Table 1.
Baseline Characteristics of the Study Population of 1233 Subjects at the Start of Extensiona
| Variable | Z3P3 (n = 617) | Z6 (n = 616) | p Value |
|---|---|---|---|
| Age, years (mean ± SD) | 75.5 (4.9) | 75.5 (4.9) | 0.89 |
| <70, n (%) | 78 (12.6) | 67 (10.9) | |
| 70 to 74, n (%) | 201 (32.6) | 219 (35.6) | |
| ≥75, n (%) | 338 (54.8) | 330 (53.6) | |
| Mean BMI (±SD), kg/m2 | 25.6 ± 4.5 | 25.3 ± 4.0 | 0.23 |
| Region, n (%) | 1.0 | ||
| Western Europe | 226 (36.6) | 222 (36.0) | |
| Eastern Europe | 137 (22.2) | 140 (22.7) | |
| North America/Oceania | 112 (18.2) | 110 (17.9) | |
| Latin America | 115 (18.6) | 116 (18.8) | |
| Asia | 27 (4.4) | 28 (4.5) | |
| Femoral neck T-score (mean ± SD) | −2.55 ± 0.57 | −2.58 ± 0.55 | 0.29 |
| ≤−2.5, n (%) | 325 (52.7) | 353 (57.3) | 0.25 |
| >−2.5 to −1.5, n (%) | 262 (42.5) | 238 (38.6) | |
| >−1.5, n (%) | 28 (4.5) | 23 (3.7) | |
| Missing, n (%) | 2 (0.3) | 2 (0.3) | |
| Mean BMD (±SD), g/cm2 | |||
| Femoral neck | 0.57 (0.06) | 0.56 (0.06) | 0.29 |
| Total hip | 0.69 ± 0.088 | 0.69 ± 0.085 | 0.16 |
| Lumbar | 0.82 ± 0.16 | 0.81 ± 0.13 | 0.40 |
| Prevalent vertebral fracture, n (%) | 0.06 | ||
| 0 | 227 (36.8) | 256 (41.6) | |
| 1 | 168 (27.2) | 177 (28.7) | |
| ≥2 | 222 (36.0) | 183 (29.7) | |
| Prior medication use,b n (%) | |||
| Hormone therapy | 56 (9.1) | 63 (10.2) | 0.50 |
| Bisphosphonates | 2 (0.3) | 7 (1.1) | 0.11 |
| Calcitonin | 28 (4.5) | 42 (6.8) | 0.09 |
| SERMs | 55 (8.9) | 63 (10.2) | 0.44 |
| Other osteoporosis medication | 5 (0.8) | 10 (1.6) | 0.21 |
| Mean (±SD) days since last infusion in the HORIZON-PFT core study to first infusion in the extension study | 394.21 ± 50.80 | 397.58 ± 51.86 | 0.25 |
SD = standard deviation; BMI = body mass index; BMD = bone mineral density; SERMs = selective estrogen receptor modulators.
a
Plus-minus values are means ± SD.
b
Reported use before HORIZON-PFT core study (before time point 0) and during core study (time point 0 to year 3).