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OSTEOPOROSIS CASE STUDIES Where to use what FDA approved Medicine and When.

Richard S. Pope MPAS, PA-C DFAAPA Arthritis Center of CT Waterbury, CT Danbury Orthopedics Danbury, CT. OSTEOPOROSIS CASE STUDIES Where to use what FDA approved Medicine and When. Faculty Disclosures. Amgen- Advisory committee denosumab

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OSTEOPOROSIS CASE STUDIES Where to use what FDA approved Medicine and When.

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  1. Richard S. Pope MPAS, PA-C DFAAPAArthritis Center of CTWaterbury, CTDanbury OrthopedicsDanbury, CT OSTEOPOROSIS CASE STUDIES Where to use what FDA approved Medicine and When.

  2. Faculty Disclosures • Amgen- Advisory committee denosumab • URL Pharma-Advisory committee and speaker’s bureau colchicine • UCB Pharma-Speaker’s Bureau certolizumab • Takeda-Speaker’s bureau febuxostat

  3. By using case studies at the end of this session the participant will be able to choose treatment or not based on the scenarios listed below: • Perimenopausal osteopenia with a family history of osteoporosis (To treat or not to treat?) • Osteoporosis by BMD without fracture in a sixty five year old female • Recent wrist fracture in a 65 year old with low bone density (Treating based on fracture and not BMD) • Severe osteoporosis with a T-score of <-3.0 with fractures (Case for anabolic treatment) • Osteoporosis in a PMP female with CKD stage 4 (15-29 ml/min/1.73²)

  4. Case 1Perimenopausal osteopenia with a family history of osteoporosis(To treat or not to treat?) • 56 year old W/F routine GYN appt. and follow up of stage II b breast CA. • Rxed with surgery Xs 2 for lumpectomy at age 44 • Six weeks of localized radiation to right breast • Chemotherapy 6 rounds of epirubicin, cytoxan and 5FU, adjuvant therapy of aromatase inhibition Xs 2 yrs. Tamoxifen for first three years. • No menses after chemotherapy age 44 BMD T-score of -2.1 in femoral neck No fractures as an adult. Mother treated for OP at age 88 GM fractured hip

  5. Case 1Perimenopausal osteopenia with a family history of osteoporosis (To treat or not to treat?) • Secondary work up for OP included: • CBC, comp. chem profile, 24 hr. urine ca+, celiac panel, Vit. D 25 OH D level, protein electrophoresis Results • + for Vit. D of 13ng/ml • 5’ 5’’ 147 lbs. FRAX?

  6. Secondary osteoporosisFRAX calculator • Enter yes if the patient has a disorder strongly associated with osteoporosis. These include type I (insulin dependent) diabetes, osteogenesisimperfecta in adults, untreated long-standing hyperthyroidism, hypogonadism or premature menopause (<45 years), chronic malnutrition, or malabsorption and chronic liver disease

  7. Case 1Perimenopausal osteopenia with a family history of osteoporosis(To treat or not to treat?) How would you manage this patient? • Because of her + family history and low Vit D level would go ahead and treat with FDA approved meds. • Replete patient with high doses of Vit D • Recommend weight bearing exercises, Ca+ 1200mg/day and vitamin D 800 IU/day • Re-check the Vit D level in three months after replacement.

  8. Case 2Osteoporosis by BMD without fracture in a sixty five year old female • 65 year old comes for routine physical and you note that she has not had a prior BMD DXA PMHx: GERD, Barrett’s esophagus Hypertension OP risk factores: no hx of fx as an adult No parental history of hip fracture but mother had multiple compression fractures and associated height loss She smokes about 15 cigarettes/day and unable to give up the habit Drinks 2+ glasses of wine daily

  9. Case 2Osteoporosis by BMD without fracture in a sixty five year old female • MEDs: -losartan 50mg -esomeprazole 40mg Barrett’s esophagus -Ibuprofen 400 prn HA and joint pain -MVI (200iu Vit D2 ergocalciferol) -Calcium carbonate 1,000mg -Vit D3(cholecalciferol 1,000 IU daily)

  10. Case 2Osteoporosis by BMD without fracture in a sixty five year old female • Lab work up shows Vit D 21ng/ml otherwise negative • BMD T-score in the lumbar spine is -2.5 To treat or not to treat? • Pt is at risk for esophageal side effects 2nd to GERD • Barrett’s esophagus As a result would avoid oral bisphosphonates

  11. Case 2Osteoporosis by BMD without fracture in a sixty five year old female • Management options Pt preference (discuss pros and cons) Raloxifene STAR trial, RUTH trial IV bisphosphonates: -zoledronic acid (data in spine/hip/non-vertebral) -ibandronate(data for spine not hip)

  12. CASE 3Recent wrist fracture in a 65 year old with low bone density (Treating based on fracture and not BMD) Sally, age 65, has been concerned over her bone health as a result of fracturing her wrist last month. She is referred to you as her PCP for evaluation by her orthopedist. She twisted her foot and fell on an outstretched hand and sustained a Colles fracture. History: • No parental history of fracture • She did smoke but has not since she was 45 • She drinks 1-2 glasses of wine every night. Denies alcohol abuse • She gets plenty of sunlight and was just in FL with her 3 grown daughters. • Other than her wrist fracture no other fractures as an adult.

  13. CASE 3Recent wrist fracture in a 65 year old with low bone density (Treating based on fracture and not BMD) • PE: height 5’6” stadiometer 1.5 inch loss • Weight 176 lbs • Very mild kyphosis • Gait and stability tests good. • Gets up without arm rests

  14. Case 3What would you do next to work up this patient? CHOOSE AS MANY AS ARE CORRECT • BMD • Chemistry profile, CBC, Vit D 25 level etc. • Dorsal spine x-ray • Use FRAX™ Calculator

  15. CASE 3Recent wrist fracture in a 65 year old with low bone density (Treating based on fracture and not BMD) • DXA BMD femoral neck T-score -2.2 • Laboratory work-up Vit D 28ng/ml • 24 hour urine calcium <200mg/dcl (nml) • iPTH and ionized Calcium (wnl) • Celiac panel negative • SPEP normal • D-spine x-ray negative for morphometric fracture

  16. Case 4 Severe osteoporosis with a T-score of <-3.0 with fractures (Case for anabolic treatment) • 79 year old male • Asymptomatic compression FxsT-10 and L-4 • Parkinson’s Disease • Recent wrist fracture • T-Scores: • Spine -3.0 T score at L-S 2-4 • Hip -2.8 • Severe osteoporosis (osteoporotic fx and BMD -2.5 or worse)

  17. Case 4 Severe osteoporosis with a T-score of <-3.0 with fractures (Case for anabolic treatment) Treatment considerations • 12 fold increased risk for subsequent vertebral fxs. • Is at extremely high risk for falls 2° Parkinson’s • Needs fall protection, home inspection for loose rugs and well lit bathrooms especially at night. • Needs aggressive therapy for severe osteoporosis.

  18. Teriparatide rhPTH[1-34] 20 mcg SQ qD • Increased spinal BMD 9% • 96% of women showed an increase in BMD • Increased femoral neck BMD 3% • Reduced new/worsening back pain • Reduced fracture-associated height loss • Reduced risk of new vertebral fractures by 65% • Reduced risk of moderate and severe vertebral fractures by 90% • Reduced risk of non-vertebral fragility fractures by 53% • Studies are too small to evaluate effect on hip fracture Neer et al. N Engl J Med 2001; 344:1434-41

  19. Case 5Osteoporosis in a patient CKD stage 4 • 86 year old female s/p CVA uses cane and has a dense left hemiparesis • Her BMD show a -3.1 BMD in her left hip • She has a history of borderline renal function and has an eGFR of 33ml/min. • She is hypertensive, diabetic and on lisinopril, insulin glargine,pravastatin, baby ASA and coumadin.

  20. Case 5Osteoporosis in a patient with renal disease Labs: • Vit D 36ng/ml • iPTH and ionized Ca+ wnl • 24 hour urine Calcium wnl • SPEP and Celiac panel are normal • Cockcroft-Gault method GFR 33mls/minute Bisphosphonates are renally cleared and are contraindicated below 35ml/minute GFR www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation

  21. Case 5Osteoporosis in a patient with renal disease Treatment Recommendations • Denosumab—is not renally excreted and therefore no dosage adjustments are required for patients with chronic kidney disease. (creatinine clearance <30 mL/min). • Patients in this population are more likely to have hypocalcemia and this is a contraindication to its use. • Screening labs should be performed for ca+ level. Phosphorus and mg+ and repeat calcium in renal ptsis recommended ten days after dosing. If serum calcium is low calcium levels should be corrected. If pt does not have renal disease serum ca+ not required. Denosumab for osteoporosis uptodate version 19.2 Accessed 7-11-2011

  22. RANKL Antibody/RANKL: Activation Of Osteoclasts CFU-M OPG RANKL RANK Y Denosumab Growth factors Hormones Cytokines Pre-fusion osteoclast Y Y OPG Multinucleated osteoclast Y Y RANKL Y Y OB Activated osteoclast Bone RANK = Receptor Activator of Nuclear factor Kappa B RANKL = RANK Ligand CFU-M = Colony-Forming-Unit Macrophage OPG = Osteoprotegerin Adapted from Boyle, et al. Nature 2003;423:337 Slide courtesy of Steve Harris MD

  23. Treatment: Summary Safe and effective therapies are available Antiresorptive agents • Prevent bone loss and preserve architecture • Improve quality of bone • Reduce the risk of vertebral fractures (all agents) • Alendronate, risedronate and zoledronic acid proven to reduce the risk of nonvertebral and hip fractures Anabolic agent: rhPTH [1-34] (teriparatide) • Increases bone density and size • Improves quality of bone • Reduces the risk of vertebral and nonvertebral fractures; no hip fracture data • RankL inhibitors (denosumab) • Inhibits function and survival of osteoclasts via RankL inhibition • Prevents bone loss by decreasing bone turnover • Reduces risk of vertebral, non-vertebral and hip fractures • Indicated for treatment of PMP only (July 2011) Patient factors determine the most appropriate drug to use

  24. Drugs to Treat Osteoporosis Cost per Effect on Fracture Risk Agent year1 Vertebral Nonvert Hip Raloxifene $976*  -- -- Calcitonin $1,517*  -- -- Brand alendronate $1,103    Generic alendronate $108 Risedronate $1,110    Ibandronate (oral) $1,024  -- -- Ibandronate (IV) $1,938 Zoledronic acid $1,249    Teriparatide $9,786   -- : antifracture efficacy proven in clinical trial --: antifracture efficacy not proven in clinical trial 1 AWP (Average Wholesale Price) varies by region and distributor * Medi-Span Drug Data. Price Rx® Prescription drug database (Accessed 30 October 2009) Red Book: Pharmacy’s Fundamental Reference. Thomson Medical Economics: Montvale, NJ. 2007.

  25. Case Summaries 1. Perimenopausal female with a low bone density. FRAX calculator and treat with life style and VitD and Ca+. 2. OP by lumbar T-score and no fx–history of Barrett’s, GERD. Avoid oral bisphosphonates, consider IV bisphosphonates or raloxifene. 3. Wrist fracture in a sixty five year old. Fracture trumps the DXA. FDA approved meds.

  26. Case Summaries Continued 4. Severe OP multiple compression fxs, T-score -3.0. Case for anabolic agent. 5. OP in a CKDstage 4- RankL inhibition in renal pts where bisphosphonates are contraindicated

  27. Thank you popr5jhjc@aol.com

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