This article in the Drug and Therapeutics Bulletin (DTB) reviews the evidence on the efficacy and tolerability of, and guidelines for, denosumab in the management of postmenopausal osteoporosis. 

Denosumab is a monoclonal antibody given subcutaneously every six months, licensed for the treatment of osteoporosis in postmenopausal women at increased risk of fractures (and also for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures).  The review notes that it reduces the incidence of new radiological vertebral fractures compared to placebo in postmenopausal women with osteoporosis when taken for three years.  Although there are no published trials comparing denosumab with alendronic acid in terms of fracture risk, it appears to be more effective than weekly alendronic acid in increasing bone mineral density (a surrogate measure).

Due to the lack of long-term safety data and its cost, the authors recommend it only for patients with osteoporosis or low bone mineral density at risk of osteoporotic fractures for whom use of established treatments to prevent osteoporotic fractures is not possible or contraindicated. Primary and secondary care clinicians should agree local arrangements for prescribing, administration and monitoring of denosumab therapy.

NICE has issued guidance on denosumab for the primary and secondary prevention of osteoporotic fractures in postmenopausal women (TAG 204) – please see the link below for details.