Table 2 Visit schedule
Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | |
|---|---|---|---|---|---|---|
Period | Screening | Baseline | Month 6 | Month 12 | Month 18 | Month 24 |
Day | -7 to -3 | 0 | 180 ± 14 | 360 ± 14 | 540 ± 14 | 720 ± 14 |
Informed consent | X | |||||
In-/exclusion criteria | X | X | ||||
Medical history | X | X | ||||
Prior/Concomitant medication | X | X | X | X | X | X |
Vital signs | X | X | X | |||
Physical examination | X | X | ||||
Adverse events | X | X | X | X | ||
DXA | X | X | X | |||
pQCT | X | X | X | |||
Laboratory test | X | X | X | |||
Bone markers | X | X | X | X | X | X |
Antibody test | X | |||||
Study drug dispensing | X | X | X | X | ||
Drug accountability | X | X | X | X | ||
Study termination sheet | X |