Introduction
Subjects and methods
Study design
Participants
Biochemical markers of bone formation
Assessment of BMD
Statistical analysis
Results
Patient disposition
Baseline characteristics
Previous treatment subgroup | ||||
---|---|---|---|---|
Characteristic | Treatment- naïve | AR pretreated | Inadequate AR responder | Total |
N (%) | 181 (23.9) | 209 (27.6) | 368 (48.5) | 758 (100.0) |
Age (years) | 70.4 (7.7) | 69.3 (7.2) | 69.8 (7.5) | 69.8 (7.5) |
Time since menopause (years) | 22.7 (9.5) | 21.4 (9.0) d
| 23.4 (9.9) | 22.7 (9.6) |
Weight (kg) | 64.4 (11.6)a
| 62.8 (10.9) | 61.3 (10.9) | 62.5 (11.1) |
Height (cm) | 158.3 (7.0) a
| 157.8 (7.1) a
| 155.7 (7.4) | 156.9 (7.3) |
BMI (kg/m2) | 25.7 (4.4) | 25.3 (4.4) | 25.2 (4.0) | 25.4 (4.2) |
Lumbar spine BMD (g/cm2) | 0.751 (0.114) b
| 0.746 (0.120) | 0.728 (0.117) | 0.738 (0.118) |
Lumbar spine BMD (T-Score) | −3.01 (0.96) c
| −3.16 (0.91) d
| −3.35 (0.95) | −3.21 (0.95) |
Total hip BMD (g/cm2) | 0.703 (0.105) | 0.703 (0.111) | 0.687 (0.110) | 0.695 (0.110) |
Femoral neck BMD (g/cm2) | 0.622 (0.108) | 0.632 (0.116) | 0.620 (0.116) | 0.624 (0.114) |
Prior AR Therapy | AR pretreated (n = 209) | Inadequate AR responder (n = 368) | ||
---|---|---|---|---|
Duration, months | Duration, months | |||
N (%) | median (Q1, Q3) | N (%) | median (Q1, Q3) | |
Any Antiresorptive | 209 (100.0) | 10 (2, 18) | 368 (100.0) | 54 (32, 89) |
Any Bisphosphonate | 175 (83.7) | 7 (2, 15) | 338 (91.8) | 36 (24, 59) |
Alendronate | 120 (57.4) | 7 (1, 13) | 218 (59.2) | 26 (13, 49) |
Risedronate | 55 (26.3) | 3 (1, 11) | 110 (29.9) | 19 (9, 26) |
Etidronate | 25 (12.0) | 9 (1, 17) | 145 (39.4) | 35 (19, 45) |
IV Bisphosphonates | 12 (5.7) | 9 (6, 17) | 40 (10.9) | 17 (11, 36) |
SERM | 26 (12.4) | 7 (2, 13) | 65 (17.7) | 21 (13, 30) |
All ET/EPT | 24 (11.5) | 28 (12, 48) | 98 (26.6) | 82 (38, 130) |
Calcitonin | 24 (11.5) | 3 (1, 8) | 65 (17.7) | 13 (4, 36) |
Vitamin D Metabolites | 2 (1.0) | 8 (4, 12) | 14 (3.8) | 34 (13, 55) |
Bone formation markers response to teriparatide
Treatment naive | AR pretreated | Inadequate AR responder | p-valueb
| |||
---|---|---|---|---|---|---|
AR pretreated vs. naive | Inadequate AR responder vs. naive | AR pretreated vs. inadequate AR responder | ||||
PINP (μg/L) | ||||||
Baseline | 48.2 (43.8 – 53.1) | 26.1(23.8 – 28.5) | 27.5 (25.7 – 29.4) | <0.0001 | <0.0001 | 0.363 |
1 month | 85.5 (78.0 – 93.6) | 56.6 (52.0 – 61.6) | 62.2 (58.4 – 66.3) | <0.0001 | <0.0001 | 0.079 |
6 months | 129.1 (116.1 – 143.5) | 118.2 (106.9 – 130.6) | 136.6 (126.8 – 147.2) | 0.235 | 0.387 | 0.022 |
b-ALP (μg/L) | ||||||
Baseline | 12.9 (12.1 – 13.7) | 10.1 (9.6 – 10.7) | 10.2 (9.8 – 10.7) | <0.0001 | <0.0001 | 0.775 |
1 month | 14.3 (13.5 – 15.2) | 12.0 (11.4 – 12.7) | 12.4 (11.9 – 12.9) | <0.0001 | <0.0001 | 0.374 |
6 months | 18.9 (17.6 – 20.3) | 17.6 (16.5 – 18.8) | 19.2 (18.3 – 20.2) | 0.152 | 0.749 | 0.045 |
t-ALP (μg/L) | ||||||
Baseline | 69.6 (66.5 – 72.9) | 64.1 (61.4 – 66.9) | 63.3 (61.3 – 65.4) | 0.010 | 0.001 | 0.655 |
1 month | 72.5 (69.4 – 75.7) | 67.9 (65.2 – 70.8) | 68.0 (65.9 – 70.1) | 0.034 | 0.019 | 0.976 |
6 months | 82.9 (79.0 – 87.0) | 82.1 (78.5 – 85.9) | 84.1 (81.3 – 87.0) | 0.777 | 0.630 | 0.407 |
BMD response to teriparatide
Signal-to-noise ratios
Correlations between PINP and BMD response
Time point (month) | Change from baseline in BMD (24 months) | |||
---|---|---|---|---|
Lumbar spine (n = 414) | Total hip (n = 401) | Femoral neck (n = 401) | ||
PINP | Baseline | 0.301 (<0.0001) | 0.218 (<0.0001) | 0.116 (<0.05) |
1 | 0.365 (<0.0001) | 0.141 (<0.005) | 0.081 (n.s.) | |
6 | 0.219 (<0.0001) | 0.111 (<0.05) | 0.107 (<0.05) | |
ΔPINP | Δ1 | 0.213 (<0.0001) | 0.000 (n.s.) | 0.081 (n.s.) |
Δ6 | 0.117 (<0.05) | 0.035 (n.s) | 0.070 (n.s.) |