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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040956
Receipt No. R000046770
Scientific Title Effect of a monoclonal antibody to sclerostin (romosozumab) on dialysis patients with osteoporosis
Date of disclosure of the study information 2020/09/01
Last modified on 2020/06/30

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Basic information
Public title Effect of a monoclonal antibody to sclerostin (romosozumab) on dialysis patients with osteoporosis
Acronym Effect of romosozumab on dialysis patients with osteoporosis
Scientific Title Effect of a monoclonal antibody to sclerostin (romosozumab) on dialysis patients with osteoporosis
Scientific Title:Acronym Effect of romosozumab on dialysis patients with osteoporosis
Region
Japan

Condition
Condition Chronic renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of romosozumab on osteoporosis in dialysis patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone density, vertebra CT, bone metabolism related markers (calcium, phosphorus, alkaline phosphatase, tartrate-resistant acid phosphatase, osteocalcin)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intramuscularly administer 210 mg of romosozumab once a month
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
90 years-old >
Gender Female
Key inclusion criteria Osteoporosis with radial bone density of T-score <-2.5SD in a female dialysis patient visiting our hospital
Key exclusion criteria Patients complicated with serious diseases such as malignancy, heart failure (NYHA III degrees or more), and liver cirrhosis
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Michio
Middle name
Last name Kuwahara
Organization Saitama Tsukinomori Clinic
Division name Division of Nephrology
Zip code 339-0012
Address 366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL 0487921811
Email kuwahara@k-naika-cl.jp

Public contact
Name of contact person
1st name Michio
Middle name
Last name Kuwahara
Organization Saitama Tsukinomori Clinic
Division name Division of Nephrology
Zip code 339-0012
Address 366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL 0487921811
Homepage URL
Email kuwahara@k-naika-cl.jp

Sponsor
Institute Saitama Tsukinomori Clinic
Institute
Department

Funding Source
Organization Saitama Tsukinomori Clinic
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 the ethics committee of Saitama Tsukinomori Clinic
Address 366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
Tel 0487921811
Email hayama@k-naika-cl.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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 01 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 Enrolling by invitation
Date of protocol fixation
2020 Year 06 Month 01 Day
Date of IRB
2020 Year 06 Month 23 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2022 Year 12 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
2020 Year 06 Month 30 Day
Last modified on
2020 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046770

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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