Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial |
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Authors: | 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 Péter Lakatos Enrique Casado Rüdiger Moericke Pedro López‐Romero Astrid Fahrleitner‐Pammer |
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Affiliation: | 1. Maastricht University Medical Center, Maastricht, The Netherlands;2. Lilly Research Center Europe, Madrid, Spain;3. University of British Columbia, Vancouver, Canada;4. CCBR Brasil Centro de Analises e Pesquisas Clínicas, Rio de Janeiro, Brazil;5. Centro Paulista de Investiga?ao Clínica, Sao Paulo, Brazil;6. “Sapienza” Rome University, Rome, Italy;7. CHU Brugmann, ULB, Brussels, Belgium;8. Regional Hospital of Orléans, Orléans, France;9. Osteoporosis Center, University of Pittsburgh, Pittsburgh, PA, USA;10. Centro de Osteopatías Comlit, Buenos Aires, Argentina;11. Institute of Rheumatology and Faculty of Medicine 1, Charles University, Prague, Czech Republic;12. Semmelweis University Medical School, Budapest, Hungary;13. University Hospital Parc Taulí Sabadell (UAB), Barcelona, Spain;14. Institut Pr?ventive Medizin & Klinische Forschung, Magdeburg, Germany;15. Division of Endocrinology and Diabetes, Medical University of Graz, Graz, Austria |
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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 20 μg 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 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‐naïve, 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 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‐naïve and previously treated patients. © 2018 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals Inc. |
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Keywords: | TERIPARATIDE VERTEBRAL FRACTURES POSTMENOPAUSAL OSTEOPOROSIS BISPHOSPHONATES SUBGROUP ANALYSIS |
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