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

UMIN ID: UMIN000000728

Registered date:30/06/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Osteoporotic
• Date of first enrollment: 2006/03/01
• Target sample size: 550
• Countries of recruitment: Japan
• Study type: Interventional

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 Outcome: 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
• Secondary Outcome: 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.)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: JOCC [Japan Osteoporosis Central-committee for Compliance study]
• Secondary 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
• Source(s) of Monetary Support: Institute of Applied Biochemistry,None