Table 1.
Baseline characteristics of participants who completed a prospective, open-label, single-arm clinical trial of etelcalcetide conducted in New York
| Characteristic | Completed Trial (n=13) | Biopsy (n=5) | No Biopsy (n=8) |
|---|---|---|---|
| Baseline age, median (IQR) | 51 (44–61) | 55 (40–61) | 50 (45–55) |
| Sex, n (%) | |||
| Female | 6 (46) | 4 (80) | 2 (25) |
| Race, n (%) | |||
| White | 2 (15) | 0 (0) | 2 (25) |
| Black | 7 (54) | 4 (80) | 3 (38) |
| Native Hawaiian | 3 (23) | 0 (0) | 3 (37) |
| Unknown | 1 (8) | 1 (20) | 0 (0) |
| Ethnicity, n (%) | |||
| Hispanic/Latinx | 2 (15) | 1 (20) | 1 (13) |
| Non-Hispanic | 11 (85) | 4 (80) | 7 (88) |
| Weight, kg, median (IQR) | 79 (66–86) | 86 (79–91) | 67 (58–82) |
| Height, cm, median (IQR) | 163 (155–168) | 155 (155–161) | 164 (163–169) |
| Tobacco usage, n (%) | |||
| Never | 6 (46) | 1 (20) | 5 (62.5) |
| Current | 5 (39) | 2 (40) | 3 (37.5) |
| Past | 2 (15) | 2 (40) | 0 (0) |
| Alcohol use, n (%) | |||
| Never | 3 (23) | 0 (0) | 3 (38) |
| Former | 7 (54) | 4 (80) | 3 (38) |
| Current | 3 (23) | 1 (20) | 2 (25) |
| Comorbidities, n (%) | |||
| Hypertension | 12 (92) | 4 (80) | 8 (100) |
| Congestive heart failure | 4 (31) | 2 (40) | 2 (25) |
| Coronary heart disease | 6 (46) | 3 (60) | 3 (38) |
| MI | 1 (8) | 0 (0) | 1 (13) |
| Hyperlipidemia | 3 (23) | 1 (20) | 2 (25) |
| Stroke | 1 (8) | 0 (0) | 1 (13) |
| Type II diabetes | 4 (31) | 2 (40) | 2 (25) |
| Liver disease | 1 (8) | 0 (0) | 1 (13) |
| Known osteoporosis at any skeletal site, n (%) | |||
| Yes | 1 (8) | 0 (0) | 1 (13) |
| No | 12 (92) | 5 (100) | 7 (88) |
| Menopausea, n (%) | |||
| Premenopausal | 1 (1.7) | 1 (25) | 0 (0) |
| Menopausal | 5 (833) | 3 (75) | 2 (100) |
| Medications, n (%) | |||
| Prednisone | 3 (23) | 2 (40) | 1 (13) |
| Vitamin D2/D3 supplement | 5 (39) | 2 (40) | 3 (38) |
| Vitamin D receptor analog | 11 (85) | 5 (100) | 6 (75) |
| Phosphate binder | |||
| Calcium acetate | 1 (7.7) | 0 (0) | 1 (13) |
| Sevelamer | 7 (53.9) | 2 (40) | 5 (63) |
| Calcium carbonate | 1 (7.7) | 0 (0) | 1 (13) |
| Atraumatic fractures, n (%) | |||
| Yes | 4 (31) | 1 (25) | 3 (38) |
| No | 9 (69) | 4 (75) | 5 (63) |
| Biochemical screenings mean (min, max) | |||
| PTH time 1 (KDIGO reference range: 160–721 pg/ml) | 1288 (815, 2570) | 1122 (836, 1553) | 1393 (815, 2570) |
| PTH time 2 (KDIGO reference range: 160–721 pg/ml) | 1434 (957, 2632) | 1429 (957, 2632) | 1437 (962, 1998) |
| Calcium (reference range 8.6–10.0 mg/dl) | 9.3 (8.7, 9.7) | 9.4 (9, 9.7) | 9.2 (8.7, 9.7) |
| Total alkaline phosphatase (reference range 46–116 IU/L) | 116 (51, 182) | 116 (85, 163) | 116 (51, 182) |
| Phosphorus (reference range 2.8–4.5 mg/dl) | 6.2 (5.2, 6.8) | 6.0 (5.0, 6.9) | 6.3 (5.4, 6.8) |
IQR, interquartile range; MI, myocardial infarction; PTH, parathyroid hormone; KDIGO, Kidney Disease Improving Global Outcomes.
a
Six female participants were included in the trial, four of them were in the biopsy arm and two were not in the biopsy arm.