UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023292 |
|---|---|
| Receipt number | R000017833 |
| Scientific Title | The effect of calcium, Vitamin D, and denosumab on osteoporosis and basal metabolism in postmenopausal diabetic women |
| Date of disclosure of the study information | 2016/07/22 |
| Last modified on | 2017/01/23 17:29:32 |
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Basic information
Public title
The effect of calcium, Vitamin D, and denosumab on osteoporosis and basal metabolism in postmenopausal diabetic women
Acronym
The effect of denosumab on basal metabolism in type 2 diabetic women
Scientific Title
The effect of calcium, Vitamin D, and denosumab on osteoporosis and basal metabolism in postmenopausal diabetic women
Scientific Title:Acronym
The effect of denosumab on basal metabolism in type 2 diabetic women
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus, Osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the change of the basal metabolism, glucose control and bone metabolism in patients with type 2 diabetes by improvement of osteoporosis with Calcium/vitamin D and Denosumab.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of the Basal metabolism, and the marker of the bone metabolism before and after taking Calcium/Vitamin D and denosumab
Key secondary outcomes
Changes of the blood glucose control level, fasting CPR, iPTH, 25hydroxyvitamin D, blood cell count, serum calcium, phosphate and other general examination of blood, and diabetic neuropathy
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
Calcium / Vitamin D / Magnesium mixed tablet ; Calcium 305mg, Cholecalciferol 0.005mg (200IU), Magnesium carbonate 59.2mg is containing per tablet. Taking 2 tablet / day prior 1 month from Denosumab 60mg injection to subcutaneous, once per 6 months.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient of type 2 Diabetes Mellitus
1: More than 50 years of age at the time of obtaining informed consent
2:With osteoporosis
3: At the participation in this study, that document consent is obtained due to free will of the patient's own by sufficient explanation and thorough understanding.
4:Control of blood pressure and blood glucose are relatively stable, and without planning for remarkable change.
Key exclusion criteria
The patients who
Taking drug for osteoporosis
With presence and past history of malignancy.
With other endocrine diseases
With liver dysfunction except fatty liver
With macro proteinuria or with increased serum creatinine level over 2.0mg/dl
Principal investigator of this study has determined to be inappropriate as a subject
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko Uchigata |
Organization
Tokyo Women's Medical University
Division name
Diabetes Center
Zip code
Address
8-1,Kawadacho Shinjyukuku Tokyo 1628666 Japan
TEL
03-3353-8111
uchigata.dmc@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Ogata |
Organization
Tokyo Women's Medical University
Division name
Diabetes Center
Zip code
Address
8-1,Kawadacho Shinjyukuku Tokyo 1628666 Japan
TEL
03-3353-8111
Homepage URL
mogatamd.dmc@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Mediclcal University
Institute
Department
Personal name
Funding Source
Organization
Diabetes Center, Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京女子医科大学病院糖尿病センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 22 | Day |
Last modified on
| 2017 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017833
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
