Assessment | Visit 1: screening and baseline | Visit 2: 6 weeks | Visit 3: 3 months | Visit 4: 6 months | Visit 5: 9 months | Visit 6: 12 months |
---|---|---|---|---|---|---|
Screening | ● | |||||
Serum calcium analysis | ●* | ● | ● | |||
Informed consent | ● | |||||
Randomization | ● | |||||
Collection of baseline data (demographic, serum metabolic panel, fracture, and surgical data) | ● | |||||
Nutritional/placebo supplementation** | ● | ● | ● | |||
Assessment of clinical fracture healing (FIX-IT) | ● | ● | ● | ● | ● | |
X-rays of tibia or femur | ● | ● | ● | ● | ● | ● |
Assessment of radiographic fracture healing (RUST) | ● | ● | ● | ● | ● | |
Serum bone marker analysis (CTX and PINP) | ● | ● | ● | |||
Assessment of adherence to supplementation | ● | ● | ||||
Laboratory serum 25(OH)D analysis | ● | ● | ● | |||
Assessment for adverse events | ● | ● | ● | ● | ● | |
Serum PTH level analysis | ● | ● | ● | |||
Assessment of fracture healing complications | ● | ● | ● | ● | ● |