Tags

Type your tag names separated by a space and hit enter

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®.
Osteoporos Int. 2013 Oct; 24(10):2561-9.OI

Abstract

SUMMARY

The relationship between baseline Fracture Risk Assessment Tool (FRAX®) 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® predicts osteoporosis treatment efficacy, we evaluated reductions in fracture incidence associated with BZA and RLX according to baseline fracture risk determined by FRAX® 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®.

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® score, but there was no clear relationship between RLX and baseline FRAX®. These findings provide independent confirmation of current literature, suggesting that the relationship between FRAX® and treatment efficacy varies for different agents.

Authors+Show Affiliations

Department of Endocrinology and Unit for Osteoporosis and Metabolic Bone Diseases, Ghent University Hospital, Ghent, Belgium, jean.kaufman@ugent.be.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23595562

Citation

Kaufman, J-M, 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 : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, vol. 24, no. 10, 2013, pp. 2561-9.
Kaufman JM, Palacios S, Silverman S, 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®. Osteoporos Int. 2013;24(10):2561-9.
Kaufman, J. M., 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 : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 24(10), 2561-9. https://doi.org/10.1007/s00198-013-2341-6
Kaufman JM, 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®. Osteoporos Int. 2013;24(10):2561-9. PubMed PMID: 23595562.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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®. AU - Kaufman,J-M, AU - Palacios,S, AU - Silverman,S, AU - Sutradhar,S, AU - Chines,A, Y1 - 2013/04/18/ PY - 2012/09/26/received PY - 2013/03/06/accepted PY - 2013/4/19/entrez PY - 2013/4/19/pubmed PY - 2014/5/9/medline SP - 2561 EP - 9 JF - Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA JO - Osteoporos Int VL - 24 IS - 10 N2 - SUMMARY: The relationship between baseline Fracture Risk Assessment Tool (FRAX®) 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® predicts osteoporosis treatment efficacy, we evaluated reductions in fracture incidence associated with BZA and RLX according to baseline fracture risk determined by FRAX® 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®. 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® score, but there was no clear relationship between RLX and baseline FRAX®. These findings provide independent confirmation of current literature, suggesting that the relationship between FRAX® and treatment efficacy varies for different agents. SN - 1433-2965 UR - https://www.unboundmedicine.com/medline/citation/23595562/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®_ L2 - https://doi.org/10.1007/s00198-013-2341-6 DB - PRIME DP - Unbound Medicine ER -