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Establishment of a systematic intervention system for fragile fracture of osteoporosis in the elderly
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注册号:

Registration number:

ChiCTR2000030927 

最近更新日期:

Date of Last Refreshed on:

2020-03-17 

注册时间:

Date of Registration:

2020-03-17 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

建立老年骨质疏松脆性骨折系统性干预体系研究 

Public title:

Establishment of a systematic intervention system for fragile fracture of osteoporosis in the elderly 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

建立老年骨质疏松脆性骨折系统性干预体系研究 

Scientific title:

Establishment of a systematic intervention system for fragile fracture of osteoporosis in the elderly 

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:

李晓 

研究负责人:

方欣硕 

Applicant:

Li Xiao 

Study leader:

Chiristian Fang 

申请注册联系人电话:

Applicant telephone:

+86 13538164383 

研究负责人电话:

Study leader's telephone:

+86 15602468311 

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:

lixiao6167@126.com 

研究负责人电子邮件:

Study leader's E-mail:

fangcx@gmail.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:

深圳福田区海园一路1号,香港大学深圳医院,住院部B栋负一层骨科实验室 

研究负责人通讯地址:

香港玛丽医院5楼 

Applicant address:

Orthopaedic Lab, -1F,B Block, HKU-SZH, 1Road Haiyuan, Shenzhen, Guangdong, China 

Study leader's address:

5F, Queen Mary Hospital, Hong Kong SAR, China 

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:

香港大学深圳医院 

Applicant's institution:

Shenzhen Hospital, Hong Kong University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

伦[2017]61 

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:

香港大学深圳医院医学研究伦理委员会 

Name of the ethic committee:

Ethics Committee for medical research, Hong Kong University-Shenzhen Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-04-10 

伦理委员会联系人:

王静贤 

Contact Name of the ethic committee:

Jingxian Wang 

伦理委员会联系地址:

深圳香港大学深圳医院后勤楼616 

Contact Address of the ethic committee:

616 Logistic Building, HKU-SZH 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

香港大学深圳医院 

Primary sponsor:

Hong Kong University-Shenzhen Hospital 

研究实施负责(组长)单位地址:

深圳福田区海园一路1号香港大学深圳医院 

Primary sponsor's address:

HKU-SZH, 1 Road Haiyuan, Futian District, Shenzhen, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

中国科学院深圳先进技术研究院

具体地址:

深圳市南山区大学城学苑大道1068

Institution
hospital:

Shenzhen Institutes of Advanced Technology,Chinese Academy of Sciences

Address:

1068 Xueyuan Avenue, Shenzhen University Town

经费或物资来源:

深圳市科技创新委员会 

Source(s) of funding:

Shenzhen Science and Technology Innovation Committee 

研究疾病:

骨质疏松 

Target disease:

Osteoporosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

建立骨质疏松初次骨折风险评估表 

Objectives of Study:

Establishment of risk assessment table for primary fracture of osteoporosis  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1.初次发生骨折; 2.发生骨折时间为一个月内; 3.临床诊断为骨质疏松患者; 4.年龄50至85岁; 

Inclusion criteria

1. First fracture; 2. The time of fracture is within one month; 3. The patients were diagnosed as osteoporosis; 4. Aged 50-85 years. 

排除标准:

1. 病理性骨折; 2. 高能量创伤性骨折; 3. 继发性骨质疏松性骨折,例如,因内分泌代谢疾病、结缔组织疾病、肾脏疾病、消化道疾病、神经肌肉系统疾病、血液系统疾病、器官移植术后和药物所致的继发性骨质疏松性骨折; 4. 囚犯; 5. 精神障碍; 6. 理解力有限 

Exclusion criteria:

1. Pathological fracture; 2. High energy traumatic fracture; 3. Secondary osteoporotic fractures, such as those caused by endocrine and metabolic diseases, connective tissue diseases, kidney diseases, digestive tract diseases, neuromuscular system diseases, blood system diseases, organ transplantation and drugs; 4. prisoners; 5. Mental disorders; 6. Limited understanding. 

研究实施时间:

Study execute time:

From2017-06-30To 2020-06-29 

征募观察对象时间:

Recruiting time:

From2018-01-24To 2021-03-27 

干预措施:

Interventions:

组别:

骨折风险因子组

样本量:

44

Group:

Fracture risk factor group

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

组别:

对照组

样本量:

43

Group:

Control Group

Sample size:

干预措施:

NA

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):

广州 

市(区县):

深圳 

Country:

China 

Province:

Guangzhou 

City:

Shenzhen 

单位(医院):

香港大学深圳医院 

单位级别:

三甲医院 

Institution
hospital:

Hong Kong University-Shenzhen Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

骨密度

指标类型:

主要指标 

Outcome:

DEXA

Type:

Primary indicator 

测量时间点:

香港大学深圳医院

测量方法:

DEXA

Measure time point of outcome:

Hong Kong University-Shenzhen Hospital

Measure method:

DEXA

指标中文名:

基本信息

指标类型:

主要指标 

Outcome:

Basic Information

Type:

Primary indicator 

测量时间点:

香港大学深圳医院

测量方法:

Measure time point of outcome:

Hong Kong University-Shenzhen Hospita

Measure method:

指标中文名:

药物史

指标类型:

主要指标 

Outcome:

History of medicine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

慢性病史

指标类型:

主要指标 

Outcome:

Chronic illness history

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

跌到风险

指标类型:

主要指标 

Outcome:

Fall risk

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

STRATIFY跌倒风险评估

指标类型:

主要指标 

Outcome:

STRATIFY Fall risk assessment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Charlson Index

指标类型:

主要指标 

Outcome:

Charlson Index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

改良版MBI

指标类型:

主要指标 

Outcome:

Modify MBI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

EQ-5D

指标类型:

主要指标 

Outcome:

EQ-5D

Type:

Primary 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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 50 years
最大 Max age 85 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):

队列入组研究,没有随机方法

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

There is no random method for cohort study.

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

2021年5月通过网络平台公开,https://rc.ortho.hku.hk/redcap/

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

Share IPD by wed around May 2021. https://rc.ortho.hku.hk/redcap/

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:

病例记录表采集

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-03-17
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