Table 1.
Summary of results from pivotal clinical trials with nitrogen-containing bisphosphonates
| Trial | N | Osteoporosis inclusion criteria | Study duration | Dosage | Increase in LS BMD %* | Fracture risk reduction % | ||
|---|---|---|---|---|---|---|---|---|
| Vertebral | Nonvertebral | Hip | ||||||
| Alendronate | ||||||||
| Phase III, Liberman et al 1995 | 994 | LS T-score ≤–2.5 with or without vertebral fracture | 3 y | 5 mg/d or10 mg/d for 3 y, or20 mg/d for 2 y then 5 mg/d for 1 y | 8.8 (10 mg/d) | 48 (p=0.03) | NS | — |
| FIT 1 Black et al 1996 | 2027 | FN T-score ≤ –2.1 with vertebral fracture | 3 y | 5 mg/d for 2 y then 10 mg/d for 1 y | 6.2 | 47 (p<0.001) | NS | 51 (p=0.047) |
| FIT 2 Cummings et al 1998 | 4432 | FN T-score ≤–2.1 with no vertebral fracture | 4 y | 5 mg/d for 2 y then 10 mg/d for 2 y | 6.8 | 44 (p=0.002) | NS | NS |
| FOSIT Pols et al 1999 | 1908 | LS T-score ≤–2.0 | 1 y | 10 mg/d | 4.9 | — | 47 (p=0.021) | — |
| Orwoll et al 2000 | 241 | Men, FN T-score ≤–2.0 & LS T-score ≤–1.0, or FN T-score ≤–1.0 with vertebral or osteoporotic fracture | 2 y | 10 mg/d | 5.3 | 89 (p=0.02) | — | — |
| Adachi et al 2001 | 208 | Glucocorticoid therapy | 2 y | 5 mg/d or 10 mg/d, or 2.5 mg/d for 1y, then 10 mg/d for 1y | 4.7 (10 mg/d) | 90 (p=0.03) | — | — |
| Risedronate | ||||||||
| VERT-NA Harris et al 1999 | 2458 | T-score ≥2 with vertebral fractures or 1 vertebral fracture and T-score ≤ –2 | 3 y | 5 mg/d | 4.3 | 41 (p=0.003) | 39 (p=0.02) | — |
| VERT-MN Reginster et al 2000 | 1226 | ≥ 2 vertebral fractures | 3 y | 5 mg/d | 5.9 | 49 (p<0.001) | — | — |
| HIP McClung et al 2001 | 5445 | Age 70–79 y with FN T-score <–4.0 or <–3.0 with ≥ 1risk factor for hip fracture | 3 y | 2.5 mg/d or 5 mg/d (pooled data) | — | — | 20 (p=0.03) | 40 (p=0.009) |
| Reid et al 2001 | 184 | Men, glucocorticoid therapy | 1 y | 2.5 mg/d or 5 mg/d | 8.2 (5 mg/d) | 82 (p=0.008) | — | — |
| Wallach et al 2000 | 518 | Glucocorticoid therapy | 1 y | 2.5 mg/d or 5 mg/d | 2.9 (5 mg/d) | 70 (p=0.01) | — | — |
| Ibandronate | ||||||||
| Phase III, Recker et al 2004 | 2862 | T-score <–2 with or without vertebral fracture | 3 y | 0.5 mg or 1 mg iv 3 monthly | 2.9, 4.0 | NS | NS | — |
| BONE Chesnut et al 2004 | 2946 | T score <–2 with vertebral fractures | 3y | 2.5 mg/d20 mg alt d for 24 d, every 3 mo | 5.24.4 | 6250 | NS | — |
*
Treatment minus placebo.
Abbreviations: BMD, bone mineral density; BONE, oral iBandronate Osteoporosis vertebral fracture trial in North America and Europe; d, day; FIT, Fracture Intervention Trial; FOSIT, Fosamax International Trial; FN, femoral neck; HIP, Hip Intervention Program; IV, intravenous; LS, lumbar spine; NS, not significant; VERT-MN, VERT-NA, Vertebral Efficacy with Risedronate Therapy-Multinational, -North American trials, respectively; y, year.