Hooper M et al. – Although alendronate (ALN) 280 mg once-weekly (OW) oral dose of bisphosphonate in buffered solution (OBS) was similarly effective as ALN 40 mg/day in reducing total alkaline phosphatase (ALP) in pts with Paget’s disease of bone (PDB), the ALN 40 mg/day tablet appears to be better tolerated than ALN 280 mg OW OBS. Methods
Study to investigate if OW of OBS is as effective, better tolerated, and more convenient
63 pts were randomized to either alendronate (ALN) 280 mg OW OBS or an ALN 40 mg/day tablet 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 mos
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 vs the ALN 40 mg/day tablet group including drug related AEs, which led to study discontinuation
See all
