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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022179
Receipt No. R000025553
Scientific Title The prospective study of denosumab for the treatment of osteoporosis in hemodialysis patients
Date of disclosure of the study information 2016/05/02
Last modified on 2020/05/22

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Basic information
Public title The prospective study of denosumab for the treatment of osteoporosis in hemodialysis patients
Acronym The effect of denosumab on hemodialysis patients with osteoporosis
Scientific Title The prospective study of denosumab for the treatment of osteoporosis in hemodialysis patients
Scientific Title:Acronym The effect of denosumab on hemodialysis patients with osteoporosis
Region
Japan

Condition
Condition Osteoporosis
Classification by specialty
Nephrology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of denosumab for hemodialysis patients with osteoporosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in bone mineral density(BMD) at distal radius,P1NP and TRACP-5b
Key secondary outcomes Change in Ca,iP,intact-PTH and side effect

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 Patients will be injected subcutaneously with 60 mg of denosumab every 6 months for 60 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hemodialysis patient with osteoporosis including these Criteria
1)young adult mean(YAM)<70 %
2)cCa 8.0-10.5 mg/dL
Key exclusion criteria Patient who have the contraindication for denosumab
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Nagasaku
Organization Yujinkai Medical Corporation Yujin-yamazaki Hospital
Division name Department of Intenal Medicine
Zip code 522-0044
Address 80 Takegahana-cho,Hikone-shi,Shiga-ken
TEL 0749-23-1800
Email dnagasaku@yujin-yamazakii.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Nagasaku
Organization Yujinkai Medical Corporation Yujin-yamazaki Hospital
Division name Department of Intenal Medicine
Zip code 522-0044
Address 80 Takegahana-cho,Hikone-shi,Shiga-ken
TEL 0749-23-1800
Homepage URL
Email dnagasaku@yujin-yamazaki.co.jp

Sponsor
Institute Yujinkai Medical Corporation Yujin-yamazaki Hospital
Institute
Department

Funding Source
Organization Yujinkai Medical Corporation Yujin-yamazaki 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 Ethics Committee of Yujinkai Medical Corporation Yujin-yamazaki Hospital
Address 80 Takegahana-cho,Hikone-shi,Shiga-ken
Tel 0749-23-1800
Email m.takahashi@yujin-yamazaki.co.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 医療法人友仁会 友仁山崎病院(滋賀県)

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 38
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 Completed
Date of protocol fixation
2014 Year 10 Month 01 Day
Date of IRB
2016 Year 05 Month 01 Day
Anticipated trial start date
2016 Year 05 Month 02 Day
Last follow-up date
2019 Year 05 Month 31 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 05 Month 02 Day
Last modified on
2020 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025553

Research Plan
Registered date File name
2017/10/18 デノスマブ研究計画書 .docx

Research case data specifications
Registered date File name
2017/10/18 研究症例データ仕様書.docx

Research case data
Registered date File name
2018/05/07 デノスマブ研究症例データ.xlsx


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