Osteoporosis International

, Volume 20, Issue 1, pp 141–150

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
Original Article

DOI: 10.1007/s00198-008-0639-6

Cite this article as:
Hooper, M., Faustino, A., Reid, I.R. et al. Osteoporos Int (2009) 20: 141. doi:10.1007/s00198-008-0639-6

Abstract

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.

Keywords

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

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2008

Authors and Affiliations

  • M. Hooper
    • 1
  • A. Faustino
    • 2
  • I. R. Reid
    • 3
  • D. Hosking
    • 4
  • N. L. Gilchrist
    • 5
  • P. Selby
    • 6
  • M. Wu
    • 7
  • G. Salzmann
    • 7
  • J. West
    • 7
  • A. Leung
    • 7
  1. 1.University of SydneyGordonAustralia
  2. 2.Servimed, LdaLisbonPortugal
  3. 3.University of AucklandAucklandNew Zealand
  4. 4.David Evans Medical Research Centre, Nottingham City HospitalNottinghamUK
  5. 5.Canterbury Geriatric Medical Research Trust, Princess Margaret HospitalChristchurchNew Zealand
  6. 6.Vitamin D Research Group, University School of Medicine, Manchester Royal InfirmaryManchesterUK
  7. 7.Merck Research Laboratories, Merck and Co., Inc.RahwayUSA