July 2012 CME (35 minutes) 7/12/2016

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1 Financial Disclosures Epidemiology and Consequences of Fractures Advisory Board: Amgen Janssen Pharmaceuticals Inc. Ann V. Schwartz, PhD Department of Epidemiology and Biostatistics UCSF Outline Osteoporotic fractures: Incidence compared with other diseases Fracture incidence Demographic determinants of fracture incidence Age Gender Race Geography Consequences of fracture Temporal trends and the future Annual incidence x hip annual incidence all ages forearm other sites vertebral 0 Osteoporotic Fractures annual estimate women annual estimate women new cases, all ages Heart Attack Stroke Breast Cancer American Heart Association,1996 American Cancer Society,1996 Riggs BL & Melton LJ 3rd, Bone, 1995;17(5 suppl):505s-511s 24July12 1

2 Common sites of fracture Spine Hip Lifetime risks of clinical fractures 50 year old white women (U.S.) Lifetime risk* Hip fracture 17% Wrist fracture 16% Vertebral fracture 16% Any fracture > 50% Breast cancer 15% Wrist *Refs: Melton; Black; Kanis Major determinants of fracture incidence Demographic: Age Gender Race Geography Previous fracture: discuss under Consequences of Fracture More on risk factors for fracture and fracture prediction: Talk by Dr. Harris later today. Age and gender are important determinants 5 year fracture risk 20% 15% 10% 5% Men Hip Vertebrae Women Hip Wrist Wrist > 85 >85 Age Group, yr Cooper C et al. J Bone Miner Res 1992 Vertebrae 24July12 2

3 Age is Independent of BMD as Risk Factor for Hip Fracture Lifetime risks of fracture: Impact of gender Age (yrs) fold increase in fracture probability from age 50 to 80 at same BMD Lifetime Risk at Age 50* Fracture Men (%) Women (%) Hip 6 17 Wrist 3 16 Clinical Vert Fx 5 16 Kanis et al, Hip BMD T-score (SD) Any 16% > 50% * Among Caucasians Osteoporosis in Men 1 in 5 to 6 men over age 50 will suffer osteoporotic fracture Hip fracture incidence by race (California) 30% of hip fractures worldwide are in men Mortality rates after fracture higher in men than women Treatment rates following fracture are abysmal Sullivan et al July12 3

4 Hip fracture rates vary dramatically by region and country Vertebral fractures have more similar prevalence worldwide Cauley et al. (2014) Nat. Rev. Endocrinol. Hip fractures are associated with increased morbidity and mortality Consequences of fracture No longer able to live independently Death within one year 20% Permanent disability 30% Unable to walk independently 40% 50% Cooper C. Am J Med Direct costs: > $10 billion / yr Lifetime attributable cost of hip fracture > $80,000 per person Brathwaite et al JAGS July12 4

5 Mortality elevated after hip fracture Women Limited Activity Days Post Fracture: Postmenopausal Women in FIT Consequences of fracture Men Haentjens et al JAMA 2010 Fink et al. Osteo Intl 2003 Impact of Vertebral Fractures 20% excess mortality in 5 yrs after fracture Deformity & height loss Acute & chronic pain Pulmonary dysfunction Diminished quality of life: loss of self-esteem, sleep disorder, depression, loss of independence High medical costs for hip and for other fractures Hip $25,519 Excess direct costs for Medicare patients with nonvertebral fractures Costs for year after fracture ( ) Expressed in 2006 dollars Pike et al PharmacoEconomics July12 5

6 Consequence of fracture: Increased risk of another fracture History of any fracture: fold greater risk of fracture True for any fracture type even traumatic fractures especially strong for men Mostly independent of BMD vanstaa, Osteop Int 2002;13:624-9 Meta-analysis: Klotzbuecher, JBMR 2000;15:721; Kanis Osteop Int 2004 Vertebral fractures dramatically increase risk of future fracture 4x risk of more vert fxs 2x risk of other fractures (vanstaa, Osteop Int 2002) Women with clinical diagnosis of vertebral fracture have 5-15% 5 yr hip fracture risk! Not in FRAX Existing Vertebral Fracture Predictive of Future Vertebral Fracture Independent of BMD Previous Vert Frx No Vert Frx Ross Low BMD Mid BMD High BMD Risk of New Vertebral Fractures (% / yr) Absolute fracture risk (%) Effect of prevalent radiographic vertebral fracture on non-vertebral fracture risk No vert fx >1 vert fx Femoral neck T-score Siris et al, Osteo Int July12 6

7 Trends in Use of Osteoporosis Therapy NYT (6/2/16): Osteoporosis drugs shunned for fear of rare side effects Osteoporosis medication use to 2004 Oral Bisphosphonate Use in the U.S. Declines after 2008 Brauer et al JAMA 2009 % of 55+ y.o. with 1 prescription in annual federal survey Jha et al JBMR July12 7

8 U.S. Google search activity for Fosamax Treatment with osteoporosis medication during year after fracture Vertebral Hip A = Lawsuit filed against Merck for Fosamax causing osteonecrosis of the jaw. B = Study published associating Fosamax with atrial fibrillation. C = Jury deliberations start for first Fosamax trial. D = ABC World News runs feature segment on Fosamax and atypical femoral fractures. Jha et al JBMR 2015 Balasubramanian et al. J Bone Joint Surg Am 2014 Osteoporosis Medication Use After Hip Fracture Prospects for the Future Hip fracture incidence declining in U.S. U.S. Patients Solomon et al JBMR 2014 Jha et al JBMR July12 8

9 Including California Low femoral neck BMD among older US adults: NHANES III ( ) and NHANES Hip fracture incidence in CA Sullivan et al 2016 Femoral neck BMD T-score < -2.5 Looker et al JBMR 2010 Hip Fracture Rates Declining in West, Increasing in East Prospects for the Future... Elderly represent fastest growing segment of population Thus, in spite of declining rates in US, total number of fractures expected to increase Age-standardized Ballane et al JBMR July12 9

10 World Population: 1990 and 2025 Age range (years) Men Women Number (000,000) Worldwide Distribution of Hip Fractures in Women: 1990 to 2050 Hip Fractures, x Women Women N. Am, Europe Mid East, Asia, Latin Am, Africa Summary Fractures are common Age is a strong determinant of fracture risk, especially for hip and spine Fractures are associated with significant morbidity, excess mortality and costs. Osteoporosis therapy use after hip fracture is <20% in women and <10% in men Age-adjusted fracture incidence is stable or even declining in the US, but total number of fractures will increase due to aging of population Thank you 24July12 10

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