Data shows patients prefer Amgen's twice-yearly inj to Merck & Co's daily tab

The USA's Amgen presented telling data from head-to-head trials comparing its candidate denosumab to Merck & Co's blockbuster Fosamax (alendronate) at the 2008 American Society of Bone and Mineral Research annual meeting in Montreal, Canada. The results indicated that denosumab could become a dominant player in the $7.0-billion global osteoporosis market.

In a Phase III, double-blind, double-dummy, active-controlled study of 1,189 healthy postmenopausal women, known as DECIDE, patients were randomized 1:1 to receive either denosumab injection (subcutaneous 60mg, Q6M) plus placebo tablet (oral weekly), or placebo injection and oral alendronate (70mg weekly). Preference and satisfaction were assessed after 12 months of treatment. More than three-quarters of patients in both study arms preferred subcutaneous injection over oral pills (77% versus 23%, p<0.0001). In addition, a significantly greater number of patients were more satisfied with twice-yearly therapy compared to weekly dosing (80% placebo injection vs 20% weekly oral alendronate; and 79% denosumab vs 21% weekly placebo; p<0.0001).

The firm also reported on a 234 bisphosphonate transition Phase III, randomized, double-blind, active-controlled, parallel-group study, known as STAND. Denosumab resulted in significant increases in bone mineral density at the total hip vs with alendronate (1.9% vs 1.05%, p<0.0001). Denosumab also increased BMD at the lumbar spine, femoral neck, hip trochanter and 1/3 radius.