今天是:2019-03-27 星期三

中国原发性骨质疏松诊疗指南和NOGG指南在椎体骨折评估指征的应用比较
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注册号:

Registration number:

ChiCTR1900020651 

最近更新日期:

Date of Last Refreshed on:

2019-01-11 

注册时间:

Date of Registration:

2019-01-11 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

中国原发性骨质疏松诊疗指南和NOGG指南在椎体骨折评估指征的应用比较 

Public title:

Comparison for the utility of CSOBMR and NOGG guidelines on the indication of vertebral fracture assessment 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项研究中国社区居住绝经后女性椎体骨折患病率的观察性、横断面研究 

Scientific title:

An Observational, Cross-Sectional Study Investigating the Prevalence of Vertebral Fractures among Community-Dwelling Postmenopausal Women in China 

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:

陈蓉 

研究负责人:

盛志峰 

Applicant:

Chen Rong 

Study leader:

Sheng Zhifeng 

申请注册联系人电话:

Applicant telephone:

+86 18607412098 

研究负责人电话:

Study leader's telephone:

+86 13574806523 

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:

cr18313005011@163.com 

研究负责人电子邮件:

Study leader's E-mail:

shengzhifeng@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:

湖南省株洲市天元区人民南路116号 

研究负责人通讯地址:

湖南省长沙市人民路139号 

Applicant address:

116 Renmin Road South, Tianyuan District, Zhuzhou, Hu'nan, China 

Study leader's address:

139 Renmin Road, 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:

410011 

申请人所在单位:

中南大学湘雅医学院附属株洲医院 

Applicant's institution:

Zhuzhou Central Hospital, 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:

(2017)伦审〖科〗第(019)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:

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:

舒畅 

Contact Name of the ethic committee:

shuchang 

伦理委员会联系地址:

湖南省长沙市湘雅二医院 

Contact Address of the ethic committee:

The 2nd Xiangya Hospital, Central South University, 139 Renmin Road, Changsha, Hunan 

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:

湖南省长沙市湘雅二医院 

Primary sponsor:

The 2nd Xiangya Hospital, Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市芙蓉区人民路139号 

Primary sponsor's address:

139 Renmin Road, 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):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

杭州默沙东制药有限公司

具体地址:

浙江省杭州市文海北路199号

Institution
hospital:

Merck Sharp

Address:

199 Wenhai Road North, Hangzhou, Zhejiang

经费或物资来源:

杭州默沙东制药有限公司 

Source(s) of funding:

Merck Sharp 

研究疾病:

椎体骨折 

Target disease:

vertebral fractures 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

诊断试验新技术临床试验 

Study phase:

Diagnostic New Technique Clincal Study 

研究目的:

比较中国骨质疏松和骨矿物研究学会和英国国家骨质疏松指南组指南对中国绝经后妇女椎体骨折的诊断价值。 

Objectives of Study:

Compare the utility of the Chinese Society of Osteoporosis and Bone Mineral Research (CSOBMR) and the UK National Osteoporosis Guideline Group (NOGG) guidelines for the indications to detection of vertebral fractures in postmenopausal Chinese women. 

药物成份或治疗方案详述:

不涉及 

Description for medicine or protocol of treatment in detail:

Not involve 

研究设计:

诊断试验诊断准确性 

Study design:

Diagnostic test for accuracy 

纳入标准:

50岁以上绝经后妇女 

Inclusion criteria

Postmenopausal women aged ≥50 years 

排除标准:

形态学异常或骨骼变形 

Exclusion criteria:

Morphological abnormalities or skeletal distortions 

研究实施时间:

Study execute time:

From2017-09-01To 2017-10-01 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

英国国家骨质疏松指南组指南

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

UK National Osteoporosis Guideline Group (NOGG) guideline

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

中国骨质疏松和骨矿物研究学会

Index test:

Chinese Society of Osteoporosis and Bone Mineral Research (CSOBMR) guideline

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

50岁以上绝经后妇女

例数:

Sample size:

255

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Postmenopausal women aged ≥50 years

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南省 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

湘雅二医院 

单位级别:

三级甲等医院 

Institution
hospital:

The 2nd Xiangya Hospital, Central South University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

身高

指标类型:

主要指标 

Outcome:

height

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

次要指标 

Outcome:

weight

Type:

Secondary 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:

bone mineral density

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸腰椎侧位片

指标类型:

主要指标 

Outcome:

Lateral radiographs of thoracolumbar spine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

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:

组织:

Sample Name:

Nil

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 50 years
最大 Max age 85 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

N/A

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

N/A

盲法:

未说明

Blinding:

未说明

原始数据公开时间:

The time of sharing IPD:

即时公开/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):

网络(中国临床试验注册中心,http://www.chictr.org.cn/index.aspx)

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

Interner(Chinese clinical trial registry,http://www.chictr.org.cn/index.aspx)

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:

ResMan

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

ResMan

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-11
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