UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041937 |
|---|---|
| Receipt number | R000047866 |
| Scientific Title | Survey of major adverse events in osteoporotic patients using eldecalcitol and bisphosphonates |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2022/02/16 15:58:27 |
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Basic information
Public title
Survey of major adverse events in osteoporotic patients using eldecalcitol and bisphosphonates
Acronym
Survey of major adverse events in osteoporotic patients using eldecalcitol and bisphosphonates
Scientific Title
Survey of major adverse events in osteoporotic patients using eldecalcitol and bisphosphonates
Scientific Title:Acronym
Survey of major adverse events in osteoporotic patients using eldecalcitol and bisphosphonates
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Orthopedics |
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey of major adverse events in osteoporotic patients using eldecalcitol and bisphosphonates
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of Hypercalcemia, acute kidney injury, urinary calculus, osteonecrosis of jaw, atypical femoral fracture
Key secondary outcomes
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
Patients with osteoporosis who started eldecalcitol or bisphosphonate
Key exclusion criteria
Patients whose gender and age information on the first prescription date cannot be confirmed
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kondo |
Organization
CHUGAI PHARMACEUTICAL CO.,LTD.
Division name
Medical Science Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-Chome,Chuo-Ku Tokyo
TEL
03-3273-0866
kondosts@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kondo |
Organization
CHUGAI PHARMACEUTICAL CO.,LTD.
Division name
Medical Science Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-Chome,Chuo-Ku Tokyo
TEL
03-3273-0866
Homepage URL
kondosts@chugai-pharm.co.jp
Sponsor or person
Institute
CHUGAI PHARMACEUTICAL CO.,LTD.
Medical Science Dept.
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
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.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
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35041084/
Number of participants that the trial has enrolled
132832
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 01 | Month | 18 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Database research
Management information
Registered date
| 2020 | Year | 09 | Month | 29 | Day |
Last modified on
| 2022 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047866
