Table 1.
Patient Demographics and Clinical Characteristics
| Demographic or Clinical Characteristic | No. of Patients |
|---|---|
| Age at study start, years | |
| 40-50 | 1 |
| 50-60 | 14 |
| 60-70 | 26 |
| 70-80 | 14 |
| 80-90 | 1 |
| Race | |
| White | 53 |
| African American | 2 |
| Asian | 1 |
| Primary treatment | |
| Radical prostatectomy | 40 |
| Radiation therapy | 13 |
| Primary androgen deprivation therapy | 3 |
| Baseline bone mineral density at spine, T score | |
| > 2.5 | 3 |
| 1.0-2.5 | 18 |
| 0.0-1.0 | 8 |
| −1.0 to 0.0 | 16 |
| −2.5 to −1.0 | 11 |
| Baseline bone mineral density at left hip, T score | |
| > 2.5 | 1 |
| 1.0-2.5 | 5 |
| 0.0-1.0 | 17 |
| −1.0 to 0.0 | 19 |
| −2.5 to −1.0 | 13 |
| < −2.5 | 1 |
| Baseline testosterone, ng/dL* | |
| 100-199 | 3 |
| 200-299 | 15 |
| 300-399 | 14 |
| 400-499 | 7 |
| 500-599 | 1 |
| 600-699 | 2 |
| Previous ADT | |
| None | 51 |
| Neoadjuvant | 2 |
| Adjuvant | 3 |
| Greatest No. of total cycles completed† | |
| 1-2 | 22 |
| 3-4 | 19 |
| 5-6 | 10 |
| 7-8 | 3 |
| 9-10 | 2 |
| Bisphosphonate use | |
| Added later during trial‡ | 8 |
| None | 48 |
| Calcium use | |
| In the study | 44 |
| None | 12 |
| Vitamin D use | |
| In the study | 49 |
| None | 7 |
Abbreviation: ADT, androgen deprivation therapy.
*
Forty-two of 56 patients had baseline testosterone levels measured.
†
Fifteen of 56 patients are still in the study.
‡
Initiation of bisphosphonates while on trial was allowed based on treating provider discretion. Of the eight patients who eventually started bisphosphonates on trial, five patients were started for osteopenia, and three patients were started for osteoporosis.