Table 1.
Baseline demographics and clinical characteristics
| Variable, n (%) | All | Patient-support program enrollment | |||
|---|---|---|---|---|---|
| N = 1996 | Yes | No | Unknown | p value* | |
| N = 790 | N = 458 | N = 748 | |||
| Age (years), mean ± SD | 76.9 ± 7.9 | 76.9 ± 7.8 | 77.0 ± 7.9 | 76.9 ± 7.8 | 0.928 |
| Female sex | 1798 (90.1) | 730 (92.4) | 406 (88.6) | 662 (88.5) | 0.031 |
| BMI (kg/m2) | |||||
| N | 1504 | 615 | 349 | 540 | |
| Mean ± SD | 21.8 ± 3.5 | 21.8 ± 3.6 | 21.8 ± 3.3 | 21.9 ± 3.6 | 0.902 |
| Current smoker | 84 (4.2) | 39 (4.9) | 17 (3.7) | 28 (3.7) | 0.322 |
| Alcohol, ≥ 3 units consumed dailya | 88 (4.4) | 25 (3.2) | 26 (5.7) | 37 (4.9) | 0.053 |
| Family history of hip fracture | 99 (5.0) | 53 (6.7) | 15 (3.3) | 31 (4.1) | 0.012 |
| Comorbidities | 510 (25.6) | 185 (23.4) | 113 (24.7) | 212 (28.3) | 0.836 |
| Previous osteoporosis medicationsb | 1023 (51.3) | 485 (61.4) | 235 (51.3) | 303 (40.5) | < 0.001 |
| Bisphosphonate | 676 (33.9) | 353 (44.7) | 149 (32.5) | 174 (23.3) | < 0.001 |
| SERMsc | 168 (8.4) | 81 (10.3) | 35 (7.6) | 52 (7.0) | 0.131 |
| Active vitamin D3 | 347 (17.4) | 165 (20.9) | 69 (15.1) | 113 (15.1) | 0.013 |
| Calcitonin | 98 (4.9) | 50 (6.3) | 18 (3.9) | 30 (4.0) | 0.092 |
| Calcium | 78 (3.9) | 27 (3.4) | 23 (5.0) | 28 (3.7) | 0.179 |
| Other | 45 (2.3) | 8 (1.0) | 15 (3.3) | 22 (2.9) | 0.007 |
| Concomitant corticosteroids | 54 (2.7) | 18 (2.3) | 19 (4.1) | 17 (2.3) | 0.084 |
| Prevalent vertebral fractures | 1321 (66.2) | 533 (67.5) | 324 (70.7) | 464 (62.0) | 0.254 |
| 0 | 675 (33.8) | 257 (32.5) | 134 (29.3) | 284 (38.0) | 0.286 |
| 1 | 622 (31.2) | 221 (28.0) | 146 (31.9) | 255 (34.1) | |
| ≥ 2 | 699 (35.0) | 312 (39.5) | 178 (38.9) | 209 (27.9) | |
| Prevalent non-vertebral fractures | 419 (21.0) | 199 (25.2) | 73 (15.9) | 147 (19.7) | < 0.001 |
| Lumbar spine (L2-L4) | |||||
| sBMD (g/cm2)d | |||||
| N | 680 | 266 | 157 | 257 | |
| Mean ± SD | 0.73 ± 0.15 | 0.73 ± 0.14 | 0.73 ± 0.17 | 0.72 ± 0.14 | 0.735 |
| T score (SD)e | |||||
| N | 677 | 266 | 157 | 254 | 0.660 |
| Mean ± SD | − 2.83 ± 1.14 | − 2.84 ± 1.10 | − 2.79 ± 1.29 | − 2.86 ± 1.08 | |
| Total hip | |||||
| sBMD (g/cm2)d | |||||
| N | 617 | 242 | 152 | 223 | 0.864 |
| Mean ± SD | 0.55 ± 0.12 | 0.55 ± 0.13 | 0.55 ± 0.11 | 0.54 ± 0.11 | |
| T scoree | |||||
| N | 612 | 242 | 152 | 218 | 0.852 |
| Mean ± SD | − 3.26 ± 1.18 | − 3.19 ± 1.33 | − 3.17 ± 1.03 | − 3.39 ± 1.10 | |
| P1NPf (μg/L) | |||||
| N | 1080 | 469 | 242 | 369 | 0.368 |
| Mean ± SD | 48.8 ± 31.4 | 46.5 ± 30.4 | 48.6 ± 29.0 | 52.0 ± 33.8 | |
| Back pain (VAS, mm) | |||||
| N | 1725 | 718 | 407 | 600 | |
| Mean ± SD | 50.7 ± 30.6 | 46.9 ± 30.6 | 55.8 ± 30.9 | 51.9 ± 29.8 | < 0.001 |
BMI body mass index, P1NP procollagen type 1 aminoterminal propeptide, sBMD standardized bone mineral density, SD standard deviation, SERM selective estrogen receptor modulator, VAS visual analog scale
*p values are for differences in baseline demographics and clinical characteristics between yes and no patients and were calculated using a two-sample t test for continuous variables and Fisher’s exact test for categorical variables
a1 unit of alcohol was 285 mL of beer, 120 mL of wine, 30 mL of distilled spirits, or 60 mL of aperitifs
bPatients may have had > 1 comorbidity or previous osteoporosis medication
cSERMs included raloxifene hydrochloride and bazedoxifene acetate
dsBMD was calculated according to Hui et al. [19] and Lu et al. [20]
eMean BMDs of young adult Japanese population [23] were used as reference values for T score calculations. Measurements obtained with the scanner of CooperSurgical Inc. (formerly Norland) product were not applied to SD calculation for male lumbar spine BMD, or for male or female total hip BMD because of unavailability of corresponding Japanese young adult men
fP1NP reference ranges were 17.1–64.7 μg/L for Japanese premenopausal women and 21.9–79.1 μg/L for postmenopausal women [24, 25]