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A study to establish the feasibility of a trial that would investigate the clinical and cost-effectiveness of stopping bisphosphonate treatment after 5 years in post-menopausal women with osteoporosis who have already had a fracture |
Stevenson MD, Oakley JE, Lloyd Jones M, Brennan A, Compston JE, McCloskey EV, Selby PL |
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Citation Stevenson MD, Oakley JE, Lloyd Jones M, Brennan A, Compston JE, McCloskey EV, Selby PL. A study to establish the feasibility of a trial that would investigate the clinical and cost-effectiveness of stopping bisphosphonate treatment after 5 years in post-menopausal women with osteoporosis who have already had a fracture. Southampton: NIHR Health Technology Assessment programme. Authors' objectives <p>The object of the proposed project is to assess the feasibility and cost-effectiveness of a trial to estimate the long-term efficacy of bisphosphonate treatment in preventing osteoporotic fracture. Such a trial is needed because the long-term effects of bisphosphonates are unknown: most randomised controlled trials were of less than 5 years' duration. Recent cost-effectiveness analyses undertaken for NICE assumed a 5-year treatment period with some residual benefit after treatment has been discontinued. However, as current guidance does not impose a limit on the duration of bisphosphonate treatment, clinicians may view this therapy as life-long. This approach has two disadvantages: it foregoes any possible residual benefit which would essentially be received without further cost and, potentially more importantly, it does not take account of concerns that, because of their mechanism of action, lengthy treatment with bisphosphonates may leave an individual with a weakened bone structure.</p>
<p>The proposed project will calculate the numbers of patients that would need to be recruited to each arm of the trial to detect surmised reductions in fracture rates, at proposed power levels. If the numbers are such that they may feasibly be recruited, the estimated expected value of the information garnered from the trial will be calculated and compared with the estimated costs of running the trial in order to determine whether it would be cost-effective to undertake the trial. </p> Indexing Status Subject indexing assigned by NLM MeSH Bone Density Conservation Agents /adverse effects /therapeutic use; Cost-Benefit Analysis; Diphosphonates /adverse effects /therapeutic use; Female; Fractures, Bone /etiology /mortality /prevention & Osteoporosis /complications /drug therapy; Randomized Controlled Trials as Topic /economics; controls Language Published English Country of organisation England English summary An English language summary is available. Address for correspondence NETSCC, Health Technology Assessment, Alpha House, University of Southampton Science Park, Southampton, SO16 7NS UK Tel: +44 23 8059 5586 Email: hta@hta.ac.uk AccessionNumber 32007000335 Date bibliographic record published 15/04/2007 Date abstract record published 15/04/2007 |
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