9/9/2015 OSTEOPOROSIS WHAT S NEW AND ON THE HORIZON IN SCREENING, DRUG HOLIDAYS, SUPPLEMENTS, CONSERVATIVE THERAPY DISCLOSURES

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1 OSTEOPOROSIS WHAT S NEW AND ON THE HORIZON IN SCREENING, DRUG HOLIDAYS, SUPPLEMENTS, CONSERVATIVE THERAPY Nelson B. Watts, MD OSTEOPOROSIS AND BONE HEALTH SERVICES CINCINNATI, OHIO DISCLOSURES Stock options/holdings, royalties, company owner, patent owner, official role: OsteoDynamics co-founder, shareholder, director I have received honoraria for lectures from the following companies in the past year: Amgen, Merck I have received consulting fees from the following companies in the past year: AbbVie, Amgen, Merck, Radius Through my employer, I have research support from the following companies: Merck, NPS WHO SHOULD HAVE A BONE DENSITY TEST? Women age 65 and older and men age 70 and older Younger postmenopausal women and men age about whom you have concern based on their clinical risk factor profile Adults who have a fracture after age 50 Adults with a condition (e.g., rheumatoid arthritis) or taking a medication (e.g., glucocorticoids ) associated with low bone mass or bone loss WHOM TO TREAT NOF GUIDELINES 2008/2013 After exclusion of secondary cause, treat postmenopausal women and men age 50 and older who have Osteoporosis Clinical diagnosis: hip or spine fracture DXA diagnosis: T-score -2.5 or below in the spine or hip T-scores between -1.0 and -2.5 and increased fracture risk Use FRAX to estimate 10-year fx risk Treat if risk is 3% for hip fracture or 20% for major osteoporotic fractures National Osteoporosis Foundation Clinician s Guide to Prevention and Treatment of Osteoporosis 1

2 TRABECULAR BONE SCORE (TBS) TRABECULAR BONE SCORE (TBS) TBS is a texture analysis parameter which correlates with micro-architecture parameters Silva et al. JBMR 2014; Epub. Roux JP et al. ASBMR 2012 Hans et al. JCD 2012 Resch et al. ASBMR2012 Bilezikian JCEM 2013 TBS, BMD AND FRACTURE RISK TRABECULAR BONE SCORE (TBS) 11 cross-sectional studies; 7 prospective Consistent association between TBS and fracture risk Meta-analysis prospective cohorts (14 studies) GR major osteoporotic fracture = 1.44 ( ) Similar predictive power in men and women Independent of LS and FN BMD BMD alone: BMD Alone BMD + TBS Based on Spine < > TBS Based on minimum hip or spine BMD T score Normal Osteopenia Osteoporosis Sub category of risk of Major osteoporotic Color Code fracture per 1'000 women per year 4 ] 4-5 ] ] 5-7 ] ] 7-10 ] ] ] ] ] > Adapted from Hans et al., JBMR 2011 Adapted from Hans et al. J Bone Miner Res. 2011;26:

3 FUNDAMENTAL MEASURES FOR BONE HEALTH EFFECT OF CALCIUM INTAKE ON BONE MASS AND FRACTURE RISK High calcium district Low calcium district CALCIUM VITAMIN D EXERCISE Metacarpal Index Hip Fracture Rate per 1000/Yr Slide courtesy of Nelson Watts Matkovic V, Am J Clin Nutr 1979;32:540 3

4 ESTROGEN WITH CALCIUM INCREASES BMD MORE THAN ESTROGEN WITHOUT CALCIUM CALCIUM SUPPLEMENTATION REDUCES RISK OF SPINE FRACTURES Percent Change in BMD Lumbar Spine (P=0.01) Femoral Neck (P=0.04) Forearm (P=0.04) ERT with calcium (n=20) ERT alone (n=11) Percent of subjects with new spine fractures over 4.3 years Elderly women (avg. age 73.5 years) Placebo *P=0.023 Calcium carbonate, 1.2 g/day Previous fracture No prev. fracture Nieves J et al, Am J Clin Nutr 1998;67:18-24 Recker R et al, JBMR 1996;11:1961 ARE CALCIUM SUPPLEMENTS BAD FOR THE HEART? ARE CALCIUM SUPPLEMENTS NOT BAD FOR THE HEART? Time to MI in Ca supplement trial Metanalysis of CVD events reported in calcium supplement trials (Ca intake 1500 mg/d) RR for MI = 1.27 (p=0.038) RR for MI, stroke or sudden death= NS 5 year RCT of 1000 mg/d calcium supplement in 1460 older women with 4 years additional follow-up MI or ASCVD death RR =0.9 NS If preexisting CVD, data suggest a slight decrease in risk Bolland & Reid BMJ 2010 Bolland & Reid BMJ 2011 Lewis, Prince et al JBMR,

5 VITAMIN D REDUCES RISK OF FALLING META-ANALYSIS OF EFFECT OF VITAMIN D ON FRACTURES Meta-Analysis 26% 23% 31% decrease in fall risk RR 0.74 (CI ) RR 0.77 (CI ) NS NS Bischoff-Ferrari HA et al, JAMA 2004;291: Bischoff-Ferrari HA et al, JAMA 2005;293: VITAMIN D AND MORTALITY: META-ANALYSIS OF 9 TRIALS 8% increase in survival HIGH DOSE VITAMIN D INCREASES FALLS AND FRACTURES 2,256 community-dwelling women, age 70, at high risk of fracture Oral cholecalciferol 500,000 IU or placebo once yearly (autumn or winter) Falls and fractures ascertained by monthly calendar and confirmed by telephone interview Falls and fractures were increased for 3 mos after dosing Peak 25-OH D level was ~50 ng/ml Autier P et al. Arch Intern Med 2007;167: Sanders KE et al, JAMA 2010;303: Copyright restrictions may apply. 5

6 VITAMIN D AND RARE CANCERS Renal Cell Non-Hodgkin lymphoma Upper GI Pancreatic Endometrial Ovarian Helzlsouer KJ et al. Am J Epidemiol 2010;172:4-9 Slide courtesy of Nelson Watts Too much information? WHAT IS WRONG WITH Ca/D STUDIES? Supplements won t help If you are not deficient If you are deficient but the dose is inadequate In most published studies Baseline status was not known (serum 25-OH D, calcium intake/absorption) or was adequate Some used a dose of supplement that would not be adequate (400 IU/d of vitamin D would raise blood 25-OH D level by only ~3 ng/ml) Slide courtesy of Nelson Watts Slide courtesy of Nelson Watts 6

7 HOW 25-OH D IS MEASURED MAKES A DIFFERENCE Binkley N et al, Clin Chem Acta 2010;411: Powe CE et al. N Engl J Med 2013; 369: DIETARY CALCIUM AND FRACTURES VITAMIN D AND MORTALITY Powe CE et al. N Engl J Med 2013; 369: Warensjö E et al, BMJ 2011;342:d1473 Melamed ML et al, Arch Intern Med 2008;168:

8 CALCIUM AND VITAMIN D SUMMARY Bauer D, N Engl J Med 2013;369: Adequate calcium and vitamin D are necessary for optimal bone health For high risk patients, calcium and vitamin D are necessary, but not sufficient Calcium intake of mg/d is adequate; caution against the use of over-aggressive supplementation Vitamin D 2000 IU/d is a reasonable supplement for those concerned about bone health or fall risk For higher-risk patients, measure 25-OH D and titrate dose to maintain a blood level ng/ml Slide courtesy of Nelson Watts FDA-APPROVED MEDICATIONS INDICATIONS Postmenopausal Osteoporosis Glucocorticoid-induced Osteoporosis Men Drug Prevention Treatment Prevention Treatment Estrogen Calcitonin (Miacalcin, Fortical ) Raloxifene (Evista ) Ibandronate (Boniva ) Alendronate (Fosamax ) Risedronate (Actonel ) Risedronate (Atelvia ) Zoledronate (Reclast ) Denosumab (Prolia ) Teriparatide (Forteo ) FDA-APPROVED MEDICATIONS EVIDENCE FOR FRACTURE REDUCTION Drug Calcitonin (Miacalcin, Fortical ) Raloxifene (Evista ) Ibandronate (Boniva ) Vertebral Fracture Nonvertebral Fracture No effect demonstrated No effect demonstrated No effect demonstrated Hip Fracture No effect demonstrated No effect demonstrated No effect demonstrated Alendronate (Fosamax ) Risedronate (Actonel, Atelvia ) Zoledronic acid (Reclast ) Denosumab (Prolia ) Teriparatide (Forteo ) No effect demonstrated Evidence for effect but not an FDA-approved indication 8

9 BISPHOSPHONATES AVAILABLE IN THE US HOW LONG SHOULD TREATMENT LAST? Alendronate* (Fosamax ) Risedronate (Actonel, Atelvia ) Ibandronate (Boniva ) Zoledronate (Reclast Daily Weekly Monthly IV 5 & 10 mg 35 & 70 mg 5 mg 35 mg 150 mg 2.5 mg 150 mg 3 mg q 3 mo 5 mg/yr *Alendronate available as alendronate alone (brand or generic) or 70 mg with vitamin D 2800 or 5600 IU (brand only) Atelvia should be taken once weekly, immediately after breakfast A question unique to bisphosphonates; no other agent used to treat osteoporosis (or other chronic disease) has a cumulative effect or potential for residual benefit Bisphosphonates have a long residence time in bone Does long-term treatment create safety concerns that limit the duration of treatment? Given the long retention in bone, with release and possibly recycling of drug, does cumulative exposure lead to a reservoir in bone, so that after therapy is stopped, sufficient drug will be released to exert a continuing benefit? ESTIMATED ALENDRONATE RETENTION If treatment were to stop after 10 years of administration of [alendronate] 10 mg per day (or 70 mg per week), the estimated skeletal release of ALN into the circulation from remodeling would be approximately the same as that produced by an oral daily dose of 2.5 mg. BISPHOSPHONATES SIDE EFFECTS / SAFETY CONCERNS Short-term side effects Hypocalcemia Esophageal irritation (oral) Acute phase response (IV and high-dose oral) Acute renal damage (IV) Musculoskeletal pain* Long-term safety concerns Osteonecrosis of the jaw* Atypical femur fractures* Rodan G et al. Curr Med Res Opin 2004;20: *Reports from post-marketing surveillance 9

10 SIDE BENEFITS OF BISPHOSPHONATE THERAPY Decreased risk of breast cancer 1-5 Decreased risk of colorectal cancer 6 Decreased risk of stroke 7 Decreased risk of MI 8 Reduced risk of gastric cancer 9 Decreased overall mortality10, Chlebowski RT et al. J Clin Oncol 2010; 28: Kang JH et al. Osteoporos Int 2012; [Epub ahead of print] 2. Dreyfuss JH. CA Cancer 2010; 60: Wolfe F et al, J Bone Miner Res 2013; 28: Newcomb PA et al. Br J Cancer 2010; 102: Abrahamsen B et al. J Bone Miner Res 2012;27: Rennert G et al. J Clin Oncol 2010; 28: Center JR et al. J Clin Endocrinol Metab 2011; 96: Vestergaard P et al. Calcif Tissue Int 2011; 88: Sambrook PN et al. Osteoporos Int 2011; 22: Rennert G, et al. J Clin Oncol 2011; 29:1146. OSTEONECROSIS OF THE JAW FEMUR FRACTURES Exposed necrotic bone in the maxillo-facial region, not healing after 6-8 weeks of appropriate management, often at the site of a dental extraction or other invasive dental procedure or in patients with poorly fitting dentures Over 90% of reported cases have been in cancer patients receiving BP doses 10x higher than used to treat osteoporosis Estimated incidence in osteoporosis: 1:10,000-1:100,000 Current guidelines from the American Dental Assn. (2011) emphasize the health consequences of osteoporosis, the benefits of bisphosphonate treatment and the low risk of ONJ in osteoporosis patients receiving bisphosphonate therapy Woo S-B et al. Ann Intern Med 2006;144: Khosla S et al. J Bone Miner Res 2008;23: Hellstein JW et al. JADA 2011:142: TYPICAL FEMUR FRACTURES No warning symptoms Caused by a fall Unilateral Proximal Acute angle (femoral neck, intertrochanteric) May be comminuted *Major features Required for diagnosis ATYPICAL FEMUR FRACTURES Prodromal thigh or groin pain Little or no trauma* ~30% bilateral Subtrochanteric* Transverse/oblique, medial spike* Little or no comminution* Begin as a localized periosteal reaction of the lateral cortex* Thick cortices Delayed healing ASBMR Task Force Shane E et al, JBMR 2010;25:

11 2014 UPDATE: ASBMR TASK FORCE ON ATYPICAL FEMUR FRACTURES Location: below lesser trochanter, above supracondylar flare Major Features (four of five) Trauma: little or none Direction: lateral transverse, may be oblique on the medial side Comminution: little or none Complete fractures: may have a medial spike; incomplete fractures involve only the lateral cortex Localized periosteal reaction/thickening of the lateral cortex Minor features (none required) Generalized increase in cortical thickness of the shaft Prodromal symptoms such as dull aching pain in groin or thigh Bilateral incomplete or complete fractures and symptoms Delayed fracture healing Shane E et al, JBMR 2014;29:1-23 SUBTROCHANTERIC FEMUR FRACTURE This patient had not been on a bisphosphonate or any other treatment for osteoporosis SUBTROCHANTERIC FRACTURES OF THE FEMUR ATYPICAL FEMORAL FRACTURES 1.5 million women 55 and older with fx from any cause 12,777 (0.9%) had femur fractures Watts NB and Diab D, J Clin Endocrinol Metab 2010;95: Schilcher J et al, N Engl J Med 2011;364:

12 ATYPICAL FEMORAL FRACTURES ATYPICAL FEMORAL FRACTURES 10.6% of all femur fractures were in the shaft 10.6% of all femur fractures were in the shaft Schilcher J et al, N Engl J Med 2011;364: were atypical fractures 0.46% of all femur fractures 4.4% of all shaft fractures Schilcher J et al, N Engl J Med 2011;364: ATYPICAL FEMORAL FRACTURES ATYPICAL FEMORAL FRACTURES Only 11% were using bisphosphonates! Assume 35% risk reduction 4,000 fractures could have been prevented 10.6% of all femur fractures were in the shaft 10.6% of all femur fractures were in the shaft Atypical fractures accounted for 0.46% of all femur fractures and 4.4% of all shaft fractures. Absolute risk increase: 5 cases per 10,000 pt years Schilcher J et al, N Engl J Med 2011;364: Atypical fractures accounted for 0.46% of all femur fractures and 4.4% of all shaft fractures. Absolute risk increase: 5 cases per 10,000 pt years Schilcher J et al, N Engl J Med 2011;364:

13 LONG-TERM EXPERIENCE WITH ALENDRONATE FIT LONG-TERM EXTENSION (FLEX) STUDY Patients who received ~5 years of alendronate in the Fracture Intervention Trial agreed to a second 5-yr study Re-randomized to stay on alendronate (n=672) or changed to placebo (n=437) For those who had 10 years of alendronate compared with stopping after 5 years Overall, clinical vertebral fractures were reduced 55% In women with T-scores -2.5 or below at the start of FLEX, nonvertebral fractures were reduced by 50% Black DM et al, JAMA 2006;296: Schwartz AV et al. J Bone Miner Res 2010;25: Cumulative incidence of fractures (%) CLINICAL VERTEBRAL FRACTURES IN THE FLEX STUDY ALN 5 years Placebo 5 years Alendronate 10 years RR 55% P= % Years Since FIT ALN/PLB ALN/ALN % Black DM et al, JAMA 2006;296: Cumulative incidence of fractures (%) CLINICAL VERTEBRAL FRACTURES IN THE FLEX STUDY ALN 5 years Placebo 5 years Alendronate 10 years RR 55% P= % Years Since FIT ALN/PLB ALN/ALN % FDA POSITION Thus, the available data on long-term efficacy do not clearly identify subgroups of patients who are more likely to benefit from drug therapy beyond 3 to 5 years decisions to continue treatment must be based on individual assessment of risks and benefits and on patient preference. In this regard, patients at low risk for fracture (e.g., younger patients without a fracture history and with a bone mineral density approaching normal) may prove to be good candidates for discontinuation of bisphosphonate therapy after 3 to 5 years, whereas patients at increased risk for fracture (e.g., older patients with a history of fracture and a bone mineral density remaining in the osteoporotic range) may benefit further from continued bisphosphonate therapy. Black DM et al, JAMA 2006;296: N Engl J Med

14 FDA POSITION FDA POSITION Thus, the available data on long-term efficacy do not clearly identify subgroups of patients who are more likely to benefit from drug therapy beyond 3 to 5 years decisions to continue treatment must be based on individual assessment of risks and benefits and on patient preference. In this regard, patients at low risk for fracture (e.g., younger patients without a fracture history and with a patients bone mineral at low density risk approaching for fracture normal) (e.g., may younger prove to patients be good candidates without a for fracture discontinuation history of and bisphosphonate with a bone therapy mineral after density 3 to 5 years, whereas approaching patients normal) at increased may risk prove for fracture to be (e.g., good older candidates patients with for a history of fracture and a bone mineral density remaining in the osteoporotic discontinuation of bisphosphonate therapy after 3 to 5 years range) may benefit further from continued bisphosphonate therapy. Thus, the available data on long-term efficacy do not clearly identify subgroups of patients who are more likely to benefit from drug therapy beyond 3 to 5 years decisions to continue treatment must be based on individual assessment of risks and benefits and on patient preference. In this regard, patients at low risk for fracture (e.g., younger patients without a fracture history and with a patients bone mineral at increased density approaching risk for normal) fracture may (e.g., prove older to be good patients candidates with a history for discontinuation of fracture of and bisphosphonate a bone mineral therapy density after 3 to 5 years, whereas remaining patients in at the increased osteoporotic risk for fracture range) (e.g., may older benefit patients further with a history of fracture and a bone mineral density remaining in the osteoporotic from continued bisphosphonate therapy range) may benefit further from continued bisphosphonate therapy. N Engl J Med 2012 N Engl J Med 2012 ALGORITHM FOR MANAGEMENT OF POSTMENOPAUSAL WOMEN ON LONG TERM BISPHOSPHONATE THERAPY In FLEX, number needed to treat (NNT) for 5 years to prevent one clinical vertebral fracture Women with vertebral fx and T-score -2.0 or below 17 Women without vertebral fx and T-score -2.5 or below 24 N Engl J Med 2012 ASBMR Long Term BP Task Force, Interim Report September

15 WHEN SHOULD THE HOLIDAY END? SECONDARY FRACTURE PREVENTION: THE FRACTURE LIAISON SERVICE MODEL Arbitrary? Longer for drugs with highest skeletal affinity (zoledronic acid), shorter for drugs with lowest skeletal affinity (risedronate) Longer for lower risk patients, shorter for those at high risk Bone turnover markers? Which marker? How high? BMD? Decrease more than the least significant change (LSC) Watts NB and Diab D, J Clin Endocrinol Metab 2010;95: Hip fracture patients Non-hip fragility fracture patients Individuals at high risk of 1 st fragility fracture or other injurious falls Older people Objective 1: Improve outcomes and improve efficiency of care after hip fractures by following the 6 Blue Book standards Objective 2: Respond to the first fracture, prevent the second through Fracture Liaison Services in acute and primary care Objective 3: Early intervention to restore independence through falls care pathway linking acute and urgent care services to secondary falls prevention Objective 4: Prevent frailty, preserve bone health, reduce accidents through preserving physical activity, healthy lifestyles and reducing environmental hazards MERCY FLS PILOT PROGRAM OSTEOPOROSIS WHAT S NEW AND ON THE HORIZON IN SCREENING, DRUG HOLIDAYS, SUPPLEMENTS, CONSERVATIVE THERAPY Hip FX to ED Ortho Post Op Order Hospital Consult and Set In EPIC Admit surgery (Includes FX Liaison Referral) FX Liaison Consult scheduled at 2 wk ortho visit for suture removal Seen 4-6 weeks later by dedicated NP After eval done and Rx started, f/u care decided in conjunction with PCP Trabecular bone score (TBS) provides an added dimension to fracture risk assessment Calcium and vitamin D are essential for bone health; not everyone needs supplements Safe and effective therapies are available Osteoporosis remains under-diagnosed and under-treated: most patients are not taking advantage of what we currently have to offer Systematically capturing patients after fracture (fracture liaison service FLS) should improve secondary prevention Stay tuned for new developments 15

16 Questions or comments? WILL YOUR BONES LAST AS LONG AS YOU DO? 16

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