Study period | ||||||||
---|---|---|---|---|---|---|---|---|
Enrollment | Allocation | Post allocation | Close out | Follow-up | ||||
Time point (month) | − 1 | 0 | 1 | 2 | 3 | 6 | ||
Preparation | Enrollment | |||||||
Informed consent | √ | |||||||
Eligibility screen | √ | |||||||
Allocation | √ | |||||||
Intervention | OA | √ | √ | √ | ||||
SA | √ | √ | √ | |||||
Assessment | Liver function Kidney function | √ | ||||||
T; BP; P; R | √ | √ | √ | √ | ||||
BMD | √ | √ | ||||||
E2; FSH | √ | |||||||
BGP; BALP | √ | |||||||
TAC; AOPP | √ | |||||||
FoxO3a; β-catenin PPARγ | √ | |||||||
VAS | √ | √ | √ | √ | √ | |||
TCM syndrome | √ | √ | ||||||
QOL | √ | √ | ||||||
Adverse events | √ | |||||||
Data analysis | √ | |||||||
Fracture rate | √ |