UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018333 |
|---|---|
| Receipt number | R000021217 |
| Scientific Title | Post marketing surveillance of Edirol |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2016/05/20 14:13:05 |
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Basic information
Public title
Post marketing surveillance of Edirol
Acronym
Post marketing surveillance of Edirol
Scientific Title
Post marketing surveillance of Edirol
Scientific Title:Acronym
Post marketing surveillance of Edirol
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Medicine in general | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
-Adverse drug reaction under conditions of actual drug use
- Factors potentially affecting safety or efficacy
- Safety and efficacy in male patients
- Hypercalcemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse reaction incidence
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 who have no previous treatment with Edirol for osteoporosis
Key exclusion criteria
No criteria
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Joji Mochizuki |
Organization
Chugai Pharmaceutical Co.Ltd
Division name
Pharmacovigilance Dept
Zip code
Address
1-1 Nihonbashi-muromachi 2-chome,Chuo-ku Tokyo,Japan
TEL
03-3273-0905
mochizukijuj@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Nomura |
Organization
Chugai Pharmaceutical Co.Ltd
Division name
Pharmacovigilance Dept
Zip code
Address
1-1 Nihonbashi-muromachi 2-chome,Chuo-ku Tokyo,Japan
TEL
03-3273-0905
Homepage URL
nomuramkt@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co.Ltd
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical 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
| 2015 | Year | 08 | 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
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Adverse events
Bone massdensity, bone metabolism marker
and fracture
Management information
Registered date
| 2015 | Year | 07 | Month | 16 | Day |
Last modified on
| 2016 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021217
