UK study to assess screening for fracture risk in elderly women
MedWire News: UK investigators have launched a major study to test the clinical and economic effectiveness of a community-based screening program to reduce fractures in older women.
The rationale, design, and methods of the "SCOOP" trial, which will include over 11,000 women and last for 5 years, are published this month in Osteoporosis International.
SCOOP is needed because osteoporotic fractures place a considerable burden on healthcare systems and have a major adverse effect on sufferers' quality of life, disability, and mortality, explain Lee Shepstone (University of East Anglia, Norwich) and colleagues.
"Given the availability of efficacious treatments and a risk-assessment tool based upon clinical risk factors and bone mineral density [the FRAX algorithm], a case exists to undertake a community-based controlled evaluation of screening for subjects at high risk of fracture, under the hypothesis that such a screening programme would reduce fractures in this population," write Lee et al.
The SCOOP study is using a pragmatic, unblinded, randomized, controlled design. It will enrol 11,580 women, aged 70-85 years, from seven defined geographic areas in England. Women will not be taking prescribed bone-protective medications (other than calcium and vitamin D) and will be contacted by post via their primary-care providers.
Participants will be randomized to screening or control. The screening arm will undergo dual-energy X-ray absorptiometry of the femoral neck for measurement of bone mineral density, which will then be used to estimate 10-year fracture risk using the FRAX algorithm.
If an individual's estimated fracture risk lies above an age-dependent threshold, their primary-care physician will consider starting treatment; the thresholds have been set at >5.24%, >6.87%, >8.52%, and >8.99% for women aged 70-74, 75-79, 80-84, and 85 years, respectively.
Women in the control arm will also have their 10-year fracture risk calculated but this information will not be acted upon or communicated to the patient or their physician.
Both groups will receive advice on lifestyle changes to promote bone health.
The treatment/follow-up period of the study will last for 60 months; the study's primary outcome is any osteoporosis-related fracture (excluding fractures of the hands, feet, nose, and skull).
Secondary outcomes include all clinical fractures, hip fractures, quality-of-life, psychologic anxiety, and mortality. Economic analyses will also be undertaken to determine the cost-effectiveness and cost-utility of the intervention, which Lee et al note is "of central importance."
"An appropriately designed screening program might reduce costs of fracture, but at the same time, it will incur additional costs of detection and treatment," they remark.
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By Joanna Lyford