UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013412
Receipt number R000015652
Scientific Title BONVIVA IV drug use results surveillance
Date of disclosure of the study information 2014/03/17
Last modified on 2019/09/19 09:13:43

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Basic information

Public title

BONVIVA IV drug use results surveillance

Acronym

BONVIVA IV drug use results surveillance

Scientific Title

BONVIVA IV drug use results surveillance

Scientific Title:Acronym

BONVIVA IV drug use results surveillance

Region

Japan


Condition

Condition

Osteoporosis

Classification by specialty

Medicine in general Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

(1)Adverse drug reaction (ADR) status/incidence
(2)Confirmation of the unexpected ADRs
(3)Identification and confirmation of factors which affect safety and efficacy(bone mass density, bone metabolism marker and fracture) profiles
(4)Confirmation of safety and efficacy profiles of male patients

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 BONVIVA for osteoporosis

Key exclusion criteria

No criteria

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Nomura

Organization

Chugai Pharmaceutical Co. Ltd.

Division name

Real World Data Science Dept.

Zip code

103-8324

Address

1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan

TEL

03-3273-0769

Email

nomuramkt@chugai-pharm.co.jp


Public contact

Name of contact person

1st name Ayaka
Middle name
Last name Shimizu

Organization

Chugai Pharmaceutical Co. Ltd.

Division name

Real World Data Science Dept.

Zip code

103-8324

Address

1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan

TEL

03-3273-0905

Homepage URL


Email

shimizuayk@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

None

Address

None

Tel

None

Email

None


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

2014 Year 03 Month 17 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

2014 Year 02 Month 14 Day

Date of IRB

2014 Year 02 Month 14 Day

Anticipated trial start date

2014 Year 03 Month 10 Day

Last follow-up date

2016 Year 02 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Adverse events
Bone mass density,bone metabolism marker and fracture


Management information

Registered date

2014 Year 03 Month 13 Day

Last modified on

2019 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015652


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name