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Abstract
Alendronate and raloxifene are among the most popular anti-osteoporosis medications. However, there is a lack of head-to-head comparative effectiveness studies comparing the two treatments. We conducted a retrospective large-scale multicenter study encompassing over 300 million patients across nine databases encoded in the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The primary outcome was the incidence of osteoporotic hip fracture, while secondary outcomes were vertebral fracture, atypical femoral fracture (AFF), osteonecrosis of the jaw (ONJ), and esophageal cancer. We used propensity score trimming and stratification based on an expansive propensity score model with all pre-treatment patient characteritistcs. We accounted for unmeasured confounding using negative control outcomes to estimate and adjust for residual systematic bias in each data source. We identified 283,586 alendronate patients and 40,463 raloxifene patients. There were 7.48 hip fracture, 8.18 vertebral fracture, 1.14 AFF, 0.21 esophageal cancer and 0.09 ONJ events per 1,000 person-years in the alendronate cohort and 6.62, 7.36, 0.69, 0.22 and 0.06 events per 1,000 person-years, respectively, in the raloxifene cohort. Alendronate and raloxifene have a similar hip fracture risk (hazard ratio [HR] 1.03, 95% confidence interval [CI] 0.94–1.13), but alendronate users are more likely to have vertebral fractures (HR 1.07, 95% CI 1.01–1.14). Alendronate has higher risk for AFF (HR 1.51, 95% CI 1.23–1.84) but similar risk for esophageal cancer (HR 0.95, 95% CI 0.53–1.70), and ONJ (HR 1.62, 95% CI 0.78–3.34). We demonstrated substantial control of measured confounding by propensity score adjustment, and minimal residual systematic bias through negative control experiments, lending credibility to our effect estimates. Raloxifene is as effective as alendronate and may remain an option in the prevention of osteoporotic fracture.
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1 Hanyang University, Department of Orthopaedic Surgery, College of Medicine, Seoul, Republic of Korea (GRID:grid.49606.3d) (ISNI:0000 0001 1364 9317)
2 University of California, Department of Computational Medicine, Los Angeles, USA (GRID:grid.19006.3e) (ISNI:0000 0000 9632 6718)
3 Lister Hill National Center for Biomedical Communications, National Library of Medicine, Bethesda, USA (GRID:grid.280285.5) (ISNI:0000 0004 0507 7840)
4 Columbia University, Department of Biomedical Informatics, New York, USA (GRID:grid.21729.3f) (ISNI:0000000419368729)
5 University of New Mexico Health Sciences Center, Department of Internal Medicine, Albuquerque, USA (GRID:grid.266832.b) (ISNI:0000 0001 2188 8502)
6 Ajou University, Department of Biomedical Informatics, Suwon, Republic of Korea (GRID:grid.251916.8) (ISNI:0000 0004 0532 3933)
7 Erasmus University Medical Center, Department of Medical Informatics, Rotterdam, The Netherlands (GRID:grid.5645.2) (ISNI:000000040459992X)
8 Real World Insights, IQVIA, Cambridge, USA (GRID:grid.418848.9) (ISNI:0000 0004 0458 4007)
9 Stanford University School of Medicine, Department of Medicine, Stanford, USA (GRID:grid.168010.e) (ISNI:0000000419368956)
10 The University of Texas Health Science Center at Houston, School of Biomedical Informatics, Houston, USA (GRID:grid.267308.8) (ISNI:0000 0000 9206 2401)
11 Georgia Tech Research Institute, Center for Health Analytics and Informatics, Atlanta, USA (GRID:grid.213917.f) (ISNI:0000 0001 2097 4943)
12 Columbia University, Department of Biomedical Informatics, New York, USA (GRID:grid.21729.3f) (ISNI:0000000419368729); NewYork-Presbyterian Hospital, Medical Informatics Services, New York, USA (GRID:grid.413734.6) (ISNI:0000 0000 8499 1112)
13 Columbia University, Department of Statistics, New York, USA (GRID:grid.21729.3f) (ISNI:0000000419368729)
14 Epidemiology Analytics, Janssen Research & Development, Titusville, USA (GRID:grid.497530.c) (ISNI:0000 0004 0389 4927)
15 University of California, Department of Computational Medicine, Los Angeles, USA (GRID:grid.19006.3e) (ISNI:0000 0000 9632 6718); University of California, Department of Biostatistics, Fielding School of Public Health, Los Angeles, USA (GRID:grid.19006.3e) (ISNI:0000 0000 9632 6718); University of California, Department of Human Genetics, Los Angeles, USA (GRID:grid.19006.3e) (ISNI:0000 0000 9632 6718)