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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000728
Receipt No. 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

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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
Obsterics 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
Institute JOCC [Japan Osteoporosis Central-committee for Compliance study]
Institute
Department

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
URL(English) https://upload.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


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