UMIN-CTR Clinical Trial

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
Email	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
Email	m-hori@masuko.or.jp

Sponsor
Institute	Masuko Memorial 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	Masuko Memorial Hospital
Address	35-28 Takehashi-cho,
Tel	+81524511307
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049181