shandong Wendeng Orthopedic Hospital — Weihai
- Wangjing Hospital, China Academy of Chinese Medical Sciences — Beijing
Identifiers
NCT: NCT07321795 · WJEC-KT-2025-047-P001