This news release describes results of a five-year study in which older women in seven areas of Britain were randomly assigned to either go through a screening procedure for osteoporosis called FRAX, or not. Women who were screened were 28% less likely to experience a hip fracture over the period of study, though their incidence of all osteoporosis-related fractures was no different than that of women who were not screened.
Strengths are that this is a large, population-based randomized trial that measures important clinical endpoints. The intervention is innovative, easy to implement, and offers the possibility that screening can be conducted more efficiently.
A discussion of the cost of treating more women as a result of enhanced screening deserved a mention.
In an aging society like Britain, a tool that reduces risk of hip fractures is an important innovation. Hip fractures can be disabling for the elderly, and many older people never fully recover from them. Unfortunately, although the release vaguely suggests that the tool is cost-effective, no specific information is provided to support that contention.
In America, the US Preventative Services Task Force (USPSTF) recommends a screening bone density scan for women 65 and over. The British study is innovative because it incorporates fracture risk into the screening process. Theoretically, using FRAX to guide bone density scan (DXA) referrals could be more cost-effective than routinely performing DXA scans based just on age. The release does not provide supportive evidence, but notes that these analyses are ongoing.
This release was very thorough in most areas. However, we’re only told that the proposed screening program is “low cost.” But the FRAX screening is just a questionnaire, so there is minimal cost to using it.
The costs of screening, of course, arise from those women who go on to get bone density scans and get treated for osteoporosis. We think the additional costs of scans and treatment deserved a mention.
Benefits are quantified. We learn how many women in the treatment arm of the study were placed on osteoporosis medication following screening and how many hip fractures were potentially avoided among the women who received the screening procedure. The release reports both the relative and absolute risk reductions associated with screening. It also projects how many hip fractures might be prevented in Britain on an annual basis if the screening procedure were adopted nationwide.
Given that this news release addresses effectiveness of a community screening effort rather than a treatment, harms are likely to be few. However, we think potential harms deserved some attention.
Harms could arise from medication complications — which for bisphosphonates (the most commonly used drug class for treating osteoporosis) can paradoxically include atypical fractures. This is a risk calculator, so we’re not as concerned about over-diagnosis. The expectation is that the risk information should be incorporated into discussions of treatment options. The bigger concern would be under-diagnosis — how many fractures occur in women whose FRAX score is low and then don’t go on to bone density scanning (DXA) so the opportunity to diagnose and treat osteoporosis is lost.
The release goes into great detail about the study design, the number of participants, and the sampling procedure. The release indicates that 12,000 women were randomized and notes that the follow up was 5 years, which is helpful information.
The release takes a balanced approach to the severity of the health issue under study. There is no disease mongering. Hip fractures are common and are associated with poor outcomes — disability, loss of independence, and death.
The source of funding and universities involved in the study are clearly stated.
This was a report of the findings of a clinical trial regarding a health condition for which no screening procedure is currently recommended.
The alternative in the US is to perform bone density scans based on age.
This was a clinical trial of the proposed adoption of a screening procedure which the researchers hope will contribute to national healthcare policy. The risk calculator used in screening, FRAX, is already widely available.
Screening for risk factors is not currently advocated in the U.K., but the release doesn’t tell us that. Readers who depend solely on this release for their information won’t know whether the FRAX risk calculator is an improvement on an already existing practice, or whether doctors simply don’t screen for osteoporosis currently. Without that information readers can’t get a perspective on exactly how novel these results are.
No unjustifiable language was identified.