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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/2374

Title: 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 (R) versus EVISTA (R) Comparison Trial) International
Authors: Sambrook, PN
Ribot, C
Solimano, JA
Ferrer-Barriendos, J
Gaines, K
Verbruggen, N
Melton, ME
Issue Date: 2004
Citation: JOURNAL OF INTERNAL MEDICINE, 255(4). p. 503-511
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 less than or equal to-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.
Notes: Univ Sydney, Sydney, NSW 2006, Australia. Univ Campus Limburg, Biomed Onderzoeksinst, Diepenbeek, Belgium. Univ Hosp, Dept Rheumatol, Maastricht, Netherlands. CHU Toulouse, Hop Rangueil, Toulouse, France. Inst Med Miraflores, Lima, Peru. Hosp Univ Cent Asturias, Oviedo, Spain. Merck & Co Inc, Whitehouse Stn, NJ USA.Sambrook, PN, Univ Sydney, Royal N Shore Hosp, Inst Bone & Joint Res, Level 4,Block 4,Pacific Highway, St Leonards, NSW 2065, Australia.sambrook@med.usyd.edu.au
URI: http://hdl.handle.net/1942/2374
DOI: 10.1111/j.1365-2796.2004.01317.x
ISI #: 000220357200009
ISSN: 0954-6820
Category: A1
Type: Journal Contribution
Validation: ecoom, 2005
Appears in Collections: Research publications

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