Osteoporotic
Conditions
Interventions
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
Sponsors
JOCC [Japan Osteoporosis Central-committee for Compliance study]
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
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary NTX 1Primary assessment item: the rate of compliance using MEMS bottles (RE(-)group, RE(+)group) 2Comparison of compliance rates by covariance analysis, and examination of the correlation between compliance and chronological transition of urinary NTX, using trend test | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.) | — |
Countries
Japan
Contacts
Public ContactMidori Amano
IHMA JAPAN IHMA JAPAN
Outcome results
None listed