Evaluation of Musculoskeletal Aging and Related Disorders Via Advanced Clinical Imaging (NCT07474571) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Musculoskeletal Aging and Related Disorders Via Advanced Clinical Imaging
China2,000 participantsStarted 2005-11-01
Plain-language summary
Study Overview This clinical research focuses on the development and validation of a multimodal artificial intelligence (AI) platform designed for the automated diagnosis and precise staging of two major musculoskeletal conditions: Osteoporosis (OP) and Osteoarthritis (OA). By integrating diverse clinical imaging data, the study aims to provide a more objective and standardized approach to assessing bone and joint degeneration.
Technological Core: Intelligent Staging
Traditional diagnosis often relies on manual interpretation, which can lead to inter-observer variability. This study employs deep learning and multimodal imaging to:
For Osteoporosis: Automatically quantify bone mineral density and micro-architectural changes to determine the stage of bone loss and evaluate fracture risk.
For Osteoarthritis: Identify subtle radiological markers such as joint space narrowing and osteophyte formation to categorize the severity of joint degeneration according to international staging standards (e.g., Kellgren-Lawrence scale).
Why This Matters Early Intervention: By identifying early-stage changes in bone density and joint integrity, clinicians can implement preventive treatments before significant disability occurs.
Standardized Care: The intelligent diagnostic model provides a "digital second opinion," ensuring consistent staging across different healthcare settings.
Efficiency: The automated workflow reduces the workload of radiologists while maintaining high diagnostic accuracy.
Ethical Compliance The study is conducted at Peking University People's Hospital under the supervision of the Institutional Review Board (Approval No. 2026PHB097-001). It strictly adheres to international ethical standards, including the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines, to ensure patient data privacy and safety.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: Adults aged at least 18 years.
* Gender: No gender restrictions; both male and female participants are eligible.
* Imaging Data: Participants must have completed relevant clinical imaging scans of skeletal sites, including but not limited to X-ray, CT (plain scan), or MRI (plain scan).
* Anatomical Integrity: The skeletal structure of the target area must be free from congenital or acquired deformities.
* Absence of Implants: No internal fixation materials or orthopedic implants in the skeletal areas being assessed.
Exclusion Criteria:
* Pathological History: Patients with a history of prior pathological fractures.
* Malignancy: Patients seeking treatment or diagnosed with bone tumors or other systemic malignancies.
* Medication History: Patients with a history of long-term steroid use, which may significantly affect bone density and joint structure.
* Recent Treatment: Patients who have undergone radiotherapy or chemotherapy within the past six months.
* Data Quality: Patients whose imaging data is of insufficient quality for AI analysis or lacks clear clinical diagnostic "gold standard" references (e.g., missing DXA results for osteoporosis staging).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone age status
Timeframe: From enrollment to the initial treatment at 2 years