The bone mineral density (BMD) T score critical value of below - 1.5 is consistent with proposed european regulatory guidelines (Compston JE et al). This chosen T score of below -1.5 is similar to the baseline mean T score (-1.44) of 128 placebo-treated patients studied by Adachi et al, amongst whom 15% experienced a new vertebral fracture (defined as >20% loss in vertebral body height) over 12 months - Grade B.
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