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


BACKGROUND
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.
Hooper
M
M
University of Sydney, 56 St Johns Ave, Gordon, NSW, 2072, Australia. mjhooper@bigpond.net.au
Faustino
A
A
Reid
I R
IR
Hosking
D
D
Gilchrist
N L
NL
Selby
P
P
Wu
M
M
Salzmann
G
G
West
J
J
Leung
A
A
D000284:Administration, Oral; D000368:Aged; D019386:Alendronate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000704:Analysis of Variance; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D066298:In Vitro Techniques; D008297:Male; D008875:Middle Aged; D010001:Osteitis Deformans / Q000188:drug therapy*; D012996:Solutions; D013607:Tablets
D050071:Bone Density Conservation Agents; D012996:Solutions; D013607:Tablets; D019386:Alendronate