Osteoporotic Vertebral Compression Fracture Cohort Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorWangjing Hospital, China Academy of Chinese Medical Sciences

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 4 trial groups
Group A: normal bone mass group
Group B: osteopenia group
Group C: osteoporosis group
Group D: Osteoporotic Vertebral Compression Fracture group

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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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