Unique ID issued by UMIN | UMIN000000728 |
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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 |
Compliance study Medication Event Monitoring System-Utilizing Survey on Bisphosphonate Compliance in Osteoporotic Patients in Japan
JOCC
Compliance study Medication Event Monitoring System-Utilizing Survey on Bisphosphonate Compliance in Osteoporotic Patients in Japan
JOCC
Japan |
Osteoporotic
Medicine in general | Endocrinology and Metabolism | Geriatrics |
Obstetrics and Gynecology | Orthopedics |
Others
NO
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
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
Confirmatory
Pragmatic
Not applicable
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
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.)
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
NO
NO
NO
Central registration
2
Prevention
Medicine | Behavior,custom |
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
Not applicable |
Not applicable |
Male and Female
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.
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.
550
1st name | |
Middle name | |
Last name | Yoshiki Nishizawa |
JOCC (Japan Osteoporosis Central committee for Compliance study)
JOCC leader
1-4-3, Asahi-machi, Abeno, Osaka 545-8585, Japan(Professor of Internal MedicineDepartment of Metabolism, Endocrinology & Molecular Medicine)
06-6645-3806
1st name | |
Middle name | |
Last name | Midori Amano |
IHMA JAPAN
IHMA JAPAN
0120-34-1989
http://www.joccweb.org/
info@joccweb.org
JOCC [Japan Osteoporosis Central-committee for Compliance study]
Institute of Applied Biochemistry
Non profit foundation
Japan
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
None
NO
2007 | Year | 06 | Month | 30 | Day |
http://www.joccweb.org/
Unpublished
http://www.joccweb.org/
The results of independent research are summarized in progress report. We paid based on the National Diet Library's deposit system.
No longer recruiting
2006 | Year | 03 | Month | 01 | Day |
2006 | Year | 03 | Month | 01 | Day |
2008 | Year | 06 | Month | 01 | Day |
2008 | Year | 07 | Month | 01 | Day |
2009 | Year | 11 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
None
2007 | Year | 06 | Month | 01 | Day |
2019 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000873
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