UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031894
Receipt number R000036404
Scientific Title Cumulative network-meta-analyses, practice guidelines and real-world prescriptions of drug treatments for post-menopausal osteoporosis
Date of disclosure of the study information 2018/04/01
Last modified on 2018/12/07 06:44:23

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Basic information

Public title

Cumulative network-meta-analyses, practice guidelines and real-world prescriptions of drug treatments for post-menopausal osteoporosis

Acronym

Cumulative network-meta-analyses, practice guidelines and real-world prescription

Scientific Title

Cumulative network-meta-analyses, practice guidelines and real-world prescriptions of drug treatments for post-menopausal osteoporosis

Scientific Title:Acronym

Cumulative network-meta-analyses, practice guidelines and real-world prescription

Region

Japan North America Europe


Condition

Condition

post-menopausal osteoporosis

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to compare the results of cumulative NMAs with the recommendations in post-menopausal osteoporosis practice guidelines, and with the actual prescription practices.

Basic objectives2

Others

Basic objectives -Others

not applicable

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Ranking of drugs to treat post-menopausal osteoporosis by means of cumulative network meta-analysis. Ranking of recommended post-menopausal osteoporosis in clinical practice guidelines in America. Ranking of actual prescriptions based on MEPS.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

50 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

post-menopausal osteoporois

Key exclusion criteria

Rheumatoid arthritis and related disease
Chronic renal failure
Cancer

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshi A Furukawa

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Health Promotion and Human Behavior, School of Public Health

Zip code


Address

Floor 2, G Buiding, Kyoto University Graduate School of Medicine, Yoshida Konoe-cho, Sakyo-ku, Kyoto, JAPAN

TEL

+81-75-753-9491

Email

furukawa@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuki Kataoka

Organization

Hyogo Prefectural Amagasaki General Medical Center

Division name

Hospital Care Research Unit

Zip code


Address

2-17-77 Higashi-Naniwa-Cho, Amagasaki, Hyogo 660-8550, Japan

TEL

+81664807000

Homepage URL


Email

youkiti@gmail.com


Sponsor or person

Institute

Department of Health Promotion and Human Behavior, School of Public Health, Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

JSPS Grant-in-Aid for Scientific Research (Grant Number17k19808)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 01 Day


Related information

URL releasing protocol

https://bmjopen.bmj.com/content/8/12/e023218

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2018 Year 12 Month 03 Day

Date of IRB


Anticipated trial start date

2018 Year 12 Month 03 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information

It is an epi-epidemiologic research based on cumulative network meta-analysis and open data.


Management information

Registered date

2018 Year 03 Month 26 Day

Last modified on

2018 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036404


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name