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Establishment and application of diagnosis and treatment norms and key techniques for prevention and treatment of common bone metabolic diseasesEstablishment and application of diagnosis and treatment norms and key techniques for prevention and treatment of common bone metabolic diseases
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注册号:

Registration number:

ChiCTR1900028681 

最近更新日期:

Date of Last Refreshed on:

2019-12-31 

注册时间:

Date of Registration:

2019-12-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

常见骨代谢疾病诊疗规范与防治关键技术的建立及应用 

Public title:

Establishment and application of diagnosis and treatment norms and key techniques for prevention and treatment of common bone metabolic diseasesEstablishment and application of diagnosis and treatment norms and key techniques for prevention and treatment of common bone metabolic diseases 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

常见骨代谢疾病诊疗规范与防治关键技术的建立与应用 

Scientific title:

Establishment and application of diagnosis and treatment norms and key techniques for prevention and treatment of common bone metabolic diseasesEstablishment and application of diagnosis and treatment norms and key techniques for prevention and treatment of common bone metabolic diseases 

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:

鲁琼 

研究负责人:

鲁琼 

Applicant:

Qiong Lu 

Study leader:

Qiong Lu 

申请注册联系人电话:

Applicant telephone:

+86 13319510566 

研究负责人电话:

Study leader's telephone:

+86 13319510566 

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:

christy_luq@csu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

christy_luq@csu.edu.cn 

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:

湖南省长沙市人民中路139号 

研究负责人通讯地址:

湖南省长沙市人民中路139号 

Applicant address:

139 Renmin Middle Road, Furong District, Changsha, Hu'nan, China 

Study leader's address:

139 Renmin Middle Road, Furong District, Changsha, Hu'nan, 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:

湖南省长沙市中南大学湘雅二医院药学部 

Applicant's institution:

The department of pharmacy of Second Xiangya Hospital, The department of pharmacy of Second Xiangya Hospital of Central South 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:

2015SQ00072 

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:

中南大学湘雅二医院伦理委员会 

Name of the ethic committee:

The Ethics Committee of The Second Xiang Ya Hospital of Central South University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

鲁琼 

Contact Name of the ethic committee:

Qiong Lu 

伦理委员会联系地址:

湖南省长沙市人民中路139号中南大学湘雅二医院 

Contact Address of the ethic committee:

The Second Xiangya Hospital of Central South University, 139 Renmin Middle Road, Furong District, Changsha, Hu'nan, China 

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:

中南大学湘雅二医院药学部 

Primary sponsor:

Department of pharmacy of Second Xiangya Hospital of Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市人民中路139号 

Primary sponsor's address:

139 Renmin Middle Road, Furong District, Changsha, Hu'nan, 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):

湖南

市(区县):

Country:

China

Province:

Hu'nan

City:

单位(医院):

中南大学湘雅二医院

具体地址:

湖南省长沙市人民中路139号

Institution
hospital:

The Second Xiangya Hospital of Central South University

Address:

139 Renmin Middle Road, Changsha

经费或物资来源:

中南大学湘雅二医院 

Source(s) of funding:

The Second Xiang Ya Hospital of Central South University 

研究疾病:

骨代谢疾病 

Target disease:

bone metabolism 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

建立OP的诊疗规范,突破防治关键技术并推广应用:研究建立中国人骨密度参考数据库和骨生化转换指标参考值,建立OP性骨折早期预警体系,在此基础上深化指南并实施应用,提高OP诊断准确率、疗效和预后判断。 

Objectives of Study:

Establish the diagnosis and treatment standards of OP, break through the key technologies of prevention and treatment, and promote their application: study and establish the reference database of Chinese bone mineral density and reference value of bone biochemical conversion index, establish the early warning system of OP fractures, deepen the guidelines and implement the application on this basis, and improve the accuracy of OP diagnosis, curative effect and prognosis judgment.Establish the diagnosis and treatment standards of OP, break through the key technologies of prevention and treatment, and promote their application: study and establish the reference database of Chinese bone mineral density and reference value of bone biochemical conversion index, establish the early warning system of OP fractures, deepen the guidelines and implement the application on this basis, and improve the accuracy of OP diagnosis, curative effect and prognosis judgment. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例研究 

Study design:

Case study 

纳入标准:

随机选择基础参考人群,年龄范围10-85岁 

Inclusion criteria

Randomly select the basic reference population aged from 10 to 95 years. 

排除标准:

排除疾病因素和药物因素影响骨代谢者 

Exclusion criteria:

Exclude the factor of the disease and medicine which can influence the bone metabolism. 

研究实施时间:

Study execute time:

From2020-01-02To 2030-06-30 

干预措施:

Interventions:

组别:

Case series

样本量:

4000

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

中南大学湘雅二医院 

单位级别:

三甲医院 

Institution
hospital:

The second Xiangya Hospital of Central South University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

骨碱性磷酸酶

指标类型:

主要指标 

Outcome:

NBAP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

25-羟维生素D

指标类型:

主要指标 

Outcome:

25-OHVitB

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甲状旁腺激素

指标类型:

主要指标 

Outcome:

PTH

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Ⅰ型胶原羧基端肽β特殊序列

指标类型:

主要指标 

Outcome:

beta-CTX

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Ⅰ型前胶原N-端前肽

指标类型:

主要指标 

Outcome:

P1NP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨钙素

指标类型:

主要指标 

Outcome:

BGP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨密度

指标类型:

主要指标 

Outcome:

BMD

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

T值

指标类型:

主要指标 

Outcome:

T-score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

碱性磷酸酶

指标类型:

主要指标 

Outcome:

ALP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白蛋白

指标类型:

主要指标 

Outcome:

ALB

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清总胆固醇

指标类型:

主要指标 

Outcome:

TC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低密度脂蛋白胆固醇

指标类型:

主要指标 

Outcome:

LDL-C

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高密度脂蛋白胆固醇

指标类型:

主要指标 

Outcome:

HDL-C

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖化血红蛋白

指标类型:

主要指标 

Outcome:

HbA1c

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

主要指标 

Outcome:

FPG\FBG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖基化终末产物

指标类型:

主要指标 

Outcome:

AGEs

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C肽释放试验

指标类型:

主要指标 

Outcome:

CP

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:

标本中文名:

血液

组织:

Sample Name:

Blood

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

No

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

No

盲法:

No

Blinding:

No

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

pubmed

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

pubmed

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:

病历记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-30
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