UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002561
Receipt No. R000003130
Scientific Title Prevention of bone fracture by intervening in bone quality in type 2 diabetes
Date of disclosure of the study information 2009/09/30
Last modified on 2016/07/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prevention of bone fracture by intervening in bone quality in type 2 diabetes
Acronym BBQ-T2DM
Scientific Title Prevention of bone fracture by intervening in bone quality in type 2 diabetes
Scientific Title:Acronym BBQ-T2DM
Region
Japan

Condition
Condition bone fracture
type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 cohort study concerning whether intervention in bone quality (by administeration of Vit.B12) improves risk against bone fracture in type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes risk reduction in intervention group in 5 years using cox proportional hazard regression model.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Vit.B12 1500ug daily p.o.
Interventions/Control_2 none
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria type 2 diabetes mellitus
agreed to examine bone density, bone X ray, blood and unine analyses every year
agreed to be randamized to administer Vit.B12
not use VitB.12 more than one month
Key exclusion criteria unable to perform examinations, nor administering vit.B12
unable to wash out Vit.B12
severe, life threatening complications
using medicines prohibited to use in combination
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akifumi Kushiyama
Organization The Institute for Adult Disease, Asahi Life Foundation
Division name div. of mebolic diseases
Zip code
Address 1-6-1, Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL 03-3639-5501
Email kusiyaa-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kushiyama Akifumi
Organization The Institute for Adult Disease, Asahi Life Foundation
Division name div. of mebolic diseases
Zip code
Address 2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo, Japan
TEL 03-3201-6781
Homepage URL http://www.asahi-life.or.jp
Email kusiyaa-tky@umin.ac.jp

Sponsor
Institute The Institute for Adult Disease, Asahi Life Foundation
Institute
Department

Funding Source
Organization The Institute for Adult Disease, Asahi Life Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 09 Month 30 Day

Related information
URL releasing protocol
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 No longer recruiting
Date of protocol fixation
2009 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 29 Day
Last modified on
2016 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003130

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.