TY - JOUR
T1 - Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial
AU - Geusens, Piet
AU - Marin, Fernando
AU - Kendler, David L.
AU - Russo, Luis A.
AU - Zerbini, Cristiano A. F.
AU - Minisola, Salvatore
AU - Body, Jean Jacques
AU - Lespessailles, Eric
AU - Greenspan, Susan L.
AU - Bagur, Alicia
AU - Stepan, Jan J.
AU - Lakatos, Peter
AU - Casado, Enrique
AU - Moericke, Ruediger
AU - Lopez-Romero, Pedro
AU - Fahrleitner-Pammer, Astrid
PY - 2018/5/1
Y1 - 2018/5/1
N2 - 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 20g or oral weekly risedronate 35mg. As previously reported, the risk of new VFx and clinical fractures (a composite of clinical VFx and nonvertebral fragility fractures [NVFFx]) was statistically significantly reduced with teriparatide compared with risedronate. Here we present the prospectively planned subgroup analyses of fracture data across subgroups, 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. 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 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 >5mg/d. For most fracture endpoints, the risk reduction of teriparatide versus risedronate did not significantly differ in any of the subgroups analyzed (treatment-by-subgroup interaction p>0.1), with most 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-naive and previously treated patients. (C) 2018 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals Inc.
AB - 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 20g or oral weekly risedronate 35mg. As previously reported, the risk of new VFx and clinical fractures (a composite of clinical VFx and nonvertebral fragility fractures [NVFFx]) was statistically significantly reduced with teriparatide compared with risedronate. Here we present the prospectively planned subgroup analyses of fracture data across subgroups, 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. 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 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 >5mg/d. For most fracture endpoints, the risk reduction of teriparatide versus risedronate did not significantly differ in any of the subgroups analyzed (treatment-by-subgroup interaction p>0.1), with most 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-naive and previously treated patients. (C) 2018 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals Inc.
KW - TERIPARATIDE
KW - VERTEBRAL FRACTURES
KW - POSTMENOPAUSAL OSTEOPOROSIS
KW - BISPHOSPHONATES
KW - SUBGROUP ANALYSIS
KW - BONE-MINERAL DENSITY
KW - RANDOMIZED CONTROLLED-TRIAL
KW - YEARLY ZOLEDRONIC ACID
KW - NONVERTEBRAL FRACTURES
KW - HIP FRACTURE
KW - ALENDRONATE
KW - BMD
KW - ABALOPARATIDE
KW - PREVENTS
U2 - 10.1002/jbmr.3384
DO - 10.1002/jbmr.3384
M3 - Article
C2 - 29329484
SN - 0884-0431
VL - 33
SP - 783
EP - 794
JO - Journal of Bone and Mineral Research
JF - Journal of Bone and Mineral Research
IS - 5
ER -