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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008417
Receipt No. R000009903
Scientific Title The effect of eldecalcitol on bone mineral density and bone markers for osteoporotic patients with type 2 diabetes.-Open label multicenter study-
Date of disclosure of the study information 2012/07/17
Last modified on 2014/07/12

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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
Middle name
Last name Mika Yamauchi
Organization Shimane University Faculty of Medicine
Division name Internal Medicine 1
Zip code
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
Middle name
Last name Mika Yamauchi
Organization Shimane University Faculty of Medicine
Division name Internal Medicine 1
Zip code
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
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
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
2014 Year 07 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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