Table 2.
Composite end points with respective components for weeks 4 and 26
| Week 4 | Week 26 | |||||
|---|---|---|---|---|---|---|
| TransCon PTH 15 µg/d | TransCon PTH 18 µg/d | TransCon PTH 21 µg/d | All TransCon PTH | Placebo | All TransCon PTH | |
| Participants with data for all criteria at wk 4 or 26 | 49 d | |||||
| Full analysis (N = 59) | 14 | 15 | 15 | 44 | 15 | |
| Modified full analysis 1 (N = 57) | 14 | 15 | 15 | 44 | 13 | |
| Modified full analysis 2 (N = 55) | 13 | 15 | 14 | 42 | 13 | |
| Participants meeting primary composite end point, No. (%) | 7 (50) | 6 (40) | 9 (60) | 22 (50) | 4 (27) | 35 (71) |
| 7 (50) | 6 (40) | 9 (60) | 22 (50) | 2 (15) | ||
| 6 (46) | 6 (40) | 9 (64) | 21 (50) | 2 (15) | ||
| (95% CI) | (23-77) | (16-68) | (32-84) | (35-65) | (8-55) | (57-83) |
| (23-77) | (16-68) | (32-84) | (35-65) | (2-45) | ||
| (12-75) | (16-68) | (35-87) | (34-66) | (2-45) | ||
| Pa | 0.26 | 0.70 | 0.14 | 0.14 | ||
| 0.10 | 0.22 | 0.02 | 0.03 | |||
| 0.20 | 0.22 | 0.02 | 0.05 | |||
| Participants meeting each component of end point, No. (%) | ||||||
| Serum calcium within normal rangeb | 12 (86) | 12 (80) | 14 (93) | 38 (86) | 14 (93) | 45 (92) |
| 12 (86) | 12 (80) | 14 (93) | 38 (86) | 12 (92) | ||
| 11 (85) | 12 (80) | 13 (93) | 36 (86) | 12 (92) | ||
| Active vitamin D = 0 µg/d | 14 (100) | 14 (93) | 15 (100) | 43 (98) | 6 (40) | 49 (100) |
| 14 (100) | 14 (93) | 15 (100) | 43 (98) | 4 (31) | ||
| 13 (100) | 14 (93) | 14 (100) | 41 (98) | 4 (31) | ||
| Calcium ≤ 1000 mg/d | 13 (93) | 13 (87) | 15 (100) | 41 (93) | 8 (53) | 46 (94) |
| 13 (93) | 13 (87) | 15 (100) | 41 (93) | 6 (46) | ||
| 12 (92) | 13 (87) | 14 (100) | 39 (93) | 6 (46) | ||
| FECa (spot morning urine) within normal range (≤ 2%) or ≥ 50% reduction from baseline | 10 (71) | 8 (53) | 9 (60) | 27 (61) | 7 (54) | |
| 10 (71) | 8 (53) | 9 (60) | 27 (61) | 5 (38) | ||
| 9 (69) | 8 (53) | 9 (64) | 26 (62) | 5 (38) | ||
| 24-h urine calcium within normal rangec | 41 (84) | |||||
Abbreviations: FECa, fractional excretion of calcium; PTH, parathyroid hormone.
a Fisher exact test used to compare differences in proportions with placebo.
b Normal range for albumin-adjusted serum calcium is 8.3 to 10.6 mg/dL (2.07-2.64 mmol/L); normal range for ionized serum calcium is 1.16 to 1.32 mmol/L.
c Normal range for 24-hour urine calcium is defined as less than or equal to 250 mg/24 h (≤ 6.25 mmol/24 h) for women, and less than or equal to 300 mg/24 h (≤ 7.5 mmol/24 h) for men.
d Percentages are based on 49 individuals with available data for all criteria at 26 weeks.