Osteoporotic Vertebral Compression Fracture Cohort Study
NCT ID: NCT07321795
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2026-01-10
2027-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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normal bone mass group
No interventions assigned to this group
osteopenia group
No interventions assigned to this group
osteoporosis group
No interventions assigned to this group
Osteoporotic Vertebral Compression Fracture group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
80 Years
ALL
Yes
Sponsors
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Hunan University of Traditional Chinese Medicine
OTHER
Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine
UNKNOWN
Shandong Wendeng Orthopedic Hospital
UNKNOWN
Wangjing Hospital, China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital of Hunan University of Chinese Medicine
Hunan, Changsha, China
Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine
Suzhou, Jiangsu, China
Shandong Wendeng Orthopedic Hospital
Weihai, Shandong, China
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WJEC-KT-2025-047-P001
Identifier Type: -
Identifier Source: org_study_id
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