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


ABSTRACT: 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 ?g) 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.

SUBMITTER: Body JJ 

PROVIDER: S-EPMC7497508 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

Body J-J JJ   Marin F F   Kendler D L DL   Zerbini C A F CAF   López-Romero P P   Möricke R R   Casado E E   Fahrleitner-Pammer A A   Stepan J J JJ   Lespessailles E E   Minisola S S   Geusens P P  

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA 20200530 10


FRAX<sup>®</sup> 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<sup>®</sup>-defined MOF compared with those treated with risedronate.<h4>Introduction</h4>The VERO trial was an active-controlled fracture endpoint clinical trial that enrolled postmenopausal wom  ...[more]

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