UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022179 |
|---|---|
| Receipt number | 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 16:51:09 |
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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
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
dnagasaku@yujin-yamazaki.co.jp
Sponsor or person
Institute
Yujinkai Medical Corporation Yujin-yamazaki Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
