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Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial.
J Bone Miner Res. 2018 05; 33(5):783-794.JB

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.

Authors+Show Affiliations

Maastricht University Medical Center, Maastricht, The Netherlands.Lilly Research Center Europe, Madrid, Spain.University of British Columbia, Vancouver, Canada.CCBR Brasil Centro de Analises e Pesquisas Clínicas, Rio de Janeiro, Brazil.Centro Paulista de Investigaçao Clínica, Sao Paulo, Brazil."Sapienza" Rome University, Rome, Italy.CHU Brugmann, ULB, Brussels, Belgium.Regional Hospital of Orléans, Orléans, France.Osteoporosis Center, University of Pittsburgh, Pittsburgh, PA, USA.Centro de Osteopatías Comlit, Buenos Aires, Argentina.Institute of Rheumatology and Faculty of Medicine 1, Charles University, Prague, Czech Republic.Semmelweis University Medical School, Budapest, Hungary.University Hospital Parc Taulí Sabadell (UAB), Barcelona, Spain.Institut Präventive Medizin & Klinische Forschung, Magdeburg, Germany.Lilly Research Center Europe, Madrid, Spain.Division of Endocrinology and Diabetes, Medical University of Graz, Graz, Austria.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

29329484

Citation

Geusens, Piet, et al. "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 : the Official Journal of the American Society for Bone and Mineral Research, vol. 33, no. 5, 2018, pp. 783-794.
Geusens P, Marin F, Kendler DL, et al. Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial. J Bone Miner Res. 2018;33(5):783-794.
Geusens, P., Marin, F., Kendler, D. L., Russo, L. A., Zerbini, C. A., Minisola, S., Body, J. J., Lespessailles, E., Greenspan, S. L., Bagur, A., Stepan, J. J., Lakatos, P., Casado, E., Moericke, R., López-Romero, P., & Fahrleitner-Pammer, A. (2018). 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 : the Official Journal of the American Society for Bone and Mineral Research, 33(5), 783-794. https://doi.org/10.1002/jbmr.3384
Geusens P, et al. Effects of Teriparatide Compared With Risedronate On the Risk of Fractures in Subgroups of Postmenopausal Women With Severe Osteoporosis: the VERO Trial. J Bone Miner Res. 2018;33(5):783-794. PubMed PMID: 29329484.
* Article titles in AMA citation format should be in sentence-case
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 Af, AU - Minisola,Salvatore, AU - Body,Jean Jacques, AU - Lespessailles,Eric, AU - Greenspan,Susan L, AU - Bagur,Alicia, AU - Stepan,Jan J, AU - Lakatos,Péter, AU - Casado,Enrique, AU - Moericke,Rüdiger, AU - López-Romero,Pedro, AU - Fahrleitner-Pammer,Astrid, Y1 - 2018/02/09/ PY - 2017/10/20/received PY - 2017/12/19/revised PY - 2017/12/28/accepted PY - 2018/1/13/pubmed PY - 2019/10/24/medline PY - 2018/1/13/entrez KW - BISPHOSPHONATES KW - POSTMENOPAUSAL OSTEOPOROSIS KW - SUBGROUP ANALYSIS KW - TERIPARATIDE KW - VERTEBRAL FRACTURES SP - 783 EP - 794 JF - Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research JO - J Bone Miner Res VL - 33 IS - 5 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 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. SN - 1523-4681 UR - https://www.unboundmedicine.com/medline/citation/29329484/Effects_of_Teriparatide_Compared_with_Risedronate_on_the_Risk_of_Fractures_in_Subgroups_of_Postmenopausal_Women_with_Severe_Osteoporosis:_The_VERO_Trial_ L2 - https://doi.org/10.1002/jbmr.3384 DB - PRIME DP - Unbound Medicine ER -