NICE publishes osteoporosis guidance after more than six years of consultationBMJ 2008; 337 doi: https://doi.org/10.1136/bmj.a2397 (Published 04 November 2008) Cite this as: BMJ 2008;337:a2397
The UK National Institute for Health and Clinical Excellence (NICE) has published final guidance on the use of drugs to prevent primary and secondary osteoporotic fractures in postmenopausal women.
The guidance recommends a range of treatments, depending on a woman’s age, her bone density, and how many indicators of fragile bones or risk factors for fracture she has.
It recommends alendronic acid as the first line treatment for primary prevention in women aged 70 or over who are given a diagnosis of osteoporosis and who have a clinical risk factor for the condition or an indicator of low bone density.
NICE defines a diagnosis as a T score of −2.5 or below on dual energy x ray absorptiometry scanning, although it says that women aged over 75 with two or more risk factors for fracture or low bone density can be assumed without a scan to have osteoporosis.
Risk factors for osteoporosis are defined as a parental history of hip fracture, alcohol intake of four or more units per day, and rheumatoid arthritis. Indictors of low bone density include low body mass index (<22 kg/m2), untreated menopause, and medical conditions such as ankylosing spondylitis, Crohn’s disease, and conditions that result in prolonged immobility, says NICE.
If women cannot take alendronic acid, it recommends risedronate sodium and disodium etidronate as second line treatments, with strontium ranelate as a third line agent if these drugs are contraindicated or cannot be tolerated.
For women who have had a fracture and a diagnosis of osteoporosis, raloxifene is recommended along with strontium ranelate as a third line agent if first and second line treatment with alendronic acid and the other recommended bisphosphonates has failed or is unsuitable.
In addition, teriparatide is recommended if none of the other secondary prevention treatments can be tolerated. This drug is also a possible alternative treatment for women who have had another fracture while taking alendronic acid, risedronate, or etidronate for one year and who have further loss of bone mass.
Juliet Compston, professor of bone medicine at the University of Cambridge School of Clinical Medicine and Addenbrooke’s Hospital, said that while “it was good that NICE had produced something on osteoporosis after six and a half years, there are a number of significant shortcomings with the guidance.”
She said that men have been excluded from the guidance, which has also failed to include people whose bone density may be affected by taking steroids.
Professor Compston was part of an expert panel, the National Osteoporosis Guideline Group, that launched its own guidelines on managing the condition last month (BMJ 2008;337:a2204, 21 Oct, doi:10.1136/bmj.a2204), in frustration at NICE’s delay in issuing guidance.
The charity the National Osteoporosis Society criticised NICE’s guidance for being overly complex, inflexible, and unethical and called for a completely fresh appraisal of osteoporosis treatments.
Nick Rijke, the society’s public and external affairs director, said, “We remain deeply dissatisfied with the guidance that NICE has produced, which is unethical and shortsighted. They excessively ration the cheapest generic drug [alendronic acid] and deprive patients who cannot tolerate [it] from access to alternative treatments to prevent fractures until their osteoporosis has become significantly worse.”
The drug company Servier, which makes strontium ranelate (Protelos), is taking NICE to judicial review in January 2009 to push for greater access to treatments for those patients who are denied choice within the guidance.
Cite this as: BMJ 2008;337:a2397
NICE’s guidance can be seen at www.nice.org.uk.