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OSTEOPOROSIS- Evaluation, Management and Prevention- Dr Selim

A condition in which the infrastructure of bone becomes thin and weakened.<br><br>Weakened bone is at higher risk for fracture to occur from minimal stresses.<br>

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OSTEOPOROSIS- Evaluation, Management and Prevention- Dr Selim

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  1. OSTEOPROSIS: EVALUATION, MANAGEMENT AND PREVENTION Dr Shahjada SelimAssociate ProfessorDepartment of Endocrinology, BSMMU, Dhaka General Secretary, Bangladesh Endocrine Society (BES) https://shahjadaselim.com

  2. Osteoporosis: Classification • Primary Osteoporosis • Type 1- Post menopausal osteoporosis • Type 2- Senile/Age related osteoporosis • Secondary Osteoporosis • Secondary to various causes 2

  3. Whom to evaluate? No uniform recommendations currently exists. Kasper et al. 2005, Kling et al 2014

  4. Kling et al 2014

  5. Kling et al 2014

  6. How to Evaluate • Appropriate clinical history: Risk assessment • Clinical examination: signs, complications, conditions • Investigations: • Diagnosis • Risk assessment • Complications • Evaluation of secondary causes as relevant.

  7. Clinical Presentations: History and physical findings • Usually asymptomatic unless fracture • Doesn’t cause generalized skeletal pain • Sudden onset of localized pain with or without H/O injury • Persistent back pain • Height loss (1.0 to 1.5 inch) • Kyphosis • Fragility fractures Kasper et al. 2005, Kling et al 2014

  8. Assess • Risk factors • Conditions/ diseases/ Medications associated with 2ndOsteopororsis Kasper et al. 2005, Kling et al 2014

  9. Investigations

  10. Two major tools • BMD [DEXA]: • Diagnosis/ Status • Treatment decision • FRAX Tool (WHO) • Risk assessment • Treatment decision Dennis M, NEJM 2016.

  11. Measures of Bone Mass (BMD) • DEXA: Standard for BMD • Others • SXA • Computed tomography– based absorptiometry (quantitative computed tomography) • Quantitative ultrasound densitometry, WHO, NOF, USPSTF

  12. WHO Criteria Kanis et al. J Bone Miner Res 1994; 9:1137-41

  13. Developed by the WHO • Designed for primary care use • in postmenopausal women and • men older than 50 years • (but validated for men and women aged 40–90 years)

  14. Risk factors are combined with femoral neck BMD to calculate 10 y probability of fracture • major osteoporotic • hip fracture risk NOF 2010

  15. FDA–approves: therapy can be initiated for patients with 10-year risk of • hip fracture of at >3% or • a risk of a major osteoporotic fracture 20% or higher. FDA, NOF 2010

  16. Z-score: • Z score: • men younger than 50 years or • premenopausal women. • secondary causes of osteoporosis. Z < −2.0 NOF: National Osteoporosis Foundation. Clinician's guide to prevention and treatment of osteoporosis. Washington, DC: National Osteoporosis Foundation, 2010;1–56 Lewiecki EM, Watts NB, McLund MR, et al. Official positions of the International Society for Clinical Densitometry. JCEM 2004;89:3651–3655

  17. Kasper et al. 2005, Kling et al 2014

  18. Biochemical Markers • Bone-specific alkaline phosphatase • Osteocalcin • Urinary hydroxyproline • Collagen crosslinks such as C-terminal-telopeptide and N-terminal telopeptide • Useful for aiding in osteoporosis diagnosis and monitoring treatment response Kasper et al. 2005, Kling et al 2014

  19. Management Aspect of Osteoporosis

  20. Goals of treatment • Prevent further bone loss • Increase or at least stabilize bone density • Prevent further fractures • Relieve deformity (e.g., kyphoplasty) • Relieve pain • Increase level of physical functioning • Increase quality of life

  21. Lifestyle Advice Diet Exercise Smoking Stop smoking Alcohol Sunlight Exposure Nutr Rev 2008;66(suppl 2):5182-5194 EndocrPract 2009;15:95-103 Cangussu LM et al. OsteoporosInt 2015;26:2413-21 Wang J et al. J Bone Miner Res 2015;30:1641-50 Ann N Y AcadSci 2006;1068:429-446

  22. Bone Health PMO • Vitamin D • Measure 25-OH vitamin D in those at risk for insufficiency • Preferable range 25-OHD : 30 ng/ml to 50 ng/ml • Supplementation if needed: generally in range of 1000-2000 IU daily with higher amounts in some patients • Calcium • Counsel on adequate dietary intake of calcium – about 1200 mg daily • Exercise • Active lifestyle, weight –bearing and balance exercises • Limit alcohol to ≤ 2 servings daily • Limit caffeine intake • Refer PT and OT as needed

  23. Nonpharmacologic Measures inPMO Treatment • Maintain adequate protein intake • Use proper body mechanics • Consider use of hip protectors in individuals with high fall risk • Take measures to reduce fall risk • Consider referral to PT and OT

  24. Common Medications Possibly Associated WithIncreased Fracture Risk • Proton-pump inhibitors (PPI’s) – ↑ hip fracture after long-term, high-dose therapy in observational studies • Selective-serotonin reuptake inhibitors (SSRI’s) – 2x ↑ risk fragility fracture seen with daily use • Thiazolidinediones (TZD’s) – ↑ risk peripheral fractures in post-menopausal womenwith type 2 diabetes on rosiglitazone compared to metformin or glyburide • 1Yang YX et al. JAMA 2006;296:2947-2953 • 2Richards JB et al. Arch Int Med 2007;167:188-194 • 3Kahn SE et al. Diabetes Care 2008;31:845-851, Loke YK et al CMAJ 2009;180:32-9

  25. Pharmacological Options • HRT • SERM/raloxifene • Calcium/Vitamin D • Calcitonin • Bisphosphonates Alendronate Risedronate Ibandronate Zoledronic acid

  26. Pharmacological Options Bone-forming agents • Fluoride • Androgens • Parathyroid hormone • Strontium ranelate Antiresorptive agents • Calcium • Vitamin D and calcitriol • Estrogen • SERMs • Calcitonin • Bisphosphonates • RANK-ligand inhibition

  27. Who Needs Pharmacologic Therapy? • Those patients with a history of a fragility fracture of the hip or spine with osteopenia • Patients without a history of fractures but with a T-score of -2.5 or lower • Patients with a T-score between -1.0 and -2.5 if FRAX 10 year major osteoporosis related fracture probability at 20% or more or hip fracture probability at 3% or more

  28. What Drugs Can Be Used to Treat PMO Use Drugs with Proven Antifracture Efficacy First line therapy • alendronate, risedronate, zoledronic acid, and denosumab Second line therapy • ibandronate Third line therapy • Raloxifene

  29. What Drugs Can Be Used to Treat PMO Last line of therapy • Calcitonin • Use teriparatide for patients with very high fracture risk or patients in whom bisphosphonate therapy has failed • Advise against the use of combination therapy • Cost, improved efficacy not documented, safety Use Drugs with Proven Antifracture Efficacy

  30. Estrogen • Estrogen meets up the hormonal scarcity in postmenopausal women • Elevates the calcium level in circulation • Decreases bone resorption

  31. Selective estrogen receptor modulator (SERM) • Raloxifene, a Selective estrogen receptor modulator (SERM) has been used to treat Osteoporosis. • It has estrogen agonist activity in some tissues and antagonist in other tissues. • It has been introduced to overcome the side effects of ERT/HRT • Not a very good option for Severe Osteoporosis & Osteoporotic pain

  32. Calcium & Vitamin D • Must be used with other treatment options • A very good option to treat Osteopenia • Insufficient to treat Osteoporosis

  33. Calcitonin • A good option to treat Postmenopausal Osteoporosis • Very effective to control Osteoporotic Pain • Can reduce vertebral fracture rate • Convenient treatment option • Difficult to treat severe Osteoporotic patients

  34. Strontium Ranelate • Side effect- Headache, Diarrhea, MI, VTE, Dermatitis, eczema. • Not used in USA. • Strontium is alternative to BP in some situation. J Clin Endocrinol Metab 2005;90:2816-2822 Clin Instrum in Aging 2008;3(2): 315-329 J Clin Endocrinol Metab 2005;90:2816-2822 Clin Instrum in Aging 2008;3(2): 315-329

  35. Testosterone Therapy • Studies of testosterone in men with osteoporosis are limited, ffective in hypogonadal adolescents, and with low testosterone level. Ref: Basic Prescribing Information,2012

  36. Effects of Bisphosphonates on Osteoclast Function Osteoclast Following Uptake of Bisphosphonate Normal Osteoclast Loss of ruffled border1 Cytoskeletal disorganization1 Altered vesicular trafficking3 Cell death by apoptosis2 • Sato, M, et al. J Clin Invest. 1991;88:2095-2105. 2. • Hughes DE, et al. J Bone Miner Res. 1995;10:1478-1487. • Rogers M. CurrPharm Des. 2003;9:2643-2658.

  37. Bisphosphonate- side effects Low bioavailability in contrast to IV, poor compliance with oral BP Having chance of GERD, PUD with oral BP. Other side effects are common for all BP - atypical fracture of femur, ONJ, AF, esophageal cancer The Journal of Family Medicine June2010;59:200-6

  38. Contd…. • Although IV BPs are generally safe, transient influenza-like symptoms may appear. • ONJ- 1-19 per 100,000 (IV: oral = 3:1). • Upto 18.6% in oncology patients • Denosumab had lower ORs than all BPs for ONJ. • Atypical fracture of femur with bisphosphonate for as long as 10 years – large studies – FIT, FLEX, HORIZON did not support Patricia |Sieber et al.Clinical Drug Investigation (2013) 33:117 122. DOI 10.1007/s40261 012 0041 1 Zhang X et al. J Bone Miner Res 2015; doi:10.1002/jbmr.2693 Khan A et al.Osteoporos Int.DOI 10.1007/s00198-015-3335-3 N Engl J Med 2010:1761-71

  39. Cont-ONJ Contd…. • IV Bisphosphonate • Cancer & anti-cancer therapy • Dental extraction, oral bone manipulating surgery • Poor fitting dental appliances • Intraoral trauma • Duration of exposure to bisphosphonate treatment • Comorbidity- malignancy, alcohol abuse, use of tobacco • Periodontal disease Formulary 2011;46:432-446

  40. Denosumab • A anti-resorptive therapy. • Monoclonal antibody against RANK ligand. • Approved for postmenopausal osteoporosis in USA. • Dose- 60mg s/c injection every 6 month

  41. PTH and Teriparatide • PTH 1-34 (teriparatide) and PTH 1-84, anabolic drug • Not beyond 2 years. • Highest BMD achievement & reduction of vertebral fracture - Add on therapy. • Side effects- • Orthostatic hypotension, nausea, myalgia, and arthralgia, risk of osteosarcoma

  42. Osteoporosis Treatments Have Different Effects on the Bone Remodeling Cycle New bone formation1 Osteoblast activity1 Osteoclast activity1 Turnover2 New bone formation; skeletal mass1 Bonevolume3 Anabolicagent teriparatide Action Function Primaryeffect Secondaryeffect Bone turnover BMD effect Bone volume Fill in the remodeling space; mineralization of existing bone4-6 Antiresorptive agents(bisphosphonates, denosumab, raloxifene) Bone resorption4,5 Osteoclast activity4,5 Osteoblast activity4,5 Turnover4,5 No effect Information regarding mechanisms of action does not provide evidence of comparative fracture protection 1. FORTEO Prescribing Information. 2. Arlot M, et al. J Bone Miner Res. 2005;20:1244–1253.3. Jiang Y, et al. J Bone Miner Res. 2003;18:1932–1941. 4. Fleisch H.. Endocr Rev. 1998;19:80-100. 5. Russell RG, et al. Osteoporos Int 1999;9:S66-S80. 6. Riggs BL, Parfitt AM. J Bone Miner Res 2005;20:177-184.

  43. Who Should Not be Considered for Teriparatide Therapy? • Hypercalcemia • Paget’s disease • Osteogenic sarcoma • Unfused epiphysis • Previous irradiation to the skeleton • Pregnancy or breast-feeding • Bone cancer or metastatic cancer to bone • Allergic reaction to PTH or to ingredients in the vehicle

  44. OsteoporosisMedication Options Broad spectrum • Alendronate, risedronate, zoledronicacid,denosumab Parenteral options if needed • Denosumab, zoledronicacid,teriparatide Spine specific efficacy • Ibandronate, raloxifene

  45. Combined denosumab and teriparatide achieves improved BMD response vs either agent alone but data for fracture risk are lacking. • Strongly recommend antiresorptive therapy following teriparatide therapy

  46. 25 20 15 10 5 0 36 0 6 18 Months Source: RMP.B3DSGHBM.SASPGM (ASMBR03) WPDF# DWD200308a BMD after discontinuation of PTH (QCT) Review: David Donley (20Aug2003) Antiresorptive after discont. Reviewer Memo: No antiresorptive after discont. Slide Modified: on: 9/18/2002 12:45:37 PM SL10 Rev: 272 Memo:

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