Table 1.
Demographic and baseline disease characteristics: concurrent glucocorticoid and bisphosphonate use and non-use
| Treatment group |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Concurrent glucocorticoids* | No concurrent glucocorticoids* | Concurrent bisphosphonates* | No concurrent bisphosphonates* | |||||||||
| Denosumab |
Denosumab |
Denosumab |
Denosumab |
|||||||||
| Characteristics | Placebo (n= 29) | 60 mg (n= 28) | 180 mg (n= 33) | Placebo (n=49) | 60 mg (n= 45) | 180 mg (n= 43) | Placebo (n = 22) | 60 mg (n= 13) | 180 mg (n= 16) | Placebo (n = 56) | 60 mg (n= 60) | 180 mg (n= 60) |
| Women (n (%)) | 20(69) | 16(57) | 20(61) | 42 (86) | 35(78) | 33(77) | 18 (82) | 9(69) | 11 (69) | 44(79) | 42 (70) | 42 (70) |
| Age, years (mean (SD)) | 55.8(12.7) | 53.9(12.3) | 56.9 (11.4) | 57.7 (10.2) | 59.4(10.5) | 58.8(10.8) | 60.4 (8.1) | 65.4 (10.3) | 62.2(9.8) | 55.7 (11.9) | 55.5 (11.0) | 56.9 (11.1) |
| Disease duration, years (mean (SD)) | 8.2 (6.9) | 10.8(7.8) | 14.1 (13.3) | 10.6 (8.7) | 10.2(6.8) | 12.0(9.6) | 9.3 (8.0) | 13.2 (7.7) | 16.04(13.3) | 9.9 (8.2) | 9.9 (7.0) | 12.0(10.7) |
| Rheumatoid factor positive (n (%)) | 23 (79) | 21 (75) | 28 (85) | 38(78) | 34(76) | 32(74) | 16 (73) | 12 (92) | 11 (69) | 45 (80) | 43 (72) | 49 (82) |
| T-score (mean (SD)) | ||||||||||||
| Lumbar spine | −0.8 (1.3) | −0.3 (1.2) | −0.7 (1.5) | −0.2 (1.5) | −0.4 (1.9) | −0.7 (1.7) | −1.5 (1.0) | −1.1 (0.7) | −1.8(1.1) | 0.0 (1.4) | −0.2 (1.7) | −0.5 (1.6) |
| Total hip | −1.0 (1.0) | −0.6 (1.3) | −0.8 (1.4) | −0.4 (1.0) | −0.9 (1.3) | −0.6 (1.2) | −1.3 (0.8) | −1.6 (1.1) | −1.8 (0.8) | −0.4 (1.1) | −0.6 (1.3) | −0.4 (1.2) |
| sCTx-l (ng/ml) | ||||||||||||
| Median (Q1, Q3) | 0.3 (0.2, 0.5) | 0.3 (0.2, 0.5) | 0.3 (0.2, 0.4) | 0.4 (0.3, 0.5) | 0.4 (0.2, 0.5) | 0.4 (0.2, 0.6) | 0.2 (0.1,0.4) | 0.2 (0.2, 0.3) | 0.2 (0.1,0.3) | 0.4 (0.3, 0.5) | 0.4 (0.3, 0.5) | 0.4 (0.3, 0.5) |
| Mean (SD) | 0.3 (0.2) | 0.4 (0.2) | 0.3 (0.2) | 0.4 (0.2) | 0.4 (0.2) | 0.4 (0.2) | 0.3 (0.2) | 0.2 (0.1) | 0.2 (0.1) | 0.4 (0.2) | 0.4 (0.2) | 0.4 (0.2) |
| P1NP (μg/l) | ||||||||||||
| Median (Q1,Q3) | 40.7 (34.4, 56.7) | 39.0 (28.4,55.1) | 32.1 (23.4,45.2) | 45.5 (35.2, 54.6) | 45.8 (33.2, 54.4) | 43.0 (30.3, 60.1) | 35.6 (28.3, 55.6) | 28.2 (21.1,37.3) | 26.4 (20.4,31.5) | 44.9 (36.6, 54.5) | 46.4 (36.0, 56.0) | 43.0 (28.9, 56.4) |
| Mean (SD) | 48.2 (28.2) | 43.5 (22.0) | 35.4 (16.0) | 46.6 (16.9) | 46.2(18.6) | 46.1 (20.6) | 41.0(18.8) | 31.0(13.2) | 28.6(14.1) | 49.5 (22.3) | 48.3 (19.9) | 44.2 (19.2) |
*
In this analysis, patients were categorised according to whether they received glucocorticoids or bisphosphonates as concomitant drugs during the study.
P1NP, serum procollagen 1N-terminal peptide; sCTx-I, serum type I C-telopeptide.