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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041937
Receipt No. 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 2021/03/02

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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
Email 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
Email kondosts@chugai-pharm.co.jp

Sponsor
Institute CHUGAI PHARMACEUTICAL CO.,LTD.
Medical Science Dept.
Institute
Department

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
Email 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 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 Preinitiation
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
2021 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047866

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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