Osteoporotic Vertebral Compression Fracture Cohort Study

NCT ID: NCT07321795

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-10

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The subjects are selected according to the inclusion criteria and exclusion criteria. A total of 200 subjects will be recruited from four participating tertiary hospitals and categorized into four groups: individuals with normal bone mass, osteopenia, osteoporosis, and Osteoporotic Vertebral Compression Fracture (OVCF) . Data collection encompasses three levels:

* 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

See the medical conditions and disease areas that this research is targeting or investigating.

OVCF Database Cohort Study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Shandong Wendeng Orthopedic Hospital

UNKNOWN

Sponsor Role collaborator

Wangjing Hospital, China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Hunan University of Chinese Medicine

Hunan, Changsha, China

Site Status

Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine

Suzhou, Jiangsu, China

Site Status

Shandong Wendeng Orthopedic Hospital

Weihai, Shandong, China

Site Status

Wangjing Hospital, China Academy of Chinese Medical Sciences

Beijing, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xu Wei, Ph.D

Role: CONTACT

+8613488716557

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shaofeng Yang, Ph.D

Role: primary

13873148670

Jintao liu, Ph.D

Role: primary

13584851171

Hongjiang Jiang, Ph.D

Role: primary

+8615895891872

Xu Wei, Ph.D

Role: primary

+8613488716557

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WJEC-KT-2025-047-P001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.