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• W3093185445 abstract "We read with great interest the article in The Lancet Diabetes & Endocrinology by Dennis Black and colleagues,1Black DM Bauer DC Vittinghoff E et al.Treatment-related changes in bone mineral density as a surrogate biomarker for fracture risk reduction: meta-regression analyses of individual patient data from multiple randomised controlled trials.Lancet Diabetes Endocrinol. 2020; 8: 672-682Summary Full Text Full Text PDF PubMed Scopus (48) Google Scholar which showed a causal association between improvements in bone mineral density (BMD) and reduction in fracture risk. We welcome these findings for their usefulness in clinical practice, since BMD is used as a parameter for treatment success when following up patients after initiation of antifracture therapies. However, we are concerned that these data will be used to establish the surrogate status of BMD as a measure of efficacy for the regulatory approval of new osteoporosis drugs. We believe this would be inappropriate for several reasons. Looking back at the history of osteoporosis treatment trials, fluoride stands out as an example of an antifracture drug that improved BMD yet increased the risk of fractures. Such a finding would possibly have been missed in a small trial using a surrogate endpoint.2Riggs BL Hodgson SF O'Fallon WM et al.Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis.N Engl J Med. 1990; 322: 802-809Crossref PubMed Scopus (984) Google Scholar Off-target effects would also probably be missed, as is the case with romosozumab, which might increase the risk of adverse cardiovascular events.3Bovijn J Krebs K Chen CY et al.Evaluating the cardiovascular safety of sclerostin inhibition using evidence from meta-analysis of clinical trials and human genetics.Sci Transl Med. 2020; 12eaay6570Crossref PubMed Scopus (33) Google Scholar These are just two examples where data from large trials assessing clinical endpoints advanced our understanding of the safety and efficacy of osteoporosis drugs. Another important consideration is that not all antifracture drugs are equally efficacious: some reduce only the risk of vertebral fractures, with no effect on hip fractures, as is the case with raloxifene and ibandronate.4Barrionuevo P Kapoor E Asi N et al.Efficacy of pharmacological therapies for the prevention of fractures in postmenopausal women: a network meta-analysis.J Clin Endocrinol Metab. 2019; 104: 1623-1630Crossref PubMed Scopus (110) Google Scholar However, if BMD data had been used to establish efficacy in the BONE trial,5Chesnut 3rd, CH Skag A Christiansen C et al.Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis.J Bone Miner Res. 2004; 19: 1241-1249Crossref PubMed Scopus (989) Google Scholar which assessed the efficacy of oral ibandronate, the conclusions would have been different. After 3 years of follow-up, total hip BMD increased by 2·9% in the intermittent ibandronate group whereas it decreased by 0·7% in the placebo group, leading to a 3·6% between-group difference in total hip BMD. If we had considered the 3·18% difference threshold in total hip BMD as a surrogate for hip fracture reduction, as found by Black and colleagues,1Black DM Bauer DC Vittinghoff E et al.Treatment-related changes in bone mineral density as a surrogate biomarker for fracture risk reduction: meta-regression analyses of individual patient data from multiple randomised controlled trials.Lancet Diabetes Endocrinol. 2020; 8: 672-682Summary Full Text Full Text PDF PubMed Scopus (48) Google Scholar we would wrongfully consider intermittent ibandronate to be an effective treatment option to reduce the risk of hip fractures. In summary, although we consider data from the Article by Black and colleagues1Black DM Bauer DC Vittinghoff E et al.Treatment-related changes in bone mineral density as a surrogate biomarker for fracture risk reduction: meta-regression analyses of individual patient data from multiple randomised controlled trials.Lancet Diabetes Endocrinol. 2020; 8: 672-682Summary Full Text Full Text PDF PubMed Scopus (48) Google Scholar reassuring, it must not be forgotten that large clinical trials assessing clinical endpoints are still the gold standard. Even though they demand longer follow-up, larger sample sizes, and higher costs, they are essential to protect the best interests of patients and physicians. We declare no competing interests. Treatment-related changes in bone mineral density as a surrogate biomarker for fracture risk reduction: meta-regression analyses of individual patient data from multiple randomised controlled trialsTreatment-related BMD changes are strongly associated with fracture reductions across randomised trials of osteoporosis therapies with differing mechanisms of action. These analyses support BMD as a surrogate outcome for fracture outcomes in future randomised trials of new osteoporosis therapies and provide an important demonstration of the value of public access to individual patient data from multiple trials. Full-Text PDF Bone mineral density as a surrogate biomarker for fracture risk reductionUsing individual patient data from 91 779 participants of 23 randomised, placebo-controlled trials in their recent Article in The Lancet Diabetes & Endocrinology, Dennis Black and colleagues1 reported that osteoporosis treatment-related changes in bone mineral density (BMD), determined by dual-energy x-ray absorptiometry, at 24 months, were significantly associated with hip, vertebral, and non-vertebral fracture risk reduction. Black and colleagues thus make the case for adoption of treatment-related BMD changes over time as a surrogate biomarker for fracture risk reduction in future randomised trials of osteoporosis therapies to reduce the high cost and time for newer osteoporosis drugs to come to the market. Full-Text PDF Bone mineral density as a surrogate biomarker for fracture risk reduction – Authors' replyWe thank Viral Shah and Josivan Lima and colleagues for their interest in and comments about our Article.1 We agree with the comment by Shah that our findings might not be applicable to men. There are only 749 men in our database and our surrogacy application with the US Food and Drug Administration (FDA) is specifically limited to post-menopausal women. Shah also suggests that bone mineral density (BMD) does not predict fractures in people with diabetes. However, we believe that this statement does not apply to post-menopausal women with type 2 diabetes. Full-Text PDF" @default.
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• W3093185445 title "Bone mineral density as a surrogate biomarker for fracture risk reduction" @default.
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