UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevention of bone fracture by intervening in bone quality in type 2 diabetes
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Akifumi Kushiyama
Organization	The Institute for Adult Disease, Asahi Life Foundation
Division name	div. of mebolic diseases
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	Kushiyama Akifumi
Organization	The Institute for Adult Disease, Asahi Life Foundation
Division name	div. of mebolic diseases
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2009 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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