UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037579
Receipt number 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 2022/08/05 14:21:59

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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 or person

Institute

Tokai University School of Medicine

Institute

Department

Personal name



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

Completed

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

2022 Year 08 Month 05 Day



Link to view the page

Value
https://center6.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