About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Study Population DescriptionThe study population consists of adult patients seeking medical consultation or treatment at the Department of Orthopaedic Trauma, Peking University People's Hospital. This population represents a diverse clinical spectrum of musculoskeletal aging, ranging from healthy skeletal status to various stages of Osteoporosis (OP) and Osteoarthritis (OA).The research employs a bidirectional cohort structure:Retrospective Cohort: Includes approximately 1,500 patients treated between November 2005 and November 2025, primarily used for model training and internal algorithm validation.Prospective Cohort: Includes at least 500 patients recruited starting from December 2025, used for independent external validation of the model's diagnostic accuracy and staging robustness in a real-world clinical setting.Participants are characterized by their availability of multimodal data, including radiological images (X-ray, CT, MRI) and clinical laboratory indicators (e.g., bone tur
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
No Interventions
Other interventionNo Interventions
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Bone age status
Bone mineral density and osteoarthitis
Sponsors and contacts
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