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Previous Volume 346:653-661 February 28, 2002 Number 9 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Perspective by Solomon, C. G. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Bisphosphonates are effective agents for the management of osteoporosis. Their low bioavailability and low potency necessitate frequent administration on an empty stomach, which may reduce compliance. Gastrointestinal intolerance limits maximal dosing. Although intermittent intravenous treatments have been used, the optimal doses and dosing interval have not been systematically explored.

Methods We studied the effects of five regimens of zoledronic acid, the most potent bisphosphonate, on bone turnover and density in 351 postmenopausal women with low bone mineral density in a one-year, randomized, double-blind, placebo-controlled trial. Women received placebo or intravenous zoledronic acid in doses of 0.25 mg, 0.5 mg, or 1 mg at three-month intervals. In addition, one group received a total annual dose of 4 mg as a single dose, and another received two doses of 2 mg each, six months apart. Lumbar-spine bone mineral density was the primary end point.

Results There were similar increases in bone mineral density in all the zoledronic acid groups to values for the spine that were 4.3 to 5.1 percent higher than those in the placebo group (P<0.001) and values for the femoral neck that were 3.1 to 3.5 percent higher than those in the placebo group (P<0.001). Biochemical markers of bone resorption were significantly suppressed throughout the study in all zoledronic acid groups. Myalgia and pyrexia occurred more commonly in the zoledronic acid groups, but treatment-related dropout rates were similar to that in the placebo group.

Conclusions Zoledronic acid infusions given at intervals of up to one year produce effects on bone turnover and bone density as great as those achieved with daily oral dosing with bisphosphonates with proven efficacy against fractures, suggesting that an annual infusion of zoledronic acid might be an effective treatment for postmenopausal osteoporosis.

Source Information

From the Department of Medicine, University of Auckland, Auckland, New Zealand (I.R.R.); the Centre de Recherche du Centre Hospitalier del Université Laval, Quebec, Que., Canada (J.P.B.); the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (P.B.); Novartis Pharmaceuticals, East Hanover, N.J. (Z.H., P.R.); Novartis Pharma, Basel, Switzerland (U.T., A.W.); the Department of Rheumatology, Université Catholique de Louvain, St. Luc, Brussels, Belgium (J.-P.D.); the Department of Endocrinology, University Hospital of Ghent, Ghent, Belgium (J.-M.K.); the Medizinische Universitätspoliklinik, Inselspital Bern, Bern, Switzerland (P.J.); the Endocrinology and Supportive Care Clinic, Institut J. Bordet, Free University of Brussels, Brussels, Belgium (J.-J.B.); and the Department of Rheumatology and Bone Diseases, Hôpital Edouard Herriot, Lyons, France (P.J.M.).

Other authors were Maria Luisa Brandi, M.D., Unità di Endocrinologia, Ospedale di Careggi, Florence, Italy; Johann Broell, M.D., Medizinische Abteilung mit Rheumatologie und Osteologie, Kaiser-Franz-Josef-Spital der Stadt Wien, Vienna, Austria; Raffaele Di Micco, M.D., Centro di Fisiopatologia della Menopausa, Ospedale Maggiore La Maternità, Bologna, Italy; Andrea Riccardo Genazzani, M.D., Ospedali Riuniti S. Chiara, Pisa, Italy; Dieter Felsenberg, M.D., Universitätsklinikum Benjamin Franklin, Strahlenklinik und Poliklinik, Berlin, Germany; Joachim Happ, M.D., Frankfurt, Germany; Michael J. Hooper, F.R.A.C.P., Department of Endocrinology, Concord Hospital, Concord, N.S.W., Australia; Jochen Ittner, M.D., Augsburg, Germany; Georg Leb, M.D., Klinische Abteilung für Endokrinologie und Nuklearmedizin, Medizinische Universitätsklinik, Graz, Austria; Hans Mallmin, M.D., Ph.D., Medicinkliniken, Akademisca Sjukhuset, Uppsala, Sweden; Timothy Murray, M.D., Metabolic Bone Clinic, St. Michael's Hospital, Toronto; Sergio Ortolani, M.D., Centro Studi Metabolismo Osseo, Istituto Auxologico Italiano, Milan, Italy; Alessandro Rubinacci, M.D., Unità Metabolica dell'Osso, Ospedale S. Raffaele, Milan, Italy; Maria Sääf, M.D., Ph.D., Endokrinologiska Kliniken, Karolinska Sjukhuset, Stockholm, Sweden; Goran Samsioe, M.D., Ph.D., Kvinnokliniken, Universitetskliniken, Lund, Sweden; and Leon Verbruggen, M.D., Ph.D., Department of Rheumatology, Academic Hospital, Brussels Free University, Brussels, Belgium.

Address reprint requests to Professor Reid at the Department of Medicine, University of Auckland, Private Bag 92019, Auckland, New Zealand, or at i.reid{at}auckland.ac.nz.

Full Text of this Article

Related Letters:

Bisphosphonates and Osteoporosis
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N Engl J Med 2002; 346:2088-2089, Jun 27, 2002. Correspondence

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