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Osteoporosis Part 3 of 3: Treatment

Osteoporosis Part 3 of 3: Treatment. Ellen Davis-Hall, PhD, PA-C Professor Clare J. Kennedy, MPAS, PA-C Assistant Professor, PA Program SAHP , COM UNMC Omaha, NE. office: 402-559-4738 email: clarekennedy@unmc.edu. PROCESS. Series of modules and questions

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Osteoporosis Part 3 of 3: Treatment

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  1. OsteoporosisPart 3 of 3: Treatment Ellen Davis-Hall, PhD, PA-C Professor Clare J. Kennedy, MPAS, PA-C Assistant Professor, PA Program SAHP , COM UNMC Omaha, NE. office: 402-559-4738 email: clarekennedy@unmc.edu

  2. PROCESS Series of modules and questions Step #1: Power point module with voice overlay Step #2: Case-based question and answer Step # 3: Proceed to additional modules or take a break

  3. Objectives • Part 1: Identify risk factors for osteoporosis with an emphasis on modifiable risk factors • Part 2: Describe the most current methods of, and standards for, diagnosis and monitoring of treatment • Part 3: Describe the available treatment modalities for osteoporosis and their effectiveness

  4. Drug Therapy Options for Osteoporosis • Antiresorptive agents • Anabolic agents

  5. Antiresorptive Agents • Bisphosphonates • Estrogen • Selective estrogen receptor modulators (SERMs) • Calcitonin

  6. Bisphosphonates-Non-hormone Compounds • Alendronate (Fosamax) • Risendronate (Actonel) • Ibandronate (Boniva)

  7. Alendronate (Fosamax) Research • Spinal BMD increases of 6-8%, and hip increases of 3-6% over three years. (Black, et al 1996) • 50% reduction in fracture risk for spine, hip and wrist (Cranney et al 2002a) • Benefits seen as early as 1 year for spinal fractures and 18 months for hip fractures (Black et all 2000) • 95% of women who take alendronate maintain or increase bone mass (Black et al, 2000) • Benefits seem to continue even 2 years after med is stopped (Tonino et al, 2000) • Also approved for treatment of male osteoporosis and prevention of steroid induced osteoporosis

  8. Risedronate (Actonel) Research • Increases BMD and reduce fracture risk significantly • Increases spine BMD by approximately 5% and hip BMD by 2-3% (Harris et al, 1999) • 41% reduction in spine fractures; 39% reduction in non-spine fractures; and 30% reduction in hip fractures (Harris et a, 1999; McClung et al, 2001) • Reductions in spine fractures can be seen after one year of therapy(Harris et al, 1999) • Approved for treatment of osteoporosis, osteopenic post-menopausal women, and prevention and treatment of steroid induced osteoporosis

  9. Ibandronate (Boniva) Research • Chesnut (2004) • Daily oral dose of 2.5 mg compared with “intermittent administration” • “Intermittent administration” consisted of 20 mg every other day for 12 doses given every three months • No difference was noted from placebo in regard to GI side effects • Vertebral fracture risk was reduced by 62% with daily dosing • Vertebral fracture risk was reduced by 50% with intermittent dosing • May hold promise as an effective and convenient alternative to current bisphosphonate therapies

  10. Clinical Advice for Bisphosphonate Use • Morning dosing, empty stomach, full glass of water • No food or other liquids other than water for 30 minutes • Should not lie down during this period • Proceed cautiously when prescribing to patients with: • known history of esophageal narrowing or ulcers of the esophagus • long term problems with stomach ulcer • heartburn that requires medication

  11. Hormone Therapy • In 1942 conjugated equine estrogen (CEE) was approved for the relief of menopausal symptoms • In 1972 use extended to postmenopausal osteoporosis • Early 1970s observation that estrogen was associated with an increased risk of endometrial cancer • PEPI (Postmenopausal Estrogen/Progestin Interventions, 1996) and HOPE (Women’s Health, Osteoporosis, Progestin, Estrogen, 2002) studies demonstrated that postmenopausal hormone therapy had a favorable effect on BMD at all sites • spine (3.5 to 7%) • hip (2 to 4%) • forearm (3 to 4.5%) • Increases apparent after 1 year use • No differences in estrogen formulations

  12. Estrogen and Fracture Risk • Research mostly observational studies • Meta-analyses suggest • Estrogen reduces the risk of non-spine fractures by 27% • Estrogen reduces the risk of spinal fractures by 33% (Torgerson and Bell-Syer, 2001)

  13. Women’s Health Initiative (WHI) • 1990s: Trials designed to answer questions about hormones • Two separate trials: • women with an intact uterus • women post-hysterectomy • Treatment: • Intact uterus group treated with CEE and medroxyprogesterone (MPA) • Post-hysterectomy group treated with CEE alone • Hip and spine fractures were reduced by one-third in both groups • Other results: • increased risk of stroke, cognitive impairment, and deep vein thrombosis in the women taking HT • No clear cardiovascular benefit was found • Breast cancer risk was increased (Cauley, et al, 2003)

  14. Decision Factors in Hormone Use • Weigh known benefits against known risks • Hormone therapy still appropriate for women with osteoporosis who cannot tolerate other medications • Perimenopausal women currently advised to take lowest dose possible for as short a time as necessary to achieve treatment goals • Even low doses of hormones are effective at preserving bone density • No long term benefit exists once discontinued • Goal of hormone therapy: Capture positive effects without incurring deleterious effects

  15. Selective Estrogen Receptor Modulators (SERMs) • Called “designer estrogens” • Interact with estrogen receptors located throughout the body. • Provide benefits of estrogen without some of the negative effects (Ettinger et al, 1999)

  16. Raloxifen (Evista) Research • Spine BMD increased 2-3% and hip BMD by 2.5% after three years.(Ettinger et al, 1999) • Spine fractures reduced by 50%, but no effect was noted on hip or other non-spine fractures (Ettinger et al, 1999, Cranney et al 2002) • Spine fracture reduction achieved at one year (Maricic et al, 2002) • No long term fracture benefit once discontinued • Other potential benefits • decrease in total cholesterol and LDL • possible decreased incidence of breast Cancer

  17. Raloxifen Use • Approved for prevention and treatment of postmenopausal osteoporosis at a dose of 60 mg/day • Side effects: • a possible return or exacerbation of hot flashes • blood clots in the legs, and/or lungs. • Drug should be discontinued if the patient is immobilized for long periods of time

  18. Calcitonin (Miacalcin) • Inhibits bone resorption by directly inhibiting osteoclasts • In 1970s and 1980s calcitonin was administered by subcutaneous injection • Calcitonin now available as a nasal spray • Prevent Recurrence of Osteoporotic Fractures (PROOF) trial found a decline of spinal fracture of 33% • No significant differences for non-spine fractures • Calcitonin has a unique pain-relief benefit for acute spinal fractures • Dose: 200 IU/day ( 1 spray, alternate nostrils) • Side effects: nasal stuffiness, nausea, dry mouth (Chesnut et al, 2000)

  19. Antiresorptive Summary • Bisphosphonates (caution in those with esophageal problems) • Hormones (weigh benefits against risks) • SERM (may increase hot flashes) • Calcitonin (decreases spinal fractures, and provides some pain relief of these fractures)

  20. Recent Concerns with Bisphosphonates • Severe bone, joint and/or muscle pain have been reported.(Wysowski and Chang, 2005) • Osteonecrosis of the jaw recently reported (Ruggiero, et al 2004; Carter and Goss, 2003; Starck and Epker, 1995) • Ocular inflammation has been reported (Fraunfelder and Fraunfelder, 2003) • Long term bone strength has been called into question (Odvina et al, 2005). • It has been suggested that bisphosphonate therapy be discontinued after 5 years (Medical Letter, 2005)

  21. Anabolic Agents • Parathyroid hormone • Fluoride • Growth hormone • Statins • Insulin-like growth factor (IGF-1)

  22. Anabolic Agents:Parathyroid Hormone (PTH) • Teriparatide (Forteo) Eli Lilly and Company recombinant human PTH (1-34) • Stimulates new bone formation • Increases bone mass • Increases trabecular connectivity • Increases mechanical strength • 20 micrograms given once daily subcutaneously for up to 2 years-with sustained effect thereafter • Increases vertebral, femoral, and total-body mineral density and is well tolerated (Neer, et al, 2001)

  23. Anabolic Agents-Fluoride • One of the first treatments for osteoporosis • Increases spine bone density but does not necessarily reduce fracture risk • Builds bone, but bone is more “brittle” • May even cause increased appendicular fractures • Research is conflicting and controversial • May prove useful in combination with a bisphosphonate, but further research is needed

  24. Summary of Part 3: Treatment • Antiresorptive therapies are our primary treatment for osteoporosis, most notably the bisphosphonates • Recent data is calling into question the quality of the bone resultant from bisphosphonate therapy • Consideration might be given to discontinue this drug after 5 years of therapy • Research is ongoing for newer pharmacological agents

  25. The End of Module Three on Osteoporosis References • Black et al, Randomized trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996, Dec 7;348(9041):1535-41 • Black et al, Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial Research Group. J Clin Endocrinol Metab 2000 Nov;85(11):4118-24 • Brett, A. Is long term bisphsphonate therapy safe? Medical Letter, 2005 May 1;25(9) • Carter et al, Bisphosphonates and avascular necrosis of the jaws. Aust Dent J 2003;48:268 • Cauley et al, Women’s Health Initiative Investigators. Effects of estrogen plus progestin on risk of fracture and bone mineral density: The Women’s Health Initiative Randomized Trial. JAMA 2003 Oct 1:290(13):1729-38 • Chesnut et al, A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: The Preventive Recurrence of Osteoporotic Fractures study. PROOF Study Group. Am J Med 2000, Sep;109(4):267-76

  26. References • Chesnut et al, Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J of Bone and Min Res 2004, March; 19(8):1241-49 • Cranney et al, Osteoporosis methodology group and the osteoporosis research advisory group. Meta-analyses of therapies for postmenopausal osteoporosis. II Meta-analysis of alendronate for the treatment of postmenopausal women. Endocr Rev 2002, Aug;23(4):508-16 • Ettinger et al, Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: Results from a 3-year randomized clinical trial. Multiple outcomes of raloxifene evaluation (MORE) investigators. JAMA 1999 Aug 18;282(7):637-45 • Fraunfelder & Fraunfelder, Bisphosphonates and ocular inflammation. N Engl J Med 2003; 348:1187 • Harris et al, 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 1999 Oct 13;282(14):1344-52

  27. References • Lindsay et al. Effect of lower doses of conjugated equine estrogens with and without medroxyprogesterone acetate on bone in early postmenopausal women. JAMA 2002 May 22-29;287(20);2668-76 • Maricic et al, Early effects of raloxifene on clinical vertebral fractures at 12 months in postmenopausal women with osteoporosis. Arch Intern Med 2002 May 27;162(10):1140-3 • McClung et al, Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 2001 Feb 1;344(5):333-40 • Neer, et al, Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal woman with osteoporosis. NEJM 2001, 344:1434-41 • Odvina et al, Severely suppressed bone turnover: A potential complication of alendronate therapy. J Clin Endocrinol Metab 2004 Dec 14 • Ruggiero, et al Osteonecrosis of the jaws associated with the use of bisphosphonates: a review of 63 cases. J Oral Maxillofac Surg 2004;62:527

  28. References • Starck & Epker, Failure of osseointegrated dental implants after diphosphonate therapy for osteoporosis: A case report. Int J Oral Maxillofac Implants1995;10:74 • Tonino et al Skeletal benefits of alendronate: 7 year treatment of postmenopausal osteoporotic women. Phase III osteoporosis Treatment Study Group. J Clin Endocrinol Metab 2000 Sep;85(9):3109-15 • Torgerson et al, Hormone replacement therapy and prevention of nonvertebral fractures: A meta-analysis of randomized trials. JAMA 2001 Jun 13;285(22):2891-7 • Torgerson et al, Hormone replacement therapy and prevention of vertebral fractures: A meta-analysis of randomized trials. BMC Musculoskelet Disord 2001;2(1):7-10 • Writing Group for the PEPI. Effects of hormone therapy on bone mineral density: Results from the Postmenopausal estrogen/Progestin Interventions (PEPI) Trial. JAMA 1996 Nov 6;276(17):1389-96 • Wysowski & Chang, Alendronate and risedronate: Reports of severe bone, joint and muscle pain. Arch Intern Med 2005; 165:527

  29. Post-test A 67 year old woman presents to your office with a DEXA score of -2.9. She has been told by her family doctor that she "should take a medication for her bones." She is currently being treated for mild hypertension with HCTZ and has a history of GERD under treatment with omeprazole. Family history is positive for breast cancer in her mother. The best drug treatment for this patient's osteoporosis is: • Alendronate • CEE/MPA • Raloxifene • Calcitonin

  30. Correct Answer:  Raloxifene

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