Table 1.
Bone Histology and Histopathology
| FREEDOM | Extension | |||
|---|---|---|---|---|
| Placebo Year 2 and/or 3 | Denosumab Year 2 and/or 3 | Denosumab Year 5 | Denosumab Year 10 | |
| N = 45a | N = 47a | N = 28b | N = 22b | |
| Evaluable biopsiesc | 62 | 53 | 28 | 22 |
| Normal lamellar bone, n (%) | 62 (100) | 53 (100) | 28 (100) | 22 (100) |
| Normal mineralization, n (%) | 62 (100) | 53 (100) | 28 (100) | 22 (100) |
| Present osteoid, n (%) | 62 (100) | 48 (91) | 23 (82) | 18 (82) |
| No visible osteoid, n (%) | 0 (0) | 5 (9.4) | 5 (17.9) | 4 (18.2) |
| Osteomalacia, n | 0 | 0 | 0 | 0 |
| Marrow fibrosis, n | 0 | 0 | 0 | 0 |
| Woven bone, n | 0 | 0 | 0 | 0 |
a
Number of subjects who enrolled in the FREEDOM bone biopsy substudy, received ≥1 dose of investigational product during FREEDOM, and had an evaluable biopsy at year 2 or year 3.
b
Number of subjects who enrolled in the extension bone biopsy substudy, received ≥1 dose of investigational product during the extension, and had an evaluable biopsy at the time point(s) of interest.
c
Number of evaluable biopsies, which serves as the denominator for percentage values in parentheses; some subjects had ≥1 evaluable biopsy during the FREEDOM trial.