Table 1.
Baseline characteristics of participants at entry to the BoHFAB study from the AZURE study.
| Characteristic | Total (n = 224) | Zoledronate (n = 120) | Control (n = 104) |
|---|---|---|---|
|
Demographics
Age (yr, mean ± SD) Height (cm, mean ± SD) Weight (kg, mean ± SD) BMI (kg/m2, mean ± SD) |
57.0 ± 9.1 162.0 ± 6.4 73.3 ± 14.1 27.8 ± 4.8 |
57.9 ± 8.7 162.2 ± 6.3 74.4 ± 13.2 28.2 ± 4.8 |
55.9 ± 9.5 162.0 ± 6.6 72.0 ± 14.6 27.3 ± 4.7 |
|
Baseline BMD T-score classification (n, %)
Normal Osteopenic Osteoporotic |
136 (60.7) 74 (33.0) 14 (6.3) |
92 (76.7) 24 (20.0) 4 (3.3) |
44 (42.3) 50 (48.1) 10 (9.6) |
|
Menopausal status at baseline (n, %)
Premenopausal Perimenopausal Postmenopausal ≤5 yr >5 yr Unknown Status unknown |
28 (12.5) 1 (0.4) 192 (85.7) 91 (40.6) 100 (44.6) 2 (0.9) 3 (1.3) |
11 (9.2) 1 (0.8) 105 (87.5) 46 (38.3) 58 (48.3) 1 (0.8) 3 (2.5) |
17 (16.3) 0 (0) 87 (83.7) 45 (43.2) 41 (39.4) 1 (1.0) 0 (0) |
|
Systemic anticancer therapy prior to study (n, %)
Chemotherapy alone Endocrine therapy alone Chemotherapy + endocrine therapy Radiotherapy Trastuzumab |
49 (21.9) 8 (3.6) 172 (76.8) 202 (90.2) 45 (20.1) |
27 (12.1) 3 (1.3) 92 (41.1) 107 (47.8) 20 (8.9) |
22 (9.8) 5 (2.2) 80 (35.7) 95 (42.4) 25 (11.2) |
|
Off study reason (n, %)
Completed study Bone metastases Recurrence or new primary tumor Death Rapid bone loss Use of prohibited concomitant treatment Use of open-label bisphosphonates Investigator recommendation Patient choice Consented but no longer eligible |
164 (73.2) 10 (4.5) 12 (5.4) 2 (0.9) 2 (0.9) 1 (0.4) 16 (7.1) 2 (0.9) 15 (6.7) 2 (0.9) |
75 (62.5) 5 (4.2) 6 (5.0) 2 (1.7) 0 (0) 1 (0.8) 6 (5.0) 2 (1.7) 8 (6.7) 1 (0.8) |
89 (85.6) 5 (4.8) 6 (5.8) 0 (0) 2 (1.9) 0 (0) 10 (9.6) 0 (0) 7 (6.7) 1 (1.0) |
| Years on BoHFAB study (mean ± SD) | 4.5 ± 1.5 | 4.5 ± 1.4 | 4.4 ± 1.6 |