Wangjing Hospital, China Academy of Chinese Medical Sciences
Phase
Observational
Started
2026-01-10
Last updated
2026-01-09
Condition(s) studied
OVCF DatabaseCohort Study
Study 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).
Eligibility
Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
Accepted
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:
1. Patients with serious concomitant cardiovascular/cerebrovascular diseases, liver/kidney diseases, malignant tumors, or other wasting diseases, and patients with infectious diseases.
2. Patients with other endocrine system diseases, such as Cushing's syndrome, hyperthyroidism, hypothyroidism, etc.
3. Patients who have participated in other clinical trials within the past 3 months.
4. Patients with concomitant Alzheimer's disease, mental illnesses or depression, or those unable to cooperate to complete the trial.
5. Patients with poor compliance
Primary outcome measure(s)
Bone Mineral Density (BMD) — 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.
Trial sites (4)
Facility
City
Region
Status
The First Affiliated Hospital of Hunan University of Chinese Medicine
Hunan
Changsha
Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine
Suzhou
Jiangsu
Shandong Wendeng Orthopedic Hospital
Weihai
Shandong
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing
China
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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