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Treatment of Osteoporosis

EVISTA. Raloxifene HCI. Bisphosphonates. Treatment of Osteoporosis. Drugs available today. Mechanism of Action. Estrogen replacement therapy (ERT). They simply slow down bone resorption. S elective E strogen R eceptor M odulators. … as a result, Maintain or increase bone mass

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Treatment of Osteoporosis

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  1. EVISTA Raloxifene HCI Bisphosphonates Treatment of Osteoporosis Drugs available today Mechanism of Action Estrogen replacement therapy (ERT) They simply slow down bone resorption Selective Estrogen Receptor Modulators … as a result, Maintain or increase bone mass Reduce fracture risk Calcitonin OSTEOPOROSIS

  2. Long-term prevention of bone loss by Estrogen • Treatment with Estrogen • Treatment with Estrogen OSTEOPOROSIS • Lindsay et al 1976 – Lancet I:1038-1040

  3. Estrogen Replacement Therapy in Osteoporosis • PROS • Decreases rate of bone loss after menopause • Maintains/increases BMD • Relieves postmenopausal symptoms • May prevent Alzheimer’s disease OSTEOPOROSIS

  4. Estrogen Replacement Therapy in Osteoporosis • CONS • Troublesome side effects, e.g., irregular bleeding, fluid retention, mastalgia, headache, mood swings (some from concomitant progestin) • Fracture risk data largely based on observational evidence • Possible increased risk of breast cancer with long-term use • Must be taken with progestin to avoid risk of endometrial • hyperplasia/cancer OSTEOPOROSIS

  5. Hormone Replacement Therapy (HRT) … also a cure for heart disease ? … NOT as we thought OSTEOPOROSIS

  6. … the warning came from the HERStudy OSTEOPOROSIS

  7. Estrogen’s effect on heart questioned A randomized Trial of E2 + Progestin on the 20 Prevention of C H D in Postmenopausal Women showed no overall effects after 4.1 years of Rx The Heart and Estrogen/progestin Replacement Study (HERS) JAMA Vol. 280 No. 7,August 19, 1998 OSTEOPOROSIS

  8. New guidelines for hormone replacement therapy (HRT) The American Heart Association is advising physicians to steer clear of prescribing HRT for the sole purpose of preventing heart attack and stroke in women who already have cardiovascular disease. New data contribute to hormone therapy confusion July 23, 2001 CNN Medical Unit ASSOCIATED PRESS ByRhonda Rowland OSTEOPOROSIS

  9. Estrogen & Strokes Oct. 24, 2001 — Estrogen pills fail to ward off new strokes in older women who have already suffered them, a study finds. The latest study, conducted by Catherine M. Viscoli and others from Yale University, was published in Thursday’s New England Journal of Medicine. MSNBC NEWS SERVICES OSTEOPOROSIS

  10. Hormone therapy benefits questioned No proof of protection against some menopause illnesses April 18, 2002 — A new report from an international panel of experts, sponsored by the National Institutes of Health, raises serious questions about many of the supposed benefits of hormone replacement therapy. OSTEOPOROSIS

  11. Estrogen Plus Progestin Study Stopped Due to Increased Breast Cancer Risk, Lack of Overall Benefit NIH, Press Release, July 9, 2002 OSTEOPOROSIS

  12. Women’s Health Initiative (WHI)Clinical Study Centers Seattle, WA Minneapolis, MN Portland, OR Buffalo, NY Milwaukee, WI Detroit, MI Worcester, MA Madison, WI Boston, MA Bronx, NY Iowa City, IA Pittsburgh, PA Pawtucket, RI Chicago, IL Sacramento, CA Stony Brook, NY Columbus, OH Newark, NJ Reno, NV Cincinnati, OH Oakland, CA Washington, DC Stanford, CA Winston-Salem, NC Memphis, TN Los Angeles, CA Chapel Hill, NC Torrance, CA Orange, CA Atlanta, GA San Diego, CA Tucson, AZ Birmingham, AL San Antonio, TX Honolulu, HI Gainesville, FL Houston, TX Miami, FL OSTEOPOROSIS

  13. WHI HRT StudyBaseline Hypotheses Benefit Risk Stroke Coronary Artery Disease Breast Cancer Threshold LevelEarly STOP=Clear Harm Threshold LevelEarly STOP=Clear Benefit • Additional Benefits: • Osteoporosis Treatment • Colon Cancer • Overall Mortality • Additional Risks: • VTE Plan to Study Until 2005 OSTEOPOROSIS Adapted from: Writing Group for the Women’s Health Initiative. JAMA. 2002;288:321-333.

  14. Women’s Health InitiativeFindings at Early Interruption Benefit Risk 29% Increase Coronary Artery Disease 41% Increase Stroke 26% Increase Breast Cancer Threshold Level Early STOP=Clear Harm Fracture Reduction Colon Cancer VTE OSTEOPOROSIS Adapted from: Writing Group for the Women’s Health Initiative. JAMA. 2002;288:321-333.

  15. Effect of HRT on Event Rates WHI HRT Study Risks Benefits Neutral 60 50 40 30 20 10 0 --- Additional Events Estrogen+Progestin 7 8 8 18 Placebo Reduced Events Number of Casesin 10,000 Women Per Year 6 5 --- CHD Stroke BreastCancer VTE ColorectalCancer HipFracture EndometrialCancer Deaths Adapted from: Women's Health Initiative. WHI HRT Update. Available at: http://www.nhlbi.nih.gov/whi/hrtupd/upd2002.htm. 2002. OSTEOPOROSIS

  16. … reactions from the other side of the Atlantic The WISDOM trial is a major research project, which will eventually involve over 16,000 post-menopausal women, aged 50-69, in the UK and a further 6,000 from Australia and New Zealand. To date, 5,000 women have been recruited in the UK.The study is funded by the Medical Research Council, the Department of Health, the British Heart Foundation and other funders. … WISDOM Study to proceed OSTEOPOROSIS

  17. … the Americans got the statistics wrong “… they had not conclusively demonstrated the increased risk of heart disease”. OSTEOPOROSIS

  18. … but U.K. Hormone Trial to Pause for Review For at least 3 months, no new patients will be enrolled … … an international panel to recommend whether to continue the trial in the face of evidence that prompted termination of a similar U.S. study Science 2 AUGUST 2002 OSTEOPOROSIS

  19. … more news … the bad news first OSTEOPOROSIS

  20. … more news Estrogen raises ovarian cancer risk July 16, 2002 — In another piece of the increasingly complex hormone-replacement health puzzle, women given estrogen-only therapy after menopause ran a significantly higher risk of ovarian cancer, researchers reported Tuesday. OSTEOPOROSIS

  21. HRT Linked to Increased Risk of Asthma Exacerbations American College of Chest Physicians PHILADELPHIA, November 8, 2001 Annual Meeting OSTEOPOROSIS

  22. … more- this time good -news … HRT reduces the risk of OSTEOPOROSIS

  23. Hormone Replacement Therapy Which system is next? OSTEOPOROSIS

  24. Life without HRT … what did Patti has to say? OSTEOPOROSIS

  25. … the Vanishing Promises of HRT OSTEOPOROSIS

  26. By Jill NelsonMSNBC CONTRIBUTOR Life without HRT Yesterday I threw out my hormones. I’d only been on them a year. Unlike chocolate or sale catalogues, I didn’t even have to run water over them to insure that I wouldn’t, in a moment of desperation, rescue them from the garbage bin and promise to quit tomorrow. I’m too concerned with my health for that. July 12, 2002— News on line OSTEOPOROSIS

  27. EVISTA Raloxifene HCI Small increase in Bone Mineral Density Risk of spinal fractures could be reduced by up to 50 %. Selective Estrogen Receptor Modulators OSTEOPOROSIS

  28. … small increase in Bone Mineral Density … ? … and reduced risk of Fractures? OSTEOPOROSIS

  29. Y E S … we now know that it is true OSTEOPOROSIS

  30. EVISTA Raloxifene HCI JAMA 2002 288:321-333 Cardiovascular and Coronary events after treatment with Raloxifene Raloxifene Therapy for 4 years did not significantly affect the risk of Cardiovascular Events OSTEOPOROSIS

  31. ? … still confused? OSTEOPOROSIS

  32. ? … then, what about the H.R.T Bar ...? Where The Problems Associated With The Menopause Are Only A Snack Away" OSTEOPOROSIS

  33. Theactive ingredients in the HRT Bar are high in plant Oestrogens (phytoestrogen) • The various seed and fruit • in the bars can help in Controlling: • Hot flushes • Mental agility • Delaying possible onset of Alzheimer's • Protecting breast tissue • Acting as antioxidants • Controlling cholesterol levels • Reducing loss of bone density … according to the OSTEOPOROSIS

  34. … Increasingly, new research is questioning the purported health benefits of soy in adults, as well as raising concerns about adverse effects in children. • JR Barrett • Soy and Children's Health: A Formula for Trouble?--NIEHS Puts A New Face on Public Service. • Environ Health Perspect 1 Jun 2002;110: A294-6 OSTEOPOROSIS

  35. Combination Therapy Bisphosphonates + Estrogens Currently, there is no evidence that Combination Treatments give better protection against fractures OSTEOPOROSIS

  36. News on line Wednesday, July 25, 2001 Head-to-Head Osteoporosis Fracture Study to Compare Evista® & Fosamax® The EVista Alendronate Comparison (EVA) trial is the first large-scale, head-to-head study comparing a SERM and a bisphosphonate. It's also the first head-to-head fracture trial comparing approved osteoporosis therapies. OSTEOPOROSIS

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