Amgen/UCB's osteoporosis drug shows promise in men

Amgen and UCB's potential blockbuster osteoporosis drug romosozumab has succeeded in a key Phase 3 trial in men with osteoporosis.

The companies announced yesterday top-line results showing the BRIDGE study of romosozumab met its primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine, in men with osteoporosis treated with romosozumab compared with placebo at 12 months.

UCB and Amgen said they plan to discuss these results with global regulators, after announcing in February that the FRAME study evaluating romosozumab in women with osteoporosis met its primary endpoint.

All secondary endpoints comparing romosozumab with placebo were also met in the BRIDGE study, the companies said.

Patients receiving romosozumab experienced a statistically significant increase in BMD at the femoral neck and total hip at 12 months and a statistically significant increase in BMD at the lumbar spine, femoral neck, and total hip at six months, compared with those receiving placebo.

In the BRIDGE study, a total of 245 men were randomised 2:1 to receive either 210 mg romosozumab subcutaneous (SC) every month (QM) or matched placebo SC QM for the duration of the 12-month treatment period.

The overall patient incidence of adverse events and serious adverse events (SAEs) was generally balanced between arms. The most frequently reported adverse events (greater than 5% in the romosozumab arm) were nasopharyngitis, back pain, hypertension, headache and constipation.

Injection site reactions were reported in 5.5% of patients in the romosozumab treatment group and 3.7% in the placebo group during the 12-month period.

Most injection site reactions were reported as mild in severity. The patient incidence of positively adjudicated cardiovascular (CV) SAEs was 4.9% (8/163) in the romosozumab group and 2.5% (2/81) in the placebo group.

The patient incidence of positively adjudicated cardiovascular death was 0.6% (1/163) in the romosozumab group and 1.2% (1/81) in the placebo group. In the FRAME study in 7,180 postmenopausal women with osteoporosis, the overall patient incidences of adjudicated CV SAEs were balanced.

Further analysis of the phase 3 BRIDGE study data is ongoing and will be submitted to a future medical conference and for publication.

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