Efficacy of teriparatide compared with risedronate on FRAX ® -defined major osteoporotic fractures: results of the VERO clinical trial.

Autor: Body JJ; CHU Brugmann, Université Libre de Bruxelles (ULB), Brussels, Belgium. jean-jacques.body@chu-brugmann.be., Marin F; Lilly Research Center Europe, Madrid, Spain., Kendler DL; University of British Columbia, Vancouver, Canada., Zerbini CAF; Centro Paulista de Investigaçao Clínica, Sao Paulo, Brazil., López-Romero P; Lilly Research Center Europe, Madrid, Spain., Möricke R; Institut Präventive Medizin & Klinische Forschung, Magdeburg, Germany., Casado E; University Hospital Parc Taulí Sabadell, Barcelona, Spain., Fahrleitner-Pammer A; Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria., Stepan JJ; Institute of Rheumatology and Faculty of Medicine 1, Charles University, Prague, Czech Republic., Lespessailles E; Regional Hospital, University of Orleans, Orleans, France., Minisola S; Sapienza Rome University, Rome, Italy., Geusens P; Maastricht University Medical Center, Maastricht, The Netherlands.
Jazyk: angličtina
Zdroj: Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA [Osteoporos Int] 2020 Oct; Vol. 31 (10), pp. 1935-1942. Date of Electronic Publication: 2020 May 30.
DOI: 10.1007/s00198-020-05463-4
Abstrakt: FRAX ® calculates the 10-year probability of major osteoporotic fractures (MOF), which are considered to have a greater clinical impact than other fractures. Our results suggest that, in postmenopausal women with severe osteoporosis, those treated with teriparatide had a 60% lower risk of FRAX ® -defined MOF compared with those treated with risedronate.
Introduction: The VERO trial was an active-controlled fracture endpoint clinical trial that enrolled postmenopausal women with severe osteoporosis. After 24 months, a 52% reduction in the hazard ratio (HR) of clinical fractures was reported in patients randomized to teriparatide compared with risedronate. We examined fracture results restricted to FRAX ® -defined major osteoporotic fractures (MOF), which include clinical vertebral, hip, humerus, and forearm fractures.
Methods: In total, 1360 postmenopausal women (mean age 72.1 years) were randomized to receive subcutaneous daily teriparatide (20 μg) or oral weekly risedronate (35 mg). Patient cumulative incidence of ≥ 1 FRAX ® -defined MOF and of all clinical fractures were estimated by Kaplan-Meier analyses, and the comparison between treatments was based on the stratified log-rank test. Additionally, an extended Cox model was used to estimate HRs at different time points. Incidence fracture rates were estimated at each 6-month interval.
Results: After 24 months, 16 (2.6%) patients in the teriparatide group had ≥ 1 low trauma FRAX ® -defined MOF compared with 40 patients (6.4%) in the risedronate group (HR 0.40; 95% CI 0.23-0.68; p = 0.001). Clinical vertebral and radius fractures were the most frequent FRAX ® -defined MOF sites. The largest difference in incidence rates of both FRAX ® -defined MOF and all clinical fractures between treatments occurred during the 6- to 12-month period. There was a statistically significant reduction in fractures between groups as early as 7 months for both categories of clinical fractures analyzed.
Conclusion: In postmenopausal women with severe osteoporosis, treatment with teriparatide was more efficacious than risedronate, with a 60% lower risk of FRAX ® -defined MOF during the 24-month treatment period. Fracture risk was statistically significantly reduced at 7 months of treatment.
Clinical Trial Information: ClinicalTrials.gov Identifier: NCT01709110 EudraCT Number: 2012-000123-41.
Databáze: MEDLINE
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