UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011670 |
|---|---|
| Receipt number | R000013602 |
| Scientific Title | Randomized, open label, controlled clinical trial of eldcalcitol for falls prevention in postmenopausal osteoporotic patients with depression. |
| Date of disclosure of the study information | 2013/09/10 |
| Last modified on | 2019/12/25 14:17:52 |
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Basic information
Public title
Randomized, open label, controlled clinical trial of eldcalcitol for falls prevention in postmenopausal osteoporotic patients with depression.
Acronym
Efficacy of eldcalcitol for falls prevention in postmenopausal osteoporotic patients with depression.
Scientific Title
Randomized, open label, controlled clinical trial of eldcalcitol for falls prevention in postmenopausal osteoporotic patients with depression.
Scientific Title:Acronym
Efficacy of eldcalcitol for falls prevention in postmenopausal osteoporotic patients with depression.
Region
| Japan |
Condition
Condition
Falls
Classification by specialty
| Geriatrics | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effecacy of eldecalcitol for falls prevention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Falls rate
Key secondary outcomes
falls related injury
Hamilton raing scale for depression
physical function
bone mineral density
mauscle volume
markers of bone metabolism
falls efficacy scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
eldecalcitol, 0.75µg/day
raloxifene, 60mg/day
Interventions/Control_2
raloxifene, 60mg/day
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
| 95 | years-old | > |
Gender
Female
Key inclusion criteria
Postmenopausal osteoporotic patients with depression
Aged 50 and over
Key exclusion criteria
Patients who are diagnosed as contraindication of raloxifene treatments
Patients who are diagnosed as contraindication of eldecalcitol treatments
Patient who have a past history of treatment with vitamin D within 6 months
Patient who have a past history of treatment for osteoporosis besides vitamin D in the past 12-months
Unsuitable for trial as evaluated by the physician-in-charge
Subject who refuse to participate in
this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Enishi |
Organization
Tokushima University Hospital
Division name
Division of Rehabilitation, Tokushima University Hospital
Zip code
7708503
Address
7708503, Japan
TEL
088-633-9313
enishi.tetsuya@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Enishi |
Organization
Tokushima University Hospital
Division name
Division of Rehabilitation, Tokushima University Hospital
Zip code
7708503
Address
Kuramoto, Tokushima 7708503, Japan
TEL
088-633-9313
Homepage URL
enishi.tetsuya@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB for Tokushima universuty hospital
Address
2-50-1, kuramoto, Tokushima
Tel
088-633-9294
awachiken@tokushima-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
| 2013 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
0
Results
none
Results date posted
| 2019 | Year | 12 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
none
Adverse events
none
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 06 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013602
