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An evaluation of the Fracture Risk Assessment Tool (FRAX®) as an indicator of treatment efficacy: the effects of bazedoxifene and raloxifene on vertebral, nonvertebral, and all clinical fractures as a function of baseline fracture risk assessed by FRAX®

(2013) OSTEOPOROSIS INTERNATIONAL. 24(10). p.2561-2569
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Abstract
The relationship between baseline Fracture Risk Assessment Tool (FRAX (R)) and treatment efficacy was evaluated using data from a pivotal phase 3 study. Relative risk of vertebral, nonvertebral, and all clinical fractures decreased with increasing probability of fracture for bazedoxifene (BZA) versus placebo but remained generally constant for raloxifene (RLX). Introduction: To determine whether the FRAX (R) predicts osteoporosis treatment efficacy, we evaluated reductions in fracture incidence associated with BZA and RLX according to baseline fracture risk determined by FRAX (R) using data from a phase 3 osteoporosis treatment study. Methods: Hazard ratios (HRs) for effects of BZA and RLX versus placebo on incidence of vertebral, nonvertebral, and all clinical fractures were calculated using a Cox regression model. Cox regression analyses were performed in subgroups at or above 10-year fracture probability thresholds determined by FRAX (R). Results: HRs for the risk of vertebral, nonvertebral, and all clinical fractures versus placebo decreased with increasing 10-year fracture probability for BZA, while those for RLX remained stable. In all 10-year fracture probability subgroups, all BZA doses significantly reduced vertebral fracture risk versus placebo (HR = 0.22-0.66). BZA at 20, 40, and 20/40 mg significantly reduced risk of nonvertebral fractures (HR = 0.45, 0.44, and 0.45, respectively) and all clinical fractures (HR = 0.38, 0.41, and 0.40, respectively) for >= 20.0 % fracture probability. Vertebral fracture risk reductions for RLX 60 mg versus placebo were significant in subgroups at lower fracture probabilities (>= 2.5->= 10.0 %), but not higher (>= 12.5 %), and in no subgroups for nonvertebral or all clinical fractures. Conclusion: The antifracture efficacy of BZA increased with increasing baseline FRAX (R) score, but there was no clear relationship between RLX and baseline FRAX (R). These findings provide independent confirmation of current literature, suggesting that the relationship between FRAX (R) and treatment efficacy varies for different agents.
Keywords
Fracture, Bazedoxifene, Fracture probability, FRAX, Osteoporosis, Raloxifene, BONE-MINERAL DENSITY, POSTMENOPAUSAL WOMEN, OSTEOPOROSIS, TRIAL, ALENDRONATE, REDUCTION, PROBABILITY, RISEDRONATE, PREVENTION, DENOSUMAB

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MLA
Kaufman, Jean, S Palacios, S Silverman, et al. “An Evaluation of the Fracture Risk Assessment Tool (FRAX®) as an Indicator of Treatment Efficacy: The Effects of Bazedoxifene and Raloxifene on Vertebral, Nonvertebral, and All Clinical Fractures as a Function of Baseline Fracture Risk Assessed by FRAX®.” OSTEOPOROSIS INTERNATIONAL 24.10 (2013): 2561–2569. Print.
APA
Kaufman, J., Palacios, S., Silverman, S., Sutradhar, S., & Chines, A. (2013). An evaluation of the Fracture Risk Assessment Tool (FRAX®) as an indicator of treatment efficacy: the effects of bazedoxifene and raloxifene on vertebral, nonvertebral, and all clinical fractures as a function of baseline fracture risk assessed by FRAX®. OSTEOPOROSIS INTERNATIONAL, 24(10), 2561–2569.
Chicago author-date
Kaufman, Jean, S Palacios, S Silverman, S Sutradhar, and A Chines. 2013. “An Evaluation of the Fracture Risk Assessment Tool (FRAX®) as an Indicator of Treatment Efficacy: The Effects of Bazedoxifene and Raloxifene on Vertebral, Nonvertebral, and All Clinical Fractures as a Function of Baseline Fracture Risk Assessed by FRAX®.” Osteoporosis International 24 (10): 2561–2569.
Chicago author-date (all authors)
Kaufman, Jean, S Palacios, S Silverman, S Sutradhar, and A Chines. 2013. “An Evaluation of the Fracture Risk Assessment Tool (FRAX®) as an Indicator of Treatment Efficacy: The Effects of Bazedoxifene and Raloxifene on Vertebral, Nonvertebral, and All Clinical Fractures as a Function of Baseline Fracture Risk Assessed by FRAX®.” Osteoporosis International 24 (10): 2561–2569.
Vancouver
1.
Kaufman J, Palacios S, Silverman S, Sutradhar S, Chines A. An evaluation of the Fracture Risk Assessment Tool (FRAX®) as an indicator of treatment efficacy: the effects of bazedoxifene and raloxifene on vertebral, nonvertebral, and all clinical fractures as a function of baseline fracture risk assessed by FRAX®. OSTEOPOROSIS INTERNATIONAL. 2013;24(10):2561–9.
IEEE
[1]
J. Kaufman, S. Palacios, S. Silverman, S. Sutradhar, and A. Chines, “An evaluation of the Fracture Risk Assessment Tool (FRAX®) as an indicator of treatment efficacy: the effects of bazedoxifene and raloxifene on vertebral, nonvertebral, and all clinical fractures as a function of baseline fracture risk assessed by FRAX®,” OSTEOPOROSIS INTERNATIONAL, vol. 24, no. 10, pp. 2561–2569, 2013.
@article{4217925,
  abstract     = {The relationship between baseline Fracture Risk Assessment Tool (FRAX (R)) and treatment efficacy was evaluated using data from a pivotal phase 3 study. Relative risk of vertebral, nonvertebral, and all clinical fractures decreased with increasing probability of fracture for bazedoxifene (BZA) versus placebo but remained generally constant for raloxifene (RLX).
Introduction: To determine whether the FRAX (R) predicts osteoporosis treatment efficacy, we evaluated reductions in fracture incidence associated with BZA and RLX according to baseline fracture risk determined by FRAX (R) using data from a phase 3 osteoporosis treatment study.
Methods: Hazard ratios (HRs) for effects of BZA and RLX versus placebo on incidence of vertebral, nonvertebral, and all clinical fractures were calculated using a Cox regression model. Cox regression analyses were performed in subgroups at or above 10-year fracture probability thresholds determined by FRAX (R).
Results: HRs for the risk of vertebral, nonvertebral, and all clinical fractures versus placebo decreased with increasing 10-year fracture probability for BZA, while those for RLX remained stable. In all 10-year fracture probability subgroups, all BZA doses significantly reduced vertebral fracture risk versus placebo (HR = 0.22-0.66). BZA at 20, 40, and 20/40 mg significantly reduced risk of nonvertebral fractures (HR = 0.45, 0.44, and 0.45, respectively) and all clinical fractures (HR = 0.38, 0.41, and 0.40, respectively) for >= 20.0 % fracture probability. Vertebral fracture risk reductions for RLX 60 mg versus placebo were significant in subgroups at lower fracture probabilities (>= 2.5->= 10.0 %), but not higher (>= 12.5 %), and in no subgroups for nonvertebral or all clinical fractures.
Conclusion: The antifracture efficacy of BZA increased with increasing baseline FRAX (R) score, but there was no clear relationship between RLX and baseline FRAX (R). These findings provide independent confirmation of current literature, suggesting that the relationship between FRAX (R) and treatment efficacy varies for different agents.},
  author       = {Kaufman, Jean and Palacios, S and Silverman, S and Sutradhar, S and Chines, A},
  issn         = {0937-941X},
  journal      = {OSTEOPOROSIS INTERNATIONAL},
  keywords     = {Fracture,Bazedoxifene,Fracture probability,FRAX,Osteoporosis,Raloxifene,BONE-MINERAL DENSITY,POSTMENOPAUSAL WOMEN,OSTEOPOROSIS,TRIAL,ALENDRONATE,REDUCTION,PROBABILITY,RISEDRONATE,PREVENTION,DENOSUMAB},
  language     = {eng},
  number       = {10},
  pages        = {2561--2569},
  title        = {An evaluation of the Fracture Risk Assessment Tool (FRAX®) as an indicator of treatment efficacy: the effects of bazedoxifene and raloxifene on vertebral, nonvertebral, and all clinical fractures as a function of baseline fracture risk assessed by FRAX®},
  url          = {http://dx.doi.org/10.1007/s00198-013-2341-6},
  volume       = {24},
  year         = {2013},
}

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