Osteoporotic Vertebral Compression Fracture Cohort Study

NCT07321795 | Not Yet Recruiting

• 1 other identifier: WJEC-KT-2025-047-P001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

OVCF Database; Cohort Study

Keywords

Osteoporotic Vertebral Compression Fractures; Traditional Chinese Medicine; Potential biomarkers; Risk prediction model

Outcome Measures

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.

  Baseline

Secondary Outcomes (31)

• Muscle Strength

  Baseline

• The bone marrow fat fraction (FF)

  Baseline

• Paravertebral muscle area

  Baseline

• Fatty infiltration

  Baseline

• Vertebral bone quality (VBQ) score

  Baseline

Study Arms (4)

normal bone mass group

osteopenia group

osteoporosis group

Osteoporotic Vertebral Compression Fracture group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants are selected from patients admitted to four participating tertiary hospitals

You may qualify if:

• years ≤ age \< 80 years; gender includes both male and female. 2.Meet the diagnostic criteria for new-onset osteoporotic vertebral compression fracture.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunan University of Traditional Chinese Medicine: collaborator
• Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine: collaborator
• Shandong Wendeng Orthopedic Hospital: collaborator
• Wangjing Hospital, China Academy of Chinese Medical Sciences: lead

Study Sites (4)

The First Affiliated Hospital of Hunan University of Chinese Medicine

Hunan, Changsha, 410021, China

Location

Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine

Suzhou, Jiangsu, 215000, China

Location

Shandong Wendeng Orthopedic Hospital

Weihai, Shandong, 264400, China

Location

Wangjing Hospital, China Academy of Chinese Medical Sciences

Beijing, 100102, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Human biological samples include serum and plasma. Serum is obtained by allowing whole blood to clot and then centrifuging to remove cells and clotting factors. Plasma is obtained by centrifuging anticoagulated whole blood, retaining clotting factors.

Central Study Contacts

Xu Wei, Ph.D

CONTACT

+8613488716557; weixu.007@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)