About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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.
Trial population
Study participants are selected from patients admitted to four participating tertiary hospitals
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Bone Mineral Density (BMD)
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.
Secondary outcomes
Muscle Strength
Left and right handgrip strength in kilograms, which is determined by a handheld dynamometer. The normal range varies by age, gender, and dominant hand. When it is lower than the normal range, it may indicate muscle weakness, sarcopenia, or neuromuscular disorders; when it is higher than the normal range, it typically reflects good musculoskeletal health and physical fitness.
The bone marrow fat fraction (FF)
The bone marrow fat fraction (FF) of lumbar vertebrae (expressed as a percentage), which is determined by magnetic resonance imaging (MRI) analysis. The normal range varies with age and vertebral level, typically between 30-50% in healthy adults. When it is higher than the normal range, it may indicate osteoporosis, aging, or metabolic bone disease; when it is lower than the normal range, it may suggest conditions such as bone marrow edema, inflammation, or hematopoietic disorders.
Paravertebral muscle area
The paravertebral muscle area (in cm²), which is determined by magnetic resonance imaging (MRI) analysis. The normal range varies based on vertebral level, age, and gender. When it is smaller than the normal range, it may indicate muscle atrophy, sarcopenia, or degenerative changes.
Fatty infiltration
The degree of paravertebral muscle fatty infiltration (expressed as a percentage or fat fraction), which is determined by magnetic resonance imaging (MRI) analysis. The normal range varies with age and vertebral level. When it is higher than the normal range, it indicates increased intramuscular fat deposition, often associated with aging, disuse, or metabolic disorders.
Sponsors and contacts
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Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead sponsor
Hunan University of Traditional Chinese Medicine
Collaborator
Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine
Collaborator
Shandong Wendeng Orthopedic Hospital
Collaborator
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