UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015794 |
|---|---|
| Receipt number | R000018380 |
| Scientific Title | Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study ) |
| Date of disclosure of the study information | 2014/12/10 |
| Last modified on | 2018/03/12 11:03:33 |
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Basic information
Public title
Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study )
Acronym
RISOTTO
(sodium RISedrOnate for sTeroid induced osTeOporosis with rheumatoid arthritis)
Scientific Title
Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study )
Scientific Title:Acronym
RISOTTO
(sodium RISedrOnate for sTeroid induced osTeOporosis with rheumatoid arthritis)
Region
| Japan |
Condition
Condition
osteoporosis, rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of monthly sodium risedronate for the treatment of coricosteroid induced osteoporosis in patients with rheumatoid arthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Percentage change from baseline in the bone mineral density of lumbar spine (L2-4) at 6 months
Key secondary outcomes
Percentage change from baseline in the bone mineral density of femoral neck and total hip at 6 months
Incidence of vertebral fractures at 6 months
Change from baseline in bone metabolic markers such as TRACP-5b and BAP at 6 months
Change from baseline in disease activity score 28 (DAS28) at 6 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
monthly risedronate sodium 75mg for 6 months
Interventions/Control_2
monthly placebo for 6 months
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Rheumatoid arthritis patients with osoteoporosis receiving corticosteroid for more than 3 months.
In addition, patients who have more than 3 in the risk factor scores in Japanese guideline for the management and treatment in patients with corticosteroid induced osteoporosis.
Key exclusion criteria
Patients who received drugs for osteoporosis within 2 months at inclusion of the study except alphacalcidol and calcitriol
Patients who had received bisphosphonates
Patients who had undergone the operation of lumbar spine
Patients who have a severe decayed tooth to be treated
Patients who are considered to be contraindicated for bisphosphonates
Patients who are thought to be inappropriate for this study by physicians
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Atsumi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Division of rheumatology, endcrinology and nephrology
Zip code
Address
N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
at3tat@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nao Horie |
Organization
Hokkaido University Hospital
Division name
Clinical Research and Medical Innovation Center
Zip code
Address
N14, W5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7735
Homepage URL
http://trctca.huhp.hokudai.ac.jp/
nhorie@med.hokudai.ac.jp
Sponsor or person
Institute
Division of rheumatology, endcrinology and nephrology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Eisai 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
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
| 2014 | 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
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 30 | Day |
Last modified on
| 2018 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018380
