Alendronate produces greater effects than raloxifene on bone density and bone turnover in postmenopausal women with low bone density: results of EFFECT (EFficacy of FOSAMAX® versus EVISTA®Comparison Trial) International1

Authors

  • P. N. Sambrook,

    1. From the 1University of Sydney, Sydney, Australia; 2Biomedisch Onderzoeksinstituut, University Campus Limburg, Diepenbeek, Belgium and Department of Rheumatology, University Hospital, Maastricht, The Netherlands; 3CHU Toulouse Hôpital de Rangueil, Toulouse, France; 4Instituto Medico Miraflores, Lima, Peru; 5Hospital Universitario Central de Asturias, Oviedo, Spain; and 6Merck & Co., Inc., Whitehouse Station, NJ, USA
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  • 1 P. Geusens,

    1. From the 1University of Sydney, Sydney, Australia; 2Biomedisch Onderzoeksinstituut, University Campus Limburg, Diepenbeek, Belgium and Department of Rheumatology, University Hospital, Maastricht, The Netherlands; 3CHU Toulouse Hôpital de Rangueil, Toulouse, France; 4Instituto Medico Miraflores, Lima, Peru; 5Hospital Universitario Central de Asturias, Oviedo, Spain; and 6Merck & Co., Inc., Whitehouse Station, NJ, USA
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  • 2 C. Ribot,

    1. From the 1University of Sydney, Sydney, Australia; 2Biomedisch Onderzoeksinstituut, University Campus Limburg, Diepenbeek, Belgium and Department of Rheumatology, University Hospital, Maastricht, The Netherlands; 3CHU Toulouse Hôpital de Rangueil, Toulouse, France; 4Instituto Medico Miraflores, Lima, Peru; 5Hospital Universitario Central de Asturias, Oviedo, Spain; and 6Merck & Co., Inc., Whitehouse Station, NJ, USA
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  • 3 J. A. Solimano,

    1. From the 1University of Sydney, Sydney, Australia; 2Biomedisch Onderzoeksinstituut, University Campus Limburg, Diepenbeek, Belgium and Department of Rheumatology, University Hospital, Maastricht, The Netherlands; 3CHU Toulouse Hôpital de Rangueil, Toulouse, France; 4Instituto Medico Miraflores, Lima, Peru; 5Hospital Universitario Central de Asturias, Oviedo, Spain; and 6Merck & Co., Inc., Whitehouse Station, NJ, USA
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  • 4 J. Ferrer-Barriendos,

    1. From the 1University of Sydney, Sydney, Australia; 2Biomedisch Onderzoeksinstituut, University Campus Limburg, Diepenbeek, Belgium and Department of Rheumatology, University Hospital, Maastricht, The Netherlands; 3CHU Toulouse Hôpital de Rangueil, Toulouse, France; 4Instituto Medico Miraflores, Lima, Peru; 5Hospital Universitario Central de Asturias, Oviedo, Spain; and 6Merck & Co., Inc., Whitehouse Station, NJ, USA
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  • 5 K. Gaines,

    1. From the 1University of Sydney, Sydney, Australia; 2Biomedisch Onderzoeksinstituut, University Campus Limburg, Diepenbeek, Belgium and Department of Rheumatology, University Hospital, Maastricht, The Netherlands; 3CHU Toulouse Hôpital de Rangueil, Toulouse, France; 4Instituto Medico Miraflores, Lima, Peru; 5Hospital Universitario Central de Asturias, Oviedo, Spain; and 6Merck & Co., Inc., Whitehouse Station, NJ, USA
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  • 6 N. Verbruggen,

    1. From the 1University of Sydney, Sydney, Australia; 2Biomedisch Onderzoeksinstituut, University Campus Limburg, Diepenbeek, Belgium and Department of Rheumatology, University Hospital, Maastricht, The Netherlands; 3CHU Toulouse Hôpital de Rangueil, Toulouse, France; 4Instituto Medico Miraflores, Lima, Peru; 5Hospital Universitario Central de Asturias, Oviedo, Spain; and 6Merck & Co., Inc., Whitehouse Station, NJ, USA
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  • and 6 M. E. Melton 6

    1. From the 1University of Sydney, Sydney, Australia; 2Biomedisch Onderzoeksinstituut, University Campus Limburg, Diepenbeek, Belgium and Department of Rheumatology, University Hospital, Maastricht, The Netherlands; 3CHU Toulouse Hôpital de Rangueil, Toulouse, France; 4Instituto Medico Miraflores, Lima, Peru; 5Hospital Universitario Central de Asturias, Oviedo, Spain; and 6Merck & Co., Inc., Whitehouse Station, NJ, USA
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  • 1

    Presented in part at the 30th European Symposium on Calcified Tissues, Rome, Italy, 8–12 May 2003, and at the joint meeting of the International Bone and Mineral Society and the Japanese Society for Bone and Mineral Research, Osaka, Japan, 3–7 June 2003.

Prof. Philip Sambrook, Institute of Bone and Joint Research Level 4, Block 4, Royal North Shore Hospital, University of Sydney, Pacific Highway, St Leonards NSW 2065, Australia. (fax: 61 (0)2 9906 1859; e-mail: sambrook@med.usyd.edu.au).

Abstract.

Objectives.  Alendronate and raloxifene are antiresorptive agents with different mechanisms of action, each used to treat osteoporosis in postmenopausal women. This study was undertaken to compare the efficacy and tolerability of alendronate to raloxifene in postmenopausal women with low-bone density.

Design.  Randomized, double-masked, double-dummy multicentre international study.

Setting.  Clinical trial centres in Europe, South America and Asia-Pacific.

Subjects.  A total of 487 postmenopausal women with low bone density, based on bone mineral density (BMD) of the lumbar spine or hip (T-score ≤−2.0).

Interventions.  Patients received either alendronate 70 mg once weekly and daily placebo identical to raloxifene or raloxifene 60 mg daily and weekly placebo identical to alendronate for 12 months.

Main outcome measures.  Evaluations included BMD of the lumbar spine and hip and markers of bone turnover at 6 and 12 months and adverse event reporting.

Results.  Alendronate demonstrated substantially greater increases in BMD than raloxifene at both lumbar spine and hip sites at 12 months. Lumbar spine BMD increased 4.8% with alendronate vs. 2.2% with raloxifene (P < 0.001). The increase in total hip BMD was 2.3% with alendronate vs. 0.8% with raloxifene (P < 0.001). Reductions in bone turnover were significantly larger with alendronate than raloxifene. Overall tolerability was similar, however, the proportion of patients reporting vasomotor events was significantly higher with raloxifene (9.5%) than with alendronate (3.7%, P = 0.010). The proportion of patients reporting gastrointestinal events was similar between groups.

Conclusion.  In postmenopausal women with low bone density, improvements in BMD and markers of bone turnover were substantially greater during treatment with alendronate compared to raloxifene.

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