UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026067 |
|---|---|
| Receipt number | R000029948 |
| Scientific Title | Pathogenesis of secondary osteoporosis caused by chronic kidney disease and hemodialysis; Analyzing bone microstructure by using HR-pQCT |
| Date of disclosure of the study information | 2017/02/09 |
| Last modified on | 2020/07/31 12:36:46 |
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Basic information
Public title
Pathogenesis of secondary osteoporosis caused by chronic kidney disease and hemodialysis;
Analyzing bone microstructure by using HR-pQCT
Acronym
Pathogenesis of secondary osteoporosis caused by chronic kidney disease and hemodialysis;
Analyzing bone microstructure by using HR-pQCT
Scientific Title
Pathogenesis of secondary osteoporosis caused by chronic kidney disease and hemodialysis;
Analyzing bone microstructure by using HR-pQCT
Scientific Title:Acronym
Pathogenesis of secondary osteoporosis caused by chronic kidney disease and hemodialysis;
Analyzing bone microstructure by using HR-pQCT
Region
| Japan |
Condition
Condition
Hemodialysis, chronic kidney disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characteristics of bone microstructure in the patients with chronic kidney disease and hemodialysis patients
Basic objectives2
Others
Basic objectives -Others
To elucidate the cause of bone fragility and susceptibility to bone fracture in the patients with chronic kidney disease and hemodialysis patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cortical and trabecular bone microstructure
Key secondary outcomes
Bone mineral density
Fragility vertebral and pelvic fracture
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic kidney disease and hemodialysis.
Patients who agree with the documents.
Key exclusion criteria
Patients with a history of articular diseases.
Patients judged inappropriate by author.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ko |
| Middle name | |
| Last name | Chiba |
Organization
Nagasaki University Hospital
Division name
Department of orthopaedic surgery
Zip code
8528501
Address
1-7-1 Sakamoto Nagasaki 852-8501
TEL
095-819-7321
kohchiba@estate.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Chiba |
Organization
Nagasaki University Hospital
Division name
Department of orthopaedic surgery
Zip code
8528501
Address
1-7-1 Sakamoto Nagasaki 852-8501
TEL
095-819-7321
Homepage URL
kohchiba@estate.ocn.ne.jp
Sponsor or person
Institute
Nagasaki University Hospital Department of Orthopaedic Surgery
Institute
Department
Personal name
Funding Source
Organization
Nagasaki 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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 09 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross-sectional study
Patient who visited our hospital from March 2016 to December 2017.
Management information
Registered date
| 2017 | Year | 02 | Month | 09 | Day |
Last modified on
| 2020 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029948
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
