TABLE II.
Percent Change from Baseline After 6 and 18 Months of Abaloparatide Compared with Placebo
| 6 Months | 18 Months | |||||
|---|---|---|---|---|---|---|
| Abaloparatide* (N = 250) | Placebo* (N = 250) | P Value | Abaloparatide* (N = 250) | Placebo* (N = 250) | P Value | |
| Trabecular volumetric BMD† | ||||||
| Gruen zone 1 | 7.45 (6.20 to 8.69) | 0.86 (−0.13 to 1.84) | <0.0001 | 10.59 (8.97 to 12.21) | −0.49 (−1.63 to 0.65) | <0.0001 |
| Gruen zone 7 | 8.45 (6.49 to 10.42) | 1.01 (−0.18 to 2.21) | <0.0001 | 12.23 (9.81 to 14.65) | −0.34 (−1.65 to 0.96) | <0.0001 |
| Cortical volumetric BMD | ||||||
| Gruen zone 1 | 0.19 (−0.42 to 0.81) | 0.47 (−0.19 to 1.12) | 0.4687 | 1.49 (0.74 to 2.23) | 0.11 (−0.56 to 0.77) | 0.0067 |
| Gruen zone 2 | 0.44 (−0.21 to 1.09) | 0.12 (−0.56 to 0.80) | 0.5810 | 1.66 (0.94 to 2.38) | −0.26 (−0.93 to 0.41) | 0.0001 |
| Gruen zone 6 | 0.78 (0.14 to 1.43) | 0.24 (−0.31 to 0.80) | 0.2413 | 1.79 (1.13 to 2.45) | −0.27 (−0.86 to 0.32) | <0.0001 |
| Gruen zone 7 | 1.32 (0.49 to 2.16) | 0.60 (−0.21 to 1.41) | 0.2716 | 2.45 (1.58 to 3.31) | 0.05 (−0.89 to 0.98) | 0.0002 |
| Cortical thickness | ||||||
| Gruen zone 1 | 1.10 (0.66 to 1.55) | 0.15 (−0.27 to 0.58) | 0.0030 | 1.60 (1.03 to 2.16) | 0.13 (−0.38 to 0.65) | 0.0002 |
| Gruen zone 2 | 0.54 (0.03 to 1.04) | 0.18 (−0.22 to 0.58) | 0.2909 | 1.50 (0.94 to 2.05) | 0.07 (−0.44 to 0.58) | 0.0002 |
| Gruen zone 6 | 0.82 (0.42 to 1.22) | −0.27 (−0.62 to 0.09) | <0.0001 | 2.22 (1.72 to 2.73) | −0.24 (−0.62 to 0.14) | <0.0001 |
| Gruen zone 7 | 0.76 (0.42 to 1.10) | −0.04 (−0.35 to 0.27) | 0.0009 | 1.79 (1.37 to 2.20) | 0.16 (−0.17 to 0.49) | <0.0001 |
| Cortical surface BMD‡ | ||||||
| Gruen zone 1 | 1.73 (1.09 to 2.38) | 0.41 (−0.20 to 1.02) | 0.0035 | 3.25 (2.46 to 4.03) | −0.06 (−0.78 to 0.65) | <0.0001 |
| Gruen zone 2 | 1.00 (0.30 to 1.70) | 0.42 (−0.13 to 0.98) | 0.2081 | 2.94 (2.19 to 3.69) | −0.16 (−0.81 to 0.49) | <0.0001 |
| Gruen zone 6 | 1.30 (0.70 to 1.90) | −0.09 (−0.58 to 0.41) | 0.0005 | 3.72 (3.03 to 4.41) | −0.50 (−1.06 to 0.05) | <0.0001 |
| Gruen zone 7 | 1.24 (0.76 to 1.71) | 0.16 (−0.23 to 0.55) | 0.0007 | 3.29 (2.74 to 3.84) | −0.08 (−0.52 to 0.36) | <0.0001 |
*
The values for the change from baseline are given as the mean percentage, with the 95% CI in parentheses.
†
Trabecular volumetric BMD change from baseline values for Gruen zones 2 and 6 are not reported because of the minimal amount of trabecular bone remaining postoperatively.
‡
Surface BMD = cortical volumetric BMD × cortical thickness.