Table1 Clinical trials of romosozumab efficacy

Phase1

72 healthy men and PM women

Safety and efficacy

Maximum BMD increase LS 5.3%; TH 2.8%; tolerant

Phase2

419 PM women with low BMD

70, 140, or 210 mg s.c. monthly or 140 or 210 mg s.c. Q3M (12 months)

LS11.3%; TH 4.1%; FN (3.7%);

Maximum BMD increase in the 210 mg s.c monthly

48 participants with low bone mass

Dose and administration intervals study

Maximum BMD increase

LS 7%; TH 3%;

252 participants with OP

Dose and administration intervals study

LS 11.3%; TH 4.7%; FN 3.8%; Maximum BMD increase in the 210 mg s.c monthly

Phase3

7180 PM patients with OP (FRAME)

Fracture risk and efficacy

The new fracture risk and clinical fracture risk are lower

436 patients with OP (STRUCTURE)

Efficacy compared with teriparatide after bisphosphonates treatment

Higher BMD (TH 3.2%; FN 3.4%; LS 4.4%)

4093 women with OP

(ARCH)

Fracture risk compared with alendronate

BMD increased at LS, TH, and FN at every timepoints;

The new fracture risk and clinical fracture risk are lower

245 men with OP

(BRIDGE)

Efficacy in male patients

Higher BMD (LS 12.1%; TH 2.5%; FN 2.2%)

76 PM women with OP

Efficacy

Higher BMD (LS 9.5%; TH 2.9%; FN 3.0%)