UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030828 |
|---|---|
| Receipt number | R000035188 |
| Scientific Title | The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis. |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2018/01/15 22:59:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis.
Acronym
EVIDENCE study
Scientific Title
The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis.
Scientific Title:Acronym
EVIDENCE study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Osteoporosis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence ratio of new vertebral fractures between zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence ratio of new vertebral fractures after two years
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
zoledronic acid
Interventions/Control_2
denosumab
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
1) Patients with rheumatoid arthritis who fulfill 2010 ACR/EULAR criteria
2) Patients fulfill the primary osteoporosis criteria in Japan
3) Aged 20 years or older
4) The patients who provided their informed consent to participate in the study
Key exclusion criteria
1) The patients with contraindication to denosumab and bisphosphonate
2) The patients who used zoledronic acid or denosumab previously
3) The patients who used teriparatide previously
4) The patients who are not included other intervention study
7) Those who are not approved to be eligible to this study by corresponding researcher
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Okano |
Organization
Osaka City University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan
TEL
06-6645-3851
ma1sa3ru@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Okano |
Organization
Osaka City University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan
TEL
06-6645-3851
Homepage URL
ma1sa3ru@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 01 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 15 | Day |
Last modified on
| 2018 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035188
