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. 2019 Nov 6;20(22):5525. doi: 10.3390/ijms20225525

Table 3.

Patient characteristics and outcomes of clinical trials with romosozumab. PMO: postmenopausal osteoporosis, M with OP: men with osteoporosis, romo.: romosozumab, deno.: denosumab, TPTD: teriparatide, ALN: alendronate, M: every month(s), W: every week, D: every day, BMD: bone mineral density.

Study Patient Group Participants Age Protocol Length BMD (%) New Fracture (%) Bone Turnover Marker (Maximum %)
[Ref No.] (N) (Year) Lumber Spine Total Hip P1NP CTX
FRAME [125,126] PMO All 7180 70.8 12months after 24 months on day 14
Treatment 3589 70.9 210mg romo./1M ⇒60mg deno./6M +17.6 +8.8 0.6 +150 −50
Control 3591 70.8 placebo/1M ⇒60mg deno./6M 12months +5.0 +2.9 2.5 no change no change
STRUCTURE [125,127] PMO All 436 71.5 12months no data on day 14
Treatment 218 71.8 210mg romo./1M +9.8 +2.9 +180 +30
Control 218 71.2 20μg TPTD/1D +5.4 −0.5 +30 no change
ARCH [125,128] PMO All 4093 74.3 12months after 24 months on 1 month
Treatment 2046 74.4 210mg romo./1M ⇒70mg ALN./1W +14.9 +8.5 6.2 +80 −40
Control 2047 74.2 70mg ALN./1W ⇒70mg ALN./1W 24months +7.0 +3.6 11.9 −10 −60
BRIDGE [129] M with OP All 245 72.1 no data on 1 month
Treatment 163 72.4 210mg romo./1M 12months +12.1 +2.5 +85.8 −30.8
Control 82 71.5 placebo/1M +1.2 −0.5 +1.2 −1.7