Randomized, active-controlled study of once-weekly alendronate 280 mg high dose oral buffered solution for treatment of Paget's disease

M. Hooper, A. Faustino, I. R. Reid, D. Hosking, N. L. Gilchrist, P. Selby, M. Wu, G. Salzmann, J. West, A. Leung

    Research output: Contribution to journalArticlepeer-review


    Summary: Daily oral tablet bisphosphonate therapy for Paget's disease of bone may cause serious upper gastrointestinal adverse events. A once-weekly alendronate 280 mg oral buffered solution was compared with an alendronate 40 mg/day tablet. While both were similarly effective, the tablet appeared to be better tolerated in this study. Introduction: Although daily doses of oral bisphosphonates are a generally safe and effective treatment for Paget's disease of bone (PDB), some patients may experience upper gastrointestinal adverse events (UGI AEs) or find the dosing requirements inconvenient and become noncompliant. A once-weekly (OW) oral dose of bisphosphonate in buffered solution (OBS) may be as effective, better tolerated, and more convenient. Methods: Sixty-three patients were randomized to either alendronate (ALN) 280 mg OW OBS (n = 42) or an ALN 40 mg/day tablet (n = 21) during a 6-month, randomized, double-blind, active-controlled trial. The primary endpoint was the mean percent decrease in total serum alkaline phosphatase (total ALP) from baseline at 6 months. Results: There were no significant differences in total ALP between groups during the 6-month period. There was a higher incidence of clinical AEs in the ALN 280 mg OW OBS (79%) vs. the ALN 40 mg/day tablet group (67%), including drug related AEs (48% and 10%, respectively), which led to study discontinuation (19.0% and 10%, respectively). Conclusions: Although ALN 280 mg OW OBS was similarly effective as ALN 40 mg/day in reducing total ALP in patients with PDB, the ALN 40 mg/day tablet appears to be better tolerated than ALN 280 mg OW OBS. © 2008 International Osteoporosis Foundation and National Osteoporosis Foundation.
    Original languageEnglish
    Pages (from-to)141-150
    Number of pages9
    JournalOsteoporosis International
    Issue number1
    Publication statusPublished - Jan 2009


    • Alendronate
    • Once-weekly
    • Oral solution
    • Paget's disease
    • Serum alkaline phosphatase
    • Upper gastrointestinal


    Dive into the research topics of 'Randomized, active-controlled study of once-weekly alendronate 280 mg high dose oral buffered solution for treatment of Paget's disease'. Together they form a unique fingerprint.

    Cite this