Table 1.
Baseline (office visit) |
Follow-up assessmentsa |
|||
---|---|---|---|---|
3 months | 6 months | 12 months | ||
Physician questionnaireb | √ | |||
Retrospective chart reviewb | √ | |||
Informed consent and eligibility | √ | |||
Demographics and risk factors for osteoporosis | √ | |||
Osteoporosis disease assessment | √ | |||
Medical history | √ | |||
Bone mineral density test/T-scorec | √ | √ | √ | √ |
Participant treatment concernsd | √ | √ | √ | √ |
Medications (osteoporosis, GI, vitamin D and calcium)e | √ | √ | √ | √ |
Gastrointestinal events | √ | √ | √ | √ |
Healthcare resource utilization questionnaire | √ | √ | √ | √ |
ADEOS adherence scalea | √ | √ | √ | √ |
Treatment satisfaction questionnaire for medications (OPSAT-Q)a | √ | √ | √ | |
Health related quality of life (EQ-5D-3L) | √ | √ | √ | |
Health related quality of life (OPAQ-SV) | √ | √ | √ | |
New falls and fractures | √ | √ | √ | |
Adverse eventsc | √ | √ | √ |
ADEOS, Adherence Evaluation of Osteoporosis treatment; EQ-5D-3L, European Quality of Life-5 Dimensions; GI, gastrointestinal; OPAQ-SV, Osteoporosis Assessment Questionnaire; OPSAT-Q, Osteoporosis Patient Satisfaction Questionnaire.
Not collected for untreated participants. Study completion/premature discontinuation form was collected for all treated participants. If participant discontinued prior to 12 month follow-up visit, the reason for discontinuation, including death and death date (if applicable), was recorded.
The physician questionnaire and retrospective chart review were completed prior to the commencement of the prospective component of the study. Physician questionnaire was completed by the Principal Investigator at all sites. The retrospective chart review was completed by a randomly selected subset of sites.
Collected by the physician during any clinical office visit, if applicable.
Collected for untreated and treated participants at baseline and for treated patients thereafter.
At baseline, all applicable medications were recorded, while during follow-up only those medications that had been changed or discontinued were recorded.