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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011999
Receipt No. 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

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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
Email 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
Email masaki-aono@satohp.co.jp

Sponsor
Institute Sato Junkanki hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013992

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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