Amgen and UCB announce positive Phase 3 FRAME results

Amgen and UCB announced this week positive results from the Phase 3 trial of a fracture study in postmenopausal women with osteoporosis (FRAME).

The data from the trial showed that FRAME was able to meet its primary goal of reducing the amount of new vertebra fractures through one to two years in women who are postmenopausal and who also have osteoporosis by treating them with romosozumab. FRAME also met its secondary goal by aiding in the reduction of clinical fractures, both in the vertebra and non-vertebra, in postmenopausal women with osteoporosis through the first year, but was unable to decrease the amount of non-vertebra fractures through one to two years.

The results of the FRAME trial revealed that women who received monthly subcutaneous injections of romosozumab were 73 percent more likely to avoid the risk of a spinal fracture as opposed to the women in the placebo group. These numbers remained the same when denosumab was substituted for romosozumab for both groups of patients during the second year of treatment.

The Phase 3 FRAME study was conducted over multiple centers, internationally on a randomized, double-blind basis on placebo-controlled parallel groups. It assessed patients receiving romosozumab the first year and denosumab the second.