Objectives. Osteoporosis a major public health threat. Bone-Up on Osteoporosis Update 2011

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1 Bone-Up on Osteoporosis Update /30/11 Kristine Olson, MS, APN, FNP-BC Nurse Practitioner Mercer Bucks Hematology Oncology 1 Objectives Review risk factors and screening for osteoporosis. Describe the impact of osteoporotic fractures on patients and society. Explain prevention and nonpharmacologic treatment of osteoporosis. Describe pharmacologic treatment of osteoporosis. 2 Osteoporosis a major public health threat Estimated 52.4 million Americans at risk (all #s are estimates) 12 million w/osteoporosis 40.4 million w/low bone mass Equals 55% of those age % w/dx are women (9.1 million) 20% w/dx are men (2.8 million) All ethnic groups have significant risk 3 1

Describe pharmacologic treatment of osteoporosis. 2 Osteoporosis a major public health threat Estimated 52.

2 Osteoporosis Prevalence Race and Ethnicity 20% non-hispanic Caucasian & Asian women > age 50 have osteoporosis 52% low bone mass 10% Hispanic women > age 50 49% low bone mass 5% non-hispanic black women > age % low bone mass 4 Osteoporosis Prevalence Race and Ethnicity Men 7% non-hispanic Caucasian & Asian men > age 50 35% low bone mass 3% Hispanic men > age 50 23% low bone mass 4% non-hispanic black men > age 50 19% low bone mass National Osteoporosis Foundation 5 Osteoporotic Fracture Incidence In 2005, osteoporosis responsible for >2 million fractures ~297,000 hip fractures ~547,000 vertebral fractures ~397,000 wrist fractures ~765,000 fractures at other sites Burge R, et al. Incidence and Economic Burden of Osteoporosis-Related Fractures in the United States JBMR. 2007; 22:

$non-hispanic black men > age 50 19% low bone mass National Osteoporosis Foundation 5 Osteoporotic Fracture Incidence In 2005, osteoporosis responsible for >2 million fractures ~297,000 hip fractures$

3 Significance of Osteoporosis in Women 7 Cost of Osteoporosis Osteoporotic fractures account for ~$17 billion in direct medical costs Projected to be over $25 million by 2025 >400,000 hospital admissions ~2.5 million physician visits >180,000 nursing home admissions 8 Osteoporosis NIH Definition A skeletal disorder characterized by compromised bone strength predisposing to an increased risk of fracture. Bone strength = Bone quality including bone density, architecture and bone turnover NIH Consensus Conference,

$compromised bone strength predisposing to an increased risk of fracture.$

4 What is Osteoporosis 10 Micrograph: Normal vs. Osteoporotic Bone 11 Vertebral Compression Fractures 12 4

5 2004 Surgeon General s Report Key Points Many Americans are at significant risk for bone loss and osteoporosis. Great improvements have been made in the bone health of Americans. More can be done by applying what is known about early prevention, assessment, diagnosis and treatment. US Dept of Health and Human Services, Bone Health and Osteoporosis: A Report of the Surgeon General, Office of the Surgeon General, Surgeon General s Report Studies showed a failure to diagnose and treat osteoporosis, even in elderly patients who have suffered a fracture. A gap between what is known and its application in the community remains large and needs to be closed. 14 Risk Factors Low bone density (osteopenia) Age Hx prior fracture Parental hx of hip fx Race Small frame Low estrogen or testosterone Lifestyle factors Low calcium intake, low activity, low BMI Vitamin D insufficiency Excess caffeine, > 3EtOH/day, tobacco, NaCl 15 5

$diagnose and treat osteoporosis, even in elderly patients who have suffered a fracture. A gap between what is known and its application in the community remains large and needs to be closed.$

6 Risk Factors Secondary Osteoporosis Genetic factors Parental hx, cystic fibrosis, Marfan Endocrine disorders Hypogonadal states GI disorders. 16 Risk Factors Secondary Osteoporosis Hematologic disorders Rheumatic & autoimmune diseases Miscellaneous conditions alcoholism, COPD, ESRD, CHF, etc. 17 Medications Associated with Decreased Bone Mass in Adults Anticoagulants (heparin) Anticonvulsants Aromatase inhibitors Barbiturates Cancer drugs Cyclosporin A Glucocorticoids oral & high-dose inhaled 18 6

16 Risk Factors Secondary Osteoporosis Hematologic disorders Rheumatic & autoimmune diseases Miscellaneous conditions

7 Medications Associated with Decreased Bone Mass in Adults Gonadotropin-releasing hormone agonists Lithium Depot medroxyprogesterone acetate Probable: PPIs (proton pump inhibitors) SSRIs (selective serotonin reuptake inhibitors) TZDs (thiazolidinediones) 19 Glucocorticoid-Induced Osteoporosis Most common form of 2ndary osteoporosis Long-term use oral > 5 mg prednisone/day for 3 mo. High dose inhaled steroids > 800 mcg/24 h ACR recommends calcium mg/day, Vit D 800 IU/day, bisphosphonate if BMD T-score <-1.0 Caution w/premenopausal women 20 Risk Factors for Falls Environmental Medical Neuro & musculoskeletal 21 7

of 2ndary osteoporosis Long-term use oral > 5 mg prednisone/day for 3 mo.

8 Bone Mineral Density Testing DXA (DEXA) of hip & spine preferred method Peripheral machines check BMD at forearm, heel or finger Use x-ray or U/S Hip BMD is single best predictor of hip fx risk 22 Defining osteoporosis by BMD 23 WHO Osteoporosis Guidelines 24 8

Use x-ray or U/S Hip BMD is single best predictor of hip fx risk

9 25 26 Pharmacologic Treatment Antiresorptive Medications Bisphosphonates Calcitonin Estrogen Estrogen agonists/antagonists Bone forming (anabolic) Medications Parathyroid hormone teriparatide New: human monoclonal AB to RANKligand denosumab (Prolia) 27 9

agonists/antagonists Bone forming (anabolic) Medications

10 Bone Remodeling Preventive maintenance Osteoclasts remove old bone Osteoblasts replace new bone Imbalance of the 2 processes Peak bone mass reached at ages Compact (Cortical) Bone & Cancellous (Trabecular) Bone 29 Bisphosphonates Alendronate oral Fosamax, Fosamax Plus D Ibandronate oral Boniva Risedronate oral Actonel Actonel with Calcium Atelvia Zoledronic acid IV Reclast 30 10

Cancellous (Trabecular) Bone 29 Bisphosphonates Alendronate oral Fosamax, Fosamax Plus D

11 Alendronate Fosamax or Fosamax Plus D, generic FDA approved for prevention & tx of postmenopausal osteoporosis Men w/osteoporosis Men & women taking glucocorticoid Prevention = 5 mg daily or 35 mg weekly Treatment = 10 mg daily or 70 mg weekly 31 Ibandronate: Boniva FDA approved for tx of postmenopausal osteoporosis Oral forms also approved for prevention: 2.5 mg tab daily or 150 mg Q mo. 3 mg IV Q 3 mo. Reduces incidence of vertebral fx by 50% over 3 years 32 Risedronate: Actonel Actonel or Actonel with Calcium FDA-approved for prevention & tx of postmenopausal osteoporosis, also men & women on glucocorticoids Approved for men w/ osteoporosis Multiple dose forms: 5 mg daily tabs, 35 mg Q wk, 35 mg Q wk w/6 tabs of 500 mg CaCO3, 75 mg 2 days/mo., 150 mg Q mo. Reduces verteb fx 41-49%, non-verteb 36% over 3 yrs., in pt. w/prior v. fx New version: Atelvia, delayed release 33 11

12 Zoledronic acid: Reclast IV: 5 mg over at least 15 min. Q yr FDA-approved for tx of postmenopausal osteoporosis Approved for prevention of new fx in pt w/recent low-trauma hip fx Reduces incidence of verteb fx 70%, non-verteb fx 25% over 3 yrs Consider pre-tx w/acetaminophen 34 Side Effects of Bisphosphonates GI problems Esoph inflam Difficulty swallowing Gastric ulcer Bone/joint/muscle pain Very rare jaw osteonecrosis A fib--zometa Visual disturbances 35 Administration of Bisphosphonates PO forms poorly absorbed Empty stomach, 8 oz. H2O only Except delayed release risedronate Atelvia 35 mg once weekly after breakfast Then NPO 30+ min. except 60+ min. w/ Boniva Sit/stand 30 to 60 min. + after Check creatinine 36 12

over 3 yrs Consider pre-tx w/acetaminophen 34 Side Effects of Bisphosphonates GI problems Esoph inflam Difficulty swallowing Gastric ulcer Bone/joint/muscle pain Very rare jaw

13 Calcitonin Miacalcin or Fortical FDA-approved for tx of osteoporosis in women at least 5 yrs postmenopausal Nasal spray 200 IU daily, or SQ Effect of fx risk not stated in Rx Info Considered safe.. rhinitis, rare epistaxis 37 Estrogen/Hormone Therapy Multiple brands/formulations FDA-approved for prevention of osteoporosis, relief of vasomotor symptoms & vulvovag atrophy in menopause WHI: 5 yrs of HT (Prempro) reduced risk verteb fx 34%, other 23% WHI: increase risk MI, stroke, breast Ca, PE, DVT in 5 yrs of HT ET arm, no inc. breast Ca in 7 yrs 38 Estrogen Agonist/Antagonist Raloxifene: Evista (SERM) 60mg PO daily FDA-approved for prevention & treatment osteoporosis in postmenopausal women Reduces risk of verteb fx 30% in pt w/prior v fx, 55% in pt w/o over 3 yrs Indicated for reducing risk of invasive breast Ca in postmenop w/osteoporosis Increased risk DVT, no dec. CHD, + hot flashes 39 13

yrs of HT (Prempro) reduced risk verteb fx 34%, other 23% WHI: increase risk MI, stroke, breast Ca, PE, DVT in 5 yrs of HT ET arm, no inc.

14 Parathyroid Hormone PTH (1-34), teriparatide, Forteo FDA-approved for tx of osteoporosis in postmenopausal women at high risk for fx. Men w/primary or hypogonadal osteoporosis w/high fx risk Anabolic (bone-building) 20 micrograms SQ daily, max 2 yrs 40 Parathyroid Hormone: Forteo Increased osteosarcoma in rats Therefore, contraindicated/black box warning: Paget s disease of bone, alk phos Prior XRT of skeleton Bone mets Hypercalcemia Skeletal malignancy Follow w/ bisphosphonate 41 Denosumab (Prolia) Antiresorptive with different pathway than bisphosphonates Human monoclonal antibody Inhibits osteoclast formation & function by binding to RANK ligand SubQ injection: 60 mg/ml given Q 6 months Indicated for postmenopausal women w/high risk for fx Or intolerant of other rx 42 14

contraindicated/black box warning: Paget s disease of bone, alk phos Prior XRT of skeleton Bone mets Hypercalcemia Skeletal malignancy Follow w/ bisphosphonate 41 Denosumab (Prolia)

17 49 Calcium & Vitamin D All adults require at least 1200 mg calcium/day via food and supplements People over age 50 average 600 to 700 mg Ca++ daily! NOF advises 800 to 1000 IU Vit. D daily to = serum 24(OH)D of 30 ng/ml or higher Vit D3, cholecalciferol, preferred 50 FRAX Tool WHO Fracture Risk Assessment Tool: Plug in 12 questions: Age, sex, weight, height, previous fx, parent hip fx, current smoking, glucocorticoid use, RA, secondary osteoporosis, EtOH 3 or + units/d, femoral neck BMD, type of DXA Calculates 10 yr probability of hip fx & 10 yr probability major osteoporotic fx (vertebral, hip, forearm or humerus) Economic model Postmenopausal female, men over

18 FRAX Tool 1 of US versions 52 Summary Osteoporosis affects millions of Americans, #s will increase Costs, in $ and morbidity & mortality, are very high $17 billion in 2005 About 400K hosp admissions 24% of hip fx pts die in yr after fx Prevention and treatment can be effective! also falls prevention! Don t forget lifestyle counseling 53 Thank You! Questions? 54 18

400K hosp admissions 24% of hip fx pts die in yr after fx Prevention and treatment can be

Medications for Prevention and Treatment of Osteoporosis

1 Medications for Prevention and Treatment of Osteoporosis Osteoporosis is a disease where the strength of bones is less than normal, making them more susceptible to fracture, or breaking, than normal