By Lara Hutchins
NICE have given the go-ahead for denosumab – the first monoclonal antibody osteoporosis treatment – to be prescribed as an alternative to bisphosphonates for primary and secondary prevention of osteoporotic fractures in post-menopausal women.
Denosumab is given as a single 60mg/ml subcutaneous injection every six months and works by inhibiting osteoclast resorption.
The FREEDOM study measured the percentages of radio graphically detected spinal fractures at 36 months in patients receiving denosumab versus placebo, at 2.3% versus 7.2% respectively. Other findings support its benefit over placebo to prevent wrist and hip fractures.
NICE says post-menopausal women with osteoporosis and a T-score greater -2.5 who are bisphosphonate intolerant (or unable to follow the administration instructions) are eligible for denosumab if they meet one other criteria including maternal or paternal hip fracture and co-existing rheumatoid arthritis.