Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): A multicentre, double-blind, double-dummy, randomised controlled trial
The Lancet Nov 15, 2017
Kendler DL, et al. - Researchers pursued a comparative exploration of the anti-fracture efficacy of teriparatide with risedronate in patients with severe osteoporosis. A substantially lower risk of new vertebral and clinical fractures was discovered in patients receiving teriparatide than in those receiving risedronate.
Methods
- The scheme of this research was a double-blind, double-dummy trial.
- Post-menopausal women with at least two moderate or one severe vertebral fracture and a bone mineral density T score of less than or equal to -1.50 were eligible for this study.
- Enrollees were randomly assigned to receive 20 μg of teriparatide once daily plus oral weekly placebo or 35 mg of oral risedronate once weekly plus daily injections of placebo for 24 months.
- The primary outcome comprised of new radiographic vertebral fractures.
- New and worsened radiographic vertebral fractures, clinical fractures (a composite of non-vertebral and symptomatic vertebral), and non-vertebral fractures were included as the secondary, gated outcomes.
Results
- A total of 680 patients were recruited in each group.
- The occurrence of new vertebral fractures was reported in 28 (5.4%) of 680 patients in the teriparatide group and 64 (12.0%) of 680 patients in the risedronate group (risk ratio 0.44, 95% CI 0.29-0.68; p < 0.0001), at 24 months.
- It was observed that the clinical fractures occurred in 30 (4.8%) of 680 patients in the teriparatide group compared with 61 (9.8%) of 680 in the risedronate group (hazard ratio 0.48, 95% CI 0.32-0.74; p=0.0009).
- The occurrence of non-vertebral fragility fractures was discovered in 25 (4.0%) patients in the teriparatide group and 38 (6.1%) in the risedronate group (hazard ratio 0.66; 95% CI 0.39-1.10; p=0.10).
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