Year: 2002
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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: New England Journal of Medicine
DOI: 10.1056/nejmoa011807
Authors: Ian R. Reid, Jacques P. Brown, Peter Burckhardt, Zebulun Horowitz, Peter Richardson, Ulrich Trechsel, Albert Widmer, Jean-Pierre Devogelaer, Jean-Marc Kaufman, Philippe Jaeger, Jean-Jacques Body, Maria Luisa Brandi, Johann Broell, Raffaele Di Micco, Andrea Riccardo Genazzani, Dieter Felsenberg, Joachim Happ, Michael J. Hooper, Jochen Ittner, Georg Leb, Hans Mallmin, Timothy Murray, Sergio Ortolani, Alessandro Rubinacci, Maria Sääf, Goran Samsioe, Leon Verbruggen, Pierre J. Meunier
Institutions: University of Auckland, Centre hospitalier de l'Université Laval, Université Laval, Centre de recherche du CHU de Québec-Université Laval, Centre Hospitalier Universitaire Vaudois, Novartis (United States), Novartis (Switzerland), UCLouvain, Ghent University Hospital, University Hospital of Bern, Université Libre de Bruxelles, Institut Jules Bordet, Kaiser-Franz-Josef-Spital, IRCCS Istituto Auxologico Italiano, Lund University, Skåne University Hospital, Karolinska University Hospital, IRCCS Ospedale San Raffaele, Hôpital Edouard Herriot
Language: English
Subfield: Orthopedics and Sports Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funder: Novartis Pharma
OpenAlex ID: W1978228601