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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037579
Receipt No. R000042716
Scientific Title Evaluation of efficacy and safety of anti-sclerostin antibody romosozumab for osteoporosis in patients undergoing hemodialysis
Date of disclosure of the study information 2019/08/02
Last modified on 2020/02/07

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Basic information
Public title Evaluation of efficacy and safety of anti-sclerostin antibody romosozumab for osteoporosis in patients undergoing hemodialysis
Acronym Evaluation of efficacy and safety of romosozumab for osteoporosis in HD patients
Scientific Title Evaluation of efficacy and safety of anti-sclerostin antibody romosozumab for osteoporosis in patients undergoing hemodialysis
Scientific Title:Acronym Evaluation of efficacy and safety of romosozumab for osteoporosis in HD patients
Region
Japan

Condition
Condition osteoporosis, end stage renal disease
Classification by specialty
Nephrology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess percent change from baseline in bone mineral density after 1-year romosozumab treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percent change from baseline in bone mineral density at month 12
Key secondary outcomes Monthly serum calcium and phosphate levels
Serum intact PTH, FGF23, BAP and TRACP5b levels at month 1, month 3, month 6, month 9 and month 12
Percent change of aortic calcification score from baseline

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 1) patient undergoing hemodialysis for more than 3 months
2) patient with osteoporosis who is scheduled to receive monthly subcutaneous romosozumab therapy
3) patient who is competent to understand the aim of this study and agree on it
Key exclusion criteria None
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Hirotaka
Middle name
Last name Komaba
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code 2591193
Address 143, Shimokasuya, Isehara, Kanagawa, Japan
TEL 0463-93-1121
Email hkomaba@tokai-u.jp

Public contact
Name of contact person
1st name Naoto
Middle name
Last name Hamano
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code 2591193
Address 143, Shimokasuya, Isehara, Kanagawa, Japan
TEL 0463-93-1121
Homepage URL
Email nhamano@tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Medical Corporation Showakai
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board for Clinical Research, Tokai University
Address 143, Shimokasuya, Isehara, Kanagawa, Japan
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.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 東海大学医学部附属病院(神奈川県),望星平塚クリニック(神奈川県),東海大学医学部付属大磯病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 02 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
2019 Year 07 Month 09 Day
Date of IRB
2019 Year 07 Month 23 Day
Anticipated trial start date
2019 Year 08 Month 02 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We compare percent changes of BMD in patients in this study with those of propensity score-matched patients involved in the cohort study we previously performed.

Management information
Registered date
2019 Year 08 Month 02 Day
Last modified on
2020 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042716

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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