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Efficacy and Tolerability of Intravenous Ibandronate Injections in Postmenopausal Osteoporosis: 2-Year Results from the DIVA Study
JOHN A. EISMAN, ROBERTO CIVITELLI, SILVANO ADAMI, EDWARD CZERWINSKI, CHRIS RECKNOR, RICHARD PRINCE, JEAN-YVES REGINSTER, MONE ZAIDI, DIETER FELSENBERG, CLAIRE HUGHES, NICOLE MAIRON, DAIVA MASANAUSKAITE, DAVID M. REID, PIERRE D. DELMAS, and ROBERT R. RECKER
ABSTRACT. Methods. This randomized, double-blind, double-dummy, noninferiority study recruited 1395 women (aged 55–80 yrs; ≥ 5 yrs since menopause) with osteoporosis [mean lumbar spine (L2–L4) BMD T-score < –2.5 and ≥ –5.0]. Patients received IV ibandronate (2 mg every 2 mo or 3 mg every 3 mo) plus daily oral placebo, or 2.5 mg daily oral ibandronate plus 2- or 3-monthly IV placebo. Supplemental vitamin D (400 IU) and calcium (500 mg) were provided throughout the 2-year study. Results. At 2 years, the 2- and 3-monthly IV regimens achieved statistically noninferior and also superior increases in lumbar spine BMD compared with the daily regimen (6.4% and 6.3% vs 4.8%, respectively; p < 0.001). Greater increases were also obtained with IV ibandronate versus daily in proximal femur BMD. Serum concentrations of the biochemical marker of bone resorption C-telopeptide of the alpha-chain of type I collagen were reduced to a similar extent in all treatment arms (53.4%–59.9%). The tolerability profile of the IV regimens was similar to that observed with daily oral therapy. Conclusion. Ibandronate IV injections are an effective and well tolerated treatment for postmenopausal osteoporosis and provide a useful alternative to oral dosing. (First Release Feb 1 2008; J Rheumatol 2008;35:488-97) Key Indexing Terms:
POSTMENOPAUSAL OSTEOPOROSIS
From the Garvan Institute of Medical Research, St. Vincent's Campus and University of New South Wales, Sydney, Australia; Washington University School of Medicine, St. Louis, Missouri, USA; University of Verona, Verona, Italy; Krakow Medical Centre, Krakow, Poland; United Osteoporosis Centers, Gainesville, Georgia, USA; University of Western Australia, Perth, Australia; University of Liège, Liège, Belgium; Mount Sinai School of Medicine, New York, New York, USA; Charité-University Medicine Berlin, Berlin, Germany; F. Hoffmann-La Roche Ltd., Basel, Switzerland; University of Aberdeen, Aberdeen, UK; University of Lyon, INSERM Research Unit 831, Lyon, France; and INSERM Research Unit 831, Omaha, Nebraska, USA. Supported by F. Hoffmann-La Roche Ltd. and GlaxoSmithKline. J.A. Eisman, MB BS, PhD, FRACP, Professor of Medicine (Conjoint), University of New South Wales, Staff Endocrinologist, St. Vincent's Hospital, Director, Bone and Mineral Research Program, Garvan Institute of Medical Research, Darlinghurst, Sydney, Australia; R. Civitelli, MD, Professor of Orthopaedic Surgery and Cell Biology and Physiology, Division of Bone and Mineral Diseases, Washington University School of Medicine, St. Louis, MO, USA; S. Adami, MD, Professor, Director, Rheumatology Unit, Department of Biomedical and Surgical Sciences, University of Verona, Verona, Italy; E. Czerwinski, Professor, Director, Krakow Medical Centre, Krakow, Poland; C. Recknor, MD, Medical Director, United Osteoporosis Centers, Gainesville, GA, USA; R. Prince, MD, FRACP, Associate Professor, University Unit of Medicine and Pharmacology, SCGH, University of Western Australia, Endocrinologist, Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Perth, Western Australia; J-Y. Reginster, MD, PhD, Department of Public Health Sciences, University of Liège, Liège, Belgium; M. Zaidi, MD, PhD, FRCP, Professor of Medicine and Physiology, Director, Mount Sinai Bone Program, Mount Sinai School of Medicine, New York, NY, USA; D. Felsenberg, MD, PhD, Centre Muscle et Bone Research Charite, University Medicine, Berlin Campus, Benjamin Franklin Free University and Humboldt-University, Berlin, Germany; C. Hughes, MSc, Project Statistician, Statistics Department; N. Mairon, MD, Clinical Science Leader, Clinical Development Department; D. Masanauskaite, MD, Clinical Scientist, Pharmaceuticals Division, Clinical Development Metabolism, F. Hoffmann-La Roche, Basel, Switzerland; D.M. Reid, MD, FRCP, Department of Medicine and Therapeutics, University of Aberdeen Medical School, Aberdeen, UK; P.D. Delmas, MD, PhD, Professor of Medicine and Rheumatology, Claude Bernard University, Lyon, Director of Research, INSERM Research Unit 831; R.R. Recker, MD, MACP, FACE, Professor of Medicine, Director, Osteoporosis Research Center, School of Medicine, Creighton University, Omaha, NE, USA. Address reprint requests to Prof. J.A. Eisman, Bone and Mineral Research Program, Garvan Institute of Medical Research, St. Vincent's Campus and University of New South Wales, 384 Victoria Street, Darlinghurst, NSW 2010 Australia. E-mail: j.eisman@garvan.org.au Accepted for publication October 26, 2007. |
