Table 1.
Demographics and Baseline Characteristics of DATA-HD Study Participants Included in the Responder Analysisa
| Characteristic | SD TPTD (20 μg) Plus Denosumab (n = 31) | HD TPTD (40 μg) Plus Denosumab (n = 29) | P Value |
|---|---|---|---|
| Age (y) | 65.8 (7.4) | 66.6 (7.2) | .68 |
| Body mass index (kg/m2) | 22.8 (2.7) | 22.5 (3.7) | .73 |
| White, non-Hispanic | 29 (94%) | 28 (97%) | .59 |
| History of adult fragility fracture | 13 (42%) | 18 (62%) | .12 |
| Previous bisphosphonate use | 18 (58%) | 15 (52%) | .62 |
| Duration of use (mo) | 44.2 (32.1) | 71.9 (51.9) | .07 |
| Time since discontinuation (mo) | 73.0 (64.2) | 76.8 (60.0) | .86 |
| Serum P1NP (μg/L) | 48.0 (16.8) | 51.5 (16.0) | .42 |
| Serum CTX (ng/L) | 426.2 (166.1) | 464.7 (164.7) | .37 |
| Baseline areal bone mineral density by DXA (g/cm 2) | |||
| Total hip | 0.748 (0.105) | 0.740 (0.073) | .71 |
| Femoral neck | 0.652 (0.097) | 0.629 (0.071) | .30 |
| Posteroanterior lumbar spine | 0.836 (0.109) | 0.800 (0.111) | .37 |
Values are presented as mean (SD) or number (%).
Abbreviations: CTX, serum C-telopeptide of type I collagen; DXA, dual x-ray absorptiometry; HD, high dose; P1NP, serum procollagen type I N-terminal propeptide; SD, standard dose; TPTD, teriparatide.
aIncludes 60 participants who had areal bone mineral density determinations at all study visits (baseline, month 9, and month 15, 79% of the Denosumab and High-Dose Teriparatide Administration population at enrollment).