ChiCTR2600116921 版本V1.0 版本创建时间2026/01/16 15:05:56 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600116921 

最近更新日期：

Date of Last Refreshed on：

2026-01-16 15:05:29 

注册时间：

Date of Registration：

2026-01-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于多模态的骨质疏松症全流程智能管理真实世界单中心回顾性观察性研究

Public title：

Multimodal-based Real-world Single-center Retrospective Observational Study on Full-process Intelligent Management of Osteoporosis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于多模态的骨质疏松症全流程智能管理真实世界单中心回顾性观察性研究

Scientific title：

Multimodal-based Real-world Single-center Retrospective Observational Study on Full-process Intelligent Management of Osteoporosis

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

祖海越 

研究负责人：

杨惠林 

Applicant：

Haiyue Zu 

Study leader：

Huilin Yang 

申请注册联系人电话：

Applicant telephone：

+86 166 0512 8900

研究负责人电话：

Study leader's telephone：

+86 166 0512 8900

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

635982934@qq.com

研究负责人电子邮件：

Study leader's E-mail：

154141733@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

江苏省苏州市姑苏区平海路899号

研究负责人通讯地址：

江苏省苏州市姑苏区平海路899号

Applicant address：

No. 899, Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

Study leader's address：

No. 899, Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

苏州大学附属第一医院

Applicant's institution：

The First Affiliated Hospital of Soochow University

研究负责人所在单位：

苏州大学附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital of Soochow University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2025)伦理批第1145号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

苏州大学附属第一医院伦理委员会

Name of the ethic committee：

The Ethics Committee of the First Affiliated Hospital of Soochow University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-28 00:00:00

伦理委员会联系人：

陈罡

Contact Name of the ethic committee：

Gang Chen

伦理委员会联系地址：

江苏省苏州市姑苏区平海路899号苏大附一院综合楼1312办公室

Contact Address of the ethic committee：

Room 1312, Comprehensive Building, First Affiliated Hospital of Soochow University, No. 899, Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 512 6797 2861

伦理委员会联系人邮箱：

Contact email of the ethic committee：

sdfyec@163.com

研究实施负责（组长）单位：

苏州大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Soochow University

研究实施负责（组长）单位地址：

江苏省苏州市姑苏区平海路899号

Primary sponsor's address：

No. 899, Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏

市(区县)：

苏州

Country：

China

Province：

Jiangsu

City：

Suzhou

单位(医院)：

苏州大学附属第一医院

具体地址：

江苏省苏州市姑苏区平海路899号

Institution
hospital：

The First Affiliated Hospital of Soochow University

Address：

No. 899, Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

经费或物资来源：

国家科研经费

Source(s) of funding：

National research funds

Target disease：

Osteoporosis

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

核心目的：揭示患者骨密度提升的关键影响因素，回顾性观察性研究 本研究的核心目的是通过回顾性观察性研究方法，系统分析影响骨密度指标变化的多维度因素，包括但不限于饮食结构、运动习惯、生活习惯、遗传因素以及环境因素。通过HIS、LIS、PACS、EMR数据，使用AI多模态分析，并标示患者骨质疏松风险，结合患者随访，数据收集与统计分析，揭示不同因素对骨密度提升的单独作用和交互效应，为骨质疏松诊疗方案、健康干预方案提供理论基础。通过观察性研究，设置对照组，为历史患者患者构建骨质疏松风险模型。  

Objectives of Study：

Core objective: To identify the key influencing factors for the increase in patient bone density, a retrospective observational study The core objective of this study is to systematically analyze multiple dimensions of factors that affect changes in bone density indicators through a retrospective observational research method. These factors include, but are not limited to, dietary structure, exercise habits, lifestyle, genetic factors, and environmental factors. Using HIS, LIS, PACS, and EMR data, AI multimodal analysis is employed, and the risk of osteoporosis in patients is marked. Combined with patient follow-up, data collection and statistical analysis are conducted to reveal the individual effects and interaction effects of different factors on the increase in bone density, providing a theoretical basis for osteoporosis diagnosis and treatment plans, as well as health intervention plans. Through an observational study, a control group is set up to construct an osteoporosis risk model for historical patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.通过计算机多模态融合，判定为骨质疏松的患者； 2.年龄≥40岁； 3.2020年11月起至2025年11月的数据。

Inclusion criteria

1. Patients diagnosed with osteoporosis through computerized multimodal fusion; 2. Age >= 40 years; 3. Data from November 2020 to November 2025.

排除标准：

1.存在严重认知障碍（如阿尔茨海默病晚期）、精神疾病（如精神分裂症急性期），无法配合完成骨密度检测、问卷调查及随访的患者； 2.处于恶性肿瘤晚期（如Ⅳ期癌症伴广泛转移）或严重肝肾功能衰竭（如肝硬化失代偿期、尿毒症透析依赖），预期生存期不足6个月，无法完成至少1次随访的患者； 3.近期（3个月内）发生严重骨折（如股骨颈骨折、椎体压缩性骨折）且处于卧床制动状态，暂时无法进行骨密度检测或康复评估的患者； 4.对骨密度检测造影剂过敏，或因身体畸形（如严重脊柱侧弯）无法配合完成DXA检测的患者； 5.无法配合机器人手术或康复机器人训练的患者（如严重关节畸形、神经功能障碍等）。

Exclusion criteria：

1. Patients with severe cognitive impairments (such as advanced Alzheimer's disease), mental disorders (such as acute schizophrenia), who cannot cooperate to complete bone density tests, questionnaires, and follow-ups. 2. Patients with advanced malignant tumors (such as stage IV cancer with extensive metastasis) or severe liver and kidney failure (such as decompensated liver cirrhosis, uremia dialysis dependence), with an expected survival period of less than 6 months, and unable to complete at least one follow-up. 3. Patients who have recently suffered a severe fracture (such as femoral neck fracture, vertebral compression fracture) and are in a bedridden and immobilized state, and are temporarily unable to undergo bone density tests or rehabilitation assessment. 4. Patients who are allergic to the contrast agent used in bone density tests, or who cannot cooperate to complete DXA tests due to physical deformities (such as severe scoliosis). 5. Patients who cannot cooperate with robotic surgery or rehabilitation robot training (such as severe joint deformities, neurological dysfunction, etc.).

研究实施时间：

Study execute time：

从 From 2025-11-30 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-29 00:00:00 至 To 2028-12-31 00:00:00  

干预措施：

Interventions：

组别：

智能干预组

样本量：

15000

Group：

Intelligent Intervention Group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

组别：

常规管理组

样本量：

15000

Group：

Regular Management Team

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 苏州 

Country：

China 

Province：

Jiangsu 

City：

Suzhou 

单位(医院)：

苏州大学附属第一医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Soochow University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

准确率（ACC）

指标类型：

主要指标

Outcome：

Accuracy Rate (ACC)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

灵敏度（SEN / 召回率）

指标类型：

主要指标

Outcome：

Sensitivity (SEN / Recall Rate)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

特异度（SPE）

指标类型：

主要指标

Outcome：

Specificity (SPE)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

决策曲线分析（DCA）

指标类型：

次要指标

Outcome：

Decision Curve Analysis (DCA)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 40 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

None

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

医院内网数据

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Intranet data of the hospital

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

尽管本研究为观察性研究，不主动施加干预措施，但仍需高度重视研究过程中可能出现的与研究程序相关或患者自身疾病进展导致的各类风险。为此我们建立了一个系统的、严格的、安全监测及不良事件处理制度，最大程度地保护受试者权益与安全。 1.明确不良事件的定义、分类与记录标准 不良事件是指受试者在参加研究过程中发生的任何不良医学事件，无论是否与研究程序有关。本研究主要关注两类事件，一是与研究操作直接相关的不良事件，如血液样本采集时局部血肿、感染、晕针，对造影剂过敏者错误实施增强CT扫描引起的过敏反应等；二是与骨质疏松症自然病程有关的疾病进展事件，尤其是新发的脆性骨折，以及因骨痛、行动不便引发的跌倒等。所有的不良事件不论轻重都必须由研究人员在原始病历和专用《病例报告表》中详细、准确地记录，包括事件名称、发生时间、严重程度、持续时间、所采取的措施和结局。 2.建立分级报告与应急处理流程 对于轻微的、常见的不良事件，研究人员会在现场进行标准处理并告知受试者注意事项，然后按常规记录，不需要特别上报。一旦出现严重不良事件即死亡、危及生命、需要住院或延长住院时间、导致持续或者显著残疾或者失能，或者其他重大医学事件，应当启动应急预案。现场研究人员应当立即对受试者实施必要的医疗救治，保证受试者的生命安全，并在事件发生后的24小时内向主要研究者及本单位伦理委员会书面报告。报告要详尽叙述事件经过、受试者状况及初步原因剖析。 3.成立独立的安全性监测委员会 本研究设立一个由未参与研究的骨科、内分泌科、老年科和统计学专家组成的独立的数据与安全性监测委员会。该委员会会定时查看研究过程中不良事件的累计数据，尤其会对严重不良事件和研究程序的因果联系展开独立评判，判定事件属于“无关”“可能有关”还是“很可能有关”。根据评价结果，委员会可以对主要研究者提出建议，包括修改研究方案、新增知情同意书以增加新的风险信息、必要时停止或者终止研究的某一部分。所有的不良事件记录、报告、处理决定均接受伦理委员会的监督和审查，保证整个过程的透明、合规，从而给研究的科学性、受试者的安全提供双重保障。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Although this study is an observational one and no active intervention measures are taken, it is still necessary to attach great importance to various risks that may occur during the research process, such as those related to the research procedures or the progression of the patients' own diseases. Therefore, we have established a systematic, strict, safety monitoring and adverse event handling system to protect the rights and safety of the subjects to the greatest extent. 1. Define the definition, classification and recording standards of adverse events Adverse events refer to any adverse medical events that occur during the participation of the subjects in the study, regardless of whether they are related to the research procedures. This study mainly focuses on two types of events: one is adverse events directly related to the research procedures, such as local hematoma, infection, syncope during blood sample collection, allergic reactions caused by incorrect implementation of enhanced CT scans for those allergic to contrast agents, etc.; the other is disease progression events related to the natural course of osteoporosis, especially new fractures, falls caused by bone pain and mobility impairment, etc. All adverse events, regardless of their severity, must be recorded in detail and accurately by the researchers in the original medical records and the dedicated "Case Report Form", including the event name, time of occurrence, severity, duration, measures taken and outcome. 2. Establish a graded reporting and emergency handling process For minor and common adverse events, researchers will conduct standard handling on the spot and inform the subjects of precautions, and then record them according to the routine. No special reporting is required if it is a minor adverse event. If a serious adverse event occurs, such as death, life-threatening condition, need for hospitalization or prolonged hospitalization, causing persistent or significant disability or incapacity, or other major medical events, an emergency response plan should be initiated. On-site researchers should immediately provide necessary medical treatment to the subjects to ensure their life safety and report in writing to the principal investigator and the ethics committee of the unit within 24 hours after the event occurs. The report should comprehensively describe the event process, the subject's condition and the preliminary cause analysis. 3. Establish an independent safety monitoring committee This study sets up an independent data and safety monitoring committee composed of experts from orthopedics, endocrinology, geriatrics and statistics who have not participated in the research. The committee will regularly review the cumulative data of adverse events during the research process, especially independently evaluate the causal relationship between serious adverse events and the research procedures, and determine whether the event is "unrelated", "possibly related" or "likely related". Based on the evaluation results, the committee can make recommendations to the principal investigator, including modifying the research protocol, adding new risk information to the informed consent form, and, if necessary, stopping or terminating certain parts of the research. All adverse event records, reports, and handling decisions are subject to the supervision and review of the ethics committee to ensure transparency and compliance, thereby providing dual guarantees for the scientific nature of the research and the safety of the subjects.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-01-16 15:05:29