2 The technology
2.1 Denosumab (Prolia, Amgen) is a monoclonal antibody that reduces osteoclast activity, and so reduces bone breakdown. Denosumab has a UK marketing authorisation for the treatment of osteoporosis in postmenopausal women at increased risk of fractures. The summary of product characteristics states in the indication that denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.
2.2 The summary of product characteristics states that conditions associated with denosumab treatment include: urinary tract infection, upper respiratory tract infection, sciatica, cataracts, constipation, rash, pain in extremity and skin infections (predominantly cellulitis). However, there was no evidence of increased incidence of cataracts or diverticulitis in postmenopausal women with osteoporosis; these conditions occurred only in patients with prostate cancer. The summary of product characteristics states that osteonecrosis of the jaw has been reported in patients receiving denosumab or bisphosphonates, with most cases occurring in people with cancer, but some occurred in people with osteoporosis. For full details of side effects and contraindications, see the summary of product characteristics.
2.3 Denosumab is administered as a single subcutaneous injection into the thigh, abdomen or back of the arm. The recommended dosage is 60 mg once every 6 months.
2.4 The acquisition cost of denosumab is £183 for a 1 ml pre-filled syringe (60 mg per ml solution; excluding VAT, 'MIMS' September 2010 edition), which is equivalent to £366 for 1 year of treatment. Costs may vary in different settings because of negotiated procurement discounts.