UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036972
Receipt number R000042119
Scientific Title Survey of fractures after discontinuation of denosumab in patients with rheumatoid arthritis.
Date of disclosure of the study information 2019/06/07
Last modified on 2022/06/14 14:13:46

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Basic information

Public title

Survey of fractures after discontinuation of denosumab in patients with rheumatoid arthritis.

Acronym

Survey of fractures after discontinuation of denosumab in patients with rheumatoid arthritis.

Scientific Title

Survey of fractures after discontinuation of denosumab in patients with rheumatoid arthritis.

Scientific Title:Acronym

Survey of fractures after discontinuation of denosumab in patients with rheumatoid arthritis.

Region

Japan


Condition

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate the number of fractures and fracture details after denosumab discontinuation.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Number and details of fractures after denosumab discontinuation.

Key secondary outcomes

None


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Preliminary survey
1.Patients who had been received denosumab for at least 1 year while participating in the DESIRABLE.
2.Outpatients who are visiting the same institution as they visited in DESIRABLE.
3.Patients who had a washout period of >7 months between denosumab doses by the date of the preliminary survey.
4.Patients who had not been diagnosed with osteoporosis by the day of 7 months after the last dose of denosumab.Regarding patients with multiple washout periods, ones who had not been diagnosed with osteoporosis by the 7 months after the last dose of denosumab about the first washout period.

Main survey
1.Patients who can give voluntary written informed consent.
2.Patients with development of fracture
in preliminary survey.

Key exclusion criteria

None

Target sample size

194


Research contact person

Name of lead principal investigator

1st name Hisashi
Middle name
Last name Nakagaki

Organization

Daiichi Sankyo Co., Ltd.

Division name

Medical Science Department

Zip code

103-8426

Address

1-2-58, Hiromachi, Shinagawa-ku, Tokyo ,Japan

TEL

03-6225-1555

Email

nakagaki.hisashi.sh@daiichisankyo.co.jp


Public contact

Name of contact person

1st name Hideaki
Middle name
Last name Sainomoto

Organization

Daiichi Sankyo RD Novare Co., Ltd

Division name

Clinical Development

Zip code

140-8710

Address

1-2-58, Hiromachi, Shinagawa-ku, Tokyo ,Japan

TEL

03-5436-8542

Homepage URL


Email

sainomoto.hideaki.mb@rdn.daiichisankyo.co.jp


Sponsor or person

Institute

Daiichi Sankyo Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Daiichi Sankyo Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical research promotion network japan

Address

1-4-9,Itachibori, Nishi-ku, Osaka ,Japan

Tel

06-4393-8403

Email

osaka@sct-net.org


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

2019 Year 06 Month 07 Day


Related information

URL releasing protocol

Unpublished

Publication of results

Published


Result

URL related to results and publications

N/A

Number of participants that the trial has enrolled

2

Results

Of the 81 patients in the preliminary survey, 2 patients developed fractures.

Results date posted

2022 Year 06 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Regarding the two subjects in the fracture survey, both were female and aged 50 and 75 years. Osteoporosis was not a complication in either of the two patients, but the 75-year-old woman had a history of fragility fracture (carpal bone).

Participant flow

The DESIRABLE study allocated 679 patients (94 centers), of which 165 were from pre-study sites (17 centers). Of these, 41 had a diagnosis of osteoporosis at the time of DESIRABLE study entry, and 43 did not meet the study selection criteria, resulting in a total of 81 patients for the feasibility study.

Adverse events

N/A

Outcome measures

For the 2 subjects in the fracture survey, fracture #1 was a traumatic left patellar fracture resulting from a fall that occurred 12 months after the last dose of denosumab. Fracture #2 was a symptomatic L1, L2, L4 lumbar compression fracture with low back pain, occurring 13 months after the last dose of denosumab. The patient with fracture #2 was 75 years old and his lumbar spine bone density 5 months prior to fracture was in the region of bone loss with a YAM value of 72%, and he was taking minodronic acid, an osteoporosis drug, at the time of fracture. The bone density of the proximal femur also showed a sharp decrease in YAM value from 88% to 75% before and after the fracture. The outcome of fractures #1 and #2 was recovery and minor injury, respectively.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 06 Month 03 Day

Date of IRB

2019 Year 05 Month 23 Day

Anticipated trial start date

2019 Year 07 Month 01 Day

Last follow-up date

2020 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

ISSN 0387-4095


Management information

Registered date

2019 Year 06 Month 05 Day

Last modified on

2022 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042119


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name