UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036838 |
|---|---|
| Receipt number | R000041940 |
| Scientific Title | Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis. |
| Date of disclosure of the study information | 2019/06/03 |
| Last modified on | 2022/06/14 13:50:24 |
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Basic information
Public title
Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis.
Acronym
Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis.
Scientific Title
Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis.
Scientific Title:Acronym
Observational study to examine the changes in bone metabolism and bone erosion 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
To examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients who participated in the phase III study of denosumab for rheumatoid arthritis (DESIRALBLE).
Basic objectives2
Others
Basic objectives -Others
To examine the changes in bone mineral density at 2 years after discontinuation of denosumab.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Percent change in lumbar spine bone mineral density
Key secondary outcomes
Changes in bone erosion score
Changes in bone turnover marker (CTX-I)
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
1)Patients who can give voluntary written informed consent.
2)Among patients who participated in the Phase III clinical study of denosumab for rheumatoid arthritis (DESIRABLE), those who were still involved in DESIRABLE at its completion (July 3, 2017).
3) Outpatients who are visiting the same institution as they visited in DESIRABLE.
Key exclusion criteria
1)Patients without informed consent.
2)Patients who are diagnosed with osteoporosis by the time of informed consent in this study.
3)Patients who have received denosumab other than during the phase III study (DESIRABLE).
4)Patients who received bisphosphonates after the date of completion of the DESIRABLE (July 3, 2017).
5)Women who are pregnant or possibly pregnant.
6)Other patients who the investigator considers to be ineligible.
Target sample size
40
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
3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo
TEL
03-6225-1555
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
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
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 | 03 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/mr/article/32/2/284/6350308
Number of participants that the trial has enrolled
59
Results
The percentage change in LS BMD decreased to baseline levels at the postdiscontinuation visit.
Results date posted
| 2022 | Year | 06 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirtynine (66.1%) patients were female, the mean (SD) age at the postdiscontinuation visit was 58.5 (9.6) years, the mean (SD) duration of RA was 7.75 (1.38) years, and the mean (SD) DAS28-CRP was 2.062 (0.908).
Participant flow
A total of 59 patients from the DESIRABLE trial were enrolled, and all 59 were included in the final analysis.
Adverse events
N/A
Outcome measures
Compared with baseline, CTX-1 levels increased after denosumab discontinuation but most patients had levels within the reference range. Bone erosion scores were not significantly different between the on-treatment period and after denosumab discontinuation (p = .0666) but there was a numerical increase postdiscontinuation. The progression in bone erosion score was significantly reduced in patients whose disease activity was in remission versus those not in remission (p = .0195).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 05 | Month | 24 | 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=R000041940
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