Table 2.
RCTs included in individual patient data (IPD) and Osteoporosis Research Advisory Group (ORAG) meta-analyses: vertebral fracture
| Adachi et al. [12] (IPD: vertebral fracture)a
|
ORAG (vertebral analysis) [8]
|
||||||
|---|---|---|---|---|---|---|---|
| Entry criteria (skeletal status, duration) | N control/Tx (5 mg only) | Mean age (placebo) | Lumbar spine BMD T-score (placebo) | N control/Tx | Mean ageb | Lumbar spine BMD T-scoreb | |
| VERT-NA [30] | 2 or more VF at baseline or 1 VF and a lumbar spine BMD T-score of ≤ −2 (3 years) | 565/579 | 69 (6.9) | −2.3 | 678/696 (5 mg group only, 2.5 mg excluded) | 69 (7.3) | −2.4 |
| VERT-MN [31] | 2 or more VF (T4–L4) at baseline (3 years) | 339/334 | 71 (6.8) | −2.4 | 346/344 (5 mg group only, 2.5 mg excluded) | 71 (7.0) | −2.7 |
| BMD-MN [33] | Lumbar spine BMD T-score (L1–L4) of ≤ −2.0 (2 years) | 74/77 | 66 (7.4) | −2.3 | 125/172 (includes 2.5 mg and 5 mg) | 64.7 (7.2) | −2.9 |
| BMD-NA [32] | Lumbar spine BMD T-score of ≤ −2.0 (1–1.5 years) | 109/102 | 64 (7.0) | −2.5 | Not included | – | – |
| Prevention of bone loss in early menopause [34] | Post-menopausal women (6–36 months); 1 VF or a femoral neck BMD of ≤ −2.5 (2 years) | 25/26 | 53 (2.9) | −0.8 | Not included | – | – |
| Clemmesen et al. (1997) [42] | At least one, but not more than four, VF (2 years) | Not included | – | – | 44/88(2.5 mg only dose in this study) | 68.3 (5.7) | −2.4 |
| Mortensen et al. (1998) [43] | Normal lumbar spine bone mass (>2 SD), 6–60-month post-menopausal (1–2 years treatment + 1 year follow-up) | Not included | – | – | 36/75 (5 mg cyclic/or daily only dose in this study) | 51.2 (3.8) | −1.0 |
VF vertebral fracture(s)
a
IPD analysis restricted to subset of patients who received risedronate 5 mg per day (or placebo) and with at least one existing vertebral fracture or a femoral neck BMD T-score of less than −2.5 at baseline