Dr Heaney has research contracts from the following companies: Eli Lilly and Co., General Mills, GlaxoSmithKline, Lane Laboratories, Mead Johnson, National Dairy Council, Proctor and Gamble Pharmaceuticals, Rhodia, and Roots, Inc. He serves as a consultant for Bayer, General Mills, GlaxoSmithKline, and National Dairy Council. Dr Heaney is also a member of the Speaker's Bureau for the Eli Lilly and Co. and National Dairy Council. He is an emeritus member of the Board of Trustees for the National Osteoporosis Foundation. Please note that the research contract and consultant income is not retained by Dr Heaney but is paid to Creighton University
Is the Use of Placebo Controls Ethically Permissible in Clinical Trials of Agents Intended to Reduce Fractures in Osteoporosis?
Version of Record online: 1 JUN 2003
Copyright © 2003 ASBMR
Journal of Bone and Mineral Research
Volume 18, Issue 6, pages 1105–1109, June 2003
How to Cite
Brody, B. A., Dickey, N., Ellenberg, S. S., Heaney, R. P., Levine, R. J., O'brien, R. L., Purtilo, R. B. and Weijer, C. (2003), Is the Use of Placebo Controls Ethically Permissible in Clinical Trials of Agents Intended to Reduce Fractures in Osteoporosis?. J Bone Miner Res, 18: 1105–1109. doi: 10.1359/jbmr.2003.18.6.1105
- Issue online: 2 DEC 2009
- Version of Record online: 1 JUN 2003
- 1World Medical Association 2000 Declaration of Helsinki: Ethical principles for medical research involving human subjects. 52nd World Medical Association General Assembly, October 3–7, 2000, Edinburgh, Scotland, October, 2000.
- 2NIH Consensus Development Panel 2001 Osteoporosis prevention, diagnosis, and therapy. JAMA 285:785–795.
- 31995 Long-term effects of calcium supplementation on bone loss and fractures in postmenopausal women: A randomized controlled trial. Am J Med 98:331–335., , , ,
- 41996 Correcting calcium nutritional deficiency prevents spine fractures in elderly women. J Bone Miner Res 11:1961–1966., , , , , ,
- 51994 Effects of calcium supplements on femoral bone mineral density and vertebral fracture rate in vitamin-D-replete elderly patients. Osteoporos Int 4:245–252., , , , , , ,
- 61994 Effect of calcium and cholecalciferol treatment for three years on hip fractures in elderly women. BMJ 308:1081–1082., , ,
- 71997 Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med 337:670–676., , ,
- 8for the Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators 1999 Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene. Results from a 3-year randomized clinical trial. JAMA 282:637–645., , , , , , , , , , , , , , , , ,
- 9for the Fracture Intervention Trials Research Group 1996 Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet 348:1535–1541., , , , , , , , , , , , , ,
- 10for the Fracture Intervention Trial Research Group 1998 Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures. Results from the fracture intervention trial. JAMA 280:2077–2082., , , , , , , , , , , , ,
- 11for FIT Research Group 2000 Fracture risk reduction with alendronate in women with osteoporosis: The Fracture Intervention Trial. J Clin Endocrinol Metab 85:4118–4124., , , , , , , ,
- 121999 Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: A randomized controlled trial. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. JAMA 282:1344–1352., , , , , , , , , , ,
- 132000 Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int 11:83–91., , , , , , , , , ,
- 142001 Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 344:333–340., , , , , , , , , , ,
- 152000 A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: The prevent recurrence of osteoporotic fractures study. PROOF Study Group. Am J Med 109:267–276., , , , , , , , , , , , , ,
- 162001 Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women. JAMA 286:2815–2822., , , , , , , ,
- 172000 Investigation and treatment of osteoporosis in patients with fragility fractures. Can Med Assoc J 163:819–822., ,
- 182000 Failure to diagnose and treat osteoporosis in elderly patients hospitalized with hip fracture. Am J Med 109:326–328., , , ,
- 192000 Treatment of osteoporosis: Are physicians missing an opportunity? J Bone Joint Surg Am 82:1063–1070., , , ,
- 201996 “Pill esophagitis”—The case of alendronate. N Engl J Med 335:1058–1059.
- 211988 Ethics and Regulation of Clinical Research 2nd ed. Yale University Press, New Haven, CT, USA.
- 221999 Randomized clinical trials: Ethical considerations. In: EdwardsRB (eds.) Advances in Bioethics, Vol. 5. VAI Press, Stamford, CT, USA, pp. 113–145.
- 232000 What makes clinical research ethical? JAMA 283:2701–2711., ,
- 24National Bioethics Advisory Commission 2001 Ethical and policy issues in research involving human participants. Available online at http://www.georgetown.edu/research/nrcbl/nbac/human/overvol1.pdf.
- 251994 The continuing unethical use of placebo controls. N Engl J Med 331:394–398.,
- 261990 Placebo-controlled trials and the logic of clinical purpose. IRB Rev Human Subjects Res 12:1–6.
- 271996 Placebo orthodoxy in clinical research. I: Empirical and methodological myths. J Law Med Ethics 24:243–251., ,
- 281997 When are placebo-controlled trials no longer appropriate. Control Clin Trials 18:602–612.
- 292000 Placebo-controlled trials and active control trials in the evaluation of new treatments: 1. Ethical and scientific issues. Ann Intern Med 133:455–463.,
- 302000 Placebo-controlled trials and active control trials in the evaluation of new treatments: 2. Practical issues and specific cases. Ann Intern Med 133:464–470.,
- 312001 The ethics of placebo-controlled trials—a middle ground. N Engl J Med 345:915–919.,
- 322002 Placebo controls in clinical trials of new therapies for conditions for which there are known effective treatments. In: GuessHA, KleinmanA, KusekJW, EngelLW (eds.) The Science of the Placebo: Toward an Interdisciplinary Research Agenda. BMJ Books, London, UK, pp. 264–280.
- 332002 Uncertain future of trials in osteoporosis. Osteoporos Int 13:443–449., , , , , , ,
- 341993 The epidemiology of vertebral fractures. European Vertebral Osteoporosis Study Group. Bone 14(Suppl 1):S89–S97., ,
- 352000 Effect of alendronate on limited-activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures. Arch Intern Med 160:77–85., , , , , ,
- 362000 Prevalent vertebral deformities predict mortality and hospitalization in older women with low bone mass. Fracture Intervention Trial Research Group. J Am Geriatr Soc 48:241–249., , , , , , ,
- 371999 Vertebral fractures predict subsequent fractures. Osteoporos Int 10:214–221., , , ,
- 381999 Prevalent vertebral deformities predict hip fractures and new vertebral deformities but not wrist fractures. Study of Osteoporotic Fractures Research Group. J Bone Miner Res 14:821–828., , , ,
- 392000 Patients with prior fractures have an increased risk of future fractures: A summary of the literature and statistical synthesis. J Bone Miner Res 15:721–739., , , ,
- 402001 Risk of new vertebral fracture in the year following a fracture. JAMA 285:320–323., , , , , , , , , , ,
- 412001 Outcomes of osteoporotic fractures. In: MarcusM, FeldmanD, KelseyJ (eds.) Osteoporosis, 2nd ed., vol. 1. Academic Press, New York, NY, USA, pp. 819–829.,
- 421999 Forearm fractures as predictors of subsequent osteoporotic fractures. Osteoporos Int 9:469–475., , , ,
- 43Food and Drug Administration Centers for Drug and Biologic Evaluation and Research 2001 Guidance for Industry: E 10 Choice of Control and Related Issues in Clinical Trials. Available online at http://www.fda.gov/cber/gdlns/clincontr0501.pdf.
- 441992 Appendicular bone mineral and woman's lifetime risk of hip fracture. J Bone Miner Res 7:639–646., ,
- 452002 Improvement in spine bone density and reduction in risk of vertebral fractures during treatment with antiresorptive drugs. Am J Med 112:281–289., , , , , ,