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. 2023 Mar 6;34(5):977–991. doi: 10.1007/s00198-022-06627-0

Table 1.

Demographic and clinical characteristics

GR risedronate cohort
n = 1080		 IR risedronate cohort
n = 1080
(*Statistically significant vs. GR risedronatea) 		Alendronate (IR)
cohort
n = 14,040
(*Statistically significant vs. GR risedronatea)
Demographics
Age at index date, mean ± SD [median] 69.1 ± 8.9 [66.0] 68.8 ± 8.5 [66.0] 70.2 ± 9.2 [67.0]*
Age category, n (%)
     60–64 years 505 (46.8%) 494 (45.7%) 5,603 (39.9%)*
     65–69 years 155 (14.4%) 186 (17.2%) 2,243 (16.0%)
     70–74 years 130 (12.0%) 124 (11.5%) 1,752 (12.5%)
     75–79 years 116 (10.7%) 113 (10.5%) 1,636 (11.7%)
     80 + years 174 (16.1%) 163 (15.1%) 2,806 (20.0%)*
Census region, n (%)
     Northeast 348 (32.2%) 392 (36.3%)* 2,669 (19.0%)*
     North Central 114 (10.6%) 161 (14.9%)* 3,675 (26.2%)*
     South 463 (42.9%) 349 (32.3%)* 4,367 (31.1%)*
     West 142 (13.1%) 165 (15.3%) 3,228 (23.0%)*
     Unknown 13 (1.2%) 13 (1.2%) 101 (0.7%)
Commercial insurance plan type, n (%)
Basic 0 (0.0%) 0 (0.0%) 0 (0.0%)
Comprehensive 183 (16.9%) 156 (14.4%) 3,132 (22.3%)*
     EPO/POS 89 (8.2%) 80 (7.4%) 765 (5.4%)*
     HMO/POS with capitation 112 (10.4%) 144 (13.3%)* 2,793 (19.9%)*
     PPO 622 (57.6%) 624 (57.8%) 6,459 (46.0%)*
     CDHP/HDHP 33 (3.1%) 45 (4.2%) 572 (4.1%)
     Unknown 41 (3.8%) 31 (2.9%) 319 (2.3%)*
Medicare coverage, n (%) 742 (68.7%) 751 (69.5%) 10,208 (72.7%)*
Baselineb comorbidities, n (%)
  Cardiovascular disease 266 (24.6%) 240 (22.2%) 3,425 (24.4%)
  Celiac disease 3 (0.3%) 10 (0.9%) 49 (0.3%)
  Chronic pulmonary disease 131 (12.1%) 146 (13.5%) 1,797 (12.8%)
  Dementia 24 (2.2%) 20 (1.9%) 396 (2.8%)
  Depression 145 (13.4%) 176 (16.3%) 2,181 (15.5%)
  Diabetes 158 (14.6%) 126 (11.7%)* 1,987 (14.2%)
  Fatigue 112 (10.4%) 125 (11.6%) 1,360 (9.7%)
  Gastrointestinal mucositis 0 (0.0%) 0 (0.0%) 0 (0.0%)
  Primary or secondary hyperparathyroidism 14 (1.3%) 31 (2.9%)* 196 (1.4%)
  Hyperthyroidism 13 (1.2%) 15 (1.4%) 163 (1.2%)
  Hypertension 432 (40.0%) 430 (39.8%) 6,147 (43.8%)*
  Hypertensive chronic kidney disease 28 (2.6%) 24 (2.2%) 481 (3.4%)
  Inflammatory bowel disease 12 (1.1%) 4 (0.4%)* 102 (0.7%)
  Joint inflammatory disease 20 (1.9%) 19 (1.8%) 277 (2.0%)
  Liver disease 19 (1.8%) 20 (1.9%) 229 (1.6%)
  Oseogenesis imperfecta 0 (0.0%) 0 (0.0%) 3 (0.0%)
  Parkinson’s disease 10 (0.9%) 4 (0.4%) 107 (0.8%)
  Peripheral neuropathy 53 (4.9%) 42 (3.9%) 599 (4.3%)
  Rheumatoid arthritis 58 (5.4%) 69 (6.4%) 562 (4.0%)*
  Underweight 11 (1.0%) 14 (1.3%) 209 (1.5%)
  Urination problem 150 (13.9%) 162 (15.0%) 1,896 (13.5%)
  Vitamin D deficiency 137 (12.7%) 122 (11.3%) 1,270 (9.0%)*
Baselineb CCI
  CCI, mean ± SD [median] 0.2 ± 1.1 [0.0] 0.3 ± 1.2 [0.0] 0.3 ± 1.3 [0.0]*
 CCI ≤ 2, n (%) 1031 (95.5%) 1027 (95.1%) 13,119 (93.4%)*
Pre-indexc fractures, n (%)
Fractures during baseline periodb
Any site 100 (9.3%) 99 (9.2%) 1,765 (12.6%)*
Hip 25 (2.3%) 29 (2.7%) 518 (3.7%)*
Pelvis 12 (1.1%) 15 (1.4%) 197 (1.4%)
Spine 36 (3.3%) 37 (3.4%) 649 (4.6%)*
Wrist/arm 34 (3.1%) 34 (3.1%) 580 (4.1%)
Fractures anytime before index date
Any site 159 (14.7%) 154 (14.3%) 2,914 (20.8%)*
Baselineb dispensing of drugs affecting the risk of fracture, n (%)
 ≥ 1 drug decreasing the risk of fracture 368 (34.1%) 319 (29.5%)* 4,279 (30.5%)*
     Beta blockers 246 (22.8%) 204 (18.9%)* 3,199 (22.8%)
     Denosumab 4 (0.4%) 5 (0.5%) 8 (0.1%)*
     Estrogens 160 (14.8%) 133 (12.3%) 1,336 (9.5%)*
≥ 1 drug increasing the risk of fracture 691 (64.0%) 660 (61.1%) 8,697 (61.9%)
     Antidepressants 248 (23.0%) 248 (23.0%) 3,427 (24.4%)
     Antiepileptics 123 (11.4%) 138 (12.8%) 1,610 (11.5%)
     Antipsychotics 16 (1.5%) 14 (1.3%) 322 (2.3%)
     Loop diuretics 67 (6.2%) 47 (4.4%) 1,130 (8.0%)*
     Opioids 273 (25.3%) 275 (25.5%) 4,283 (30.5%)*
     Proton-pump inhibitors 274 (25.4%) 230 (21.3%)* 2,492 (17.7%)*
     Sedatives 210 (19.4%) 183 (16.9%) 2,517 (17.9%)
     Systemic corticosteroids 294 (27.2%) 267 (24.7%) 3,194 (22.7%)*
High risk of fracture based on baseline comorbidity and/or medicationd, n (%) 799 (74.0%) 758 (70.2%)* 10,057 (71.6%)
Days supply of the first prescription of the index treatment, n (%)
   ≤ 30 days 727 (67.3%) 605 (56.0%)* 8,699 (62.0%)*
   > 30 days 353 (32.7%) 475 (44.0%)* 5,341 (38.0%)*

Year of the index date, n (%)

(by design same distribution)

  2009 0 (0.0%) 0 (0.0%) 0 (0.0%)
  2010 1 (0.1%) 1 (0.1%) 13 (0.1%)
  2011 434 (40.2%) 434 (40.2%) 5,642 (40.2%)
  2012 254 (23.5%) 254 (23.5%) 3,302 (23.5%)
  2013 175 (16.2%) 175 (16.2%) 2,275 (16.2%)
  2014 70 (6.5%) 70 (6.5%) 910 (6.5%)
  2015 65 (6.0%) 65 (6.0%) 845 (6.0%)
  2016 40 (3.7%) 40 (3.7%) 520 (3.7%)
  2017 27 (2.5%) 27 (2.5%) 351 (2.5%)
  2018 14 (1.3%) 14 (1.3%) 182 (1.3%)
  2019 0 (0.0%) 0 (0.0%) 0 (0.0%)

CCI Charlson comorbidity index, CDHP consumer directed health plan, EPO exclusive provider organization, GR gastro-resistant, HDHP high-deductible health plan, HMO health maintenance organization, IR immediate release, POS point of service, SD standard deviation.

aP-value < 0.05; p-values were based on t-tests for continuous variables, and chi-square tests for categorical variables.

bThe 6-month period prior to the index date is defined as the baseline period. All women had health insurance coverage and were observed for at least 6 months before the index date.

cEntire time period for a given woman in the data before the index date during the 2009–2019 study period.

dWomen with a high baseline risk of fracture due to comorbidities and/or medications were identified based on the presence of ≥ 1 baseline diagnosis for heart failure, chronic pulmonary disease, dementia, depression, diabetes, Parkinson’s disease, or osteoporotic fracture; and/or ≥ 1 baseline dispensing of a treatment increasing the risk of fracture (e.g., systemic corticosteroids, sedatives, proton pump inhibitors), or loop diuretics.