Table 1 Baseline and clinical characteristics of recruited patients with rheumatoid arthritis (RA)
Variable | Total (n = 114) | Bazedoxifene group (nb = 57) | Control group (nc = 57) |
|---|---|---|---|
Age, years | 59.2 ± 6.3 | 59.3 ± 6.7 | 59.1 ± 6.0 |
Body mass index | 23.9 ± 3.5 | 23.8 ± 3.9 | 24.0 ± 3.1 |
Age of menopause | 48.6 ± 4.8 | 48.2 ± 5.0 | 49.1 ± 4.6 |
Use of hormone replacement therapy (HRT) | 25 (21.9) | 11 (19.3) | 14 (24.6) |
Duration of HRT use | 22.8 ± 24.0 | 28.3 ± 25.3 | 18.6 ± 23.1 |
Smoking | |||
≤ 100/lifetime | 108 (94.7) | 55 (96.5) | 53 (93.0) |
Smoker in the past | 4 (3.5) | – | 4 (7.0) |
Current smoker | 2 (1.8) | 2 (3.5) | – |
Age of diagnosis with RA, years (n = 111, nb = 56, nc = 55) | 50.5 ± 9.0 | 49.4 ± 9.0 | 51.6 ± 9.0 |
DAS28-ESR | 4.4 ± 1.3 | 4.3 ± 1.3 | 4.4 ± 1.4 |
DAS28-CRP | 3.3 ± 1.2 | 3.2 ± 1.1 | 3.3 ± 1.3 |
Comorbidities | |||
Charlson comorbidity index score | 1.2 ± 0.5 | 1.3 ± 0.6 | 1.2 ± 0.4 |
Cardiovascular disease | 2 (1.8) | 1 (1.8) | 1 (1.8) |
Hypertension | 42 (36.8) | 24 (42.1) | 18 (31.6) |
Peptic ulcer disease | 1 (0.9) | – | 1 (1.8) |
Mild liver disease | 7 (6.1) | 2 (3.5) | 5 (8.8) |
Diabetes without chronic complications | 9 (7.9) | 6 (10.5) | 3 (5.3) |
Diabetes with chronic complications | 3 (2.6) | 3 (5.3) | – |
Laboratory tests | |||
Erythrocyte sedimentation rate (mm/h) | 35.4 ± 26.6 | 34.0 ± 26.0 | 36.9 ± 27.5 |
C-reactive protein (mg/dl) | 0.8 ± 1.1 | 0.7 ± 0.7 | 0.9 ± 1.3 |
Rheumatoid factor positivity | 81 (71.1) | 41 (71.9) | 40 (70.2) |
Anti-CCP positivity (n = 111, nb = 54, nc = 57) | 99 (89.2) | 47 (87.0) | 52 (91.2) |
Antinuclear antibody positivity (n = 109, nb = 53, nc = 56) | 69 (63.3) | 33 (62.3) | 36 (64.3) |
Bone-specific alkaline phosphatase | 14.7 ± 4.7 | 14.3 ± 4.2 | 15.1 ± 5.1 |
Osteocalcin | 19.8 ± 9.5 | 20.5 ± 10.6 | 19.1 ± 8.2 |
C-telopeptide | 0.5 ± 0.2 | 0.5 ± 0.2 | 0.5 ± 0.2 |
N-telopeptide | 46.5 ± 18.5 | 46.2 ± 19.6 | 46.7 ± 17.6 |
Bone mineral density | |||
Lumbar spine | 0.9 ± 0.1 | 0.9 ± 0.1 | 0.9 ± 0.1 |
Lt. hip neck | 0.6 ± 0.1 | 0.6 ± 0.1 | 0.6 ± 0.1 |
Rt. hip neck | 0.6 ± 0.1 | 0.6 ± 0.1 | 0.6 ± 0.1 |
T-score | |||
L-spine | − 1.3 ± 0.8 | − 1.3 ± 0.8 | − 1.3 ± 0.7 |
Lt. hip neck | − 1.9 ± 1.9 | − 1.7 ± 0.7 | − 2.0 ± 2.7 |
Rt. hip neck | − 1.6 ± 0.7 | − 1.6 ± 0.6 | − 1.5 ± 0.8 |
Trabecular bone score | 1.3 ± 0.1 | 1.3 ± 0.1 | 1.3 ± 0.1 |
Fracture risk assessment tool (FRAX) score | 13.8 ± 5.1 | 14.6 ± 5.0 | 13.0 ± 5.1 |
Hip FRAX score | 5.3 ± 3.7 | 5.7 ± 3.5 | 4.9 ± 3.8 |
Patients at high risk of fracture* | 80 (70.2) | 40 (70.2) | 40 (70.2) |
Patients at moderate or high risk of fracture† | 112 (98.2) | 56 (98.2) | 56 (98.2) |
Current medications | |||
DMARDs | 114 (100.0) | 57 (100.0) | 57 (100.0) |
Methotrexate | 95 (83.3) | 50 (87.7) | 45 (78.9) |
Biologic DMARDs | 17 (14.9) | 9 (15.8) | 8 (14.0) |
Etanercept | 7 (6.1) | 4 (7.0) | 3 (5.3) |
Abatacept | 5 (4.4) | 4 (7.0) | 1 (1.8) |
Golimumab | 3 (2.6) | 1 (1.8) | 2 (3.5) |
Adalimumab | 2 (1.8) | – | 2 (3.5) |
Non-selective NSAIDs | 11 (9.6) | 5 (8.8) | 6 (10.5) |
COX2 selective inhibitor | 85 (74.6) | 43 (75.4) | 42 (73.7) |
Equivalent dose of prednisolone (mg/day)‡ (n = 107, nb = 53, nc = 54) | 3.0 (1.1–10.0) | 3.2 (1.1–10.0) | 2.7 (1.3–5.0) |
HAQ | 0.6 ± 0.6 | 0.7 ± 0.6 | 0.5 ± 0.5 |
EuroQol-5 dimension | 0.8 ± 0.1 | 0.8 ± 0.1 | 0.8 ± 0.1 |
Visual analog scale (VAS) of pain | 43.2 ± 27.2 | 44.4 ± 26.4 | 41.9 ± 28.2 |
VAS of global health | 41.3 ± 25.7 | 41.9 ± 25.4 | 40.7 ± 26.3 |
VAS of sleep | 28.1 ± 28.7 | 28.1 ± 28.7 | 28.1 ± 29.0 |
VAS of fatigue | 40.3 ± 26.8 | 42.6 ± 27.2 | 37.9 ± 26.4 |