UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011999 |
|---|---|
| Receipt number | R000013992 |
| Scientific Title | Denosumab in hemodialysis patients with osteoporosis : comparison of usefullness between high and low turnover bone. |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2013/10/09 15:20:21 |
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Basic information
Public title
Denosumab in hemodialysis patients with osteoporosis : comparison of usefullness between high and low turnover bone.
Acronym
Denosubmab in hemodialysis patients with osteoporosis.
Scientific Title
Denosumab in hemodialysis patients with osteoporosis : comparison of usefullness between high and low turnover bone.
Scientific Title:Acronym
Denosubmab in hemodialysis patients with osteoporosis.
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
compare the usefulness of denosumab to hemodialysis patients with osteoporosis between high and low turn over of the bone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.improvement of BMD
2.prevalent of bone fracture
Key secondary outcomes
improvement of turn over of the bone
i-PTH,P,Ca,BAP,TRAPC5b
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
denosumab is admininistered in 60mg by subctaneous injection in each 6 month.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients diagnosed with osteoporosis
Key exclusion criteria
bedridden patients
tube feeding patients
hypocalcemia patients
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sato Yuzuru |
Organization
Sato Junkanki hospital
Division name
president of hospital
Zip code
Address
8-2-3choume asoudamati matsuyama city ehime pref.
TEL
089-933-0808
yuzuru-sato@satohp.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Aono |
Organization
Sato Junkanki hospital
Division name
vice-principal
Zip code
Address
8-2-3choume asoudamati matsuyama city ehime pref.
TEL
089-933-0808
Homepage URL
masaki-aono@satohp.co.jp
Sponsor or person
Institute
Sato Junkanki hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 01 | 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
| 2013 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 30 | 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
| 2013 | Year | 10 | Month | 09 | Day |
Last modified on
| 2013 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013992
