UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040956
Receipt number 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 2024/02/15 12:48:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Radial bone density (distal 1/3, distal 1/10), bone metabolism-related markers [calcium, phosphorus, parathyroid hormone, alkaline phosphatase, bone-type alkaline phosphatase (BAP), osteocalcin (OC), I type procollagen-N-propeptide (P1NP), tartrate-resistant acid phosphatase-5b (TRACP-5b)]

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

A female dialysis patient attending our hospital with osteoporosis whose radial bone density is less than 70% based on the YAM value.

Key exclusion criteria

Patients complicated with serious diseases such as malignancy, heart failure (NYHA III degrees or more), and liver cirrhosis

Target sample size

10


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 or person

Institute

Saitama Tsukinomori Clinic

Institute

Department

Personal name



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

6

Results

BAP, OC, and P1NP significantly increased after romosozumab administration. No significant change was observed in TRACP-5b. There were no significant changes in the YAM values of the distal 1/3 and 1/10 of the radius.

Results date posted

2024 Year 02 Month 15 Day

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

2020 Year 06 Month 01 Day

Date of IRB

2020 Year 06 Month 23 Day

Anticipated trial start date

2021 Year 12 Month 01 Day

Last follow-up date

2023 Year 10 Month 31 Day

Date of closure to data entry

2023 Year 11 Month 15 Day

Date trial data considered complete

2023 Year 11 Month 15 Day

Date analysis concluded

2024 Year 02 Month 01 Day


Other

Other related information

The main results of this study are as follows. 1. The BAP value significantly increased from 18.9+3.0 (SE, IU/L) before romosozumab administration to 35.6+6.0 1 month later, and the significant increase continued until 3 months later. The OC value significantly increased from 161+28 (ng/mL) before administration to 238+36 1 month later, and the significant increase continued until 3 months later. The P1NP value significantly increased from 472+134 (ng/mL) before administration to 714+146 one month later. The TRACP-5b value increased from 816+91 (mU/dL) before administration in 3 patients and decreased in 3 patients, so no significant changes were observed. 2. YAM values in the distal third of the radius increased in 2 patients but decreased in 4 patients, so no significant change was observed. The YAM value at the distal 1/10 of the radius also increased in 2 patients and decreased in 4 patients, so there was no significant change. The change in YAM value in the distal third region improved from -3.33+4.45%/year one year before administration to -1.33+1.75%/year one year after administration. In addition, the distal 1/10 region also improved from -6.5+9.95%/year to -0.83+4.95%. As described above, romosozumab was considered to promote bone formation based on bone metabolism markers, but no effect on bone resorption was observed. For the radius, romosozumab had an effect of suppressing the decrease in YAM values, but had no effect on improving YAM values.
The summary of this study was presented at the 66th Annual Meeting of the Japanese Society of Dialysis Therapy (Yokohama, June 2021) and the 67th Annual Meeting of the Japanese Society of Dialysis Therapy (Yokohama, July 2022).


Management information

Registered date

2020 Year 06 Month 30 Day

Last modified on

2024 Year 02 Month 15 Day



Link to view the page

Value
https://center6.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