Table 1.
Baseline Patient Characteristics
| Month 2 cohort | Month 12 cohort | |||
|---|---|---|---|---|
| Romosozumab | Romosozumab | |||
| Placebo | 210 mg QM | Placebo | 210 mg QM | |
| (N = 18) | (N = 16) | (N = 33) | (N = 40) | |
| Age, years | 72.5 | 70.0 | 70.0 | 72.5 |
| (63.0, 75.0) | (65.0, 73.0) | (66.0, 77.0) | (68.0, 76.0) | |
| BMI, kg/m2 | 24.15 | 24.10 | 23.60 | 23.90 |
| (21.80, 27.20) | (22.75, 26.10) | (21.90, 25.70) | (21.75, 26.30) | |
| Prior osteoporotic fracture, n (%) | 5 (27.8) | 0 (0.0) | 14 (42.4) | 11 (27.5) |
| Prevalent vertebral fracture, n (%) | 3 (16.7) | 0 (0.0) | 3 (9.1) | 9 (22.5) |
| BMD T−score: | ||||
| Lumbar L1 to L4 | −3.12 | −2.77 | −3.00 | −2.88 |
| (−3.55, −2.20) | (−3.41, −1.97) | (−3.60, −2.07) | (−3.46, −1.82) | |
| Total hip | −2.39 | −2.47 | −2.56 | −2.52 |
| (−2.72, −2.21) | (−2.61, −2.01) | (−2.90, −2.13) | (−2.78, −2.21) | |
| Femoral neck | −2.67 | −2.72 | −2.81 | −2.74 |
| (−2.88, −2.55) | (−2.87, −2.61) | (−2.94, −2.64) | (−2.93, −2.60) | |
N = number of randomized patients who enrolled in the bone biopsy substudy, received at least one dose of investigational product, and had an evaluable biopsy. Values are median (Q1, Q3) unless otherwise specified.
Q1, Q3 = quartiles 1 and 3; QM = once monthly.