UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000728
Receipt number R000000873
Scientific Title Compliance study Medication Event Monitoring System-Utilizing Survey on Bisphosphonate Compliance in Osteoporotic Patients in Japan
Date of disclosure of the study information 2007/06/30
Last modified on 2019/02/06 10:24:29

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Basic information

Public title

Compliance study Medication Event Monitoring System-Utilizing Survey on Bisphosphonate Compliance in Osteoporotic Patients in Japan

Acronym

JOCC

Scientific Title

Compliance study Medication Event Monitoring System-Utilizing Survey on Bisphosphonate Compliance in Osteoporotic Patients in Japan

Scientific Title:Acronym

JOCC

Region

Japan


Condition

Condition

Osteoporotic

Classification by specialty

Medicine in general Endocrinology and Metabolism Geriatrics
Obstetrics and Gynecology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Recording of new- generation bisphosphonate compliance in osteoporotic patients utilizing Medication Event Monitoring System(MEMS bottles) and comparing the group receiving positive compliance instruction with the one receiving ordinary compliance instruction

Basic objectives2

Others

Basic objectives -Others

RE(-) group: under ordinary compliance instruction (in routine clinical practices)
RE(+) group: under positive compliance instruction by giving patients feedback based on measured results of urinary NTX and interview sheets

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Urinary NTX
1 Primary assessment item: the rate of compliance using MEMS bottles (RE(-)group, RE(+)group)
2 Comparison of compliance rates by covariance analysis, and examination of the correlation between compliance and chronological transition of urinary NTX, using trend test

Key secondary outcomes

1 Secondary assessment items:
a. the correlation between compliance and chronological transition of urinary NTX (CTX)
b. stratified analysis of backgrounds of patients (birth date, sex, body height, body mass, complication, age of menopause, history of bone fracture during osteoporosis, etc.)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine Behavior,custom

Interventions/Control_1

RE(-)group: under ordinary compliance instruction (in routine clinical practices)

Interventions/Control_2

RE(+)group: under positive compliance instruction by giving patients feedback based on measured results of urinary NTX and interview sheets

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

2) subjects of survey are patients that were diagnosed as osteoporosis based on diagnosis manual for primary and secondary osteoporosis (cf.figure1) and that are (or to be) given new-generation bisphosphonate
2) aged 20 or over, hospitalized or outpatient
3) patients who submitted written consent
#grounds for each criterion
1) :this study is intended for osteoporosis patients. Male patients, for whom the safety of the drug to be evaluated in this study has not been verified yet, should be paid special attention in medication.
2)and 3):set with ethical concerns.

Key exclusion criteria

1) patients who have difficulty using a MEMS bottle
2) patients judged unsuitable as the subjects of this study by a doctor in charge
#grounds for each criterion
1) : difficult to assess in this study
2) : set in order to exclude cases other than 1) inappropriate for this study.

Target sample size

550


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Nishizawa

Organization

JOCC (Japan Osteoporosis Central committee for Compliance study)

Division name

JOCC leader

Zip code


Address

1-4-3, Asahi-machi, Abeno, Osaka 545-8585, Japan(Professor of Internal MedicineDepartment of Metabolism, Endocrinology & Molecular Medicine)

TEL

06-6645-3806

Email



Public contact

Name of contact person

1st name
Middle name
Last name Midori Amano

Organization

IHMA JAPAN

Division name

IHMA JAPAN

Zip code


Address


TEL

0120-34-1989

Homepage URL

http://www.joccweb.org/

Email

info@joccweb.org


Sponsor or person

Institute

JOCC [Japan Osteoporosis Central-committee for Compliance study]

Institute

Department

Personal name



Funding Source

Organization

Institute of Applied Biochemistry

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

IHMA JAPAN: location of JOCC office, in charge of data management
Japanese Association for the Promotion of State of the Art in Medicine: in charge of CRF and CRO control

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization


Address


Tel


Email



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

2007 Year 06 Month 30 Day


Related information

URL releasing protocol

http://www.joccweb.org/

Publication of results

Unpublished


Result

URL related to results and publications

http://www.joccweb.org/

Number of participants that the trial has enrolled


Results

The results of independent research are summarized in progress report. We paid based on the National Diet Library's deposit system.

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

No longer recruiting

Date of protocol fixation

2006 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2006 Year 03 Month 01 Day

Last follow-up date

2008 Year 06 Month 01 Day

Date of closure to data entry

2008 Year 07 Month 01 Day

Date trial data considered complete

2009 Year 11 Month 01 Day

Date analysis concluded

2010 Year 03 Month 01 Day


Other

Other related information

None


Management information

Registered date

2007 Year 06 Month 01 Day

Last modified on

2019 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000873


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name