Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial

Journal of Bone and Mineral Research, Vol. 33, No. 5, May 2018, pp 783–794

DOI: 10.1002/jbmr.3384

Piet Geusens, Fernando Marin, David L Kendler Luis A Russo, Cristiano AF Zerbini, Salvatore Minisola, Jean Jacques Body, Eric Lespessailles, Susan L Greenspan, Alicia Bagur, Jan J Stepan, P_eter Lakatos, Enrique Casado, R€udiger Moericke, Pedro L_opez-Romero, and Astrid Fahrleitner-Pammer

 

ABSTRACT

The 2-year, randomized, double-blind, active-controlled fracture endpoint VERO study included 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. Patients were treated with either s.c. daily teriparatide 20mg or oral weekly risedronate 35 mg. As previously reported, the risk of new VFx and clinical fractures (a composite of clinical VFx and nonvertebral fragility fractures [NVFFx]) was statisticall significantly reduced with teriparatide compared with risedronate. Here we present the prospectively planned subgroup analyses o fracture data across subgroups, which were predefined by the following baseline characteristics: age, number and severity o 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. Heterogeneity of the treatment effect on the primary endpoint (new VFx), and the four key secondary endpoints (including clinical fractures and NVFFx) were investigated by logistic and Cox proportional hazards regression models. A total of 1360 women were randomized and treated (680 per group). 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 prior major NVFx, 43.2% were osteoporosis drug-na€ıve, 39.3% were recent bisphosphonate users, and 9.3% were taking glucocorticoids at a prednisone-equivalent dose of >5 mg/d. For most fracture endpoints, the risk reduction of teriparatide versu risedronate did not significantly differ in any of the subgroups analyzed (treatment-by-subgroup interaction p>0.1), with mos subgroups mirroring results from the total study population.

In conclusion, in postmenopausal women with severe osteoporosis, the antifracture efficacy of teriparatide compared with risedronate was consistent in a wide range of patient settings, including treatment-na€ıve and previously treated patients.

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