Osteoporosis Evaluation and Treatment

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1 Osteoporosis Evaluation and Treatment Anne Schafer, MD Assistant Professor of Medicine Division of Endocrinology & Metabolism October 28, 2011 No conflicts of interest

2 Objectives Explain when to initiate screening Describe nonpharmacologic strategies for better bone health Identify candidates for pharmacologic therapy Answer patients questions about potential risks of osteoporosis medications Osteoporosis Has Tremendous Medical and Economic Impact Mortality after hip fracture ~25% at 1 yr Of survivors, only 50% recover prefracture functional status 1.5 million fractures per year in US Direct cost $18 billion (Lu-Yao, Am J Pub Health, 1994; Magaziner, J Gerontol, 1990; Burge, JBMR, 2007)

3 Osteoporosis Definition A chronic, progressive disease characterized by low bone mass, microarchitectural deterioration of bone, bone fragility and a consequent increase in fracture risk Decreased bone quality as well as quantity (National Osteoporosis Foundation, 2008) Osteopenia Definition Preferred term is low bone mass Bone mineral density (BMD) lower than that considered normal but not low enough to be classified as osteoporosis May be useful for epidemiologic studies, but not a disease

4 Risk Factors for Osteoporosis Non Modifiable Increasing age Female gender White or Asian race Family history Previous osteoporotic fracture Modifiable Low BMI Current smoking Alcohol ( 3/day) Immobilization Glucocorticoids Sex hormone deficiency Amenorrhea Menopause Risk Factors for Falls Cognitive impairment Frailty Impaired vision Residential facility History of falls

5 Screening for Osteoporosis National Osteoporosis Foundation: Women age 65 and men age 70 Younger postmenopausal women, and men age 50-69, with additional risk factors Adults with a condition or taking a medication associated with bone loss Adults who fracture after age 50 (National Osteoporosis Foundation, 2008) Screening for Osteoporosis US Preventive Services Task Force: Women age 65 Younger women whose risk is equal to that of a 65 y.o. white woman who has no additional risk factors 9.3% ten-year risk for any osteoporotic fracture, by the US FRAX algorithm Current evidence insufficient to assess benefits vs. harms in men (United States Preventive Services Task Force, 2011)

6 DXA Scanning Dual-energy X-ray absorptiometry (DXA) assesses areal (2-dimensional) BMD at key regions of interest Lumbar spine, total hip, femoral neck Same machine, by same operator, for optimal longitudinal assessment Reports BMD (g/cm 2 ), T-scores, Z-scores T-scores: compared to sex-matched reference population of young adults Z-scores: age- and sex-matched WHO Definitions Normal = BMD within one SD of a young normal adult (T-score +1.0 to -1.0) Low bone mass ( osteopenia ) = BMD between 1 and 2.5 SDs below young normal adult (T-score -1.0 to -2.5) Osteoporosis = BMD 2.5 or more SDs below young normal adult (T-score -2.5) For use in postmenopausal women and men age 50 (WHO, 1994)

7 What about premenopausal women and men <50? Diagnose with care! ISCD: Use race-adjusted Z-scores, with low BMD for chronological age defined as Z-score -2.0 Diagnosis of osteoporosis not made on densitometric criteria alone Example of diagnostic challenge: Adolescent girl who has not attained peak bone mass (Simonelli et al., J Clin Densitom, 2008) Other Limitation of WHO Definition Does not recognize that a presumptive diagnosis of osteoporosis can be made by a low-trauma (fragility) fracture regardless of the patient s BMD

8 Approach to Osteoporosis Treatment 1) Evaluation for secondary causes of osteoporosis and/or fracture 2) Institution of nonpharmacologic strategies 3) Selection of pharmacologic therapy Secondary Causes of Osteoporosis and/or Fracture Vitamin D deficiency Rheumatoid arthritis Calcium deficiency Medications Malabsorption (e.g., celiac Glucocorticoids disease, gastric bypass Aromatase inhibitors surgery) Depo-Provera Hypogonadism Thyroid hormone Thyrotoxicosis excess Thiazolidinediones Primary hyperparathyroidism Phenytoin Anorexia nervosa Androgen deprivation Multiple myeloma therapy

9 How extensive a laboratory workup does a patient need? Depends on degree of suspicion Pre-menopausal women, men deserve more Severe (e.g., multiple fractures, very low Z-scores) Basic: Serum Ca, alb, Cr, 25(OH)D, TSH, CBC, LFTs Next level: 24-hour urinary Ca, PTH, SPEP/UPEP, testosterone in men As clinically indicated: Celiac disease antibodies, 24-hour urinary free cortisol or dexamethasone suppression test Nonpharmacologic Strategies Calcium Vitamin D Weight-bearing & resistance exercise Smoking cessation Alcohol moderation Fall prevention measures Home safety evaluation Medication review Hip protectors

10 New IOM Dietary Reference Intakes AGE CALCIUM (mg) (RDA) CALCIUM (mg) (UL) VITAMIN D (IU) (RDA) VITAMIN D (IU) (UL) (men) 1200 (women) > , pregnant/ lactating (Institute of Medicine, 2010) Vitamin D: The Controversy IOM: 25-hydroxyvitamin D level of 20 ng/ml adequate for bone health Based on rigorous RCT evidence Population-based recommendation Others insist 30 ng/ml optimizes Ca absorption, suppresses PTH, protects against fractures/falls More than IU daily may be needed to achieve 20 (or 30) ng/ml Malabsorption, obesity (Institute of Medicine, 2010; Endocrine Society, 2011)

11 Do calcium supplements cause heart attacks? 2008, 2010: Secondary analysis of calcium supplementation RCT, and subsequent metaanalysis, both suggested increase in CV events with calcium supplementation Limitations CV outcomes not primary outcomes Event frequency low Non-uniform adjudication of outcomes Other studies show no increased risk Calcium + vitamin D does reduce fracture risk in older adults (Bolland, BMJ, 2008; Bolland, BMJ, 2010; Chapuy, NEJM, 1992; Boonen, JCEM, 2007) Pharmacologic Therapy NOF recommends osteoporosis medication for postmenopausal women and men 50 with An osteoporotic hip or vertebral fracture T-score at the femoral neck or spine -2.5 after secondary causes excluded Low bone mass (T-score < -1.0 but > -2.5) and FRAX 10-year risk of - major osteoporotic fracture 20%, or - hip fracture 3% (Tosteson, Osteoporos Int, 2008)

12 FRAX Estimates 10-year absolute fracture risk Especially for those in low bone mass ( osteopenia ) range Example: 80 y.o. w/ prior fracture and taking prednisone, 52 y.o. with no risk factors, both with femoral neck T-score -2.0 Applies to postmenopausal women and men 50 y.o., who are treatment naïve (Kanis, Osteoporos Int, 2008) FRAX (

13 Pharmacologic Therapy Antiresorptive agents Bisphosphonates (oral or IV) Raloxifene Hormone therapy Calcitonin Denosumab Anabolic agents Parathyroid hormone (PTH) Oral Bisphosphonates Alendronate, risedronate, ibandronate Alendronate and risedronate: Decreased risk of spine, nonvertebral, hip fractures Ibandronate: Decreased risk spine fracture Side effect: esophagitis Full glass of water, do not lie down Inefficiently absorbed Take on empty stomach (Black, 1996; Cummings, 1998; Harris, 1999; McClung, 2001; Chesnut, 2004)

14 IV Bisphosphonates Zoledronic acid Once yearly infusion Decreased risk spine, nonvertebral, hip fxs Given within 90 days after hip fracture: Decreased risk of new spine and nonvertebral fxs, and decreased mortality Side effect: transient flu-like symptoms Potential complication: osteonecrosis of the jaw Risk 1-10/100 with IV therapy at cancer doses; ~1/100,000 with oral therapy for osteoporosis (Black, N Engl J Med, 2007; Lyles, N Engl J Med, 2007; Khosla, JBMR, 2007) Raloxifene, Estrogen, Calcitonin Raloxifene Decreased risk spine fractures (not NVF) Decreased risk breast cancer Increased risk venous thromboembolism Estrogen or estrogen/progestin therapy Decreased risk spine, nonvertebral, hip fxs Other concerns Calcitonin Decreased risk spine fracture (not NVF) Analgesic benefit in pts with vertebral fxs? (Ettinger, JAMA, 1999; Rossouw, JAMA, 2002; Anderson, JAMA, 2004; Chesnut, Am J Med, 2000)

15 Denosumab Monoclonal antibody to RANK-ligand Decreased risk of spine, nonvertebral, hip fractures SubQ injection q 6 months Expensive Can be used in renal failure But be careful that you are treating osteoporosis, not CKD-MBD (Cummings, N Engl J Med, 2009) Teriparatide (PTH Therapy) Sole anabolic agent available Increases bone formation Decreased risk of spine and nonvertebral fractures Daily subq injection Approved for 2 years of use Consider in severe disease, especially spine > hip Follow course with a bisphosphonate (Neer, N Engl J Med, 2001; Black, N Engl J Med, 2005)

16 You start Ms. O, a 70 y.o. woman with osteoporosis, on alendronate. How long will I take this medication? Duration of Bisphosphonate Therapy FLEX trial: After 5 years of alendronate (ALN), randomized to continued ALN vs. placebo ALN group had continued reduction in clinical (but not radiographic) vertebral fx Those in ALN group with femoral neck T- scores -2.5 had continued nonvertebral fx risk reduction (Black, JAMA, 2006; Schwartz, J Bone Miner Res, 2010)

17 Duration of Bisphosphonate Therapy HORIZON-PFT extension trial: After 3 years of zoledronic acid (ZOL), randomized to continued ZOL vs. placebo Those with 3 years on, 3 years off had a small but significant decline in BMD Those with 6 years ZOL had fewer radiographic vertebral fractures (but no difference in other fracture types) (Black, ASBMR abstract, 2010) Duration of Bisphosphonate Therapy No formal guidelines One reasonable approach: Discuss with pt after ~5 yrs Repeat DXA If FN (or other?) T-score at that point is -2.5, or if very high risk of fracture (e.g., hx of hip or vertebral fracture), continuing therapy may be beneficial.

18 My friend told me this medication actually causes fractures of the femur. Atypical Femur Fractures Recent reports, some in setting of long-term bisphosphonate therapy Xray findings: Subtrochanteric Transverse Thick cortices Atraumatic Fx before fall +/- prodromal pain (Neviaser, J Orthop Trauma, 2008)

19 Atypical Femur Fractures Is the connection to bisphosphonate therapy real? Should it change practice? Danish registry study: Similar associations between ALN use and atypical femur fracture, typical hip fracture Post-hoc analysis of RCT data: 12 fractures in 10 (of 14,195) women 2.3 per 10,000 person-years Wide confidence intervals, not stat sig (Abrahamsen, J Bone Miner Res, 2009; Black, N Engl J Med, 2010) Atypical Femur Fractures If relationship is real, risk is very low: Treating 1000 women for 3 years would prevent 100 fxs, including 10 hip fxs, and could cause 1 atypical femur fx ASBMR Task Force: Causal association not established But, risk may with duration of med use Thoughtful decision-making about duration of therapy (Black, N Engl J Med, 2010; Shane, J Bone Miner Res, 2010)

20 How will we know whether the medication is working? Monitoring response to therapy The challenge: Not all patients BMD will increase on therapy. Treatment failure? Women adherent to ALN but with no change or a 4% decrease in BMD still had fracture reduction compared to those taking placebo. Bisphosphonates also appear to improve bone quality, geometry. (Chapurlat, Osteoporos Int, 2005)

21 Monitoring response to therapy One reasonable approach: Educate patient that while BMD helps decide whether to treat, it s less useful for assessing treatment response. If repeating DXA, look for meaningful loss in BMD, and be prepared to explain this to patient. Meaningful loss reassess adherence, secondary causes Objectives Explain when to initiate screening Describe nonpharmacologic strategies for better bone health Identify candidates for pharmacologic therapy Answer patients questions about potential risks of osteoporosis medications

22 Thank you! Thank you for your attention!

23 Osteoporosis Evaluation and Treatment References Anne Schafer, MD 1. Abrahamsen B, Eiken P, Eastell R. Subtrochanteric and diaphyseal femur fractures in patients treated with alendronate: A register-based national cohort study. J Bone Miner Res 2009;24: Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: The Women s Health Initiative randomized controlled trial. JAMA 2004;291: Black DM, Bilezikian JP, Ensrud KE, et al. One year of alendronate after one year of parathyroid hormone (1-84) for osteoporosis. N Engl J Med 2005;353: Black DM, Cummings SR, Karpf DB, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures: Fracture Intervention Trial Research Group. Lancet 1996;348: Black DM, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007;356: Black DM, Kelly MP, Genant HK, et al. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. N Engl J Med 2010;362: Black DM, Schwartz AV, Ensrud KE, et al. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX). JAMA 2006;296: Bolland MJ, Avenell A, Baron JA, et al. Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis. BMJ 2010;341:c Bolland MJ, Barber PA, Doughty RN, et al. Vascular events in healthy older women receiving calcium supplementation: randomized controlled trial. BMJ 2008;336: Boonen S, Lips P, Bouillon R, Bischoff-Ferrari HA, Vanderschueren D, Haentjens P. Need for additional calcium to reduce the risk of hip fracture with vitamin D supplementation: Evidence from a comparative metaanalysis of randomized controlled trials. J Clin Endocrinol Metab 2007;92: Burge R, Dawson-Hughes B, Solom DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporotis-related fractures in the United States, J Bone Miner Res 2007;22: Chapurlat RD, Palermo L, Ramsay P, Cummings SR. Risk of fracture among women who lose bone density during treatment with alendronate: The Fracture Intervention Trial. Osteoporos Int 2005;16: Chapuy MC, Arlot ME, Duboeuf F, et al. Vitamin D3 and calcium to prevent hip fractures in the elderly women. N Engl J Med 1992;327: Chesnut CH 3 rd, Silverman S, Andriano K, et al. A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: The prevent recurrence of osteoporotic fractures study. Am J Med 2000;109: Chesnut CH 3 rd, Skag A, Christiansen C, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 2004;19: 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: 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:

24 18. Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: Results from a 3-year randomized clinical trial. JAMA 1999;282: Harris ST, Watts NB, Genant HK, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: A randomized controlled trial. JAMA 1999;282: Holick MF, Binkley NC, Bischoff-Ferrari HA, et al. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2011;96: Institute of Medicine. Dietary reference intakes for calcium and vitamin D. Institute of Medicine, Kanis JA, Johnell O, Oden A, Johansson H, McCloskey E. FRAX and the assessment of fracture probability in men and women from the UK. Osteoporos Int 2008;19: Khosla S, Burr D, Cauley J, et al. Bisphosphonate-associated osteonecrosis of the jaw: Report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2007: Lu-Yao GL, Baron JA, Barrett JA, Fisher ES. Treatment and survival among elderly Americans with hip fractures: a population-based study. Am J Public Health 1994;84: Lyles KW, Colon-Emeric CS, Magaziner JS, et al. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med 2007;357: Magaziner J, Simonsick EM, Kashner TM, Hebel JR, Kenzora JE. Predictors of functional recovery one year following hospital discharge for hip fracture: a prospective study. J Gerontol 1990;45:M McClung MR, Geusens P, Miller PD, et al. Effect of risedronate on the risk of hip fracture in elderly women: Hip Intervention Program Study Group. N Engl J Med 2001;344: National Osteoporosis Foundation. Clinician s guide to prevention and treatment of osteoporosis. Washington, DC: National Osteoporosis Foundation, Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 2001;344: Neviaser AS, Lane JM, Lenart BA, Edobor-Osula F, Lorich DG. Low-energy femoral shaft fractures associated with alendronate use. J Orthop Trauma 2008;22: 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: Schwartz AV, Bauer DC, Cummings SR, et al. Efficacy of continued alendronate for fractures in women with and without prevalent vertebral fracture: the FLEX trial. J Bone Miner Res 2010;25: Shane E, Burr D, Ebeling PR, et al. Atypical subtrochanteric and diaphyseal femoral fractures: Report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2010;25: Simonelli C, Adler RA, Blake GM, et al. Dual-energy X-ray absorptiometry technical issues: the 2007 ISCD official positions. J Clin Densitom 2008;11: Tosteson AN, Melton LJ 3 rd, Dawson-Hughes B, et al. Cost-effective osteoporosis treatment thresholds: the United States perspective. Osteoporos Int 2008;19: United States Preventive Services Task Force. Screening for osteoporosis: United States preventive services task force recommendation statement. Ann Int Med 2011;154: World Health Organization. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. World Health Organization technical report series 1994;843:1-129.

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