NIPH Clinical Trials Search

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


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 criteria
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


public contact
Name Midori Amano
Address Japan
Telephone 0120-34-1989
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
Affiliation JOCC (Japan Osteoporosis Central committee for Compliance study) JOCC leader