Table 5.
Characteristics of Responders and Nonresponders to Teriparatide, Mean (95% CI) or N (%)
| Timepoint | Responders (n = 32) | Nonresponders (n = 7) | P | |
|---|---|---|---|---|
| Characteristics | ||||
| Age, years | Baseline | 37.2 (34.5, 39.9) | 35.9 (27.9, 43.8) | 0.67 |
| Weight, kg | Baseline | 57.2 (53.7, 60.8) | 65.2 (53.1, 77.3) | 0.08 |
| Height, cm | Baseline | 163.1 (160.5, 165.8) | 158.6 (154.2, 163.0) | 0.14 |
| Body mass index, kg/m2 | Baseline | 21.5 (20.4, 22.6) | 26.1 (20.4, 31.8) | 0.006 |
| Adult low trauma fractures, n | Baseline | 3.2 (2.0, 4.3) | 2.9 (0.2, 5.5) | 0.83 |
| Active n (%) | 25 (76) | 3 (43) | 0.17 | |
| Placebo n (%) | 8 (24) | 4 (57) | ||
| Compliance | 12M | 94.9 | 94.7 | 0.95 |
| Areal BMD by DXA, g/cm 2 | ||||
| Lumbar spine | Baseline | 0.779 (0.745, 0.814) | 0.838 (0.781, 0.893) | 0.14 |
| 12M | 0.861 (0.823, 0.899) | 0.830 (0.749, 0.911) | 0.48 | |
| 12M Absolute Change | 0.08 (0.068, 0.091) | −0.007 (−0.046, 0.031) | <0.0001 | |
| Total Hip | Baseline | 0.749 (0.721, 0.776) | 0.825 (0.685, 0.965) | 0.055 |
| 12M | 0.771 (0.742, 0.801) | 0.833 (0.691, 0.975) | 0.13 | |
| 12M Absolute Change | 0.027 (0.016, 0.037) | 0.008 (−0.016, 0.033) | 0.13 | |
| Femoral Neck | Baseline | 0.634 (0.601, 0.667) | 0.692 (0.571, 0.814) | 0.16 |
| 12M | 0.652 (0.614, 0.689) | 0.680 (0.563, 0.798) | 0.53 | |
| 12M Absolute Change | 0.020 (0.012, 0.029) | −0.012 (−0.022, −0.003) | 0.0009 | |
| Distal Radius (1/3 site) | Baseline | 0.671 (0.652, 0.689) | 0.657 (0.587, 0.727) | 0.58 |
| 12M | 0.665 (0.644, 0.685) | 0.653 (0.590, 0.715) | 0.61 | |
| 12M Absolute Change | −0.004 (−0.012, 0.003) | −0.009 (−0.026, 0.008) | 0.56 | |
| TBS (L1-L4) | Baseline | 1.28 (1.24, 1.32) | 1.33 (1.25, 1.40) | 0.30 |
| 12M | 1.32 (1.28, 1.36) | 1.32, (1.23, 1.41) | 0.98 | |
| 12M Absolute Change | 2.66 (0.49, 4.83) | −0.57 (−6.75, 5.61) | 0.19 | |
| Serum Biochemistry | ||||
| 25-OHD, nmol/L | Baseline | 101.3 (91.8, 110.8) | 93.3 (72.0, 114.5) | 0.48 |
| Parathyroid hormone, pmol/L | Baseline | 2.02 (1.80, 2.23) | 2.17 (1.58, 2.76) | 0.53 |
| Calcium,* mmol/L | Baseline | 2.32 (2.27, 2.35) | 2.32 (2.30, 2.37) | 0.59 |
| IGF-1 | Baseline | 123.5 (109.8, 137.2) | 139.1 (88.6, 189.7) | 0.37 |
| IGF-1 Z-score | Baseline | −0.51 (−0.86, −0.16) | −0.34 (−2.11, 1.42) | 0.73 |
| C-telopeptide, ng/mL | Baseline | 0.317 (0.26, 0.37) | 0.29 (0.17, 0.42) | 0.69 |
| 3M | 0.576 (0.40, 0.75) | 0.470 (−0.05, 0.99) | 0.63 | |
| 3M Absolute Change | 0.22 (0.07, 0.38) | 0.17 (−0.20, 0.53) | 0.76 | |
| P1NP, ng/mL | Baseline | 36.2 (31.2, 41.2) | 36.7 (31.2, 42.1) | 0.93 |
| 3M | 96.9 (62.5, 131.2) | 75.3 (7.2, 143.4) | 0.62 | |
| 3M Absolute Change | 57.5 (23.2, 91.8) | 40.2 (−21.4, 101.8) | 0.68 | |
| Osteocalcin, ng/mL | Baseline | 14.4 (11.8, 16.9) | 14.0 (10.9, 17.1) | 0.89 |
| 3M | 39.1 (31.6, 46.5) | 31.3 (3.3, 59.3) | 0.43 | |
| 3M Absolute Change | 23.9 (17.7, 30.1) | 18.4 (−6.5, 43.4) | 0.51 | |
| Bone biopsy measurements | ||||
| Cancellous BFR, mm2/mm/yr | Baseline | 0.012 (0.008, 0.015) | 0.005 (0.0002, 0.011) | 0.14 |
| Endocortical BFR, mm2/mm/yr | Baseline | 0.022 (0.015, 0.030) | 0.007 0.003, 0.016) | 0.10 |
| Intracortical BFR, mm2/mm/yr | Baseline | 0.027 (0.019, 0.036) | 0.015 (−0.004, 0.033) | 0.24 |
| Cancellous MdPm (%) | Baseline | 5.84 (4.15, 7.53) | 2.87 (0.73, 5.00) | 0.17 |
| Endocortical MdPm (%) | Baseline | 10.7 (7.24, 14.1) | 4.13 (−0.67, 8.93) | 0.14 |
| Intracortical MdPm (%) | Baseline | 10.6 (7.26, 14.0) | 5.61 (−1.71, 12.9) | 0.25 |
Bold indicates P values < 0.05.
Abbreviations: 25-OHD, 25-hydroxyvitamin D; BFR, bone formation rate; BMD, bone mineral density; DXA, dual-energy x-ray absorptiometry; IGF-1, insulin-like growth factor 1; MdPm, mineralizing perimeter; P1NP, N-terminal propeptides of procollagen type 1; TBS, trabecular bone score.