Table 1.
Baseline demographic and key characteristics for all subjects who entered the month 0 to 24 double-blind period and were assigned to no further active treatment or zoledronate from months 48 to 72
| Initial study baseline (month 0) | Month 48 baseline | |||
|---|---|---|---|---|
| No further active treatmenta (N = 51) | Zoledronate 5 mg IV single doseb (N = 90) |
No further active treatmenta (N = 51) | Zoledronate 5 mg IV single doseb (N = 90) |
|
| Age, mean (SD), years | 67.2 (6.4) | 65.8 (5.6) | 71.8 (6.4) | 70.3 (5.6) |
| BMD T-score, mean (SD) | ||||
| Lumbar spine | − 2.32 (0.54) | − 2.34 (0.64) | − 1.04 (0.88) | − 1.28 (0.83) |
| Total hip | − 1.63 (0.61) | − 1.42 (0.61) | − 1.29 (0.65) | − 1.16 (0.63) |
| Femoral neck | − 1.98 (0.54) | − 1.86 (0.55) | − 1.70 (0.56) | − 1.63 (0.61) |
| Serum P1NP, median (Q1, Q3), μg/L | 51.2 (37.4, 64.5) | 49.9 (39.2, 60.8) | 66.8 (51.0, 90.4) | 46.7 (33.2, 54.3) |
| Serum β-CTX, median (Q1, Q3), ng/mL | 0.54 (0.42, 0.65) | 0.48 (0.37, 0.63) | 0.55 (0.44, 0.82) | 0.38 (0.30, 0.49) |
N = number of subjects assigned to treatment groups from months 48 to 72
No further active treatment: Subjects randomized to romosozumab (any dose or schedule) in the month 0–24 double-blind period, received denosumab 60 mg Q6M in the month 24–36 extension period, received a second course of romosozumab 210 mg QM from months 36 to 48, and received no further active treatment from months 48 to 72
Zoledronate 5 mg IV single dose: Subjects randomized to romosozumab (any dose or schedule) or placebo in the month 0 to 24 double-blind period, received denosumab or placebo in the month 24 to 36 extension period, received a second course of romosozumab 210 mg QM from months 36 to 48, and received a single IV dose of zoledronate 5 mg from months 48 to 72
aIncludes all subjects who enrolled in the month 48 to 72 follow-on phase assigned to no further active treatment including 1 subject who had been randomized to placebo in the initial 24 months and was incorrectly assigned to no further active treatment
bIncludes 2 subjects who were incorrectly assigned to zoledronate from months 48 to 72 and 3 subjects who were assigned to zoledronate at month 48 but did not receive treatment
β-CTX β-isomer of the C-terminal telopeptide of type I collagen, BMD bone mineral density, IV intravenous, P1NP procollagen type 1 N-terminal propeptide, Q1 quartile 1, Q3 quartile 3, SD standard deviation