TABLE 1.
Baseline demographic and clinical characteristics of patients in the ARCH QCT/FEA substudy and the ARCH overall study
| Patients included in the ARCH QCT/FEA substudy | Patients included in the ARCH overall study | |||
|---|---|---|---|---|
| Characteristic | Romosozumab/alendronate n = 49 | Alendronate/alendronate n = 41 | Romosozumab/alendronate n = 2046 | Alendronate/alendronate n = 2047 |
| Age (years), mean ± SD | 73.1 ± 7.1 | 72.8 ± 7.6 | 74.4 ± 7.5 | 74.2 ± 7.5 |
| aBMD T‐score, mean ± SD | ||||
| Lumbar spine | −2.8 ± 1.2 | −3.4 ± 1.0 | −2.9 ± 1.3 | −3.0 ± 1.2 |
| Total hip | −2.7 ± 0.7 | −2.8 ± 0.7 | −2.8 ± 0.7 | −2.8 ± 0.7 |
| Femoral neck | −2.8 ± 0.4 | −2.8 ± 0.5 | −2.9 ± 0.5 | −2.9 ± 0.5 |
| QCT lumbar spine vBMD (mg/cm3), mean ± SD | ||||
| Integral | 130.3 ± 25.0 | 120.5 ± 27.5 | ND | ND |
| Cortical | 284.6 ± 41.8 | 270.9 ± 51.4 | ND | ND |
| Trabecular | 60.1 ± 18.0 | 53.7 ± 20.6 | ND | ND |
| FEA vertebral strength (N), mean ± SD | ||||
| Integral | 3459 ± 906 | 3192 ± 775 | ND | ND |
| Cortical | 2105 ± 467 | 1988 ± 431 | ND | ND |
| Trabecular | 1354 ± 514 | 1203 ± 422 | ND | ND |
| Previous osteoporotic fracture at ≥45 years of age, n1 (%) | 48 (98.0) | 41 (100.0) | 2022 (98.8) | 2029 (99.1) |
| Prevalent vertebral fracture, n1 (%) | 46 (93.9) | 41 (100.0) | 1969 (96.2) | 1964 (95.9) |
| Severe | 27 (55.1) | 24 (58.5) | 1369 (66.9) | 1321 (64.5) |
| Previous nonvertebral fracture at ≥45 years of age, n1 (%) | 23 (46.9) | 16 (39.0) | 767 (37.5) | 770 (37.6) |
| History of hip fracture, n1 (%) | 3 (6.1) | 0 (0) | 175 (8.6) | 179 (8.7) |
Notes: Previous osteoporotic fractures include both nonvertebral and prevalent vertebral fractures, excluding high trauma and pathologic fractures. 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 or number of randomized patients enrolled in the ARCH overall study. n1 = number of patients with the characteristic.
Abbreviations: aBMD, areal bone mineral density; ARCH, Active‐Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk; FEA, finite element analysis; ND, not determined; QCT, quantitative computed tomography; vBMD, volumetric bone mineral density.