UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of pioglitazone on bone formation and resorption markers in type 2 diabetes mellitus.
Title of the study (Brief title)	Effects of pioglitazone on bone
Region	Japan

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

Objectives
Narrative objectives1	we compared the effects of pioglitazone and metformin on bone metabolism in clinical practice using bone metabolic makers, homocystein and pentosidine in Japanese patients with type 2 diabetes mellitus.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint was changes in bone resorption markers after 3 months by pioglitazone.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	pioglitazone group(males 30 mg/day, females 15 mg/day) 3months
Interventions/Control_2	metformin group(750 mg/day) 3months
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	Not applicable
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	The subjects of this research were male and female type 2 diabetes patients, aged less than 80 years, who attended the First Department of Medicine at the University of Occupational and Environmental Health, Japan, and its associated centers between January 2010 and March 2012.
Key exclusion criteria	Patients treated with pioglitazone, metformin or insulin, with type 1 diabetes, history of secondary osteoporosis, heart failure, renal failure, liver failure, and patients receiving any drugs that affect bone metabolism (bisphosphonates, vitamin K, estrogen, calcium, anabolic steroids, or male and female hormones) were excluded from the research.
Target sample size	60

Research contact person
Name of lead principal investigator	Yosuke Okada
Organization	University of Occupational and Environmental Health, Japan
Division name	First Department of Internal Medicine, School of Medicine
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL	093-603-1611
Email	y-okada@med.uoeh-u.ac.jp

Public contact
Name of contact person	Hiroko Mori
Organization	University of Occupational and Environmental Health, Japan
Division name	First Department of Internal Medicine, School of Medicine
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL	093-603-1611
Homepage URL
Email	morihiro@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization	University of Occupational and Environmental Health, Japan
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 08 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 29 Day
Anticipated trial start date	2010 Year 01 Month 30 Day
Last follow-up date
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	2016 Year 08 Month 29 Day
Last modified on	2016 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027428