Amgen’s denosumab found to increase bone density

Clinical trials of Amgen’s osteoporosis denosumab have been found to increase bone density in phase II trial participants, Amgen said.

Researchers discovered that, in a trial of 412 post-menopausal women, the bone density of patients who were given denosumab increased between 1.9 and 3.6 per cent in the hip, and 3.0 to 6.7 per cent in the lumbar spine. Levels of bone-absorbing marker C-telopeptide also decreased.

The women were given either denosumab twice yearly, a placebo or existing treatment Fosamax weekly. Placebo patients saw their bone density decline, while the Fosamax results were found to be similar to those from denosumab.

“These exciting data suggest that denosumab, when administered in twice-yearly injections, may show promise in the treatment of osteoporosis,” said Michael McClung of the Providence Portland Medical Center and head investigator.

“Continued research will further our understanding of the potential of denosumab in bone loss management.”

Denosumab works by inhibiting the protein RANK Ligand, which the company says mediates cells that consume bone. It is the first such inhibitor to reach phase II development.

Adverse affects included dyspepsia (stomach pain) which affected 6 to 15 per cent of denosumab users.

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