UMIN-CTR Clinical Trial

Basic information
Public title	The effect of eldecalcitol on bone mineral density and bone markers for osteoporotic patients with type 2 diabetes.-Open label multicenter study-
Acronym	The effect of eldecalcitol on osteoporotic patients with type 2 diabetes.
Scientific Title	The effect of eldecalcitol on bone mineral density and bone markers for osteoporotic patients with type 2 diabetes.-Open label multicenter study-
Scientific Title:Acronym	The effect of eldecalcitol on osteoporotic patients with type 2 diabetes.
Region	Japan

Condition
Condition	osteoporosis
Classification by specialty	Medicine in general Endocrinology and Metabolism Geriatrics Obsterics and gynecology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to investigate the effects of eldecalcitol on osteoporotic patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Change of lumbar spine bone mineral density 2.Change of total hip bone mineral density
Key secondary outcomes	1.X-ray of thoracolumbar(Number of fracture occurred) 2.Body composition 3.Blood and urinaly biochemical test(FBS, HbA1c, IRI, CRP, Cr, CK, CRP, Alb, Ca, P, T-Chol, Homocysteine, Pentosidine, Adiponectin, Sclerostin, esRAGE, DKK-1, 25(OH)D, Urinaly Ca, Urinaly Cr, Urinaly Alb, Urinaly NTX) 4.Muscular strength/Balance function test(Grasping power, Open eyes standing on one leg test) 5.Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	eldecalcitol for 48 weeks
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	1.Primary osteoporotic patients 2.Postmenopausal type 2 diabetes patients with more than 6.5% of HbA1c 3.Patients with informed of consent
Key exclusion criteria	1.Patients who have taken bisphosphonate treatments 2.Patients who have taken medicine such as SERMs, glucocorticoid, vitamin K, active vitamin D, calcitonin, insulin within two months from the day of eldecalcitol dosage 3.Patients who are inappropriate for this study by physician
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Mika Middle name Last name Yamauchi
Organization	Shimane University Faculty of Medicine
Division name	Internal Medicine 1
Zip code	6938501
Address	89-1, Enya, Izumo, Shimane 693-8501, Japan
TEL	0853202183
Email	yamauchi@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Mika Middle name Last name Yamauchi
Organization	Shimane University Faculty of Medicine
Division name	Internal Medicine 1
Zip code	6938501
Address	89-1, Enya, Izumo, Shimane 693-8501, Japan
TEL	0853-20-2183
Homepage URL
Email	yamauchi@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nakaoka clinic Tai clinic Chibune Hospital:endocrinology
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shimane University Faculty of Medicine
Address	Enya-cho, Izumo
Tel	0853202183
Email	ishikazu@jn.shimane-u.ac.jp

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	2012 Year 07 Month 17 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	Preinitiation
Date of protocol fixation	2012 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date	2012 Year 07 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 07 Month 12 Day
Last modified on	2021 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009903