Disclosure Everything a Pharmacist Needs to Know About

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WHO Classification of BMD NOF Treatment Guidelines. T score For postmenopausal women and men age 50 and older. Normal 1 0 or higher after appropriate evaluation for secondary causes. Osteopenia Between 1 0 and 2 5 Osteoporosis by T score Low BMD High Fx Risk. Osteoporosis 2 5 or lower T score 2 5 or less at T score between 1 0 and. FN TH or LS or 2 5 at FN TH or LS, Severe Osteoporosis 2 5 or lower fragility fracture. Clinical Osteoporosis FRAX 10 year probability, Applies to postmenopausal women and men age 50 and older. Cannot be used in premenopausal women and men under age 50 Hip or vertebral clinical of hip fracture 3 or. Should never be used in children under age 20,or morphometric major osteoporotic. T score 2 5 is not always osteoporosis fracture 20. A patient may have osteoporosis with a T score 2 5 fracture or. WHO Study Group 1994, ISCD Official Positions National Osteoporosis Foundation Clinician s Guide to Prevention and Treatment of Osteoporosis 2014. Medications for Osteoporosis Individualizing Initial Treatment. Inhibit Bone Resorption Stimulate Bone Formation,Agent Comments.
Antiresorptive Anabolic,Pro inexpensive work well in many patients. Alendronate Fosamax generic Teriparatide Forteo Oral BPs. Con GI distress avoid with low GFR bad rep in lay press. Risedronate Actonel Atelvia generic Abaloparatide Tymlos. Pro very long dosing interval post hip fracture data. Ibandronate Boniva generic ZOL,Con acute phase reaction avoid with low GFR IV. Zoledronate Reclast generic Pro long dosing interval greatest BMD increase SC. Denosumab Prolia Con FDA list of side effects back pain high cholesterol etc. Raloxifene Evista generic Pro anabolic, Con high cost daily injection refrigeration rat osteosarcoma. Salmon Calcitonin Miacalcin generic, Pro anabolic no refrigeration less hypercalcemia than TPT. Estrogen various Abalo,Con cost daily injection rat osteosarcoma.
CE Baxedoxifene Duavee Pro not a BP decreases breast cancer risk. Con VTE hot flashes no proven hip fracture decrease. Personal opinion,Indications, Medication PMO GIO Women Men Men Fracture Risk Reduction in RCTs. Prevention Treatment Prevention Treatment,Medication Spine Nonvertebral Hip. Estrogen many forms,CE BZA Duavee Estrogen many forms. Raloxifene Evista generic CEE BZA Duavee, Alendronate Fosamax generic Raloxifene Evista generic. Risedronate Actonel generic Alendronate Fosamax generic. Risedronate DR Atelvia Risedronate Actonel generic. Ibandronate PO Boniva generic Ibandronate Boniva generic in post hoc analyses. Ibandronate IV Boniva Zoledronate Reclast generic, Zoledronate Reclast generic Calcitonin Miacalcin generic.
Calcitonin IN Miacalcin generic Denosumab Prolia,Denosumab Prolia. Teriparatide Forteo,Abaloparatide Tymlos,Teriparatide Forteo. Abalopartide Tymlos,A Brief History Osteoporosis Care. of Osteoporosis Better WHI 2002,USA DXA Reimbursement Cuts 2007. Bureaucracy Media Reports,Limited Time,How did we get Guidelines Competing.
Fear of Side Effects,Drug Holidays,where we are today More Marketing. Approval of More Drugs,Priorities,US Surgeon General s Report Guidelines Vitamin D. Increasing Availability of DXA Risk Communication,Bone Mass Measurement Act Treatment Gap. Mass Marketing,Approval of Alendronate 1995 CRISIS. Worse WHO Diagnostic Criteria 1994,E Michael Lewiecki MD.
Personal Opinion,DXA Introduced 1987,Reduced Bisphosphonate. Treatment Gap Getting Worse Prescription Rates Starting in 2008. Review of US insurance claims data commercial Medicare. in 96 887 patients hospitalized with hip fracture 2002 2011. Solomon DH et al J Bone Miner Res 2014 29 1929 1937 Jha S et al J Bone Miner Res 2015 30 2179 2187. US Hip Fracture Trends 2002 2015,26 Hip Fracture Rates. 14 391 additional hip fractures,900 Strategies to Reduce. 884 576 million additional expenses,the Treatment Gap. Age adjusted to the 2014 Age Distribution,24 2 878 additional deaths 850.
Fractures per 100 000 Women Age 65,22 800 Public awareness empowerment of patients. Percent of Women Age 65,DXA Medicare Payments,139 738 Shared decision making. Alignment of incentives, 18 Osteoporosis Diagnosis 700 More effective use of current treatments. 17 9 693 New drug development,Harmonization of guidelines. Fracture liaison services,42 Better risk communication.
DXA Testing 13 2,12 550 Restore DXA reimbursement,11 3 Improve DXA quality. Treat to target,Sharing knowledge Bone Health TeleECHO. Lewiecki EM et al ASBMR Oral Presentation 1077 2016. Survey of 1 222 Community,Can pharmacists help,Pharmacists in Canada. Screening for Screening for,Osteoporosis Risk of Falls. Believed should be involved 47 50,Actually were involved 17 19.
Barriers to providing these services,Lack of time 79. Lack of clinical tools 65, Lack of coordination with other healthcare professionals 55. Laliberte M C et al Osteoporos Int 2013 24 1803 1815. Systematic Review of Pharmacist What You Can Do, Interventions for Osteoporosis Care If you have the interest the time and the resources. 25 studies identified 3 RCTs Identify patients who qualify for DXA testing. Educate patients on long term glucocorticoids on, Interventions included patient counseling high risk of fracture. education QUS and physician contact Counsel on falls prevention calcium and vitamin D. Results interventions increased DXA Distribute educational materials. testing and calcium intake in high risk Inform on correct administration of oral BPs. Advise fracture patients on risk of future fractures. Communicate balance of benefits and risks, Limitations study bias no study examined Assess adherence to therapy.
adherence to treatment more and better Recognize the myths understand the data and. designed studies are needed appreciate the uncertainties in osteoporosis care. Elias MN et al Osteoporos Int 2011 22 2587 2596,Controversies Uncertainties. Indications for DXA,Evaluation Treatment,Women age 65 and men age 70. DXA Non pharmacological,Indications Best exercise, Testing intervals Calcium and CV disease Younger postmenopausal women. Quality Target vitamin D level perimenopausal women and men age 50. Reimbursement Pharmacological 69 based on risk factor profile. Fracture risk assessment Initial drug selection, Wise use of FRAX How long to treat Adults with fragility fracture disease or. Other algorithms Changing therapy condition associated with low BMD or. Secondary causes Combining therapy bone loss,Best w u for a patient Benefit vs risk.
Extracted from NOF Clinician s Guide to Prevention and Treatment. of Osteoporosis and ISCD Official Positions 2015,High Fracture Risk with Any Dose. UK General Practice Research Database, 244 235 oral glucocorticoid users compared to 244 235 controls. Prednisone 2 5 mg day 2 5 7 5 mg day 7 5 mg day,There is no safe dose of prednisone. van Staa TP et al J Bone Miner Res 2000 15 993 1000 From Osteoporosis Canada at http www osteoporosis ca. From American Bone Health at https americanbonehealth org From National Osteoporosis Foundation at https www nof org. Osteoporosis Wheel of Fear,Atrial Fib Jaw Rot,Joint Pain Bones. Calcium with or without vitamin D intake from food or. Muscles Ache Femur Snaps, supplements has no relationship beneficial or harmful.
to the risk for cardiovascular and cerebrovascular. disease mortality or all cause mortality in generally Back Pain Heartburn. healthy adults at this time,Fatal Blood,Stroke Clots. Kopecky SL et al Ann Intern Med 2016 165 12 867 668. Bisphosphonate Safety Issues Denosumab Safety, Side Effects Side Benefits Message to patients The most common side effects of. Short term Improved implant survival, Prolia include back pain pain in the arms and legs high. risk of breast cancer,GI distress, risk of endometrial cancer cholesterol muscle pain and bladder infections. Acute phase reaction,risk of colorectal cancer,Hypocalcemia risk of stroke.
Renal toxicity Adverse reactions in 2 of Patients with Osteoporosis. risk of gastric cancer,and More Frequent Than with PBO. Long term risk of MI in RA patients, Osteonecrosis of the jaw risk of type 2 DM Term Prolia N 3886 PBO N 3876. Atypical femur fractures mortality Back Pain 1347 34 7 1340 34 6. Prieto Alhambra D et al Arthritis Rheum 2014 66 3233 3240. Questionable Chlebowski RT et al J Clin Oncol 2010 28 3582 3590. Newcomb PA et al J Clin Oncol 2015 33 1186 1190 Pain in extremity 453 11 7 430 11 1. Chronic musculo skeletal pain Dreyfuss JH CA Cancer J Clin 2010 60 343 344. Newcomb PA et al Br J Cancer 2010 102 799 802 Hypercholesterolemia 280 7 2 236 6 1. Atrial fibrillation Rennert G et al J Clin Oncol 2010 28 3577 3581. Vestergaard P et al Calcif Tissue Int 2011 88 255 262. Esophageal cancer Rennert G et al J Clin Oncol 2011 9 1146 1150 Myalgia 114 2 9 94 2 4. Kang JH et al Osteoporos Int 2012 23 2551 2557, Impaired fracture healing Abrahamsen B et al J Bone Miner Res 2012 27 679 686 Cystitis 228 5 9 225 5 8. Center JR et al J Clin Endocrinol Metab 2011 96 1006 1014. Wolfe F et al J Bone Miner Res 2013 28 984 991, Konstantinos A et al J Clin Endocrinol Metab 2015 100 1933 1940. Sambrook PN et al Osteoporos Int 2011 22 2551 2556 https www prolia com about safety and package insert May 2017. Lee P et al J Clin Endocrinol Metab 2016 101 1945 1953. Osteonecrosis of the Jaw Atypical Femur Fractures,Unadjusted and Age adjusted Risk of AFF.
Atypical Femur Fracture According to Duration of Bisphosphonate Therapy. 100 000 person years,Incidence of AFF per,Years of Bisphosphonate Exposure. Risk of AFF increases with duration of BP therapy 1. Risk of AFF is low in proportion to fractures prevented by BP therapy 1. After BP withdrawal risk of AFF rapidly decreases by 70 per year 2. Ruggiero SL J Oral Maxillofac Surg 2004 62 527 534 1 Dell RM et al J Bone Miner Res 2012 27 2544 2550 2 Schilcher J et al N Engl J Med 2011 364 1728 37. Benefits and Risks,10 Year Probabilities,Motor Vehicle Accidents Osteoporosis. 80 year old woman with FN T score 3 3, Includes 0 01 Atypical Femur Fracture Risk Wearing seat belts. reduces the risk of Treatment with,serious crash related bisphosphonates. injuries and deaths by reduces the risk of, Includes 0 5 Atypical Femur Fracture Risk about 50 fractures by about 50.
Untreated probability of major osteoporotic fracture calculated by FRAX ONJ estimate is 1 100 000 patient. treatment years from ASBMR Task Force by Khosla S et al J Bone Miner Res 2007 22 1479 149 AFF estimate. untreated is 0 01 10 000 and treated is 5 10 000 patient years from Schilcher J et al N Engl J Med 2011 364 1728. There are about 2 3 million adults treated in ERs each year for injuries from MVAs and about 2. 1737 Risk estimates assume long term bisphosphonate therapy resulting in 50 reduction in fracture risk MVA and million osteoporotic fractures each year The risk of seat belt injuries and serious side effects from. murder data from the CDC at http www cdc gov nchs data nvsr nvsr56 nvsr56 10 pdf Image copyright 2011 osteoporosis treatment is very small in proportion to the benefits Data from multiple sources. Lewiecki EM Slide version, Osteoporosis Drugs Don t Work After 5 Years Drug Holiday. Reality The evidence supports anti Elective temporary withholding of bisphosphonate. fracture efficacy for as long as 10 years in after at least 3 5 years in appropriate patients. appropriately selected patients NOT drug retirement. NOT stopping treatment,NOT for non bisphosphonates. Uncertainty Rationale persistence of anti fracture benefit while. RCTs with a placebo group are typically 3 possibly reducing long term risks. years for osteoporosis drugs Very little data many opinions. No data beyond 10 years Periodic reevaluation of balance of benefits and. Studies with other drugs for chronic diseases are often far shorter and. we typically don t know the long term effects of any drugs for any disease. Adapted from Whitaker M et al N Engl J Med 2012 366 2048 2051 Black DM et al N Engl J Med 2012 366 2051 2053. Bonnick SL J Clin Densitom 2011 14 377 383 Watts NB et al J Clin Endocrinol Metab 2010 95 1555 1565. Postmenopausal Women Treated with,Oral BP 5 Years or IV BP 3 Years. Low fracture risk hip T score 2 5 and,no hip spine or multiple osteoporotic. fracture before or during therapy,Consider drug holiday of 2 3 years.
High fracture risk hip T score 2 5 or hip,spine or multiple osteoporotic fracture. before or during therapy,Consider continuing oral BP up to 10 years. and IV BP up to 6 years, Adler RA et al J Bone Miner Res 2016 31 16 35 Adler RA et al J Bone Miner Res 2016 31 16 35. Loss of Fracture Protection after,Discontinuation of Denosumab. Systematic review of literature on,discontinuing Dmab.
No Holiday with Denosumab Return of fracture risk to baseline after. discontinuation and possible increase in,risk of multiple VFs. Stopping Dmab should be followed by,alternative treatment. Tsourdi E et al ECTS Position Statement Bone 2017 Epub. Sequencing with Anabolic Therapy,Anabolic after potent BP ALN delay. or attenuation of anabolic effect,Anabolic after Dmab BMD decrease. transient sustained,Anabolic after mild antiresorptive ET.
RIS expected onset of anabolic effect,Antiresorptive. 1 Everything a Pharmacist Needs to Know About Osteoporosis E Michael Lewiecki MD FACP FACE Director New Mexico Clinical Research amp Osteoporosis Center

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