Amgen and UCB report positive data from osteoporosis drug trial

Amgen and UCB have announced positive findings from a study of the investigational agent romosozumab, showing its efficacy in the treatment of osteoporosis.

Data from the phase III FRAME study has shown that romosozumab was able to significantly reduce the incidence of new vertebral fractures in postmenopausal women with osteoporosis after 12 and 24 months of treatment, meeting the study's co-primary endpoints.

The FRAME trial enrolled 7,180 women and was the first to evaluate fracture risk reduction as early as one year as a primary endpoint. Significant bone mineral density gains were seen at six and 12 months at the lumbar spine, total hip and femoral neck.

Both patient groups transitioned to denosumab treatment in the second year of the study. Bone mineral density continued to increase and vertebral fracture risk reduction benefits were shown to persist through the change of the therapy.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "Romosozumab, with its dual effect as a bone builder and anti-resorptive, has the potential to play a distinct and important role in the treatment of women with postmenopausal osteoporosis at increased risk of fracture."

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