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Treatment of Osteoporosis

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Presentation on theme: "Treatment of Osteoporosis"— Presentation transcript:

1 Treatment of Osteoporosis
Drugs available today Mechanism of Action Estrogen replacement therapy (ERT) They simply slow down bone resorption Bisphosphonates Selective Estrogen Receptor Modulators EVISTA Raloxifene HCI … as a result, Maintain or increase bone mass Reduce fracture risk Calcitonin 9/20/2018 OSTEOPOROSIS

2 Long-term prevention of bone loss by Estrogen
Treatment with Estrogen Treatment with Estrogen 9/20/2018 OSTEOPOROSIS Lindsay et al 1976 – Lancet I:

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 9/20/2018 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 9/20/2018 OSTEOPOROSIS

5 Hormone Replacement Therapy
(HRT) … also a cure for heart disease ? … NOT as we thought 9/20/2018 OSTEOPOROSIS

6 … the warning came from the HERStudy 9/20/2018 OSTEOPOROSIS

7 showed no overall effects after 4.1 years of Rx
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 9/20/2018 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 By Rhonda Rowland 9/20/2018 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 9/20/2018 OSTEOPOROSIS

10 No proof of protection against some menopause illnesses
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. 9/20/2018 OSTEOPOROSIS

11 Estrogen Plus Progestin Study Lack of Overall Benefit
Stopped Due to Increased Breast Cancer Risk, Lack of Overall Benefit NIH, Press Release, July 9, 2002 9/20/2018 OSTEOPOROSIS

12 Women’s Health Initiative (WHI) Clinical Study Centers
Seattle, WA Minneapolis, MN Portland, OR Buffalo, NY Milwaukee, WI Detroit, MI Madison, WI Worcester, MA Boston, MA Iowa City, IA Bronx, NY Chicago, IL Pittsburgh, PA Pawtucket, RI Sacramento, CA Columbus, OH Stony Brook, NY Reno, NV Newark, NJ 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 Honolulu, HI San Antonio, TX Houston, TX Gainesville, FL Miami, FL 9/20/2018 OSTEOPOROSIS

13 WHI HRT Study Baseline Hypotheses
Benefit Risk Stroke Breast Cancer Coronary Artery Disease John T. Hardy, M.D., P.C., 2001 CME ISS Charleston Threshold Level Early STOP=Clear Harm Threshold Level Early STOP=Clear Benefit Additional Benefits: Osteoporosis Treatment Colon Cancer Overall Mortality Additional Risks: VTE Plan to Study Until 2005 9/20/2018 OSTEOPOROSIS Adapted from: Writing Group for the Women’s Health Initiative. JAMA. 2002;288:

14 Women’s Health Initiative Findings at Early Interruption
Benefit Risk 29% Increase Coronary Artery Disease 41% Increase Stroke 26% Increase Breast Cancer John T. Hardy, M.D., P.C., 2001 CME ISS Charleston Threshold Level Early STOP=Clear Harm Fracture Reduction Colon Cancer VTE 9/20/2018 OSTEOPOROSIS Adapted from: Writing Group for the Women’s Health Initiative. JAMA. 2002;288:

15 Effect of HRT on Event Rates
WHI HRT Study Effect of HRT on Event Rates Risks Benefits Neutral 60 50 40 30 20 10 --- Additional Events Estrogen +Progestin 7 8 8 18 Placebo Reduced Events Number of Cases in 10,000 Women Per Year 6 5 --- CHD Stroke Breast Cancer VTE Colorectal Cancer Hip Fracture Endometrial Cancer Deaths Adapted from: Women's Health Initiative. WHI HRT Update. Available at: 9/20/2018 OSTEOPOROSIS

16 other side of the Atlantic
… 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 9/20/2018 OSTEOPOROSIS

17 … the Americans got the statistics wrong
“… they had not conclusively demonstrated the increased risk of heart disease”. 9/20/2018 OSTEOPOROSIS

18 U.K. Hormone Trial to Pause for Review
… 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 9/20/2018 OSTEOPOROSIS

19 … more news … the bad news first 9/20/2018 OSTEOPOROSIS

20 Estrogen raises ovarian cancer risk
… 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. 9/20/2018 OSTEOPOROSIS

21 American College of Chest Physicians
HRT Linked to Increased Risk of Asthma Exacerbations American College of Chest Physicians PHILADELPHIA, November 8, 2001 Annual Meeting 9/20/2018 OSTEOPOROSIS

22 … HRT reduces the risk of
… more - this time good - news … HRT reduces the risk of 9/20/2018 OSTEOPOROSIS

23 Hormone Replacement Therapy
Which system is next? 9/20/2018 OSTEOPOROSIS

24 … what did Patti has to say?
Life without HRT … what did Patti has to say? 9/20/2018 OSTEOPOROSIS

25 … the Vanishing Promises
of HRT 9/20/2018 OSTEOPOROSIS

26 News on line Life without HRT By Jill Nelson MSNBC CONTRIBUTOR
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 9/20/2018 OSTEOPOROSIS

27 EVISTA Selective Estrogen Receptor Modulators
Small increase in Bone Mineral Density EVISTA Raloxifene HCI Risk of spinal fractures could be reduced by up to 50 %. Selective Estrogen Receptor Modulators 9/20/2018 OSTEOPOROSIS

28 … and reduced risk of Fractures?
… small increase in Bone Mineral Density … ? … and reduced risk of Fractures? 9/20/2018 OSTEOPOROSIS

29 … we now know that it is true
Y E S … we now know that it is true 9/20/2018 OSTEOPOROSIS

30 EVISTA Raloxifene HCI Raloxifene Therapy for 4 years
JAMA : Cardiovascular and Coronary events after treatment with Raloxifene EVISTA Raloxifene HCI Raloxifene Therapy for 4 years did not significantly affect the risk of Cardiovascular Events 9/20/2018 OSTEOPOROSIS

31 ? … still confused? 9/20/2018 OSTEOPOROSIS

32 ? … then, what about the H.R.T Bar ...?
Where The Problems Associated With The Menopause Are Only A Snack Away" 9/20/2018 OSTEOPOROSIS

33 The active 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 9/20/2018 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 9/20/2018 OSTEOPOROSIS

35 Bisphosphonates + Estrogens
Combination Therapy Bisphosphonates + Estrogens Currently, there is no evidence that Combination Treatments give better protection against fractures 9/20/2018 OSTEOPOROSIS

36 News on line Head-to-Head Osteoporosis Fracture Study to Compare
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. 9/20/2018 OSTEOPOROSIS


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