Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis

Chris Gilfillin, Jean Jacques Body, Steven Boonen, Matti Valimaki, Christian Roux, Dieter Felsenberg, Peter Donhauser, M. Popovtzer, J. Foldes, R. Pollak, Silvano Adami, Gaetano Crepaldi, Aldo Pinchera, Ian Reid, Nigel Gilchrist, Joe Singh, Johan Halse, Unni Syversen, Jacob Stakkestad, Ame HuisethSverre Hemminghytt, Melo Gomes, Pierre Davis, Jan A. De Weerd, Stanley Lipschitz, Tobie De Villiers, Rene Rizzoli, P. Jaeger, Ian Smith, Arthur Bankhurst, Norman H. Bell, Michael Bliziotes, Henry G. Bone, Robert W. Downs, Ronald Emkey, Mark Ettinger, Murray Favus, Susan Greenspan, Maria Greenwald, Steven Harris, Karl L. Insogna, Conrad Johnston, Avedis Khachadurian, Douglas Kiel, Mary Korytkowski, Michael A. Levine, Barcey Levy, Marjorie Luckey, Robert Marcus, Michael McClung, Harris McIlwain, Clark McKeever, Paul Miller, Arnold M. Moses, David A. Podlecki, Joel Posner, Robert R. Recker, Clifford Rosen, Tammy Schlotzhauer, Thomas Schnitzer, Richard P. Tonino, Nelson Watts, Stuart R. Weiss

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184 Scopus citations

Abstract

The aim of this study was to provide confirmation that once-weekly dosing with 70 mg of alendronate (seven times the daily oral dose) and twice-weekly dosing with 35 mg is equivalent to the 10-mg once-daily regimen and to gain more extensive safety experience with this new dosing regimen. Twelve hundred fifty-eight postmenopausal women (aged 42-95 years) with osteoporosis (bone mineral density [BMD] of either lumbar spine or femoral neck at least 2.5 SDs below peak young adult mean or prior vertebral or hip fracture) were assigned to receive oral once-weekly alendronate, 70 mg (n = 519); twice-weekly alendronate, 35 mg (n = 369); or daily alendronate 10 mg (n = 370) for a total of 2 years of double-blind experience. Mean BMD increases from baseline (95 % CI) at 24 months in the once-weekly, twice-weekly, and daily treatment groups, respectively, were 6.8% (6.4, 7.3), 7.0% (6.6, 7.5), and 7.4% (6.9, 7.8) at the lumbar spine and 4.1% (3.8, 4.5), 4.3% (3.9, 4.7), and 4.3% (3.9, 4.7) at the total hip. These increases in BMD as well as the BMD increases at the femoral neck, trochanter, and total body and the reductions of biochemical markers of bone resorption (urinary cross-linked N-telopeptides of type I collagen [NTx]) and bone formation (serum bone-specific alkaline phosphatase [BSAP]) were similar for the three dosing regimens. All treatment regimens were well tolerated with a similar incidence of upper gastrointestinal (GI) adverse experiences. The incidence rates of clinical fractures, captured as adverse experiences, were similar among the groups. The 2-year results confirm the conclusion reached after 1 year that once-weekly alendronate is therapeutically equivalent to daily dosing, providing patients with a more convenient dosing option that may potentially enhance adherence to therapy.

Original languageEnglish
Pages (from-to)1988-1996
Number of pages9
JournalJournal of Bone and Mineral Research
Volume17
Issue number11
Publication statusPublished - Nov 1 2002
Externally publishedYes

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All Science Journal Classification (ASJC) codes

  • Surgery

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Gilfillin, C., Body, J. J., Boonen, S., Valimaki, M., Roux, C., Felsenberg, D., ... Weiss, S. R. (2002). Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis. Journal of Bone and Mineral Research, 17(11), 1988-1996.