2. The Management and Treatment of Osteoporosis Michele Vaca Hossack, MD

3. Objectives To reinforce the US Preventive Services Task Force Recommendations for Osteoporosis screening The management of Osteoporosis in females, males and elderly patients s/p fractures The teach the interpretation of Dexa Scans To present Evidence Based Medicine in comparing the efficacy of the treatment options for osteoporosis

4. Definitions Osteoporosis- state of severe bone loss and microarchitectural disturbance that renders bone susceptible to fracture with minimal trauma Osteopenia- Any state in which bone mass is reduced below normal

5. Osteoporosis vs. Osteopenia T -score Degree of Risk of (No of SD below bone lossFracture mean of young adults) 0 to -1 NormalNone -1 to -2.5 Osteopenia Small to Moderate Below 2.5 OsteoporosisModerate to Severe WHO

6. Why is Osteoporosis important? Of women who survive to age 80 40% will sustain one major osteoporotic fracture 13% of men over 50 will have osteoporotic fractures 1 in 3 men aged > 60 will have an osteoporotic fracture fractures decrease quality of life The annual cost of osteoporotic fractures exceeds 10 billion dollars

7. Serious Consequences of vertebral fractures Compression fractures cause chronic back pain Compression fractures are disabling fecal incontinence can lead to isolation and depression increased risk for additional vertebral fractures within 12 months (The mortality rate for multiple fractures is 20%) cause of nursing home placement

8. Serious Consequences of hip fractures Hip fractures 20% of women die within one year of fracture only 40% regain baseline level of function frequent cause of nursing home placement if an ORIF of hip is not done in 24-48 hrs a step off walking deformity is common

9. Clinical Case 66 y/o female c chronic back pain x 2yrs. Pt c back pain increasing in intensity over the past week. Pt. recalls falling down on the pavement and landing on her rear end several months ago, but no recent trauma. PMHX sig for osteoarthritis, HTN, and hypercholesterolemia PSHX none Meds HCTZ, naprosyn, ranitidine

10. What would you do? Lumbar x-ray rest ice Naprosyn Ultram (tramadol) for breakthrough pain Dexa Scan

11. Results The patient returns in 4 weeks with some improvement with pain medications, but continues to experience pain 5/10 3x’s a week lumbar xray- Dexa Scan-

12. Representative Scheme for Interpreting DEXA Scan T-scoreDegree of Risk of (No. of SD below bone lossfracture mean of young adults) 0 to -1nonenone -1 to -2moderatesmall -2 to -3severemoderate Below -3Very severeSevere

13. Osteoporosis vs. Osteopenia T -score Degree of Risk of (No of SD below bone lossFracture mean of young adults) 0 to -1 NormalNone -1 to -2.5 Osteopenia Small to Moderate Below 2.5 OsteoporosisModerate to Severe WHO

14. Who to treat? Patients c fractures of hip and spine Dexa Score >2.5 Dexa Score 1.5 to 2.5 if risk factors are present –postmenopausal women –women > 65, men > 70 –glucocorticoids –history of fracture –High fall risk –family history of osteoporosis

15. How would you manage this patient? Inquire about medication’s side effects Insure adherence with medication plan Tailor medication regimen to the patient Use non-narcotics first (Naprosyn, Tylenol) Narcotics if needed to get patient mobile Limit bed rest and inactivity Physical therapy to prevent immobility heat nasal calcitonin orthopaedic referral

16. Rule out secondary causes of osteoporosis CBC Chem 10 (calcium, phosphorus, albumin) 25-OH Vitamin D 24-hr urine calcium tsh if on thyroxine spep if cbc is abnormal PTH if serum or urine calcium abnormal

17. Treatment Calcium intake (1200-1500mg/day) Vitamin D (800 IU/day) Weight Bearing Exercise (Walking, Biking) Life-style modification (moderate alcohol, no smoking) Fall Risk Prevention avoid sedatives, narcotics, anticholinergics

18. Treatment Alendronate (FDA approved) Risedronate (FDA approved) Raloxifene (FDA approved) Nasal Calcitonin (FDA approved) Parenteral Calcitonin (FDA approved) Teriparatide (FDA approved) –anabolic effect on Bone

19. Reference Wehren et. al, Putting evidence-based medicine into clinical practice: Comparing anti-resorptive agents for the treatment of osteoporosis. Current Medical Resident Opinion. 2004 Jul;20(7): 1161-2

20. A Meta-analyses study at the University of Maryland School of Medicine which utilized published data by the Osteoporosis Research Advisory Group, and the Osteoporosis Methodology Group Alendronate was 34% more effective than calcitonin (confidence interval.48-.90) on vertebral fracture incidence Alendronate was significantly more effective than risedronate, calcitonin, estrogen, etidronate, raloxifene (Relative Risk:.70,.64,.59,.52) on the incidence of non-vertebral fractures

21. Reference Luckey et. al, Once-weekly alendronate 70 mg and raloxifene 60 mg daily in the tretment of postmenopausal osteoporosis. Menopause. 2004; Jul-Aug; 11(4):405-15.

22. Alendronate 70mg qweek vs Raloxifene 60 mg qd 12 month randomized, double-blind study 456 women with osteoporosis at 52 sites in the United States Endpoint: percent change from baseline after 1 year Alendronate significant increase in LS BMD 4.4%, p<.001) than raloxifene 1.9%, Alendronate significant increase in hip BMD, p<.001) than raloxifene

23. Bisphosphonates –proven effective to prevent hip, vertebral, and Colle’s fractures. –Side effect GI upset Raloxifene –Proven effective in patients with low BMD in the vertebrae –Not proven effective in patients with low BMD in the appendicular skeleton –patients who can not tolerate GI side effects of bisphosphonates

24. Teriparatide (1-34 Fragment of Parathyroid hormone) –administered parenteral –expensive –oriented for severe osteoporosis –prevalent vertebral fractures Stronium (not FDA approved) –anti-fracture efficacy at all sites –good tolerance –may play a role in the future

25. Women’s Health Initiative Estrogen-progestin does not reduce the risk of coronary heart disease increases the risk of breast cancer increases the risk of stroke increases the risk of venous thromboembolic events decreases vertebral compression and hip fractures

26. Surveillance Screening In this patient, when would you repeat a Dexa Scan? Repeat scan after 1 year of treatment

27. Clinical Case 120 lb, 130/80 60 y/o f c migraine headaches that occur once a month presents to the office. PMHX: HTN PSHX: none After addressing her chief complaint, Do you screen this patient for osteoporosis? If this patient was 65 would you screen for osteoporosis?

28. www.guidelines.gov

29. U.S.Preventive Services Task Force Recommendations Women aged 65 and older be screened routinely for osteoporosis Women aged 60 and older c increased risk for osteoporotic fractures Rating of Recommendation B No recommendation for or against routine screening for women who are younger than 60 or in women aged 60-64 who are not at increased risk for osteoporotic fractures. Rating of Recommendation C

30. ORAI-Osteoporosis Risk Assessment Instrument Lower body weight (weight < 70 kg) no use of estrogen therapy age –women greater than 65 greater than 60 c risk factors –men greater than 70

31. Identifying High Risk Patients Ask about fractures (low trauma >40) Ask about family history Measure Height check weight check smoking, alcohol check for glucorcorticoid use early menopause s/p oopherectomy at an early age Disease and medications that increase risk caffeine low calcium and vitamin D intake decreased physical activity

32. Clinical Case 135 lbs, 130/80 65 y/o male s c/o. PMHX: HTN, Hypercholesterolemia, DM,Prostate Cancer PSHX: TURP Meds: atenolol, lipitor, glucophage, lupron For Health Care Maintenance, Would you screen this patient for osteoporosis?

33. US Preventive Task Force Recommendation for Men Men greater than or equal 70 y/o should have DEXA screening Men greater than or equal 65 y/o c risk factor should have DEXA screening

34. Osteoporosis in Men one in three men aged > 60 will have an osteoporotic fracture Spinal fractures occur in 5% of men >50 hip fractures occur in 6% of men >50 life expectancy for men 76.8 years Diamond, T. Pharmacotherapy of osteoporosis in men. Expert Opinion Pharmacotherapy. 2005 Jan; 6(1):45-58.

35. Diseases that cause Bone loss Glucocorticoids Hypogonadism (GNRH agonist Rx for prostate cancer) alcoholism Hyperparathyroidism COPD Gastrectomy Glucocorticoids Anticonvulsants Organ Transplantation

36. Definition of Osteoporosis in Men Who criteria based on bone density in wormen only ISCD recommends the use of a male database as a reference population for the prevalence of osteoporosis is then similar to the prevalence of fractures in men NHANES data

37. What would be your work up to rule out secondary causes Cbc chemistry 10 Phosphorus 24-hour urine calcium 25 hydroxyvitamin D Testosterone TFTs (if on thyroxine) PTH (if 24-hour unrine calcium is abnormal)

38. Treatment Calcium intake (1200-1500mg/day) Vitamin D (800 IU/day) Exercise Life-style modification (moderate alcohol, no smoking) Alendronate (FDA approved) Risedronate (FDA approved) Raloxifene (FDA approved) Teriparatide (FDA Approved)