CoChat
Sign Up
Cited by 228

The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.

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

Black, Dennis M, Bauer, Douglas C, Vittinghoff, Eric, Lui, Li-Yung, Grauer, Andreas, Marin, Fernando, Khosla, Sundeep, de Papp, Anne, Mitlak, Bruce, Cauley, Jane A, McCulloch, Charles E, Eastell, Richard, Bouxsein, Mary L·2020·The Lancet Diabetes & Endocrinology
DOI 10.1016/s2213-8587(20)30159-5
Open this paper in CoChat — free account

Abstract

Background The validation of bone mineral density (BMD) as a surrogate outcome for fracture would allow the size of future randomised controlled osteoporosis registration trials to be reduced. We aimed to determine the association between treatment-related changes in BMD, assessed by dual-energy x-ray absorptiometry, and fracture outcomes, including the proportion of treatment effect explained by BMD changes. Methods We did a pooled analysis of individual patient data from multiple randomised placebo-controlled clinical trials. We included data from multicentre, randomised, placebo-controlled, double-blind trials of osteoporosis medications that included women and men at increased osteoporotic fracture risk. Using individual patient data for each trial we calculated mean 24-month BMD percent change together with fracture reductions and did a meta-regression of the association between treatment-related differences in BMD changes (percentage difference, active minus placebo) and fracture risk reduction. We also used individual patient data to determine the proportion of anti-fracture treatment effect explained by BMD changes and the BMD change needed in future trials to ensure fracture reduction efficacy. Findings Individual patient data from 91 779 participants of 23 randomised, placebo-controlled trials were included. The trials had 1-9 years of follow-up and included 12 trials of bisphosphonate, one of odanacatib, two of hormone therapy (one of conjugated equine oestrogen an…

Overview

Integrity signals

Registry

Crossref · 10.1016/s2213-8587(20)30159-5

Cites

9 of 9 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Hip bone mineral density (BMD) is an example of a valid surrogate marker.

    “Bone density (BMD) of the hip is an example of a valid surrogate marker.”

    From Endpoints for geroscience clinical trials: health outcomes, biomarkers, and biologic age (2022) · cites this paper as [13]

  • A large meta-analysis combining all clinical trials demonstrated a strong correlation (R2 = 0.73) between change in hip BMD and reduction in risk of hip fracture.

    “The large meta-analysis combining all clinical trials demonstrated a strong (R2 = 0.73) correlation between change in hip BMD and reduction in risk of hip fracture (Fig. 2a) connecting the parts of the causal pathway (Fig. 2b) and validating hip BMD as a surrogate marker.”

    From Endpoints for geroscience clinical trials: health outcomes, biomarkers, and biologic age (2022) · cites this paper as [13]

Citations

Cites

Flagged first, then by citations

Research works printed but not linked: 53

  1. Qaseem, 2017, Treatment of low bone density or osteoporosis to prevent fractures in men and women: a clinical practice guideline update from the American College of Physicians, Ann Intern Med, 166, 818, 10.7326/M15-1361 · DOI · Paper page
  2. Bouxsein, 2019, Change in bone density and reduction in fracture risk: a meta-regression of published trials, J Bone Miner Res, 34, 632, 10.1002/jbmr.3641 · DOI
  3. Ciani, 2017, Time to review the role of surrogate end points in health policy: state of the art and the way forward, Value Health, 20, 487, 10.1016/j.jval.2016.10.011 · DOI
  4. Amur, 2015, Biomarker qualification: toward a multiple stakeholder framework for biomarker development, regulatory acceptance, and utilization, Clin Pharmacol Ther, 98, 34, 10.1002/cpt.136 · DOI
  5. Ciani, 2016, Use of surrogate end points in healthcare policy: a proposal for adoption of a validation framework, Nat Rev Drug Discov, 15, 516, 10.1038/nrd.2016.81 · DOI
  6. Zysset, 2015, Clinical use of quantitative computed tomography-based finite element analysis of the hip and spine in the management of osteoporosis in adults: the 2015 ISCD official positions—part II, J Clin Densitom, 18, 359, 10.1016/j.jocd.2015.06.011 · DOI
  7. Johannesdottir, 2017, Comparison of non-invasive assessments of strength of the proximal femur, Bone, 105, 93, 10.1016/j.bone.2017.07.023 · DOI
  8. Johnell, 2005, Predictive value of BMD for hip and other fractures, J Bone Miner Res, 20, 1185, 10.1359/JBMR.050304 · DOI
  9. Marshall, 1996, Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures, BMJ, 312, 1254, 10.1136/bmj.312.7041.1254 · DOI · Paper page
  10. Sarkar, 2002, Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy, J Bone Miner Res, 17, 1, 10.1359/jbmr.2002.17.1.1 · DOI
  11. Watts, 2004, Relationship between changes in bone mineral density and vertebral fracture risk associated with risedronate: greater increases in bone mineral density do not relate to greater decreases in fracture risk, J Clin Densitom, 7, 255, 10.1385/JCD:7:3:255 · DOI
  12. Watts, 2005, Relationship between changes in BMD and nonvertebral fracture incidence associated with risedronate: reduction in risk of nonvertebral fracture is not related to change in BMD, J Bone Miner Res, 20, 2097, 10.1359/JBMR.050814 · DOI
  13. Chen, 2006, Change in lumbar spine BMD and vertebral fracture risk reduction in teriparatide-treated postmenopausal women with osteoporosis, J Bone Miner Res, 21, 1785, 10.1359/jbmr.060802 · DOI
  14. Austin, 2012, Relationship between bone mineral density changes with denosumab treatment and risk reduction for vertebral and nonvertebral fractures, J Bone Miner Res, 27, 687, 10.1002/jbmr.1472 · DOI
  15. Jacques, 2012, Relationship of changes in total hip bone mineral density to vertebral and nonvertebral fracture risk in women with postmenopausal osteoporosis treated with once-yearly zoledronic acid 5 mg: the HORIZON-Pivotal Fracture Trial (PFT), J Bone Miner Res, 27, 1627, 10.1002/jbmr.1644 · DOI
  16. Miller, 2010, Increases in hip and spine bone mineral density are predictive for vertebral antifracture efficacy with ibandronate, Calcif Tissue Int, 87, 305, 10.1007/s00223-010-9403-y · DOI
  17. Bruyère, 2012, Relationships between changes in bone mineral density or bone turnover markers and vertebral fracture incidence in patients treated with bazedoxifene, Calcif Tissue Int, 91, 244, 10.1007/s00223-012-9629-y · DOI
  18. Blake, 2005, Long-term effect of strontium ranelate treatment on BMD, J Bone Miner Res, 20, 1901, 10.1359/JBMR.050810 · DOI
  19. Nielsen, 1999, Influence of strontium on bone mineral density and bone mineral content measurements by dual x-ray absorptiometry, J Clin Densitom, 2, 371, 10.1016/S1094-6950(06)60402-2 · DOI
  20. Neer, 2001, Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis, N Engl J Med, 344, 1434, 10.1056/NEJM200105103441904 · DOI · Paper page
  21. Eastell, 1991, Classification of vertebral fractures, J Bone Miner Res, 6, 207, 10.1002/jbmr.5650060302 · DOI
  22. Genant, 1993, Vertebral fracture assessment using a semiquantitative technique, J Bone Miner Res, 8, 1137, 10.1002/jbmr.5650080915 · DOI · Paper page
  23. Genant, 1994, Universal standardization for dual x-ray absorptiometry: patient and phantom cross-calibration results, J Bone Miner Res, 9, 1503, 10.1002/jbmr.5650091002 · DOI
  24. Hanson, 1997, Standardization of femur BMD, J Bone Miner Res, 12, 1316, 10.1359/jbmr.1997.12.8.1316 · DOI
  25. Looker, 1995, Prevalence of low femoral bone density in older U.S. women from NHANES III, J Bone Miner Res, 10, 796, 10.1002/jbmr.5650100517 · DOI
  26. Reginster, 2000, Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis, Osteoporos Int, 11, 83, 10.1007/s001980050010 · DOI · Paper page
  27. Silverman, 2008, Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial, J Bone Miner Res, 23, 1923, 10.1359/jbmr.080710 · DOI
  28. Miller, 2016, Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial, JAMA, 316, 722, 10.1001/jama.2016.11136 · DOI
  29. Pols, 1999, Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study, Osteoporos Int, 9, 461, 10.1007/PL00004171 · DOI
  30. Greenspan, 2007, Effect of recombinant human parathyroid hormone (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial, Ann Intern Med, 146, 326, 10.7326/0003-4819-146-5-200703060-00005 · DOI
  31. Cauley, 2003, Effects of estrogen plus progestin on risk of fracture and bone mineral density: the Women's Health Initiative randomized trial, JAMA, 290, 1729, 10.1001/jama.290.13.1729 · DOI
  32. Jackson, 2006, Effects of conjugated equine estrogen on risk of fractures and BMD in postmenopausal women with hysterectomy: results from the women's health initiative randomized trial, J Bone Miner Res, 21, 817, 10.1359/jbmr.060312 · DOI
  33. Burzykowski, 2006, Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation, Pharm Stat, 5, 173, 10.1002/pst.207 · DOI
  34. Lassere, 2008, Stat Methods Med Res, 17, 303, 10.1177/0962280207082719 · DOI
  35. Lassere, 2012, BMC Med Res Methodol, 12, 27, 10.1186/1471-2288-12-27 · DOI
  36. 1998, Design of the Women's Health Initiative clinical trial and observational study, Control Clin Trials, 19, 61, 10.1016/S0197-2456(97)00078-0 · DOI
  37. Lewiecki, 2016, Best practices for dual-energy x-ray absorptiometry measurement and reporting: International Society for Clinical Densitometry guidance, J Clin Densitom, 19, 127, 10.1016/j.jocd.2016.03.003 · DOI
  38. Singh, 2012, Drug safety assessment in clinical trials: methodological challenges and opportunities, Trials, 13, 138, 10.1186/1745-6215-13-138 · DOI
  39. Bajan, 2015, Can we predict neurological outcome following out-of-hospital cardiac arrest (OHCA) and therapeutic hypothermia?, Indian J Crit Care Med, 19, 301, 10.4103/0972-5229.158253 · DOI
  40. Simes, 2002, Relationship between lipid levels and clinical outcomes in the Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) Trial: to what extent is the reduction in coronary events with pravastatin explained by on-study lipid levels?, Circulation, 105, 1162, 10.1161/hc1002.105136 · DOI
  41. Cortazar, 2014, Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis, Lancet, 384, 164, 10.1016/S0140-6736(13)62422-8 · DOI
  42. Korn, 2016, Statistical controversies in clinical research: assessing pathologic complete response as a trial-level surrogate end point for early-stage breast cancer, Ann Oncol, 27, 10, 10.1093/annonc/mdv507 · DOI
  43. Drazen, 2015, Sharing individual patient data from clinical trials, N Engl J Med, 372, 201, 10.1056/NEJMp1415160 · DOI
  44. Taichman, 2016, Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors, Ann Intern Med, 164, 505, 10.7326/M15-2928 · DOI
  45. Liberman, 1995, Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis, N Engl J Med, 333, 1437, 10.1056/NEJM199511303332201 · DOI
  46. Black, 1996, Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures, Lancet, 348, 1535, 10.1016/S0140-6736(96)07088-2 · DOI · Paper page
  47. Orwoll, 2000, Alendronate for the treatment of osteoporosis in men, N Engl J Med, 343, 604, 10.1056/NEJM200008313430902 · DOI
  48. Recker, 2004, Insufficiently dosed intravenous ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis, Bone, 34, 890, 10.1016/j.bone.2004.01.008 · DOI
  49. McClung, 2001, Effect of risedronate on the risk of hip fracture in elderly women, N Engl J Med, 344, 333, 10.1056/NEJM200102013440503 · DOI · Paper page
  50. McClung, 2019, Odanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study, Lancet Diabetes Endocrinol, 7, 899, 10.1016/S2213-8587(19)30346-8 · DOI · Paper page
  51. Cummings, 2011, Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women, J Bone Miner Res, 26, 397, 10.1002/jbmr.191 · DOI
  52. Cummings, 2010, Lasofoxifene in postmenopausal women with osteoporosis, N Engl J Med, 362, 686, 10.1056/NEJMoa0808692 · DOI
  53. Ettinger, 1999, Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial, JAMA, 282, 637, 10.1001/jama.282.7.637 · DOI · Paper page

Cited by

Sorted by citations

Metadata

Authors
Black, D. M., Bauer, D. C., Vittinghoff, E., Lui, L.-Y., Grauer, A., Marin, F., Khosla, S., de Papp, A., Mitlak, B., Cauley, J. A., McCulloch, C. E., Eastell, R., & Bouxsein, M. L.
Venue
The Lancet Diabetes & Endocrinology
Publisher
Elsevier BV
Published
2020-08
Volume
8
Issue
8
Pages
672-682
ISSN
2213-8587
DOI
10.1016/s2213-8587(20)30159-5
Cited by
228
References
9
Language
en
Update notices
erratum (2020-10-01)
Licence
Funders
  • Amgen
  • Actavis
  • Samsung
  • Eli Lilly and Company
  • Daiichi-Sankyo
  • AbbVie
  • Pfizer
  • Bayer Schering
  • University of California, San Francisco
  • GlaxoSmithKline
  • Merck Sharp and Dohme
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases
  • American Society for Bone and Mineral Research
  • Roche
  • Foundation for the National Institutes of Health
  • National Heart, Lung, and Blood Institute
  • Novartis

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review