Denosumab (Prolia®) for the treatment of osteoporosis

Denosumab (Prolia®) is used to treat bone loss, particularly among women after the menopause and people who are at a higher risk of breaking bones or who are undergoing certain cancer treatments. In 2017 there were reports that stopping therapy with denosumab could lead to excessive counter-reactions such as loss of bone density and a greater risk of broken bones in the area of the spine. The present report compares the effectiveness and safety of denosumab with that of a placebo (a drug that appears to be real but isn’t) and other therapies for bone loss. It also looks at the cost-benefit ratio as well as social, ethical, legal and organisational matters.

On the basis of a research of the literature, the findings of studies involving four groups of patients with different disease patterns in different countries were evaluated. Denosumab was less effective than other drugs for women after the menopause suffering from bone loss. The drug was effective when it came to preventing broken bones in the area of the spine among women with breast cancer. Men with osteoporosis saw an increase in bone density when treated with denosumab or one of the other drugs in the comparison. The drug was effective in preventing broken bones in the area of the spine among men undergoing treatment for prostate cancer. In none of the four groups did the studies show a clearly increased risk of the excessive counter-reactions feared after stopping treatment with the drug.

The report concludes that among most of the patient groups treated, denosumab achieved similar effects to other therapies and displayed a similar degree of safety. However, patients treated with denosumab were more likely to stick to their treatment. On the basis of the studies the report was unable to meaningfully assess how likely it was that excessive counter-reactions would occur after treatment with the drug was stopped or the severity of these reactions. In the analysis of costs and benefits, Denosumab was not the cheapest therapy when compared directly with other treatments.

Last modification 06.05.2022

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