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 Huiseth & 43 others Sverre 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

Research output: Contribution to journalArticle

182 Citations (Scopus)

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
StatePublished - Nov 1 2002
Externally publishedYes

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Alendronate
Postmenopausal Osteoporosis
Bone Density
Femur Neck
Spine
Therapeutics
Incidence
Hip Fractures
Bone Resorption
Collagen Type I
Osteogenesis
Femur
Osteoporosis
Alkaline Phosphatase
Hip
Young Adult
Biomarkers
Safety
Bone and Bones
Serum

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

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.

Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis. / Gilfillin, Chris; Body, Jean Jacques; Boonen, Steven; Valimaki, Matti; Roux, Christian; Felsenberg, Dieter; Donhauser, Peter; Popovtzer, M.; Foldes, J.; Pollak, R.; Adami, Silvano; Crepaldi, Gaetano; Pinchera, Aldo; Reid, Ian; Gilchrist, Nigel; Singh, Joe; Halse, Johan; Syversen, Unni; Stakkestad, Jacob; Huiseth, Ame; Hemminghytt, Sverre; Gomes, Melo; Davis, Pierre; De Weerd, Jan A.; Lipschitz, Stanley; De Villiers, Tobie; Rizzoli, Rene; Jaeger, P.; Smith, Ian; Bankhurst, Arthur; Bell, Norman H.; Bliziotes, Michael; Bone, Henry G.; Downs, Robert W.; Emkey, Ronald; Ettinger, Mark; Favus, Murray; Greenspan, Susan; Greenwald, Maria; Harris, Steven; Insogna, Karl L.; Johnston, Conrad; Khachadurian, Avedis; Kiel, Douglas; Korytkowski, Mary; Levine, Michael A.; Levy, Barcey; Luckey, Marjorie; Marcus, Robert; McClung, Michael; McIlwain, Harris; McKeever, Clark; Miller, Paul; Moses, Arnold M.; Podlecki, David A.; Posner, Joel; Recker, Robert R.; Rosen, Clifford; Schlotzhauer, Tammy; Schnitzer, Thomas; Tonino, Richard P.; Watts, Nelson; Weiss, Stuart R.

In: Journal of Bone and Mineral Research, Vol. 17, No. 11, 01.11.2002, p. 1988-1996.

Research output: Contribution to journalArticle

Gilfillin, C, Body, JJ, Boonen, S, Valimaki, M, Roux, C, Felsenberg, D, Donhauser, P, Popovtzer, M, Foldes, J, Pollak, R, Adami, S, Crepaldi, G, Pinchera, A, Reid, I, Gilchrist, N, Singh, J, Halse, J, Syversen, U, Stakkestad, J, Huiseth, A, Hemminghytt, S, Gomes, M, Davis, P, De Weerd, JA, Lipschitz, S, De Villiers, T, Rizzoli, R, Jaeger, P, Smith, I, Bankhurst, A, Bell, NH, Bliziotes, M, Bone, HG, Downs, RW, Emkey, R, Ettinger, M, Favus, M, Greenspan, S, Greenwald, M, Harris, S, Insogna, KL, Johnston, C, Khachadurian, A, Kiel, D, Korytkowski, M, Levine, MA, Levy, B, Luckey, M, Marcus, R, McClung, M, McIlwain, H, McKeever, C, Miller, P, Moses, AM, Podlecki, DA, Posner, J, Recker, RR, Rosen, C, Schlotzhauer, T, Schnitzer, T, Tonino, RP, Watts, N & Weiss, SR 2002, 'Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis', Journal of Bone and Mineral Research, vol. 17, no. 11, pp. 1988-1996.
Gilfillin C, Body JJ, Boonen S, Valimaki M, Roux C, Felsenberg D et al. Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis. Journal of Bone and Mineral Research. 2002 Nov 1;17(11):1988-1996.
Gilfillin, Chris ; Body, Jean Jacques ; Boonen, Steven ; Valimaki, Matti ; Roux, Christian ; Felsenberg, Dieter ; Donhauser, Peter ; Popovtzer, M. ; Foldes, J. ; Pollak, R. ; Adami, Silvano ; Crepaldi, Gaetano ; Pinchera, Aldo ; Reid, Ian ; Gilchrist, Nigel ; Singh, Joe ; Halse, Johan ; Syversen, Unni ; Stakkestad, Jacob ; Huiseth, Ame ; Hemminghytt, Sverre ; Gomes, Melo ; Davis, Pierre ; De Weerd, Jan A. ; Lipschitz, Stanley ; De Villiers, Tobie ; Rizzoli, Rene ; Jaeger, P. ; Smith, Ian ; Bankhurst, Arthur ; Bell, Norman H. ; Bliziotes, Michael ; Bone, Henry G. ; Downs, Robert W. ; Emkey, Ronald ; Ettinger, Mark ; Favus, Murray ; Greenspan, Susan ; Greenwald, Maria ; Harris, Steven ; Insogna, Karl L. ; Johnston, Conrad ; Khachadurian, Avedis ; Kiel, Douglas ; Korytkowski, Mary ; Levine, Michael A. ; Levy, Barcey ; Luckey, Marjorie ; Marcus, Robert ; McClung, Michael ; McIlwain, Harris ; McKeever, Clark ; Miller, Paul ; Moses, Arnold M. ; Podlecki, David A. ; Posner, Joel ; Recker, Robert R. ; Rosen, Clifford ; Schlotzhauer, Tammy ; Schnitzer, Thomas ; Tonino, Richard P. ; Watts, Nelson ; Weiss, Stuart R. / Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis. In: Journal of Bone and Mineral Research. 2002 ; Vol. 17, No. 11. pp. 1988-1996.
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title = "Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis",
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.",
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AU - Gilfillin, Chris

AU - Body, Jean Jacques

AU - Boonen, Steven

AU - Valimaki, Matti

AU - Roux, Christian

AU - Felsenberg, Dieter

AU - Donhauser, Peter

AU - Popovtzer, M.

AU - Foldes, J.

AU - Pollak, R.

AU - Adami, Silvano

AU - Crepaldi, Gaetano

AU - Pinchera, Aldo

AU - Reid, Ian

AU - Gilchrist, Nigel

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AU - Halse, Johan

AU - Syversen, Unni

AU - Stakkestad, Jacob

AU - Huiseth, Ame

AU - Hemminghytt, Sverre

AU - Gomes, Melo

AU - Davis, Pierre

AU - De Weerd, Jan A.

AU - Lipschitz, Stanley

AU - De Villiers, Tobie

AU - Rizzoli, Rene

AU - Jaeger, P.

AU - Smith, Ian

AU - Bankhurst, Arthur

AU - Bell, Norman H.

AU - Bliziotes, Michael

AU - Bone, Henry G.

AU - Downs, Robert W.

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AU - Ettinger, Mark

AU - Favus, Murray

AU - Greenspan, Susan

AU - Greenwald, Maria

AU - Harris, Steven

AU - Insogna, Karl L.

AU - Johnston, Conrad

AU - Khachadurian, Avedis

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AU - Luckey, Marjorie

AU - Marcus, Robert

AU - McClung, Michael

AU - McIlwain, Harris

AU - McKeever, Clark

AU - Miller, Paul

AU - Moses, Arnold M.

AU - Podlecki, David A.

AU - Posner, Joel

AU - Recker, Robert R.

AU - Rosen, Clifford

AU - Schlotzhauer, Tammy

AU - Schnitzer, Thomas

AU - Tonino, Richard P.

AU - Watts, Nelson

AU - Weiss, Stuart R.

PY - 2002/11/1

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N2 - 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.

AB - 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.

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