Osteoporotic Vertebral Compression Fractures: A Multi-center Cohort Study Based on Disease and Syndrome Differentiation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Bone Mineral Density (BMD)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
osteoporosis group
Osteoporotic Vertebral Compression Fracture group
osteopenia group
normal bone mass group
结局指标
主要结局
Bone Mineral Density (BMD)
时间窗: Baseline
DXA will be used to measure lumbar spine (L1-L4) and bilateral hip density, recording the T-score for each site. Instrument precision will be set to 1% (i.e., repeated measurement error \< 1%). Professionals will be responsible for post-use accuracy checks and maintenance.
次要结局
- Muscle Strength(Baseline)
- Vertebral bone quality (VBQ) score(Baseline)
- The bone marrow fat fraction (FF)(Baseline)
- Paravertebral muscle area(Baseline)
- Visual Analogue Scale (VAS) Score(Baseline)
- Fatty infiltration(Baseline)
- Lumbar Oswestry Disability Index (ODI) Score(Baseline)
- OP TCM Syndrome Information(Baseline)
- OVCF TCM Syndrome Information(Baseline)
- Total Type I Procollagen N-terminal Propeptide (P1NP)、β-Cross-linked C-telopeptide of Type I Collagen (β-CTX)(Baseline)
- 25-Hydroxyvitamin D (25(OH)D)(Baseline)
- Serum bone glaprotein (BGP)(Baseline)
- Intact Parathyroid Hormone (PTH)(Baseline)
- Total Cholesterol (TC)(Baseline)
- Triglycerides (TG)(Baseline)
- High-Density Lipoprotein Cholesterol (HDL-C)(Baseline)
- Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline)
- Leptin(Baseline)
- Visfatin(Baseline)
- Apelin(Baseline)
- Chemerin(Baseline)
- Interleukin-6 (IL-6)(Baseline)
- Interleukin-10 (IL-10)(Baseline)
- Transforming Growth Factor-β (TGF-β)(Baseline)
- Tumor Necrosis Factor-α (TNF-α)(Baseline)
- Irisin(Baseline)
- Testosterone(Baseline)
- Myostatin(Baseline)
- Estrogen(Baseline)
- Serum Creatinine(Baseline)
- Cystatin C(Baseline)