UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008417 |
|---|---|
| Receipt number | 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 | 2021/07/31 14:13:07 |
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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 |
| Obstetrics 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
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
yamauchi@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009903
