Geusens P, et al. - Authors attempted to compare the effects of teriparatide vs risedronate on the risk of fractures among postmenopausal women with established osteoporosis, who had at least 2 moderate or 1 severe baseline vertebral fractures (VFx), and bone mineral density (BMD) T-score ≤–1.5. It was determined that the antifracture efficacy of teriparatide compared with risedronate was consistent in a wide range of patient settings, with the inclusion of treatment-naive and previously treated patients.

Methods

• The 2 year, randomized, double-blind, active-controlled fracture endpoint VERO study examined postmenopausal women with established osteoporosis, who had at least 2 moderate or 1 severe baseline vertebral fractures (VFx), and bone mineral density (BMD) T-score ≤-1.5.
• Subjects were treated with either s.c. daily teriparatide 20 μg or oral weekly risedronate 35 mg.
• Using logistic and Cox proportional hazards regression models, heterogeneity of the treatment effect on the primary endpoint (new VFx), and the four key secondary endpoints (including clinical fractures and NVFFx) were analyzed.

Results

• Teriparatide statistically significantly reduced the risk of new VFx and clinical fractures (a composite of clinical VFx and nonvertebral fragility fractures [NVFFx]) compared with risedronate.
• Prospectively planned subgroup analyses of fracture data across subgroups were illustrated, which were predefined by the following baseline characteristics: Age, number and severity of prevalent VFx, prevalent nonvertebral fractures (NVFx), glucocorticoid use, prior osteoporosis drugs, recent bisphosphonate use, clinical VFx in the year before study entry, and baseline BMD.
• Randomization was performed of 1,360 women and treated (680 per group).
• As per the data, mean age was 72.1 years, mean (SD) number of prevalent VFx was 2.7 (2.1), 55.4% had a BMD T-score <-2.5, 36.5% had a recent clinical VFx, 28.3% had a prior major NVFx, 43.2% were osteoporosis drug-naive, 39.3% were recent bisphosphonate users, and 9.3% were taking glucocorticoids at a prednisone-equivalent dose of >5 mg/d.
• It was discovered that the risk reduction of teriparatide vs risedronate for most fracture endpoints, did not notably vary in any of the subgroups analyzed (treatment-by-subgroup interaction p > 0.1).
• Most subgroups mirrored results from the total study cohort.