Cancellous bone histomorphometry after 12 months of DMAb or Pbo
| Index | n | Denosumab (N=17) | n | Pbo (N=12) |
|---|---|---|---|---|
| Structural and static parameters | ||||
| Trabecular bone volume, % | 16 | 7.730 (5.710, 13.320) | 12 | 10.625 (5.985, 13.295) |
| Trabecular number, 1/mm | 16 | 0.725 (0.405, 0.980) | 12 | 0.835 (0.600, 1.045) |
| Osteoid volume, % | 16 | 0.040 (0.010, 0.215)* | 12 | 0.375 (0.240, 1.495) |
| Osteoid surface, % | 16 | 0.495 (0.275, 1.86)* | 12 | 3.735 (2.015, 8.200) |
| Osteoid width, μm | 16 | 5.300 (3.885, 6.985) | 12 | 7.555 (5.915, 9.910) |
| Eroded surface, % | 16 | 0.000 (0.000, 0.060)* | 12 | 0.325 (0.025, 0.585) |
| Dynamic parameters† | ||||
| Mineral apposition rate, μm/d | 6 | 0.695 (0.430, 1.040) | 12 | 0.725 (0.580, 0.850) |
| Mineralization surface, % | 6 | 0.755 (0.500, 1.670) | 12 | 2.075 (1.100, 5.280) |
| Bone formation rate, %/yr | 6 | 3.675 (1.080, 11.060) | 12 | 10.100 (5.320, 28.010) |
| Activation frequency, /yr | 6 | 0.0421 (0.0152, 0.1129) | 12 | 0.1270 (0.0640, 0.4540) |
N=subjects in bone biopsy substudy; n=subjects with observed data.
↵* P<0.02 vs Pbo.
↵† Of 17 biopsies from DMAb subjects, 7 had double labels, 1 single label, 9 no label in the trabecular compartment. Of 8 evaluable samples with either double or single label, 2 with double labels were excluded (1 had label outside measured field and 1 was only evaluable for cortical width).