Table 1.
Baseline demographics and disease characteristics of the intention-to-treat population
|
Intensive pathway |
Non-intensive pathway |
||||
|---|---|---|---|---|---|
| Zoledronic acid (n=555) | Clodronic acid (n=556) | Zoledronic acid(n=426) | Clodronic acid (n=423) | ||
| Age (years; median, range) | 59 (31–74) | 59 (33–78) | 73 (59–89) | 73 (57–88) | |
| Sex | |||||
| Female | 201 (36%) | 218 (39%) | 191 (45%) | 185 (44%) | |
| Male | 354 (64%) | 338 (61%) | 235 (55%) | 238 (56%) | |
| Ethnic origin | |||||
| White | 537 (97%) | 534 (96%) | 412 (97%) | 415 (98%) | |
| Black African | 2 (<1%) | 8 (1%) | 2 (<1%) | 2 (<1%) | |
| Black Caribbean | 2 (<1%) | 5 (<1%) | 6 (1%) | 1 (<1%) | |
| Chinese | 7 (1%) | 6 (1%) | 1 (<1%) | 2 (<1%) | |
| Polynesian | 1 (<1%) | 0 | 0 | 0 | |
| Other | 6 (1%) | 1 (<1%) | 3 (<1%) | 1 (<1%) | |
| Data not available | 0 | 2 (<1%) | 2 (<1%) | 2 (<1%) | |
| International Staging System stage | |||||
| I | 129 (23%) | 146 (26%) | 63 (15%) | 47 (11%) | |
| II | 198 (36%) | 182 (33%) | 139 (33%) | 173 (41%) | |
| III | 174 (31%) | 169 (30%) | 173 (41%) | 160 (38%) | |
| Data not available | 54 (10%) | 59 (11%) | 51 (12%) | 43 (10%) | |
| Hyperdiploidy | |||||
| Yes | 159 (29%) | 171 (31%) | 117 (27%) | 132 (31%) | |
| No | 133 (24%) | 132 (24%) | 87 (20%) | 76 (18%) | |
| Data not available | 263 (47%) | 253 (46%) | 222 (52%) | 215 (51%) | |
| Bone disease | |||||
| Yes | 404 (73%) | 411 (74%) | 291 (68%) | 295 (70%) | |
| No | 149 (27%) | 138 (25%) | 130 (31%) | 123 (29%) | |
| Data not available | 2 (<1%) | 7 (1%) | 5 (1%) | 5 (1%) | |
| Bone disease or other skeletal-related event | |||||
| Yes | 393 (71%) | 406 (73%) | 275 (65%) | 276 (65%) | |
| No | 159 (29%) | 141 (25%) | 143 (34%) | 135 (32%) | |
| Data not available | 3 (<1%) | 9 (2%) | 8 (2%) | 12 (3%) | |
| Bone pain | |||||
| Yes | 428 (77%) | 415 (75%) | 275 (65%) | 287 (68%) | |
| No | 120 (22%) | 132 (24%) | 147 (35%) | 131 (31%) | |
| Data not available | 7 (1%) | 9 (2%) | 4 (<1%) | 5 (1%) | |
| Baseline radiotherapy to bone | |||||
| Yes | 80 (14%) | 86 (15%) | 43 (10%) | 49 (12%) | |
| No | 473 (85%) | 469 (84%) | 382 (90%) | 372 (88%) | |
| Data not available | 2 (<1%) | 1 (<1%) | 1 (<1%) | 2 (<1%) | |
| Baseline vertebral fractures | |||||
| Yes | 152 (27%) | 166 (30%) | 114 (27%) | 130 (31%) | |
| No | 388 (70%) | 373 (67%) | 302 (71%) | 286 (68%) | |
| Data not available | 15 (3%) | 17 (3%) | 10 (2%) | 7 (2%) | |
| Other baseline fractures | |||||
| Yes | 74 (13%) | 73 (13%) | 42 (10%) | 42 (10%) | |
| No | 460 (83%) | 460 (83%) | 376 (88%) | 371 (88%) | |
| Data not available | 21 (4%) | 23 (4%) | 8 (2%) | 10 (2%) | |
| Baseline osteolytic lesions | |||||
| Yes | 303 (55%) | 293 (53%) | 209 (49%) | 205 (48%) | |
| No | 239 (43%) | 247 (44%) | 212 (50%) | 207 (49%) | |
| Data not available | 13 (2%) | 16 (3%) | 5 (1%) | 11 (3%) | |
| Calcium after hydration (mmol/L) | |||||
| Median (IQR) | 2·4 (2·2–2·5) | 2·4 (2·3–2·5) | 2·4 (2·2–2·5) | 2·4 (2·3–2·5) | |
| Data not available | 37 (7%) | 51 (9%) | 37 (9%) | 37 (9%) | |
Data are number (%), unless otherwise indicated. Data, in part, from Morgan and colleagues.12