UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Post marketing surveillance of Edirol
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Joji Mochizuki
Organization	Chugai Pharmaceutical Co.Ltd
Division name	Pharmacovigilance Dept
Address	1-1 Nihonbashi-muromachi 2-chome,Chuo-ku Tokyo,Japan
TEL	03-3273-0905
Email	mochizukijuj@chugai-pharm.co.jp

Public contact
Name of contact person	Makoto Nomura
Organization	Chugai Pharmaceutical Co.Ltd
Division name	Pharmacovigilance Dept
Address	1-1 Nihonbashi-muromachi 2-chome,Chuo-ku Tokyo,Japan
TEL	03-3273-0905
Homepage URL
Email	nomuramkt@chugai-pharm.co.jp

Sponsor
Institute	Chugai Pharmaceutical Co.Ltd
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021217