Introduction
Materials and Methods
Ibandronate 0.5 mg (n = 376) | Ibandronate 1 mg (n = 382) | Risedronate (n = 376) | |
---|---|---|---|
Women, n (%) | 356 (94.7) | 354 (92.7) | 343 (91.2) |
Mean age, years (SD) | 72.9 (6.34) | 72.2 (6.38) | 73.0 (6.29) |
Aged 60–74 years, n (%) | 219 (58.2) | 245 (64.1) | 227 (60.4) |
Aged ≥ 75 years, n (%) | 157 (41.8) | 137 (35.9) | 149 (39.6) |
Mean weight, kg (SD) | 50.6 (8.00) | 50.9 (7.36) | 51.1 (8.35) |
Mean height, cm (SD) | 149.2 (6.66) | 149.5 (6.56) | 149.4 (6.70) |
Mean BMD T-score (SD) | |||
Lumbar spine (L2–L4) | −2.71 (1.01) | −2.68 (1.01) | −2.59 (1.06) |
Femoral neck | −2.48 (0.73) | −2.41 (0.80) | −2.53 (0.79) |
Total hip | −2.17 (0.87) | −2.09 (0.86) | −2.18 (0.86) |
Prevalent vertebral fractures, n (%) | |||
1 | 186 (49.5) | 184 (48.2) | 183 (48.7) |
2 | 97 (25.8) | 106 (27.7) | 95 (25.3) |
>2 | 93 (24.7) | 92 (24.1) | 98 (26.1) |
Mean uCTX, µg/mmol CR (SD) | 382.4 (226.2) | 368.6 (209.9) | 373.2 (261.0) |
Mean uNTX, nM BCE/mM CR (SD) | 73.6 (39.31) | 69.4 (35.42) | 68.9 (35.16) |
Mean BALP, IU/L (SD) | 33.6 (13.15) | 33.9 (13.11) | 32.4 (11.96) |
Mean 25-OH vitamin D, ng/mL (SD) | 19.6 (6.44) | 20.0 (6.69) | 19.7 (6.56) |
Results
Increase in hip BMD in Patients Without/With Vertebral Fractures
Future Vertebral Fracture Incidence Predicted by Changes in Hip BMD at 6 months
Treatment | Ibandronate | Risedronate | ||||
---|---|---|---|---|---|---|
Hip BMD at 6 months | ||||||
≤0 % | >0 to ≤3 % | >3 % | ≤0% | >0 to ≤3 % | >3 % | |
(Months) | (n = 85) | (n = 150) | (n = 118) | (n = 116) | (n = 145) | (n = 89) |
12 | 10 (12.5 %) | 9 (6.3 %) | 6 (5.3 %) | 18 (15.9 %) | 16 (11.6 %) | 8 (9.3 %) |
24 | 14 (18.2 %) | 12 (8.8 %) | 7 (6.4 %) | 23 (20.7 %) | 17 (12.8 %) | 8 (9.4 %) |
36 | 19 (26.4 %) | 17 (13.3 %) | 12 (11.8 %) | 27 (27.0 %) | 22 (18.5 %) | 11 (14.1 %) |
Treatment | Ibandronate | Risedronate | ||||
---|---|---|---|---|---|---|
Lumbar spine BMD at 6 monthsa
| ||||||
≤0 % | >0 to ≤3 % | >3 % | ≤0 % | >0 to ≤3 % | >3 % | |
(Months) | (n = 44) | (n = 81) | (n = 236) | (n = 61) | (n = 100) | (n = 190) |
12 | 3 (7.7 %) | 5 (6.3 %) | 11 (4.8 %) | 3 (5.2 %) | 10 (10.3 %) | 17 (9.3 %) |
24 | 5 (12.8 %) | 7 (9.2 %) | 15 (7.0 %) | 5 (9.1 %) | 10 (10.6 %) | 21 (11.7 %) |
36 | 6 (17.1 %) | 15 (22.4 %) | 23 (11.2 %) | 5 (10.0 %) | 11 (12.8 %) | 32 (20.3 %) |
Gain in hip BMD at 6 months | Treatment duration | Against ≤0 | Odds ratio (95 % CI) | |
---|---|---|---|---|
Ibandronate | Risedronate | |||
12 months | >0 to ≤3 % | 0.52 (0.20, 1.41) | 0.79 (0.37, 1.70) | |
>3 % | 0.40 (0.13, 1.21) | 0.54 (0.22, 1.36) | ||
24 months | >0 to ≤3 % | 0.55 (0.23, 1.31) | 0.64 (0.32, 1.31) | |
>3 % | 0.41 (0.15, 1.14) | 0.41 (0.17, 1.00) | ||
36 months | >0 to ≤3 % | 0.51 (0.24, 1.09) | 0.69 (0.35, 1.33) | |
>3 % | 0.47 (0.20, 1.09) | 0.44 (0.20, 0.99) |
Gain in lumbar spine BMD at 6 monthsa
| Treatment duration | Against ≤0 | Odds ratio (95 % CI) | |
---|---|---|---|---|
Ibandronate | Risedronate | |||
12 months | >0 to ≤3 % | 0.87 (0.18, 4.16) | 2.65 (0.67, 10.46) | |
>3 % | 0.77 (0.18, 3.21) | 2.31 (0.62, 8.65) | ||
24 months | >0 to ≤3 % | 0.76 (0.20, 2.79) | 1.46 (0.46, 4.68) | |
>3 % | 0.70 (0.21, 2.29) | 1.68 (0.57, 4.96) | ||
36 months | >0 to ≤3 % | 1.54 (0.51, 4.63) | 1.65 (0.52, 5.25) | |
>3 % | 0.72 (0.25, 2.03) | 3.01 (1.05, 8.64) |