Trial flowchart
| Items | Before enrolment | Baseline period | Treatment period | Treatment for 8 weeks |
| Recruitment | √ | |||
| Enrolment | √ | |||
| Inclusion criteria | √ | |||
| Exclusion criteria | √ | |||
| Informed consent | √ | √ | ||
| Basic characteristic variables | √ | √ | √ | |
| Randomisation and allocation concealment | √ | √ | √ | |
| Primary outcomes | ||||
| BTM (bone formation) | ||||
| ALP | √ | √ | ||
| BGP | √ | √ | ||
| PINP | √ | √ | ||
| BTM (bone resorption) | ||||
| β-CTX | √ | √ | ||
| Urinary Ca/Cr | √ | √ | ||
| PTH (parathyroid hormone) | √ | √ | ||
| Secondary outcomes | ||||
| BMD (DXA) | √ | √ | ||
| BMD (QCT) | √ | √ | ||
| Blood phosphate | √ | √ | ||
| Blood calcium | √ | √ | ||
| Safety evaluation | ||||
| Pain | √ | √ | √ | |
| Redness and swelling of the skin | √ | √ | √ | |
ALP, alkaline phosphatase; BGP, bone glaprotein; BMD, bone mineral density; BTM, bone turnover marker; DXA, dual-energy X-ray absorptiometry; PINP, procollagen type I N-terminal propeptide; QCT, quantitative computed tomography.