Table 2.
Six Months of Teriparatide Versus Placebo: Effects on aBMD, Trabecular Bone Score (TBS), Bone Turnover Markers (BTMs) and Bone Formation on Transiliac Biopsy in Premenopausal IOP, Mean (95% CI)
| Time | Teriparatide (N = 28) | Placebo (N = 13) | Difference | |
|---|---|---|---|---|
| Aim 1: Six months of teriparatide versus placebo: Effects on aBMD by DXA, Biochemistries, and TBS | ||||
| Primary Outcomes | ||||
| Lumbar Spine aBMD, g/cm2 | Baseline | 0.77 | 0.82 | −0.05 (−0.12, 0.01) |
| 6M | 0.81 | 0.84 | −0.02 (−0.09, 0.04) | |
| % Change | 5.51 | 1.55 | 3.96 (1.16, 6.76) | |
| Key Secondary Outcomes | ||||
| Total Hip aBMD, g/cm2 | Baseline | 0.74 | 0.81 | −0.07 (−0.13, −0.007) |
| 6M | 0.75 | 0.81 | −0.06 (−0.12, 0.002) | |
| % Change | 1.32 | 0.08 | 1.24 (−0.79, 3.28) | |
| Femoral Neck aBMD, g/cm2 | Baseline | 0.62 | 0.69 | −0.07 (−0.14, −0.002) |
| 6M | 0.63 | 0.70 | −0.06 (−0.13, 0.003) | |
| % Change | 0.50 | 0.50 | 0.00 (−2.34, 2.34) | |
| Distal Radius (1/3 site) aBMD, g/cm2 | Baseline | 0.67 | 0.69 | −0.02 (−0.06, 0.01) |
| 6M | 0.67 | 0.68 | −0.01 (−0.05, 0.03) | |
| % Change | 0.13 | −0.98 | 1.11 (−0.47, 2.69) | |
| P1NP, ng/mL | Baseline | 35.3 | 39.5 | −4.2 (−13.0, 4.6) |
| 3M | 102.1 | 33.3 | 68.8 (13.2, 124.4) | |
| 6M | 116.0 | 37.8 | 78.1 (18.5, 137.8) | |
| Osteocalcin (OCN), ng/mL | Baseline | 14.4 | 15.3 | −0.88 (−5.39, 3.63) |
| 3M | 39.7 | 13.2 | 26.5 (15.0, 38.0) | |
| 6M | 41.5 | 13.4 | 28.1 (14.0, 42.2) | |
| C-telopeptide (CTx), ng/mL | Baseline | 0.317 | 0.350 | −0.03 (−0.14, 0.08) |
| 3M | 0.625 | 0.294 | 0.33 (0.05, 0.62) | |
| 6M | 0.659 | 0.308 | 0.35 (0.04, 0.66) | |
| Other Outcomes | ||||
| Trabecular Bone Score (TBS; Exploratory) | Baseline | 1.28 | 1.30 | −0.02 (−0.09, 0.06) |
| 6M | 1.31 | 1.31 | 0.00 (−0.07, 0.07) | |
| IGF-1, ng/mL | Baseline | 124.4 | 123.7 | 0.66 (−24.8, 26.1) |
| 3M | 112.3 | 107.8 | 4.5 (−21.0, 30.0) | |
| 6M | 115.6 | 116.1 | −0.50 (−27.2, 26.2) | |
| Aim 2: Six months of teriparatide versus placebo: Tissue-based Bone Formation on Three-month Quadruple Biopsy | ||||
| Primary Outcomes | N = 27 | N = 11 | ||
| Cancellous BFR/BS, mm2/mm/yr | Baseline | 0.011 | 0.010 | 0.001 (−0.006, 0.007) |
| 3M | 0.037 | 0.012 | 0.025 (0.008, 0.04) | |
| Endocortical BFR/BS, mm2/mm/yr | Baseline | 0.019 | 0.021 | −0.002 (−0.017, 0.01) |
| 3M | 0.077 | 0.024 | 0.053 (0.02, 0.09) | |
| Intracortical BFR/BS, mm2/mm/yr | Baseline | 0.025 | 0.025 | −0.0001 (−0.017, 0.02) |
| 3M | 0.047 | 0.026 | 0.021 (−0.007, 0.05) | |
| Cancellous MdPm (%) | Baseline | 5.51 | 5.37 | 0.14 (−3.13, 3.41) |
| 3M | 16.7 | 6.06 | 10.7 (3.57, 17.8) | |
| Endocortical MdPm (%) | Baseline | 9.77 | 9.95 | −0.18 (−6.85, 6.49) |
| 3M | 33.8 | 10.2 | 23.6 (10.5, 36.7) | |
| Intracortical MdPm (%) | Baseline | 9.28 | 11.1 | −1.86 (−8.41, 4.70) |
| 3M | 15.6 | 9.03 | 6.57 (−1.82, 15.0) |
Abbreviations: aBMD, areal bone mineral density; BFR, bone formation rate; DXA, dual-energy x-ray absorptiometry; IGF-1, insulin-like growth factor 1; IOP, idiopathic osteoporosis; MdPm, mineralizing perimeter; P1NP, N-terminal propeptides of procollagen type 1.