UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049741 |
|---|---|
| Receipt number | R000056658 |
| Scientific Title | The effect of romosozumab and denosumab on bone mineral density in patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2022/12/10 |
| Last modified on | 2026/01/04 12:12:30 |
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Basic information
Public title
The effect of romosozumab and denosumab on bone mineral density in patients with rheumatoid arthritis
Acronym
The effect of romosozumab and denosumab on bone mineral density in patients with rheumatoid arthritis
Scientific Title
The effect of romosozumab and denosumab on bone mineral density in patients with rheumatoid arthritis
Scientific Title:Acronym
The effect of romosozumab and denosumab on bone mineral density in patients with rheumatoid arthritis
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the effects of romosozumab and denosumab on bone mineral density in patients with rheumatoid arthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of bone mineral density at one year after administration of the drugs
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
romosozumab 210mg will be administered subcutaneously every month for one year.
Interventions/Control_2
denosumab 60mg will be administered subcutaneously every 6 months for one year.
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
| 50 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with rheumatoid arthritis and osteoporosis who are outpatients or hospitalized at participating facilities will be subjected to the current study. Patients with severe osteoporosis according to the diagnostic criteria of the Japan Society of Bone and Metabolism and the Japanese Society of Osteoporosis should be included in the romosozumab group. The control denosumab group includes patients with osteoporosis and rheumatoid arthritis for whom bisphosphonates are not sufficiently effective, or patients with severe osteoporosis who need to increase bone density relatively early.
Key exclusion criteria
1. Patients who are not diagnosed with rheumatoid arthritis or osteoporosis.
2. Patients with a history of ischemic heart disease or cerebrovascular disease within the past 1 year are excluded from the romosozumab group.
3.Patients who are allergic to romosozumab or denosumab.
4.Patients who are judged to be unsuitable as subjects by the principal investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Nagase |
Organization
Tokyo Metropolitan Tama Medical center
Division name
Department of Rheumatic surgery
Zip code
183-8524
Address
2-8-29, Musashidai, Fuchu
TEL
0423235111
nagaseyuichi17@gmail.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Nagase |
Organization
Tokyo Metropolitan Tama Medical center
Division name
Department of Rheumatic surgery
Zip code
183-8524
Address
2-8-29, Musashidai, Fuchu
TEL
0423235111
Homepage URL
nagaseyuichi17@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Tama medical center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropoliitan Tama Medical center
Address
2-8-29, Musashidai, Fuchu
Tel
0423235111
nagaseyuichi17@gmail.com
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
| 2022 | Year | 12 | Month | 10 | 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
Twenty-six patients were enrolled in the romosozumab group and 24 in the denosumab group.
The percent change of lumbar vertebral bone mineral density in the romosozumab group was increased by 10.0% after one year.
The percentage change in bone mineral density at the femoral neck in the romosozumab group increased by 5.0% after one year.
In some cases, small Asian RA cases required discontinuation of treatment due to joint or muscle pain after injection of Romosozumab.
Results date posted
| 2023 | Year | 06 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age in the romosozumab group was 76.2 years, the mean duration of rheumatoid arthritis was 23.4 years, the glucocorticoid use rate was 59.3%, and the median 25(OH) vitamin D level was 19.2.
T
Participant flow
Adverse events
Joint pain: 2 cases, fever: 1 case, chest discomfort: 1 case, shortness of breath on exertion: 1 case, numbness in the toes: 1 case, concomitant malignant lymphoma: 1 case
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056658
