What is Prolia®?
Since 2010 the active ingredient Denosumab is on the market, which is distributed by the company AMGEN under the trade names Prolia® and XGEVA®. The human monoclonal IgG2 anti-RANKL antibody is used for the treatment of bone loss (osteoporosis). The efficacy is achieved by Denosumab interfering with the so-called RANK/RANKL system of bone metabolism, thereby reducing bone loss.
Prolia® is used for bone loss (osteoporosis) in post-menopausal women who are prone to bone fractures as well as in men with an increased risk of bone fractures, e.g. under hormone therapy for prostate cancer. By interfering with the RANK/RANKL system, which plays a central role in bone resorption, the drug would potentially be effective in other diseases with a tendency to fracture, such as steroid-induced bone resorption and rheumatoid arthritis. Prolia® is administered as an injection into the subcutaneous fatty tissue (subcutaneous).
Usual dosages as a ready-to-use syringe are 60mg and 120mg. The active ingredient leads to an increased bone mineral density and a reduction in the rate of vertebral fractures when used every six months. The effectiveness of the drug has been proven in two high-quality studies.
The HALT study examined 734 men, on average 75.3 years old, who are being treated with hormones because of their prostate cancer. After two years, patients treated with Prolia® had an average increase in bone density of 5.6%, while the placebo group (without medication) had a loss of 1.0%. At the same time, 1.5% of patients under Prolia® therapy suffered vertebral fractures, compared to 3.9% without Prolia®.
The FREEDOM study evaluated 7868 post-menopausal women with osteoporosis. Under treatment, 2.3% of women suffered a fractured vertebra and 0.7% a fractured femur within three years, compared to 7.2% and 1.2% in the placebo group. This is similar in efficacy to zoledronate and teriparatide, which are also used to prevent fractures.
