Table 1 The schedule of pre-screening, interventions, and assessments
Assessment | Pre-screening | Baseline | Monitoring | Withdrawal | |||
|---|---|---|---|---|---|---|---|
Time | Day 60~ −1 | Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | |
Visit | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | |
Informed consent | ○ | – | – | – | – | – | – |
Baseline characterization check | ○ | – | – | – | – | – | – |
Adherence check | – | – | • | • | • | • | • |
Concomitant treatments |
| ||||||
Adverse events | – |
| |||||
Vital signs | ○ | ○ | • | • | • | • | • |
Laboratory data | – | ○ | • | • | • | • | • |
X-ray | – | ○ | – | – | – | • | – |
DXA (BMD measurement) | – | ○ | – | – | – | • | – |
HR-pQCT | – | ○ | – | – | – | • | • |
