SEARCH

SEARCH BY CITATION

REFERENCES

  • 1
    World 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.
  • 2
    NIH Consensus Development Panel 2001 Osteoporosis prevention, diagnosis, and therapy. JAMA 285:785795.
  • 3
    Reid IR, Ames RW, Evans MC, Gamble GD, Sharpe SJ 1995 Long-term effects of calcium supplementation on bone loss and fractures in postmenopausal women: A randomized controlled trial. Am J Med 98:331335.
  • 4
    Recker RR, Hinders S, Davies KM, Heaney RP, Stegman MR, Lappe JM, Kimmel DB 1996 Correcting calcium nutritional deficiency prevents spine fractures in elderly women. J Bone Miner Res 11:19611966.
  • 5
    Chevalley T, Rizzoli R, Nydegger V, Slosman D, Rapin CH, Michel JP, Vasey H, Bonjour JP 1994 Effects of calcium supplements on femoral bone mineral density and vertebral fracture rate in vitamin-D-replete elderly patients. Osteoporos Int 4:245252.
  • 6
    Chapuy MC, Arlot ME, Delmas PD, Meunier PJ 1994 Effect of calcium and cholecalciferol treatment for three years on hip fractures in elderly women. BMJ 308:10811082.
  • 7
    Dawson-Hughes B, Harris SS, Krall EA, Dallal GE 1997 Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med 337:670676.
  • 8
    Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, Christiansen C, Delmas PD, Zanchetta JR, Stakkestad J, Glüer CC, Krueger K, Cohen FJ, Eckert S, Ensrud KE, Avioli LV, Lips P, Cummings SR for 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 282:637645.
  • 9
    Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, Bauer DC, Genant HK, Haskell WL, Marcus R, Ott SM, Torner JC, Quandt SA, Reiss TF, Ensrud KE for the Fracture Intervention Trials Research Group 1996 Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet 348:15351541.
  • 10
    Cummings SR, Black DM, Thompson DE, Applegate WB, Barrett-Connor E, Musliner TA, Palermo L, Prineas R, Rubin SM, Scott JC, Vogt T, Wallace R, Yates AJ, LaCroix AZ for 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 280:20772082.
  • 11
    Black DM, Thompson DE, Bauer DC, Ensrud K, Musliner T, Hochberg MC, Nevitt MC, Suryawanshi S, Cummings SR for FIT Research Group 2000 Fracture risk reduction with alendronate in women with osteoporosis: The Fracture Intervention Trial. J Clin Endocrinol Metab 85:41184124.
  • 12
    Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, Chesnut CH, Brown J, Eriksen EF, Hoseyni MS, Axelrod DW, Miller PD 1999 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 282:13441352.
  • 13
    Reginster JY, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, Lund B, Ethgen D, Pack S, Roumagnac I, Eastell R 2000 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 11:8391.
  • 14
    McClung MR, Geusens P, Miller PD, Zippel H, Bensen WG, Rou C, Adami S, Fogelman I, Diamond T, Eastell R, Meunier PJ, Reginster JY 2001 Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 344:333340.
  • 15
    Chesnut CH, Silverman S, Andriano K, Genant H, Gimona A, Harris S, Kiel D, LeBoff M, Maricic M, Miller P, Moniz C, Peacock M, Richardson P, Watts N, Baylink D 2000 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 109:267276.
  • 16
    Siris ES, Miller PK, Barrett-Connor E, Faulkner KG, Wehren LE, Abbot TA, Berger ML, Santora AC, Sherwood LM 2001 Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women. JAMA 286:28152822.
  • 17
    Hajcsar EE, Hawker G, Bogoch ER 2000 Investigation and treatment of osteoporosis in patients with fragility fractures. Can Med Assoc J 163:819822.
  • 18
    Kamel HK, Hussain MS, Tariq S, Perry HM, Morley JE 2000 Failure to diagnose and treat osteoporosis in elderly patients hospitalized with hip fracture. Am J Med 109:326328.
  • 19
    Freedman KB, Kaplan FS, Bilker WB, Strom BL, Lowe RA 2000 Treatment of osteoporosis: Are physicians missing an opportunity? J Bone Joint Surg Am 82:10631070.
  • 20
    Castell DO 1996 “Pill esophagitis”—The case of alendronate. N Engl J Med 335:10581059.
  • 21
    Levine RJ 1988 Ethics and Regulation of Clinical Research 2nd ed. Yale University Press, New Haven, CT, USA.
  • 22
    Levine RJ 1999 Randomized clinical trials: Ethical considerations. In: EdwardsRB (eds.) Advances in Bioethics, Vol. 5. VAI Press, Stamford, CT, USA, pp. 113145.
  • 23
    Emanuel EJ, Wendler D, Grady C 2000 What makes clinical research ethical? JAMA 283:27012711.
  • 24
    National 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.
  • 25
    Rothman KJ, Michels KB 1994 The continuing unethical use of placebo controls. N Engl J Med 331:394398.
  • 26
    Freedman B 1990 Placebo-controlled trials and the logic of clinical purpose. IRB Rev Human Subjects Res 12:16.
  • 27
    Freedman B, Weijer C, Glass KC 1996 Placebo orthodoxy in clinical research. I: Empirical and methodological myths. J Law Med Ethics 24:243251.
  • 28
    Brody BA 1997 When are placebo-controlled trials no longer appropriate. Control Clin Trials 18:602612.
  • 29
    Temple R, Ellenberg SS 2000 Placebo-controlled trials and active control trials in the evaluation of new treatments: 1. Ethical and scientific issues. Ann Intern Med 133:455463.
  • 30
    Ellenberg SS, Temple R 2000 Placebo-controlled trials and active control trials in the evaluation of new treatments: 2. Practical issues and specific cases. Ann Intern Med 133:464470.
  • 31
    Emanuel EJ, Miller FG 2001 The ethics of placebo-controlled trials—a middle ground. N Engl J Med 345:915919.
  • 32
    Levine RJ 2002 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. 264280.
  • 33
    Kanis JA, Oden A, Johnell O, Caulin F, Bone H, Alexandre J-M, Abadie E, Lekkerkerker F 2002 Uncertain future of trials in osteoporosis. Osteoporos Int 13:443449.
  • 34
    Cooper C, O'Neill T, Silman A 1993 The epidemiology of vertebral fractures. European Vertebral Osteoporosis Study Group. Bone 14(Suppl 1):S89S97.
  • 35
    Nevitt MC, Thompson DE, Black DM, Rubin SR, Ensrud K, Yates AJ, Cummings SR 2000 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 160:7785.
  • 36
    Ensrud KE, Thompson DE, Cauley JA, Nevitt MC, Kado DM, Hochberg MC, Santora AC Jr, Black DM 2000 Prevalent vertebral deformities predict mortality and hospitalization in older women with low bone mass. Fracture Intervention Trial Research Group. J Am Geriatr Soc 48:241249.
  • 37
    Melton LJ, Atkinson EJ, Cooper C, O'Fallon WM, Riggs BL 1999 Vertebral fractures predict subsequent fractures. Osteoporos Int 10:214221.
  • 38
    Black DM, Arden NK, Palermo L, Pearson J, Cummings SR 1999 Prevalent vertebral deformities predict hip fractures and new vertebral deformities but not wrist fractures. Study of Osteoporotic Fractures Research Group. J Bone Miner Res 14:821828.
  • 39
    Klotzbuecher CM, Ross PD, Landsman PB, Abbott TA, Berger M 2000 Patients with prior fractures have an increased risk of future fractures: A summary of the literature and statistical synthesis. J Bone Miner Res 15:721739.
  • 40
    Lindsay R, Silverman SL, Cooper C, Hanley DA, Barton I, Broy SB, Licata A, Benhamon L, Geusens P, Flowers K, Stracke H, Seeman E 2001 Risk of new vertebral fracture in the year following a fracture. JAMA 285:320323.
  • 41
    Greendale GA, Barrett-Connor E 2001 Outcomes of osteoporotic fractures. In: MarcusM, FeldmanD, KelseyJ (eds.) Osteoporosis, 2nd ed., vol. 1. Academic Press, New York, NY, USA, pp. 819829.
  • 42
    Cuddihy M-T, Gabriel SE, Crowson CS, O'Fallon WM, Melton LJ III 1999 Forearm fractures as predictors of subsequent osteoporotic fractures. Osteoporos Int 9:469475.
  • 43
    Food 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.
  • 44
    Black DM, Cummings SR, Melton LJ 1992 Appendicular bone mineral and woman's lifetime risk of hip fracture. J Bone Miner Res 7:639646.
  • 45
    Cummings SR, Karpf DB, Harris F, Genant HK, Ensrud K, LaCroix AZ, Black DM 2002 Improvement in spine bone density and reduction in risk of vertebral fractures during treatment with antiresorptive drugs. Am J Med 112:281289.