▪ The Phase II ASTEROID trial with setrusumab in osteogenesis imperfecta (OI) disappointingly missed the primary endpoint of an improvement in trabecular volumetric bone mineral density (Tr vBMD) of the radius (wrist) measured by HR-pQCT, but did hit various secondary endpoints. ▪ There was unexpected heterogeneity in patient’s trabecular bone baseline values in their wrists (high and low), which contributed to the primary endpoint being missed. ▪ There were, however, significant increases in total vBMD (measured using HR-pQCT) of the radius in both the medium and high dose arms; mean increase in vBMD were 4.11% (p=0.004) with high dose, 4.5% (p=0.028) with medium dose, and 0.58% (p=0.97) with low dose.
11 Nov 2019
Setrusumab set to advance
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Setrusumab set to advance
- Published:
11 Nov 2019 -
Author:
Mick Cooper PhD -
Pages:
2
▪ The Phase II ASTEROID trial with setrusumab in osteogenesis imperfecta (OI) disappointingly missed the primary endpoint of an improvement in trabecular volumetric bone mineral density (Tr vBMD) of the radius (wrist) measured by HR-pQCT, but did hit various secondary endpoints. ▪ There was unexpected heterogeneity in patient’s trabecular bone baseline values in their wrists (high and low), which contributed to the primary endpoint being missed. ▪ There were, however, significant increases in total vBMD (measured using HR-pQCT) of the radius in both the medium and high dose arms; mean increase in vBMD were 4.11% (p=0.004) with high dose, 4.5% (p=0.028) with medium dose, and 0.58% (p=0.97) with low dose.