Delineando a pesquisa clínica 4a Ed

(AlbertoBarroso) #1
postmenopausal women with osteoporosis treated with raloxifene: results from a 3-
year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation
(MORE) investigators. JAMA 1999;282:637–645.


  1. The Women’s Health Initiative Study Group. Design of the women’s health
    initiative clinical trial and observational study. Control Clin Trials 1998;19:61–109.

  2. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria.
    Stat Med 1989;8:431–440.

  3. Cummings SR, Karpf DB, Harris F, et al. Improvement in spine bone density and
    reduction in risk of vertebral fractures during treatment with antiresorptive drugs.
    Am J Med 2002;112:281–289.

  4. Hulley S, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for
    secondary prevention of coronary heart disease in postmenopausal women. JAMA
    1998;280:605–613.

  5. Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of
    fractures in postmenopausal women with osteoporosis. N Engl J Med
    2009;361(8):756–765.

  6. Mosca L, Barrett-Connor E, Wenger NK, et al. Design and methods of the
    Raloxifene Use for The Heart (RUTH) Study. Am J Cardiol 2001;88:392–395.

  7. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus
    progestin in healthy postmenopausal women: principal results from the women’s
    health initiative randomized controlled trial. JAMA 2002;288:321–333.

  8. McClung M, Boonen S, Torring O, et al. Effect of denosumab treatment on the risk
    of fractures in subgroups of women with postmenopausal osteoporosis. J Bone
    Miner Res 2011;27:211–218.

  9. Cummings SR, Black DM, Thompson DE, et al. Effect of alendronate on risk of
    fracture in women with low bone density but without vertebral fractures: results
    from the fracture intervention trial. JAMA 1998;280:2077–2082.

  10. Fries R, Shariat K, von Wilmowsky H, et al. Sildenafil in the treatment of
    Raynaud’s phenomenon resistant to vasodilatory therapy. Circulation
    2005;112:2980–2985.

  11. Freiman JA, Chalmers TC, Smith H Jr, et al. The importance of beta, the type II
    error and sample size in the design and interpretation of the randomized control trial.
    Survey of 71 “negative” trials. N Engl J Med 1978;299:690–694.

  12. Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials?
    Stat Med 1984;3:409–420.

  13. Friedman LM, Furberg C, DeMets DL. Fundamentals of clinical trials, 4th ed.
    New York: Springer, 2010.

  14. Avins AL. Can unequal be more fair? Ethics, subject allocation, and randomised
    clinical trials. J Med Ethics 1998;24:401–408.

  15. Prentice RL, Caan B, Chlebowski RT, et al. Low-fat dietary pattern and risk of
    invasive breast cancer: the women’s health initiative randomized controlled dietary

Free download pdf