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The Journal of Clinical Endocrinology & Metabolism Vol. 88, No. 9 4199-4205
Copyright © 2003 by The Endocrine Society

Contribution of Raloxifene and Calcium and Vitamin D3 Supplementation to the Increase of the Degree of Mineralization of Bone in Postmenopausal Women

G. Boivin, P. Lips, S. M. Ott, K. D. Harper, S. Sarkar, K. V. Pinette and P. J. Meunier

Institut National de la Santé et de la Recherche Médicale Unité 403 (G.B., P.J.M.), Faculté de Médecine R. Laennec, 69372 Lyon Cedex 08, France; Department of Endocrinology (P.L.), Vrije Universiteit Medical Centre, Amsterdam 1007 MB, The Netherlands; Department of Medicine (S.M.O.), University of Washington, Seattle, Washington 98195-6426; and Lilly Research Laboratories (K.D.H., S.S., K.V.P.), Eli Lilly and Company, Indianapolis, Indiana 46285

Address all correspondence and requests for reprints to: Georges Boivin, Ph.D., Director of Research, Institut National de la Santé et de la Recherche Médicale Unité 403, Faculté de Médecine R. Laennec, 69372 Lyon Cedex 08, France. E-mail: boivin{at}laennec.univ-lyon1.fr.

Raloxifene has been shown to increase bone mineral density and reduce the risk of vertebral fracture in postmenopausal women with osteoporosis. In this study, we report the results of the first prospective longitudinal study to evaluate the mean degree of mineralization of bone (MDMB) in a group of patients enrolled in the Multiple Outcomes of Raloxifene Evaluation trial. Patients were randomly assigned to one of three treatment groups: placebo (n = 24), raloxifene 60 mg/d (RLX60; n = 22), or raloxifene 120 mg/d (RLX120; n = 18). All patients received daily calcium (500 mg) and vitamin D3 (400–600 IU) supplementation for the duration of the study. Iliac crest biopsies were taken at baseline and after 2 yr of treatment. Quantitative microradiography was used to analyze the biopsy specimens and revealed a statistically significant (P < 0.05) mean percentage increase in total MDMB of 7.0, 5.3, and 5% for RLX60-, RLX120-, and placebo-treated patients, respectively, compared with baseline. Raloxifene treatment was found to shift the distribution of total bone mineral to higher values of MDMB (RLX60, 29%; RLX120, 8%) with greater heterogeneity, compared with placebo. The profile of MDMB observed in biopsies after treatment with placebo and raloxifene, compared with baseline, closely resembles physiological premenopausal bone.

This work was supported by Eli Lilly and Company.

Abbreviations: ANCOVA, Analysis of covariance; BMD, bone mineral density; BSU, basic structural unit; FWHM, full width at half maximum; MDMB, mean degree of mineralization of bone (tissue); MORE, Multiple Outcomes of Raloxifene Evaluation; RLX60, raloxifene 60 mg/d; RLX120, raloxifene 120 mg/d.




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