UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042107
Receipt number R000048053
Scientific Title Effects of denosumab on the treatment of osteoporosis and inhibition of bone erosion in rheumatoid arthritis
Date of disclosure of the study information 2020/10/14
Last modified on 2021/10/15 10:31:56

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Basic information

Public title

Effects of denosumab on the treatment of osteoporosis and inhibition of bone erosion in rheumatoid arthritis

Acronym

Evaluation of the Therapeutic Effect of Denosumab on Rheumatoid Arthritis and Osteoporosis

Scientific Title

Effects of denosumab on the treatment of osteoporosis and inhibition of bone erosion in rheumatoid arthritis

Scientific Title:Acronym

Evaluation of the Therapeutic Effect of Denosumab on Rheumatoid Arthritis and Osteoporosis

Region

Japan


Condition

Condition

Rheumatoid Arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of denosumab in treating osteoporosis and inhibiting bone erosion in rheumatoid arthritis cases.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of Bone Mineral Density at week 52

Key secondary outcomes

Evaluation of Bone Erosion at week 52


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

40 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Meet the diagnosis of rheumatoid arthritis and osteoporosis

Key exclusion criteria

Use of parathyroid hormones drugs
History of bone metabolic disease
hypocalcemia

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yu
Middle name
Last name Mori

Organization

Tohoku University Graduate School of Medicine

Division name

Orthopedic Surgery

Zip code

9808574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

0227177245

Email

yu-mori@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Yu
Middle name
Last name Mori

Organization

Tohoku University Graduate School of Medicine

Division name

Orthopedic Surgery

Zip code

9808574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

0227177245

Homepage URL


Email

yu-mori@med.tohoku.ac.jp


Sponsor or person

Institute

Department of Orthopedic Surgery, Tohoku University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

self funding

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

Tohoku University Graduate School of Medicine Ethics Committee

Address

2-1 Seiryo-machi, Aoba-ku, Sendai

Tel

0227178007

Email

med-kenkyo@grp.tohoku.ac.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 10 Month 14 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

2020 Year 10 Month 12 Day

Date of IRB

2020 Year 12 Month 24 Day

Anticipated trial start date

2021 Year 01 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

N/A


Management information

Registered date

2020 Year 10 Month 14 Day

Last modified on

2021 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048053


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name