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Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis
Journal article   Open access   Peer reviewed

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

R Rizzoli, S L Greenspan, G Bone III, T J Schnitzer, N B Watts, S Adami, A J Foldes, C Roux, M A Levine, B Uebelhart, …
Journal of bone and mineral research, Vol.17(11), pp.1988-1996
11/2002
DOI: 10.1359/jbmr.2002.17.11.1988
PMID: 12412806
url
https://doi.org/10.1359/jbmr.2002.17.11.1988View
Published (Version of record) Open Access

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.
 Bone Resorption Double-Blind Method Drug Administration Schedule Peptides - urine Humans Middle Aged Osteoporosis, Postmenopausal - complications Collagen Type I Treatment Outcome Lumbar Vertebrae - drug effects Osteoporosis, Postmenopausal - drug therapy Alendronate - adverse effects Bone Density - drug effects Fractures, Bone - etiology Collagen - urine Aged, 80 and over Adult Female Aged Alkaline Phosphatase - blood Gastrointestinal Diseases - chemically induced Alendronate - administration & dosage

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