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Osteoporosis International

Published in:

01-03-2012 | Original Article

Arzoxifene versus raloxifene: effect on bone and safety parameters in postmenopausal women with osteoporosis

Authors: D. L. Kendler, S. Palacios, D. A. Cox, J. Stock, J. Alam, S. A. Dowsett, J. Zanchetta

Published in: Osteoporosis International | Issue 3/2012

Abstract

Summary

Arzoxifene increased bone mineral density and decreased bone turnover to a significantly greater extent than raloxifene. The hot flush incidence was lower with arzoxifene than raloxifene.

Introduction

To assess the effect of arzoxifene versus raloxifene on change in lumbar spine (LS) bone mineral density (BMD) in postmenopausal women with osteoporosis.

Methods

In this 12-month study (NEXT trial), participants were randomly assigned to arzoxifene 20 mg/day (N = 158) or raloxifene 60 mg/day (N = 162). All received daily calcium and vitamin D. Change in LS BMD was assessed by DXA. Secondary objectives included assessment of femoral neck (FN) and total hip BMD, serum bone turnover markers, and safety.

Results

Treatment groups were similar at baseline (mean age 63 years, mean LS BMD T-score −2.9). At 12 months, the increase in LS BMD with arzoxifene was greater than with raloxifene (+2.75% vs. +1.66%), as was FN and total hip BMD (P < 0.05). For LS and FN, this effect was also evident at 6 months. Arzoxifene reduced bone turnover to a greater extent than raloxifene at 3, 6, and 12 months (P < 0.05). The proportion of women reporting ≥1 adverse event did not differ between treatment groups, nor did vaginal bleeding. No cases of endometrial polyps, hyperplasia, or cancer were reported. Nasopharyngitis and bronchitis were reported more frequently with arzoxifene versus raloxifene (10.1% vs. 2.5%, and 5.1% vs. 0%, respectively) and new/worsening hot flushes were reported less frequently with arzoxifene (7.0% vs. 16.7%) (P < 0.05).

Conclusions

Arzoxifene increased BMD and suppressed bone turnover to a greater extent than raloxifene and resulted in a lower incidence of new/worsening hot flushes. Based on subsequent findings from a fracture outcome study, this difference did not translate into improved fracture efficacy.

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Title: Arzoxifene versus raloxifene: effect on bone and safety parameters in postmenopausal women with osteoporosis
Authors: D. L. Kendler
S. Palacios
D. A. Cox
J. Stock
J. Alam
S. A. Dowsett
J. Zanchetta
Publication date: 01-03-2012
Publisher: Springer-Verlag
Published in: Osteoporosis International / Issue 3/2012
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI: https://doi.org/10.1007/s00198-011-1587-0

At a glance: The STEP trials

Springer Medicine

Arzoxifene versus raloxifene: effect on bone and safety parameters in postmenopausal women with osteoporosis

Abstract

Summary

Introduction

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Summary

Introduction

Methods

Results

Conclusions

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