TABLE 2.
Least squares mean vBMD percentage change from baseline at the lumbar spine (integral, cortical, and trabecular) with romosozumab or alendronate treatment at months 6, 12, and 24
| Least squares mean vBMD percentage change from baseline | ||||
|---|---|---|---|---|
| Parameter |
Romosozumab/alendronate (n = 40) % (95% CI) |
Alendronate/alendronate (n = 36) % (95% CI) |
Difference (romosozumab − alendronate) % (95% CI) |
p for difference |
| Month 6 | ||||
| Integral | 17.7 (14.5, 20.8)* | 5.6 (3.7, 7.6)* | 12.0 (8.3, 15.8) | p < 0.001 |
| Cortical | 13.4 (11.3, 15.6)* | 4.6 (2.8, 6.4)* | 8.9 (6.1, 11.7) | p < 0.001 |
| Trabecular | 20.7 (14.8, 26.6)* | 3.8 (−3.3, 11.0) † | 16.9 (7.5, 26.2) | p < 0.001 |
| Difference (trabecular minus cortical) | 7.5 (3.0, 11.9); p = 0.001 | −1.0 (−8.0, 6.0); p = 0.780 | 8.5 (0.2, 16.7) | p = 0.045 |
| Month 12 | ||||
| Integral | 21.9 (18.8, 25.1)* | 7.3 (5.0, 9.7)* | 14.6 (10.7, 18.5) | p < 0.001 |
| Cortical | 16.1 (13.7, 18.5)* | 5.9 (4.0, 7.7)* | 10.2 (7.2, 13.3) | p < 0.001 |
| Trabecular | 25.4 (19.4, 31.3)* | 5.9 (−1.6, 13.5) † | 19.4 (9.8, 29.1) | p < 0.001 |
| Difference (trabecular minus cortical) | 9.3 (4.8, 13.9); p < 0.001 | 0.1 (−7.0, 7.0); p = 0.990 | 9.3 (0.9, 17.6) | p = 0.031 |
| Month 24 | ||||
| Integral | 21.4 (17.5, 25.3)* | 7.9 (5.2, 10.6)* | 13.5 (8.7, 18.3) | p < 0.001 |
| Cortical | 17.8 (15.2, 20.5)* | 5.2 (3.2, 7.2)* | 12.7 (9.3, 16.0) | p < 0.001 |
| Trabecular | 21.4 (14.4, 28.4)* | 5.2 (−7.4, 17.8) † | 16.2 (1.7, 30.8) | p = 0.030 |
| Difference (trabecular minus cortical) | 3.9 (−2.3, 10.0); p = 0.220 | −0.3 (−12.9, 12.2); p = 0.960 | 4.2 (−9.9, 18.2) | p = 0.55 |
Notes: n = number of randomized patients enrolled in the QCT/FEA imaging component of the ARCH substudy and with values at baseline and ≥1 postbaseline QCT visit. Month 6 and month 12 measurements were during the double‐blind period where patients received monthly romosozumab 210 mg sc or weekly oral alendronate 70 mg for 12 months; month 24 measurements were during the open‐label period when patients received open‐label weekly oral alendronate 70 mg for 12 months. Data were based on ANCOVA model adjusting for treatment, presence of severe vertebral fracture at baseline, and baseline vBMD value. Missing values were imputed by carrying forward the last nonmissing postbaseline value prior to the missing value and within the treatment period.
Abbreviations: ANCOVA, analysis of covariance; ARCH, Active‐Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk; CI, confidence interval; FEA, finite element analysis; QCT, quantitative computed tomography; vBMD, volumetric bone mineral density.
p < 0.001 versus baseline.
p > 0.05 versus baseline.