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osteoporotic Fragility fractures treatment

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osteoporosis, fragility fracture

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osteoporotic Fragility fractures treatment

  1. 1. 1 HOPE SELLING
  2. 2. 2 EVALUATION AND MEDICAL MANAGEMENT OF FRAGILITY FRACTURES Thomas jeffersonian hospital and Rothman institute article in orthopedic clinical of North America April 2014 Presented By: Harjot Singh Gurudatta Moderator: DR. RAJAN SHARMA
  3. 3. 3 Definition of fragility fracture: (WHO) Fracture during activity that would not normally injure young healthy bone (i.e., fall from standing height or less) • Fragility fractures are a large and growing health issue – 1 in 2 women and 1 in 4 men over 50 yrs of age will suffer a fracture in their remaining lifetime • A prior fracture increases the risk of a new fracture 2- to 5-fold • Yet few fracture patients receive evaluation and treatment of osteoporosis, the underlying cause of most fragility fractures – Calls for action to improve the evaluation and treatment of fracture patients have been published around the World
  4. 4. 4 Fragility fractures are common • 1 in 2 women and 1 in 5 men over age 50 will suffer a fracture in their remaining life time • 55% of persons over age 50 are at increased risk of fracture due to low bone mass • At age 50, a woman’s lifetime risk of fracture exceeds combined risk of breast, ovarian & uterine cancer • At age 50, a man’s lifetime risk of fracture exceeds risk of prostate cancer
  5. 5. 5 Osteoporotic fractures: Comparison with other diseases 1996 new cases, annual estimate women 30+ 184 300 all ages annual incidence all ages 250 000 hip 250 000 forearm 250 000 other sites 750 000 vertebral 2000 1500 1000 500 0 Osteoporotic fractures annual estimate women 29+ Heart attack Stroke Breast cancer Annual incidence x 1000 1 500 000 513 000 228 000 American Heart Association, 1996 American Cancer Society, 1996 Riggs & Melton, Bone, 1995; 17(5 suppl):505S-511S
  6. 6. 6 Consequences of hip fracture Permanent disability Death within one year Cooper. Am J Med 1997; 103(2A):12s-19s. Unable to carry out at least one independent activity of daily living Unable to walk independently 40% 30% 20% 80% One year after hip fracture
  7. 7. 7 Consequences of vertebral fractures • Acute and chronic pain – Narcotic use, decrease mobility • Loss of height & deformity – Reduced pulmonary function – Kyphosis, protuberant abdomen • Diminished quality of life: – Loss of self-esteem, distorted body image, sleep disorders, depression, loss of independence • Increased fracture risk • Increased mortality
  8. 8. 8 Consequences of distal radius fractures • The most common fracture in women at middle age – Incidence increases just after menopause • The most common fracture in men below 70 years • Only 50% report good functional outcome at 6 months • Up to 30% of individuals suffer long-term complications O'Neill et al. Osteoporos Int. 2001; 12:555-558
  9. 9. 9 Fragility fractures are common and have severe consequences Fragility fractures lead to major morbidity, decreased quality of life and increased mortality – 10-25% excess mortality – 50% unable to walk independently after hip fracture – 50% show substantial decline from prior level of function (many lose ability to live independently) – Increased depression, chronic pain, disability – Increased risk of subsequent fracture
  10. 10. 10 Definition of osteoporosis “…a systemic skeletal disease characterized by low bone mass and micro-architectural deterioration of bone tissue, leading to enhanced bone fragility and a consequent increase in fracture risk.” World Health Organization (WHO), 1994
  11. 11. 11 Major risk factors for fractures • Prior fragility fracture • Increased age • Low bone mineral density • Low body weight • Family history of osteoporotic fracture • Glucocorticoid use • Smoking
  12. 12. 12 Assessing bone density • X-ray observation – “Osteopaenic on x-ray” implies significant bone loss already – decreased opacity, thin cortices, wide canals, current fracture, healing fractures – A “late finding” in the course of the disease, but may be the “first finding” for a patient
  13. 13. 13 Assessment of bone mineral density by DXA Current gold standard for diagnosis of osteoporosis BMD (g/cm2) = Bone mineral content (g) / area (cm2) Diagnosis based on comparing patient’s BMD to that of young, healthy individuals of same sex
  14. 14. 14 WHO criteria for diagnosis of osteoporosis T-score: Difference expressed as standard deviation compared to young (20’s) reference population Kanis et al. J Bone Miner Res 1994; 9:1137-41 T-score Normal - 1.0 and above Osteopaenia - 1.0 to - 2.5 Osteoporosis - 2.5 and below Severe (established) osteoporosis - 2.5 and below, plus one or more osteoporotic fracture(s)
  15. 15. 15 Bone strength is more than BMD BMD is surrogate criteria for OP as BP for Stroke young elderly Images from L. Mosekilde, Technology and Health Care. 1998 Image courtesy of David Dempster
  16. 16. 16 Determinants of whole bone strength • Geometry – Gross morphology (size & shape) – Microarchitecture • Properties of bone material / bone matrix – Mineralization – Collagen characteristics – Microdamage Applied load Bone strength > 1  fracture Factor of risk
  17. 17. 17 Bone remodelling balance influences bone strength Bone strength SIZE & SHAPE macroarchitecture microarchitecture MATERIAL tissue composition matrix properties BONE REMODELLING formation / resorption AGEING, DISEASE and THERAPIES
  18. 18. 18 High Bone Turnover Resorption > Formation Decreased Bone Strength Decreases Bone Mass Disrupts Trabecular Architecture Increases Cortical Porosity Decreases Cortical Thickness STOCHASTIC REMODELLING Alters Bone Matrix Composition L. Mosekilde Tech and Health Care, 1998
  19. 19. 19 But bone quality is not the only factor… Bone size (mass) Bone shape Architecture Matrix properties Fall incidence Fall characteristics Energy absorption External protection Fall impact Bone strength Fracture risk Neuromuscular function Environmental risks Age
  20. 20. 20 Optimal care of the fragility fracture patient • Diagnosis of “fragility” fracture – Identify “fragility” fracture & underlying disease, incorporate into existing workup – Influences treatment plan from the onset • General fracture management – Stabilize patient, pain relief, fracture care • Rehabilitation – Minimize dependence, maximize mobility • Secondary prevention – Treat and monitor underlying disease, prevent future fractures
  21. 21. 21 Optimal care of the fragility fracture patient • Diagnosis of “fragility” fracture – Identify “fragility” fracture & underlying disease, incorporate into existing workup – Influences treatment plan from the onset
  22. 22. 22 High risk for secondary osteoporosis • Severe chronic liver or kidney diseases • Steroid medication (>7.5mg for more than 6 months) • Malabsorption (eg. Crohn´s disease) • Rheumatoid arthritis • Systemic inflammatory disorders • Hyperthyroidism • Primary hyperparathyroidism • Antiepileptic medication
  23. 23. 23 Fragility fracture patient assessment * In addition to routine pre-op or fracture evaluation • Family history of OP • Menarche / Menopause • Nutrition • Medications – (past and present) • Level of activity • Fracture history • Fall history & risk factors for falls • Smoking, alcohol intake • Risk factors for secondary OP • Prior level of function History should include:
  24. 24. 24 Fragility fracture patient assessment In addition to routine pre-op or fracture evaluation • Height • Weight • Limb exam – ROM, strength, deformity, pain, neurovascular status • Spine exam – pain, deformity, mobility • Functional status Physical exam should include:
  25. 25. 25 Laboratory tests* • SR / CRP • Blood count • Calcium • Phosphate • Alkaline Phosphatase (AP) • GGT • Renal function studies • Basal TSH • Intact PTH • Protein-immunoelectrophoresis • Vit D (25 and 1.25) NOTES: - * These are in addition to routine pre-op labs such as coagulation studies - These are screening labs, more may be indicated based on these results
  26. 26. 26 Bone mineral density and spine radiograph for vertebral fracture assessment • Bone mineral density assessment by DXA – Establish severity of osteoporosis – Baseline for monitoring treatment efficacy • Consider spine radiographs (thoracic and lumbar, AP and ML views) for patients with: – Back pain – Loss of height > 4 cm – Progressive kyphosis
  27. 27. 27 DEXA– Flaws? • DEXA overestimate the bone mineral density of taller subjects and underestimate the bone mineral density of smaller subjects. • In DEXA, bone mineral content is divided by the area of the site being scanned. • DEXA calculates BMD using area (aBMD: areal Bone Mineral Density), it is not an accurate measurement of true bone mineral density, which is mass divided by a volume.
  28. 28. 28 DEXA– Flaws? • The confounding effect of differences in bone size is due to the missing depth value in the calculation of bone mineral density. • The radiation dose is approximately 1/10th that of a standard chest X-ray • BMD testing with DXA is very susceptible to operator error.
  29. 29. 29 DEXA– Flaws? • A repeat BMD measurements should be done on the same machine each time, or at least a machine from the same manufacturer. • Error between machines, or trying to convert measurements from one manufacturer's standard to another can introduce errors large enough to wipe out the sensitivity of the measurements. • DEXA results need to be adjusted if the patient is taking strontium, and calcium supplements. • Metallic artifacts in cloths or pockets cause errors. • Osteomalacia, Osteoarthritis of spine, old Fractures of spine and hip, aortic calcification affect BMD readings.
  30. 30. 30 Who should be screened? • Problem of over-interpretation of results, & healthy average people think they are at a much higher risk. • In 2000 an NIH consensus conference concluded: "Until there is good evidence to support the cost-effectiveness of routine screening, or the efficacy of early initiation of preventive drugs, an individualized approach is recommended.
  31. 31. 31 Who to screen • Women > 65 years. • Men > 70 years. • Postmenopausal women /men >50 years with clinical risk factors. • H/o fracture at age > 50 years. • Chronic steroid use. • Risk factor for secondary OP
  32. 32. 32 Bone density at various sites for prediction of hip fractures Cummings SR, Black DM, Nevitt MC, Browner W, Cauley J, Ensrud K, et al. The Study of Osteoporotic Fractures Research Group. Lancet 1993; 34: 72-75. • BMD poor predictor of fractures. • When different scanners are used on the same patients, the proportion of patients diagnosed with osteoporosis varies from 6% up to 15%. • Over 80% of low trauma fractures occur in people who do not have osteoporosis (T score – 2.5).
  33. 33. 33 NOF recommendations • National Osteoporosis Foundation US and the American Association of Clinical Endocrinologists recommend routine monitoring of bone mineral density within two years of starting treatment. NHS no recommendation • The UK National Osteoporosis Guidelines Group, US National Institutes of Health, and the Osteoporosis Society of Canada do not make a recommendation either way on monitoring.
  34. 34. 34 FRAX Do you know what is your T – Score? Take one minute test! Do you know what are your chances of getting fractures in next 10 years? Go online FRAX site! For Treatment consult your physician or your “Osteoporosis Society”
  35. 35. 35
  36. 36. 36 Dr. Judith Brenner New York University power of the FRAX tool • Add daily consumption of two or more alcoholic drinks, and the risk becomes 9 percent. • Instead of 60, say the woman is 80 years old, slender and with no family or personal history of fractures, smoking or steroid use. Dr. Brenner calculated her risk of fracturing a hip in 10 years as 10 percent and of having any major osteoporotic fracture at 35 percent.
  37. 37. 37 Rehabilitation in the fragility fracture patient Goal is to improve strength, balance, position sense, reactions to: – Improve level of function / independence – Decrease risk of falls – Decrease risk of fractures Balance (position sense, reaction) Mechanical vibration plate Limb and core strength Mobility in activities of daily living Safety in gait and transfers Sensory and visual limitations Home safety evaluation and adaptation
  38. 38. 38 Interventions to reduce future fracture risk • Basics – Nutrition, exercise, fall prevention strategies – Modify risk factors as able (smoking, excess alcohol) – Treat co-morbidities (i.e., endocrine disorder?) • Pharmacological agents
  39. 39. 39 Interventions: General recommendations • Regular physical activity – Maintaining safe ambulatory status, indep ADLs – Daily limb and core home exercise routine • Sufficient intake of calcium and vitamin D – daily 1000-1500 mg calcium, 400-800 IU vitamin D – by foods or foods and supplements combined • Adequate nutrition • Avoid cigarettes, excess alcohol
  40. 40. 40 Who to treat ? Postmenopausal women /men > 50 yrs with Prior h/o hip/vertebral # or T Score < -2.5 or T Score -1 to -2.5 & 10 yr risk (FRAX) : HIP # > 3 % or major osteoporotic # > 20 %
  41. 41. 41 Pharmacological agents for treatment of osteoporosis Effective therapies are widely available and can reduce vertebral, hip and other fractures by 30% to 65%, even in patients who have already suffered a fracture
  42. 42. 42 Pharmacological agents shown to reduce fracture risk Bisphosphonates • Alendronate (FOSAMAX®) • Risedronate (ACTONEL®) • Ibandronate (BONVIVA®) • Zolendronate (ACLASTA®) SERMs • Raloxifene (EVISTA®) Stimulators of bone formation • rh-PTH (FORTEO®) Mixed mode of action • Strontium ranelate (PROTELOS®) Hormone therapy • Estrogen / progestin
  43. 43. 43 Bone marrow precursors Osteoblasts Osteoclast Lining cells Stimulators of Bone Formation Fluoride PTH analogs Sr Ranelate (?) Inhibitors of Bone Resorption Estrogen, SERMs Bisphosphonates Calcitonin Inhibitors of RANKL Cathepsin K Therapeutic strategies
  44. 44. 44 Mainstay of treatment : Bisphosphonates Approval in US for osteoporosis • Alendronate week : 1995 • Risedronate : 2000 • Ibandronate mnth: 2005 • Zoledronate yearly.iv : 2007.
  45. 45. 45 Treatments & Efficacy Vertebral Fx Non-vertebral Fx Other Fx Hip Fx Oral HRT Yes Yes Yes Etidronate* Yes Alendronate* Yes Yes Yes Risedronate* Yes Yes Yes Ibandronate* Yes [Yes] Raloxifene* Yes Calcitriol* Yes Strontium Ranelate* Yes Yes [Yes]
  46. 46. 46 Vertebral Fx Non-vertebral Fx Other Fx Hip Fx Subcutaneous Teriparatide* Yes Yes 1-84 PTH* Yes Denosumab* Yes Yes Yes Intravenous Pamidronate Ibandronate* Zoledronate* Yes Yes Yes Intranasal or Subcutaneous Calcitonin* Yes
  47. 47. 47 Appropriate use of appropriate treatments can halve the incidence of fractures Vertebral Fx Nonvertebral Fx Other Fx Hip Fx Alendronate* Yes Yes Yes Risedronate* Yes Yes Yes Zoledronic acid* Yes Yes Yes PTH* Yes Yes ??? Strontium ranelate* Yes Yes ??? Denosumab* Yes Yes Yes plus calcium + vitaminD
  48. 48. 48 Taking Bisphosphonates
  49. 49. 49 Contraindications
  50. 50. 50 Hot topics
  51. 51. 51 Vitamin D levels • 25-OHD Vit D status Manifestation Management • <25 nmol/l Deficient Rickets/ Osteomalacia High-dose calciferol • 25-50 nmol/l Disease risk Vit D supps • 50-75 nmol/l Adequate Healthy Lifestyle advice • >75 nmol/l Optimal Healthy None – Divide by 2.5 for ug/L
  52. 52. 52 Patients who did not need treatment in the first place Discontinue Treatment Lower risk patients, if DXA is stable/increasing Consider a drug holiday after 3-5 years of treatment Higher risk patients (fractures, corticosteroid Rx, very low BMD) Consider a drug holiday after 10 years of therapy May use teriparatide or raloxifene (but not another potent antiresorptive agent – ie. denosumab) during the holiday from bisphosphonates
  53. 53. 53 Treatment of vitamin D deficiency Deficiency (25-OHD <25 nmol/l) 10 000 IU calciferol daily or 60 000 IU calciferol weekly for 8-12 weeks* or Calciferol 300 000 or 600 000 IU orally or by intramuscular injection once or twice
  54. 54. 54 Treatment of vitamin D insufficiency Insufficiency (25-OHD 25-50 nmol/l) or maintenance therapy following deficiency 1000-2000 IU calciferol daily or 10 000 IU calciferol weekly –
  55. 55. 55 Hormone replacement therapy
  56. 56. 56 HRT: A CONSENSUS • Prime role of HRT is relief of menopausal Sx • Risks/benefits need to be explained to each woman (breast Ca extra 2-6 cases per 1000 women treated with HRT for 5 years) • Use lowest effective estrogen dose, assess CV risk • Review need annually (esp aged>60)
  57. 57. 57 HRT: A CONSENSUS • Can give up to age 50 if prem menopause • Do not use as primary or secondary prev. of CAD/CVA, or Alzheimers • Transdermal estrogen has lower DVT risk
  58. 58. 58 RALOXIFENE • SERM licensed for OP • Reduces vertebral (not non-vertebral) fracture risk, just as does calictonin • Reduces development of new breast Ca. • No increased risk of CVD (reduces CV events!) • Increased risk of thromboembolism • May worsen flushes • Well tolerated, easy dosing
  59. 59. 59 NICE 2005: (secondary prevention) • Teriparatide – use in women >65 years unresponsive to / intolerance of bisphosphonates, and: –with extremely low BMD (<-4) –with very low BMD (<-3), multiple fractures PLUS an additional risk factor National Institute for Clinical Excellence, Technology Appraisal 87, Jan 2005
  60. 60. 60 Emerging Rx’s in osteoporosis Prof Compston 2010 • Denosumab – Monoclonal Ab to RANKL which drives osteoclasts – Subcut every 6m/12m! 60mg – Dramatic and quick effect – Fracture reduction similar to Zoledronate – Cost similar to risedronate (in 2010)! – NICE appraised
  61. 61. 61 Denosumab Binds RANK Ligand and Inhibits Osteoclast Formation, Function, and Survival RANKL RANK OPG Denosumab Osteoclast Formation, Function, and Survival Inhibited Bone Formation Bone Resorption Inhibited CFU-GM Prefusion Osteoclast Osteoblasts Hormones Growth Factors Cytokines Adapted from: Boyle WJ, et al. Nature. 2003;423:337-342.
  62. 62. 62 Few Simple ways You need not know about your T-score • If you are or consider your self Obese, • If you are exposed to Sun during your shopping in open markets at least twice a week, • If you take Milk and you are a vegetarian, • If you are taking regular Morning walk, • If you are regular about exercises (YOGA). • Your Relatives’ Death is not due to Fractures but due to age and co morbidity.
  63. 63. 63 Summary There is an acute need for reconsidering – Globalization of Diagnosis of Osteoporosis & Osteopenia, – BMD screening, – Redefining Risk factors & role of fall and BMD in fractures, – Cost effectiveness of drug treatment, – Hype about Hip fractures, – Role of Big Pharma in propaganda of diagnosis, management, corruption in scientific literature, misuse political system and creation a state of “Fear psychosis & Hope selling”.
  64. 64. 64

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