UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043078 |
|---|---|
| Receipt number | R000049181 |
| Scientific Title | Impact of serum magnesium and bone mineral density on systemic fractures in chronic hemodialysis patients |
| Date of disclosure of the study information | 2021/01/21 |
| Last modified on | 2021/01/21 16:50:02 |
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Basic information
Public title
Impact of serum magnesium and bone mineral density on systemic fractures in chronic hemodialysis patients
Acronym
Mg and BMD on fractures among HD patients
Scientific Title
Impact of serum magnesium and bone mineral density on systemic fractures in chronic hemodialysis patients
Scientific Title:Acronym
Mg and BMD on fractures among HD patients
Region
| Japan |
Condition
Condition
End-stage renal failure
fragility fractures
Classification by specialty
| Nephrology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the association of serum magnesium and BMD with the risk of incident fractures in patients undergoing hemodialysis
Basic objectives2
Others
Basic objectives -Others
Investigation for the marker which improved the prediction of fractures
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Any type of fragility fractures
Key secondary outcomes
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
patients who had undergone hemodialysis for least 2 months at Masuko Memorial Hospital
Key exclusion criteria
Patients undergoing combination therapy with peritoneal dialysis were excluded.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Mayuko |
| Middle name | |
| Last name | Hori |
Organization
Masuko Memorial Hospital
Division name
Nephrology
Zip code
453-8566
Address
Nakamura-ku Nagoya
TEL
+81524511307
m-hori@masuko.or.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | Hori |
Organization
Masuko Memorial Hospital
Division name
Nephrology
Zip code
453-8566
Address
Nakamura-ku Nagoya
TEL
+81524511307
Homepage URL
m-hori@masuko.or.jp
Sponsor or person
Institute
Masuko Memorial 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
Masuko Memorial Hospital
Address
35-28 Takehashi-cho,
Tel
+81524511307
m-hori@masuko.or.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
増子記念病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 21 | 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
358
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
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
assess the association of serum magnesium and BMD with the risk of incident fractures and to determine whether the prediction of the risk of fractures in patients undergoing hemodialysis based on the combination of Mg level and lumbar spine BMD is more accurate than the prediction based on either variable alone
Management information
Registered date
| 2021 | Year | 01 | Month | 21 | Day |
Last modified on
| 2021 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049181
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| Registered date | File name |
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