Amgen has announced the publication of results from two highly successful studies investigating the safety and effectiveness of denosumab at reducing fracture risk in patients suffering from osteoporosis.
The Phase III studies investigated the effectiveness of denosumab in more than 7,800 women with postmenopausal osteoporosis and in more than 1,400 men with non-metastatic prostate cancer undergoing androgen deprivation therapy (ADT) leading to bone loss.
In both studies, published in The New England Journal of Medicine, patients receiving twice-yearly denosumab experienced significant increases in bone mineral density (BMD) compared to placebo, resulting in a 60% reduction in vertebral fracture in both patient populations.
The Fracture REduction Evaluation of Denosumab (FREEDOM) trial, multi-centre, randomised, double-blind, placebo-controlled study was used to establish fracture reduction in postmenopausal women with osteoporosis.
The trial showed that women receiving a subcutaneous shot of denosumab twice yearly experienced a 68% reduction in the risk of suffering a vertebral (spine) fracture, a 40% reduction in the risk of suffering a hip fracture and a 20% reduction in the risk of suffering a nonvertebral fracture.
Lead investigator and study author Steven Cummings MD said that the new treatment reduces the risk of all major types of fractures and, because it is given as an injection twice a year, it also has the potential to help compliance to treatment.
The overall incidence and type of side effects with denosumab were shown to be similar to placebo in the FREEDOM study.
The Hormone AbLation Therapy (Halt) study, used to demonstrate fracture prevention in men with non-metastatic prostate cancer undergoing ADT showed that 62% reduction in the risk of suffering a new vertebral fracture with denosumab compared to placebo at 36 months, with significant reduction observed as early as month 12.
Results from the multi-centre, randomised, double-blind, placebo-controlled study showed that men receiving 60mg of denosumab administered subcutaneously experienced a 6.7% increase in BMD at the lumbar spine compared to those receiving placebo (primary endpoint) at 24 months.
Denosumab is the first fully human monoclonal antibody in late-stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts, the cells that break down bone.
Amgen has submitted marketing applications for use of denosumab in the US, EU, Canada, Switzerland and Australia.