UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022364 |
|---|---|
| Receipt number | R000025762 |
| Scientific Title | Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2016/05/20 |
| Last modified on | 2019/02/12 11:09:31 |
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Basic information
Public title
Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis
Acronym
Effectiveness of minodronate in osteoporotic patients with rheumatoid arthritis
Scientific Title
Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis
Scientific Title:Acronym
Effectiveness of minodronate in osteoporotic patients with rheumatoid arthritis
Region
| Japan |
Condition
Condition
Osteoprotic patients with rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To build preliminary data of effectiveness and safety for 2 different treatments; 1) minodoronate alone or 2) minodronate plus active vitamin D in osteoporotic patients with rheumatoid arthritis
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Value changes of bone mineral density (lumber as well as bilateral proximal hip) before treatment and at 24 months after treatment
Key secondary outcomes
Frequencies of adverse effects (at 6, 12, and 24 months after treatment)
Value chanes of the following at 6, 12, and 24 months after treatment
1. Bone mineral density (lumber as well as bilateral proximal hip) values
2. Values of bone turnover markers
3. Values of serum vitamin D
4. Values of serum PTH
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The selection criteria is based on which treatment each patient wants to take
Interventions/Control_2
Minodronate group: oral intake 50mg per month
Interventions/Control_3
Minodronate plus active vitamin D group: oral intake 50mg minodronate per month and eldecalcitol 0.75ug per day after breakfast
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Rheumatoid arthritis compliactated with steoporosis, aged over 20.
2. The patients who desire to take the above treatment
3. The patients who agree to perform this study after sufficient informed consent
Key exclusion criteria
1. The patients who are allergic to minodronate or eldecalcitol
2. The patients with hypercalcemia before treatment
3. The patients whom we judge as inappropriate
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Nakamura |
Organization
Shinshu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
Asahi3-1-1, Matsumoto 3908621, Japan
TEL
0263372659
yxn14@aol.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Nakamura |
Organization
Shinshu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
Asahi3-1-1, Matsumoto 3908621, Japan
TEL
0263372659
Homepage URL
https://shinshu.bvits.com/rinri/Apply/show.aspx?TYPE=0&ID=2426
yxn14@aol.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 19 | Day |
Last modified on
| 2019 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025762
