Table 1.
| Combination therapy user (n = 92) | Combination therapy nonuser (n = 1109) | p Value c | |
|---|---|---|---|
| Age at screening, years | 63.37 ± 6.73 | 64.49 ± 7.11 | 0.15 |
| BMI, kg/m2 | 27.01 ± 6.40 | 28.07 ± 6.20 | 0.12 |
| Race/ethnicity | 0.06 | ||
| White | 76 (82.61) | 810 (73.04) | |
| Black | 8 (8.70) | 201 (18.12) | |
| Other/unknown | 8 (8.70) | 98 (8.84) | |
| Smoking | 1.00 | ||
| Never smoked | 41 (44.57) | 490 (44.75) | |
| Past smoker | 43 (46.74) | 509 (46.48) | |
| Current smoker | 8 (8.70) | 96 (8.77) | |
| Prevalent fracture at baseline | 48 (52.17) | 441 (40.16) | 0.03 |
| Self‐reported health status | 0.32 | ||
| Excellent | 5 (5.49) | 33 (3.01) | |
| Very good | 17 (18.68) | 241 (21.95) | |
| Good | 49 (53.85) | 504 (45.90) | |
| Fair | 17 (18.68) | 269 (24.50) | |
| Poor | 3 (3.30) | 51 (4.64) | |
| Physical activity, mets‐hours/week | 9.68 ± 12.49 | 9.28 ± 10.97 | 0.74 |
| History of 2 or more falls in last 12 months | 12 (13.04) | 173 (15.67) | 0.65 |
| History of treated diabetes | 3 (3.26) | 57 (5.14) | 0.62 |
| Age at menopause, years | 47.83 ± 5.91 | 47.45 ± 7.09 | 0.57 |
| Alcohol use | 0.34 | ||
| Nondrinker | 13 (14.13) | 132 (12.01) | |
| Past drinker | 36 (39.13) | 350 (31.85) | |
| Current drinker, <1 Drink per month or week | 24 (26.09) | 361 (32.85) | |
| Current drinker, 1–3 drinks/week | 6 (6.52) | 111 (10.10) | |
| Current drinker, 3–<7 drinks/week | 9 (9.78) | 74 (6.73) | |
| Current drinker, 7+ drinks/week | 4 (4.35) | 71 (6.46) | |
| CT or OS enrollment | 0.02 | ||
| OS | 79 (85.87) | 825 (74.39) | |
| CT | 13 (14.13) | 284 (25.61) | |
| Dietary modification (DM) trial enrollment | 0.05 | ||
| Not randomized to DM | 84 (91.30) | 899 (81.06) | |
| Placebo | 5 (5.43) | 127 (11.45) | |
| Treatment | 3 (3.26) | 83 (7.48) | |
| HT trial enrollment | 0.75 | ||
| Not randomized to HT | 85 (92.39) | 999 (90.08) | |
| Placebo (E, E + P Trial) | 4 (4.35) | 50 (4.51) | |
| Intervention (E, E + P Trial) | 3 (3.26) | 60 (5.41) | |
| Joint pain severity at baseline | 0.05 | ||
| None | 0 (0) | 52 (4.74) | |
| Mild | 28 (30.43) | 348 (31.69) | |
| Moderate | 45 (48.91) | 434 (39.53) | |
| Severe | 19 (20.65) | 264 (24.04) | |
| Anti‐CCP antibody status | 0.01 | ||
| Not measured | 35 (38.04) | 266 (23.99) | |
| Negative | 16 (17.39) | 267 (24.08) | |
| Positive | 41 (44.57) | 576 (51.94) | |
| Geographic study site | 0.64 | ||
| Northeast | 19 (20.65) | 250 (22.54) | |
| South | 22 (23.91) | 315 (28.40) | |
| Midwest | 23 (25.00) | 265 (23.90) | |
| West | 28 (30.43) | 279 (25.16) | |
| Log transformed total calcium intake (diet plus supplements) | 7.03 ± 0.59 | 6.94 ± 0.65 | 0.18 |
| Log transformed total vitamin D intake (diet plus supplements) | 5.77 ± 0.79 | 5.66 ± 0.90 | 0.25 |
| Total caloric intake, calories | 7.26 ± 0.39 | 7.25 ± 0.45 | 0.92 |
| DMARD (excluding combination therapy) use | 42 (45.65) | 411 (37.06) | 0.12 |
| Minocycline | 1 (1.09) | 18 (1.62) | 1.00 |
| Leflunomide | 0 (0) | 0 (0) | |
| Azathioprine | 5 (5.43) | 28 (2.52) | 0.10 |
| Cyclosporine | 0 (0) | 4 (0.36) | 1.00 |
| Gold | 0 (0) | 10 (0.90) | 1.00 |
| Glucocorticosteroids | 38 (41.30) | 372 (33.54) | 0.14 |
| Osteoporosis medication use d | 49 (53.26) | 491 (44.27) | 0.10 |
| Other medication use e | 39 (42.39) | 543 (48.96) | 0.23 |
Anti‐CCP = Anti‐cyclic citrullinated protein antibody; BMI = body mass index (calculated as weight in kilograms divided by height in meters squared); CT = clinical trial; DMARD = disease‐modifying antirheumatic drug; E = estrogen‐alone; E + P = estrogen plus progestin; HT = hormone therapy; Met‐hours/week = metabolic equivalents‐hours/week; OS = observational study.
Values expressed and mean ± SD for continuous variables and N (%) for categorical variables.
Combination therapy was defined as use of methotrexate and hydroxychloroquine, or methotrexate and sulfasalazine.
Differences were assessed using T tests for continuous variables and Fisher's exact test for categorical variables.
Use of hormone therapy/estrogen (oral/patch), raloxifene, teriparatide, bisphosphonates, and calcitonin.
Use of other medications affecting bone metabolism: proton pump inhibitors, thiazolidinediones, thyroid medications, psychoactive medications, antimanic drugs, hypnotics, anticonvulsants, antidepressants, and oral corticosteroids.