NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000728

Registered date:30/06/2007

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

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedOsteoporotic
Date of first enrollment2006/03/01
Target sample size550
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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

Outcome(s)

Primary OutcomeUrinary 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
Secondary Outcome1 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.)

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria2) 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.
Exclude criteria1) 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.

Related Information

Contact

public contact
Name Midori Amano
Address Japan
Telephone 0120-34-1989
E-mail info@joccweb.org
Affiliation IHMA JAPAN IHMA JAPAN
scientific contact
Name Yoshiki Nishizawa
Address 1-4-3, Asahi-machi, Abeno, Osaka 545-8585, Japan(Professor of Internal MedicineDepartment of Metabolism, Endocrinology & Molecular Medicine) Japan
Telephone 06-6645-3806
E-mail
Affiliation JOCC (Japan Osteoporosis Central committee for Compliance study) JOCC leader