Table 1.
Baseline Characteristics of all Participants, Those Randomized to Teriparatide-First and Those Randomized to Placebo-First, Analysed by Intention-to-Treat; Mean (95% CI) or N (%)
| All Patients (N = 41) | Teriparatide-First (N = 28) | Placebo-First (N = 13) | P Value | |
|---|---|---|---|---|
| Columbia | 32 | 23 | 9 | |
| Creighton | 9 | 5 | 4 | |
| Characteristics | ||||
| Age, years | 36.9 (34.5, 39.3) | 37.8 (34.8, 40.8) | 35.1 (30.7, 39.4) | 0.29 |
| Weight, kg | 58.4 (55.0, 61.8) | 56.5 (52.4, 60.3) | 62.7 (55.9, 69.5) | 0.08 |
| Height, cm | 162.2 (160.0, 164.5) | 162.1 (159.4, 164.7) | 162.5 (157.7, 167.4) | 0.86 |
| Body mass index (BMI), kg/m2 | 22.2 (20.9, 23.5) | 21.4 (20.2, 22.7) | 24.0 (20.7, 27.2) | 0.072 |
| Adult low trauma fractures, n (%) | 32 (80) | 21 (78) | 11 (85) | 0.6 |
| Number of adult low trauma fractures | 3.1 (2.1, 4.1) | 2.8 (1.6, 3.9) | 3.8 (1.6, 5.9) | 0.3 |
| Bone measurements by DXA | ||||
| Lumbar spine BMD, g/cm2 | 0.79 (0.76, 0..82) | 0.77 (0.74, 0.81) | 0.82 (0.76, 0.89) | 0.10 |
| Lumbar spine BMD Z-score | −2.19 (−0.49, −1.90) | −2.29 (−2.62, −1.95) | −1.99 (−2.61, −1.37) | 0.34 |
| Total hip BMD, g/cm2 | 0.76 (0.73, 0.79) | 0.74 (0.71, 0.78) | 0.81 (0.75, 0.88) | 0.03 |
| Total hip BMD Z-score | −1.31 (−1.55, −1.08) | −1.47 (−1.73, −1.20) | −0.96 (−1.48, −0.44) | 0.05 |
| Femoral neck BMD, g/cm2 | 0.64 (0.61, 0.68) | 0.62 (0.59, 0.66) | 0.69 (0.63, 0.76) | 0.045 |
| Femoral neck BMD Z-score | −1.59 (−1.86, −1.32) | −1.75 (−2.08, −1.41) | −1.23 (−1.69, −0.77) | 0.07 |
| Distal radius BMD, g/cm2 | 0.67 (0.66, 0.69) | 0.67 (0.64, 0.69) | 0.69 (0.66, 0.72) | 0.19 |
| Distal radius BMD Z-score | 0.04 (−0.26, 0.34) | −0.08 (−0.48, 0.33) | 0.30 (−0.13, 0.73) | 0.25 |
| Trabecular bone score (TBS; L1L4) | 1.28 (1.25, 1.32) | 1.28 (1.23, 1.32) | 1.30 (1.25, 1.34) | 0.61 |
| Biochemistries | ||||
| Serum N-terminal propeptide of procollagen type 1 (P1NP), ng/mL | 36.7 (32.6, 40.8) | 35.3 (29.6, 41.0) | 39.5 (34.4, 44.6) | 0.55 |
| Serum osteocalcin (OCN), ng/mL | 14.7 (12.6, 16.8) | 14.4 (11.4, 17.4) | 15.3 (12.9, 17.7) | 0.34 |
| Serum C-telopeptide (CTx), ng/mL | 0.327 (0.277, 0.378) | 0.317 (0.250, 0.384) | 0.350 (0.265, 0.434) | 0.70 |
| Serum 25-OHD, nmol/L | 98.1 (89.4, 106.8) | 95.6 (85.9, 105.3) | 103.3 (83.6, 123.1) | 0.42 |
| Serum parathyroid hormone, pmol/L | 2.06 (1.87, 2.26) | 1.94 (1.74, 2.14) | 2.32 (1.88, 2.76) | 0.06 |
| Serum calcium,* mmol/L | 2.32 (2.27, 2.35) | 2.30 (2.30, 2.32) | 2.32 (2.22, 2.40) | 0.91 |
| Urine calcium, mmol/molCr | 371.3 (311.4, 431.3) | 375.3 (292.4, 458.4) | 358.0 (254.2, 461.8) | 0.79 |
| Urine calcium, mg/gCr | 131.3 (110.1, 152.5) | 132.7 (103.4, 162.1) | 126.6 (89.9, 163.3) | 0.96 |
| Serum insulin-like growth factor 1 (IGF-1), ng/mL** | 124.2 (112.4, 136.0) | 124.4 (108.8, 140.0) | 123.7 (104.2, 143.3) | 0.09 |
| IGF-1 Z-score | −0.48 (−0.84, −0.12) | −0.28 (−0.68, 0.13) | −0.92 (−1.71, −0.14) | 0.09 |
| Bone biopsy measurements | ||||
| Number (N) | 38 | 27 | 11 | |
| Cancellous BFR, mm2/mm/yr | 0.011 (0.008, 0.014) | 0.011 (0.007, 0.015) | 0.010 (0.006, 0.015) | 0.82 |
| Endocortical BFR, mm2/mm/yr | 0.020 (0.013, 0.026) | 0.019 (0.011, 0.027) | 0.021 (0.010, 0.033) | 0.77 |
| Intracortical BFR, mm2/mm/yr | 0.025 (0.018, 0.033) | 0.025 (0.016, 0.034) | 0.025 (0.009, 0.041) | 0.99 |
| Cancellous MdPm (%) | 5.47 (4.00, 6.93) | 5.51 (3.56, 7.45) | 5.37 (3.19, 7.54) | 0.93 |
| Endocortical MdPm (%) | 9.83 (6.85, 12.8) | 9.77 (5.92, 13.6) | 9.95 (4.89, 15.0) | 0.96 |
| Intracortical MdPm (%) | 9.82 (6.87, 12.8) | 9.28 (6.02, 12.5) | 11.1 (3.84, 18.4) | 0.57 |
Abbreviations: 25-OHD, 25-hydroxyvitamin D; BFR, bone formation rate; BMD, bone mineral density; DXA, dual-energy x-ray absorptiometry; MdPm, mineralizing perimeter.
*Albumin-adjusted; **Immulite restandardized