Table 2.
Ibandronate fracture-reduction pivotal studies
| Frequency and route | Dose | Fracture risk, relative risk reduction, % (P-value)
|
||||
|---|---|---|---|---|---|---|
| Vertebral fracture
|
Non-vertebral fracture
|
|||||
| 1 year | 2 years | 3 years | 2 years | 3 years | ||
| Oral | ||||||
| Daily | 2.5 mg | 59 (MVF) (0.0561)13 59 (SVF) (0.0164)14 |
61 (MVF) (0.0006)13 59 (SVF) (0.0004)14 |
62 (MVF) (0.0001)13 49 (CVF) (0.0117)13 59 (SVF) (0.0001)14 |
69 (0.013)13 (subgroup T-score <−3.0) | |
| Intermittent | 20 mg every other day for 12 doses every 3 months | 56 (MVF) (0.0017)13 | 50 (MVF) (0.0006)13 48 (CVF) (0.0143)13 |
37 (0.22)13 (subgroup T-score <−3.0) | ||
| ACE | ||||||
| Pooled analysis (150 mg orally monthly and intravenous doses) | ACE ≥10.8 mg | 29 (0.041)22 38 (0.038)23 |
||||
Abbreviations: ACE, annual cumulative exposure; CVF, clinical vertebral fractures; MVF, morphometric vertebral fractures; SVF, severe vertebral fractures.