Period | Pre-selection | Inclusion | Follow-up | End of the study |
---|---|---|---|---|
Week (W) | W0 | W12 | W24 | |
Pre-inclusion criteria | X | |||
Inclusion/Non-inclusion criteria | X | |||
Informed consent | X | |||
Inclusion clinical examination | X | |||
Analysis of posture and gait | X | X | X | |
Assigning a 'Patient's kit'according to inclusion number in compliance with randomization lists | X | |||
Serum 25OHD measurement | X | X | X | |
Serum calcium measurement | X | X | X | |
Serum parathyroid hormone measurement | X | X | X | |
Treatment administration | X | |||
Compliance (account of fully consumed vials) | X | X | ||
Follow-up clinical examination | X | X | ||
Cognitive scores (including ADAS-cog) | X | X | X | |
Functional scores | X | X | X | |
AEs and SAEs | X | X | X |