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仙灵骨葆治疗绝经后骨质疏松症疗效和剂量相关性观察
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注册号:

Registration number:

ChiCTR-TRC-05000347 

最近更新日期:

Date of Last Refreshed on:

2015-05-14 

注册时间:

Date of Registration:

2005-10-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

仙灵骨葆治疗绝经后骨质疏松症疗效和剂量相关性观察 

Public title:

XLGB Efficacy and Dose Response of Postmenopausal Osteoporosis Treatment 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

仙灵骨葆治疗绝经后骨质疏松症疗效和剂量相关性观察 

Scientific title:

XEDPOP 

研究课题代号(代码):

Study subject ID:

XLGB-1001 

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:

秦岭 

研究负责人:

秦岭,朱汉民 

Applicant:

Qin Ling 

Study leader:

Qin Ling, Zhu Hanmin 

申请注册联系人电话:

Applicant telephone:

+852 98412759 

研究负责人电话:

Study leader's telephone:

+852 98412759 

申请注册联系人传真 :

Applicant Fax:

+852 26324618 

研究负责人传真:

Study leader's fax:

+852 26324618 

申请注册联系人电子邮件:

Applicant E-mail:

lingqin@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

lingqin@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

www.ort.cuhk.edu.hk 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

www.ort.cuhk.edu.hk 

申请注册联系人通讯地址:

香港威尔斯亲王医院临床医学大楼5楼矫形外科及创伤学系 

研究负责人通讯地址:

香港威尔斯亲王医院临床医学大楼5楼矫形外科及创伤学系 

Applicant address:

5F, Clinical Science Building, Prince of Wales Hospital 

Study leader's address:

5F, Clinical Science Building, Prince of Wales Hospital 

申请注册联系人邮政编码:

Applicant postcode:

Shatin 

研究负责人邮政编码:

Study leader's postcode:

Shatin 

申请人所在单位:

香港中文大学医学院矫形外科及创伤学系 

Applicant's institution:

Department of Orthopedics & Traumatology, the Chinese University of Hong KongV 

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:

2006伦审(1)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

上海华东医院药物临床试验伦理委员会 

Name of the ethic committee:

Clinical Trial Ethic Committee of Shanghai Hua Dong Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2005-10-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

香港中文大学医学院矫形外科及创伤学系 

Primary sponsor:

Department of Orthopedics & Traumatology, the Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

香港威尔斯亲王医院临床医学大楼5楼矫形外科及创伤学系 

Primary sponsor's address:

5F, Clinical Science Building, Prince of Wales Hospital 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

NA

市(区县):

Country:

China

Province:

NA

City:

单位(医院):

美国信纳克临床医学研究中心

具体地址:

香港皇后大道中18号新世界大厦2栋6层 香港健康与医学研究中心

Institution
hospital:

SYNARC

Address:

Center for Health and Medical Research, Hong Kong,6th Floor,Tower II, New World Tower,No.18, Queen's Road Central, Hong Kong

经费或物资来源:

中国科学技术发展基金会 

Source(s) of funding:

Chinese Development Foundation for Science and Technology 

研究疾病:

骨质疏松 

Target disease:

Osteoporosis 

研究疾病代码:

ICD: N95.8. 

Target disease code:

ICD: N95.8. 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

评价仙灵骨葆治疗绝经后骨质疏松症的量效关系以及不同剂量的安全性与耐受性 

Objectives of Study:

To evaluate the efficacy and dose response of XLGB in percentage change in bone mineral density, as well as safety and tolerability in two different dose levels 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

健康绝经后女性、腰椎骨密度值或股骨颈骨密度值的T分数低于正常青年人均值2个标准差 

Inclusion criteria

T score of bone mineral density at either lumbar spine or femoral neck in healthy postmenopausal women should be lower than -2.0SD 

排除标准:

试验前服用过雌激素受体选择性调节剂;3个月内曾经接受雌激素替代疗法、降钙素、氟化物;长期口服糖皮质激素、抗凝血剂;24个月内服用磷酸盐药物;6个月内服用甲状旁腺激素、放射学骨折椎体超过3个、代谢性骨病史、腰椎或股骨颈骨密度低于正常青年人均值4个标准差;5年年内有恶性疾病;临床意义的血液病、内分泌疾病、心血管、肾脏、肝脏、胃肠疾病、精神疾病、神经系统疾病;实验室指标筛查异常;腰椎骨折史、脊柱侧突等严重畸形。 

Exclusion criteria:

(1) previous exposure to selective estrogen receptor modulators; (2) use of hormone replacement therapy, calcitonin, sodium fluoride, anabolic steroids, chronic oral glucocorticoid, anticoagulant within the past 3 months; (3) use of bisphosphonates during the past 24 months; (4) use of parathyroid hormone during the past 6 months; (5) use of any other investigational drugs during the past month; (6) radiographic evidence of more than 3 vertebral fractures; (7) current medical disease associated with the development of metabolic bone disease; (8) T-scores of the femoral neck or lumbar spine (L1-L4) BMD more than 4.0 SD; (9) current or past history of clinically significant hematological, endocrinological, cardiovascular, renal, hepatic, gastrointestinal, psychiatric, or neurological diseases or drug allergies to estrogen-like hormonal drugs; (10) history of fracture of the lumbar spine (L1-L4), scoliosis, osteoarthritis, or other clinical spinal deformity which would interfere with BMD measurement. 

研究实施时间:

Study execute time:

From2005-10-25To 2008-04-20 

干预措施:

Interventions:

组别:

安慰剂组

样本量:

60

Group:

Placebo

Sample size:

干预措施:

每日口服12粒安慰剂胶囊、500mg元素钙、200IU维生素D

干预措施代码:

Intervention:

Daily administration with 12 placebo capsules, and 500 mg calcium and 200IU Vit D

Intervention code:

组别:

低剂量组

样本量:

60

Group:

Low-dose XLGB

Sample size:

干预措施:

每日口服6粒仙灵骨葆胶囊、6粒安慰剂胶囊、500mg元素钙、200IU维生素D

干预措施代码:

Intervention:

Daily administration with 6 active capsules plus 6 placebo capsules, 500 mg calcium and 200IU Vit D

Intervention code:

组别:

高剂量组

样本量:

60

Group:

High-dose XLGB

Sample size:

干预措施:

每日口服12粒仙灵骨葆胶囊、500mg元素钙、200IU维生素D

干预措施代码:

Intervention:

Daily administration with 12 active capsules, and 500 mg calcium and 200IU Vit D

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海华东医院 

单位级别:

三甲医院 

Institution
hospital:

The Shanghai east China hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海第九人民医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai people's hospital of 9  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

 

Country:

China 

Province:

Jilin 

City:

 

单位(医院):

吉林大学第一医院 

单位级别:

三甲医院 

Institution
hospital:

The first hospital of jilin university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中日友好医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing the sino-japanese friendship hospital  

Level of the institution:

Tertiary A hospital 

国家:

美国 

省(直辖市):

旧金山 

市(区县):

 

Country:

USA 

Province:

San Francisco 

City:

 

单位(医院):

美国加州大学旧金山分校放射医学系 

单位级别:

美国加州大学旧金山分校放射医学系 

Institution
hospital:

The university of California San Francisco, radiology  

Level of the institution:

The university of California San Francisco, radiology 

国家:

美国 

省(直辖市):

旧金山 

市(区县):

 

Country:

USA 

Province:

San Francisco 

City:

 

单位(医院):

美国信纳克临床医学研究中心波特兰实验室 

单位级别:

美国信纳克临床医学研究中心波特兰实验室 

Institution
hospital:

The United States, clinical medicine, letter Portland laboratory research center  

Level of the institution:

The United States, clinical medicine, letter Portland laboratory research center 

国家:

美国 

省(直辖市):

波特兰 

市(区县):

 

Country:

USA 

Province:

Portland 

City:

 

单位(医院):

美国信纳克临床医学研究中心波特兰实验室 

单位级别:

美国信纳克临床医学研究中心波特兰实验室 

Institution
hospital:

The United States, clinical medicine, letter Portland laboratory research center  

Level of the institution:

The United States, clinical medicine, letter Portland laboratory research center 

国家:

法国 

省(直辖市):

里昂 

市(区县):

 

Country:

France 

Province:

Lyons 

City:

 

单位(医院):

美国信纳克临床医学研究中心里昂实验室 

单位级别:

美国信纳克临床医学研究中心波特兰实验室 

Institution
hospital:

The United States, clinical medicine, letter Lyon laboratory research center  

Level of the institution:

The United States, clinical medicine, letter Lyon laboratory research center 

测量指标:

Outcomes:

指标中文名:

不良事件

指标类型:

主要指标 

Outcome:

Side events

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰椎(第二至第四腰椎)骨密度

指标类型:

主要指标 

Outcome:

Lumbar spine 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:

血清骨钙素

指标类型:

次要指标 

Outcome:

Serum osteocalcine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌肉功能

指标类型:

次要指标 

Outcome:

Muscle function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量表评分

指标类型:

次要指标 

Outcome:

Quality of Life score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清雌二醇

指标类型:

次要指标 

Outcome:

Serum E2

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人体平衡力

指标类型:

次要指标 

Outcome:

Balance

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清I型胶原羧基端末端肽

指标类型:

次要指标 

Outcome:

Serum CTX-I

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

股骨颈骨密度

指标类型:

次要指标 

Outcome:

Femoral Neck BMD

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 58 years
最大 Max age 75 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):

计算机软件

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

Computer Software

盲法:

入选对象、药品分发人员、骨密度检查人员、骨代谢检查人员、生活质量表评分人员、人体平衡力与肌肉功能检查人员、统计学人员 盲法

Blinding:

Examiner for balance and muscle function: Blinding Patient, Drug Distributor, BMD Examiner: Blinding

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

百汇鹰阁公司、依格斯公司

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

GCRC, EXCEL

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:

美国加州大学旧金山分校放射医学统计学研究室、美国创新生物医学研究与咨询公司

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

IBRC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2005-10-26
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