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news.Amgen has released the open-label extension FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months) trial results evaluating the efficacy and safety of Prolia (denosumab) over five years.
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Prolia, administered as a single subcutaneous injection of 60mg once every six months, specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).
The results of the trial suggested that during fourth and fifth year of the study in postmenopausal women with osteoporosis receiving Prolia continued increase in lumbar spine and total hip bone mineral density (BMD).
Amgen said that Prolia resulted in BMD gains after five continuous years of treatment (13.7% for lumbar spine BMD and 7% for total hip BMD).
Prolia is approved in the European Union (EU) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.