Table 2.
Subject non-adherence, non-compliance, and non-persistence (efficacy populations)
| Crude rate, n (%) | Absolute ratea reduction | Rate ratioa | p valuea | ||
|---|---|---|---|---|---|
| Denosumab | Alendronate | (95% CI) | (95% CI) | ||
| First year | (n = 126) | (n = 124) | |||
| Adherenceb | 111 (88.1) | 95 (76.6) | |||
| Non-adherence | 15 (11.9) | 29 (23.4) | 10.5 (1.3, 19.7) | 0.54 (0.31, 0.93) | 0.026 |
| Compliancec | 114 (90.5) | 97 (78.2) | |||
| Non-compliance | 12 (9.5) | 27 (21.8) | 11.0 (2.2, 19.7) | 0.48 (0.26, 0.87) | 0.014 |
| Persistenced | 114 (90.5) | 99 (79.8) | |||
| Non-persistence | 12 (9.5) | 25 (20.2) | 9.8 (1.1, 18.5) | 0.50 (0.27, 0.93) | 0.029 |
| Second year | (n = 106) | (n = 115) | |||
| Adherenceb | 98 (92.5) | 73 (63.5) | |||
| Non-adherence | 8 (7.5) | 42 (36.5) | 30.9 (20.6, 41.3) | 0.20 (0.10, 0.41) | <0.001 |
| Compliancec | 99 (93.4) | 78 (67.8) | |||
| Non-compliance | 7 (6.6) | 37 (32.2) | 27.7 (17.6, 37.7) | 0.20 (0.09, 0.43) | <0.001 |
| Persistenced | 103 (97.2) | 82 (71.3) | |||
| Non-persistence | 3 (2.8) | 33 (28.7) | 27.4 (18.1, 36.7) | 0.09 (0.03, 0.30) | <0.001 |
aBased on the Cochran–Mantel–Haenszel method stratified by center and prior osteoporotic fracture
bAdherence was defined as satisfying the criteria for both compliance and persistence
cCompliance was defined as receiving two injections 6 months ± 4 weeks apart (denosumab) or at least 80% of weekly doses (alendronate)
dPersistence was defined as receiving either two injections total (denosumab) or at least two weekly doses in the last month (alendronate), and completing the year of treatment within the allotted time (both groups)