Table 1.
RCTs included in individual patient data (IPD) and Osteoporosis Research Advisory Group (ORAG) meta-analyses: non-vertebral fracture
| Harrington et al. [13] (IPD: non- vertebral)a | ORAG (non-vertebral analysis) [8] | ||||||
|---|---|---|---|---|---|---|---|
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| Study (duration) | Entry criteria (skeletal status, duration) | N control/Tx (5mg only) | Mean age | Lumbar spine BMD T-score | N control/Tx | Mean ageb | Lumbar spine BMD T-scoreb |
| VERT-NA (3 years) [30] | 2 or more VF at baseline or 1 VF and a lumbar spine BMD T-score of ≤ −2 | 282/265 | 68 (7.4) | −3.4 (0.69) | 815/812 (5 mg group only, 2.5 mg excluded) | 69 (7.3) | −2.4 |
| VERT-MN (3 years) [31] | 2 or more VF at baseline | 80/69 | 69 (7.0) | −3.6 (0.72) | 406/406 (5 mg group only, 2.5 mg excluded) | 71 (7.0) | −2.7 |
| BMD-MN (2 years) [33] | Lumbar spine BMD T-score of ≤ −2.0 | 112/100 | 65 (7.1) | −3.2 (0.52) | 125/172 (includes 2.5 mg and 5 mg) | 64.7 (7.2) | −2.9 |
| BMD-NA (1–1.5 years) [32] | Lumbar spine BMD T-score of ≤ −2.0 | 134/130 | 62 (7.6) | −3.1 (0.50) | 220/428 (includes 2.5 mg and 5 mg) | 62.5 (0.3) | −2.8 |
| Clemmesen et al. (2 years) [42] | At least one, but not more than four, VF | Not included | – | – | 44/88 (2.5 mg only dose in this study) | 68.3 (5.7) | −2.4 |
| Mortensen et al. (3 years) [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 |
| HIP [44] | Age 70–79: femoral neck T-score ≤−4 or femoral neck T-score ≤−3 + 1 risk factor) age 80 and over: at least 1 non-skeletal risk factor or low BMD (≤−4 or ≤−3 + risk factor) | Not includedc | – | – | 3,134/6,197 (includes 2.5 mg and 5 mg) | 78 (9.7) | −2.8 Femoral neck = −3.7 |
VF vertebral fracture(s)
a
Analysis restricted to subset of patients who received risedronate 5 mg per day (or placebo) and who had a lumbar spine T-score of less than −2.5. Patients had to have all four lumbar spine (L1–L4) vertebrae intact
b
From ORAG Table 2 [8] (based on all treatment groups–placebo; 2.5 mg and/or 5 mg groups were applicable)
c
The HIP study was not included because patients were substantially older (mean age 78 years) than the other study populations that were included (mean age 66 years)