Table 4.
Association Between Bisphosphonates (BP) Given Before and/or After Denosumab (Dmab) and Vertebral Fractures (VFs, MVFs, NVFs) in the Rebound Period (Period 3)
| Bisphosphonate | Risk of VFs | Multiple VFs | No. of VFs | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No VF in period 3 | VFs in period 3 | HR | p Value | No MVF in period 3 | MVF in period 3 | OR | p Value | IRR | p Value | |
| No BP (reference) | 70 (63.6%) | 40 (36.4%) | — | — | 70 (67.3%) | 34 (32.7%) | — | — | — | — |
| BP before Dmab only | 120 (87.6%) | 17 (12.4%) | 0.24 | <0.0001 | 120 (92.3%) | 10 (7.7%) | 0.20 | 0.001 | 0.220 | <0.0001 |
| BP after Dmab only | 170 (97.1%) | 5 (2.9%) | 0.042 | <0.0001 | 170 (98.3%) | 3 (1.7%) | 0.06 | <0.0001 | 0.059 | <0.0001 |
| BP before and after | 235 (97.1%) | 7 (2.9%) | 0.048 | <0.0001 | 235 (99.2%) | 2 (0.8%) | 0.03 | <0.0001 | 0.039 | <0.0001 |
VFs = vertebral fractures; MVFs = multiple vertebral fractures; NVFs = number of vertebral fractures; HR = hazard ratio; OR = odds ratio.
Patients who got bisphosphonates after denosumab (period 3) only after having suffered a VF are considered as having received no BP after denosumab. The total number of patients in this analysis is 664, while the study total is 797 patients, because exact information on the treatment with bisphosphonates was missing in 133 cases.