Osteoporosis. A Silent Killer. David A. Chappell, MD Endocrinology Private Practice Petaluma, California

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1 Osteoporosis A Silent Killer David A. Chappell, MD Endocrinology Private Practice Petaluma, California

2 Relevant Disclosures Speakers Bureau Astra Zeneca Boehringer Ingelheim

3 AACE/ACE Guidelines American Association of Clinical Endocrinologist and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis Endocrine Practice Vol 22 (Suppl 4) September 2016

4 Osteoporosis Q1 How to assess fracture risk and diagnose Osteoporosis Q2 What is the appropriate evaluation? Q3 Fundamental measures for bone health? Q4 Who needs pharmacologic therapy? Q5 What medication should be used to treat Osteoporosis? Q6 How is treatment Monitored? Q7 What is successful treatment of Osteoporosis? Endocrine Practice Vol 22 (Suppl 4) September 2016

5 Osteoporosis Q8 How long should patients be treated? Q9 What is the role for combination treatment? Q10 Should sequential use of agents be considered? Q11 Should vertebral augmentation be considered? Q12 When to refer to Osteoporosis specialist? Endocrine Practice Vol 22 (Suppl 4) September 2016

6 Osteoporosis: A Major Public Health Issue IS 2-million-2 Many? 5,500 Fractures Daily National Bone Health Alliance

7 Osteoporosis is a Common Condition in Women in the U.S. Number or Events Annually 2,000, ,000,000 1,500,000 1,000, , , , , , , Osteoporotic Fracture Heart Attack Stroke Breast Cancer Uterine Cancer Ovarian Cancer NIH Consensus Conference: Osteoporosis Prevention, Diagnosis, and Therapy. JAMA 2001; 285:

8 What are the Consequences of Underdiagnosing and Undertreating Osteoporosis? In women with hip fracture: Fracture begets future fracture Deteriorated quality of life Long-term care admission Mortality 40% had prior fracture 1 40% need assistance walking 2 18% enter LTC 3 23% die within 1 year 4 Lifetime risk of hip fracture in women >50 is 12.1% 5 1. Hajcsar EE, et al. CMAJ 2000, 163: ; 2. Cooper C. Am J Med. 1997:103:12S-19S; 3. Jean et al. JBMR 2012 On-line September Ioannidis G, et al. CMAJ 2009;181: Hopkins et al Osteo Intl 2012; 23:

9 Osteoporosis :Microscopic Structure Normal Moderate Severe Normal Trabecula Thinning of Trabecula Perforation of Trabecula Osteoporosis is a systemic disease characterized by low bone mass & micro-architectural deterioration with a consequent increase in bone fragility and susceptibility to fracture

10 Osteoporosis Q1 How is fracture risk assessed?

11 Osteoporosis Compromises Bone Strength Increases Risk of Fracture Bone Quality Bone Strength + Bone Density + Fall Risk 1. Architecture 2. Turnover 3. Damage Accumulation 4. Mineralization 5. Collagen quality abmd = g/cm 2 vbmd = g/cm 3 Fracture Risk 1. LE Strength 2. Balance 3. Joint Flexibility 4. Vision Adapted from NIH Consensus Development Panel on Osteoporosis. JAMA 2001

12 Evaluation for Osteoporosis Evaluation all post menopausal women > age 50 for Osteoporosis risk Take History to Assess Bone Health Age, Sex, Family History Menstrual history Prior History of Fracture Steroids, Smoking or Alcohol Vitamin D Deficiency Calcium &/or nutrient Malabsorption Eating disorder Seizure disorder (phenobarbital, phenytoin) Bone Density BMD in all > 65 BMD earlier if risk factors present

13 Osteoporosis should be diagnosed if : 1. In the Presence of a Fragility Fracture in the absence of other metabolic bone disorders, or 2. BMD T-Score is 2.5 or lower in any single ROI : Lumbar Spine, Femoral Neck, total hip or 33% radius even in the absence of prevalent fracture, or 3. Osteoporosis may also be diagnosed in patients with low bone mass (T-Score -1.0 to -2.4, Osteopenia ) who are at increased fracture risk using FRAX Country Specific thresholds US Thresholds are: Global fracture risk of 20% or greater or hip fracture risk 3% or greater

14 Fracture Risk Assessment How do we Combine these Risks into a usable Fracture Risk Assessment? WHO FRAX tool IOS App FRAX Calculator Android Google Play

15 FRAX Fracture Risk Calculator

16 FRAX Fracture Risk Calculator

17 FRAX Fracture Risk Calculator Limitations of FRAX Under estimates risk as it only reports risk for hip and major fractures which comprise only half of all fractures Under estimates risk in patients with multiple prior osteoporosis-related fractures Under estimates risk in patients with lumbar spine BMD lower than the femoral neck Under estimates risk in patients at high risk of falling May under estimate risk in patients secondary osteoporosis Estimates risk only for those who are drug-naive

18 Lifestyle Modification Lifestyl e Treat Treat Fracture Risk Determines Need for Treatment HIGH RISK FOR FRACTURE CONSIDER FOR TREATMENT IF: 1. Already Fractured 2. Low BMD T-score < -2.5 at any measured site 3. FRAX Global risk > 20% 4. FRAX Hip Risk > 3% 5. Reassess in 1-2 years CONSIDER PREVENTIVE THERAPY IF: 1. Other risk factors present 2. Patient is worried about fracture 3. Lifetime risk considered to be high 4. Reassess in 2-3 years NO NEED FOR PREVENTIVE THERAPY 1. May choose Hormone Therapy for other reasons 2. Reassess in 3-5 years 3. Lifestyle Modification

19 Q2 : Evaluation for Secondary Causes of Osteoporosis Evaluate for prevalent fractures Height loss, Lateral spine x-rays or VFA Many vertebral fractures go undetected Routine tests include: Consider baseline bone turnover markers Serum Ctx, BSAP or P1NP Complete blood cell count (CBC), Serum calcium, PTH, Creatinine, Albumin, PO4, 25 OH Vitamin D, Alkaline Phosphatase Urinary Calcium: Creatinine Ratio Additional tests may be appropriate: WHEN TO CONSIDER VFA Women > 70 Height loss of 1.5 inches Self reported fracture or undocumented back pain Chronic Steroid therapy Thyroid-Stimulating Hormone (TSH), Urinary cortisol, Testosterone in Men, Protein electrophoresis (SPEP/UPEP)

20 Q3 Fundamental measures for bone health Avoid Excess alcohol intake limit to two drinks a day or less Counsel patients to stop or avoid smoking Counsel patients to maintain an active lifestyle including weight-bearing, balance and resistance exercises Improve strength, balance & coordination, Reduce risk of falling Improve joint mobility & flexibility Counsel on fall prevention including a Safe environment: Bathroom safety, Rugs and night lights Avoid sedatives, hypotensive agents Walking aids (cane, walker) Consider referral to physical therapy

21 Calcium Intake Goal is to get as much as possible form dietary sources, supplementing to achieve the daily goal if necessary. Recommended daily intake: Age mg/day Age mg/day Age > mg/dl FOOD CALCIUM FOOD CALCIUM Turnip Greens, ½ cup 100 Plain Yogurt, 8 oz 400 Kale cooked 1 cup 100 Cheese, solid 1.5 oz 300 Cabbage, 1 cup 75 Sardines, 3 oz 325 Bread Slice 75 Milk, 8 oz 300 Tortilla, corn & flower 45 Tofu ½ cup 250 Broccoli ½ cup 25 Cottage Cheese 1 cup 140 Office of Dietary Supplements, National Institute of Health

22 Calcium Intake The optimal intake and utility of calcium supplements is controversial A Swedish study found both dietary and supplement calcium intake of > 1500 mg per day was associated with an increased mortality A Canadian study of 0ver 9,000 subjects found an increased survival advantage to those taking supplements Studies suggest dietary calcium may be preferred over supplements. Total calcium intake should not exceed 1500 mg per day Office of Dietary Supplements, National Institute of Health

23 Vitamin D Recommendations There is considerable disagreement among experts as the optimal and safe upper doses FOOD Vit D Goal Blood Levels of Vit D Ng/dl Cod Liver Oil 1 Tbs 1360 Deficiency <15 Swordfish, 3 oz 566 Insufficiency Salmon, 3 oz 447 Adequate Tuna, 3 oz 154 High Milk, 8 oz 120 Potentially Harmful >150 Egg yoke, 1 40 Institute of Medicine: Age < units/day Age > units/day Safe Maximum dose: 4,000 u/d Maintain 25-OH D levels at least ng/ml Office of Dietary Supplements, National Institute of Health

24 Other Supplements Magnesium may be beneficial in those using proton pump inhibitors or diuretics long term Vitamin A, K and phytoestrogen Excessive vitamin A, > 10,000 iu/d, should be avoided as it has been shown to have detrimental effects on bone Data on Vitamin K is inconclusive not recommended Phytoestrogens/ isoflavones No evidence of benefit NOT recommended Caffeine high intake associated with increase fractures Protein Adequate protein intake of ~ 0.8 g/kg /day Office of Dietary Supplements, National Institute of Health

25 AACE Osteoporosis Practice Guidelines-2016 Q4: Who needs treatment for Osteoporosis? 1. Patients with low bone mass and a history of fragility fracture of the hip or spine 2. Patients with a T-score of 2.5 or lower in the spine, femoral neck, total hip or 33% radius 3. Patients with a T-Score between-1.0 and 2.5 if the FRAX 10 year probability for major osteoporotic fracture is > 20%, or the hip fracture risk is > 3%. (US country specific recommendations) Endocrine Practice Vol 22 (Suppl 4) September 2016

26 Q5 What Osteoporosis Medications should be used? 1. Approved agents with efficacy to reduce hip, non-vertebral and spine fractures 1. Alendronate, Residronate, Zolendronate, & Denosumab are appropriate as initial therapy 2. Teriparatide, Denosumab, or Zolendronate should be considered for patients unable to use oral therapy 3. Denosumab is the agent of choice for patients with CKD 4. Raloxifene or Ibandronate may be appropriate in some cases where patients requiring drugs with spine-specific efficacy 5. Calcitonin (increases cancers) and Strontium ( increased CV risk) therefore their use is not recommended 6. Estrogen use for non skeletal benefits will also serve to help prevent postmenopausal bone loss Endocrine Practice Vol 22 (Suppl 4) September 2016

27 Anti-fracture Efficacy of Current Therapies Type of Fracture Therapeutic Options for Fracture Prevention in PMO Women 1 * Alendronate Bisphosphonates Risedronate Antiresorptive Therapy Zoledronic Acid Denosumab Raloxifene Estrogen * (Hormone Therapy) Bone Formation Therapy Teriparatide Vertebral Hip - - Nonvertebral - * Based on GRADE A evidence as assessed in the Osteoporosis Canada 2010 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada For postmenopausal women, indicates first line therapies and Grade A recommendation. Hormone therapy (estrogen) can be used as first-line therapy in women with menopausal symptoms. In Clinical trials, non-vertebral fractures are a composite endpoint including hip, femur, pelvis, tibia, humerus, radius, and clavicle. 1. Papaioannou A, et al. CMAJ. 2010;182:

28 Mechanism of Action of Available Osteoporosis Therapies Osteoclast Precursors Estrogen therapy Selective estrogen receptor modulators Hormones Multinucleated Osteoclast RANKL RANK Bisphosphonates Binds to bone; inhibits osteoclasts Teriparatide PTH analog Denosumab RANK Ligand inhibitor Osteoblast Osteoclast Adapted from: Boyle WJ et al. Nature 2003; 423:

29 Safety and Tolerability of Available Treatments Bisphosphonates Denosumab Raloxifene Teriparatide Hypocalcemia* Hypocalcemia* Vasodilation Transient orthostatic hypotension GI symptoms Postmarketing reports of musculoskeletal pain Infections (serious events 4.1% vs. 3.4% placebo) Dermal events (10.8% vs. 8.2% placebo) Osteonecrosis of jaw Osteonecrosis of jaw Stroke Venous thromboembolism ( risk vs. placebo) Lipid and triglyceride monitoring Osteosarcoma (only observed in animal trials, not clinical trials) Urolithiasis Atypical Fracture (rare) Atypical Fracture (rare) Renal impairment ** Atrial fibrillation (2.5% vs. 1.9% placebo) Suppression of bone turnover * Correct with adequate calcium & Vitamin D intake prior to initiating therapy. Rarely, oral bisphosphonates have been associated with severe esophageal events. Uncommon; mostly with cancer patients and/or dental procedures. Consider risk/benefit balance for women with a history of stroke or risk factors for stroke or venous thromoboembolism. Urinary calcium monitoring should be considered for patients with active urolithiasis and hypercalciuria. ** Recommended that all patients have their renal function assessed prior to treatment. Refer to respective Product Monographs for full Prescribing Information.

30 Osteonecrosis of the Jaw (ONJ) Bisphosphonate-Related Osteonecrosis of the Jaw Frequency: 1:1,700 to 1:20,000 Risk factors: Dento-alveolar surgery Steroid therapy Chemotherapy High dose Bisphosphonate Duration of therapy Treatment Avoid surgical manipulation Antibiotics

31 Atypical Subtrochanteric Femur Fracture Ask about new thigh or pelvic pain Plain X-ray of the femur best screening tool Discontinue antiresorptive Consider prophylactic rodding Some recommending teriparatide therapy

32 Is your patient afraid to take their medication? Help put patient concerns in perspective Fatal motor vehicle accidents 8.4/100,000 person/year 1 Murder 1.8/100,000 person/year 2 ONJ* <1/100,000 pts/year 3 Atypical fracture** 2/100,000 pts on 2 yrs BPs 113.3/100,000 pts on 8 yrs BPs 4 For every 100 hip fractures prevented there is 1 atypical femur fracture 5 *The risk of ONJ is higher among cancer patients treated with high doses anti-resorptives 6 **Reports of AFF have also been documented with other osteoporosis therapies 7-8 and in patients who have never received BP therapy 9 1. Transportation Canada Casualty Rates Statistics Canada Homicide Rate Khan A, et al.j Rheumatol. 2011;38: Dell R, et al. JBMR (12): Wang et al JBMR 2011; 26: Khosla S et al. JBMR 2007:22: Kim SY et al. JBMR. 26(5): Amgen, data on file. 9. Shane E et al. JBMR 2010; 25:

33 AACE Osteoporosis Practice Guidelines-2016 Q7: What is successful treatment? Successful treatment is defined as stable or increasing BMD with no evidence of new fractures For patients taking antiresorptive agents target for success is Bone turnover at or below median value for PM women Consider alternative therapy or reassessment for secondary causes in those who have recurrent fractures or significant bone loss

34 AACE Osteoporosis Practice Guidelines-2016 Q8: How long should patients be treated Treatment with teriparatide should be limited to 2 years For Oral bisphosphonates, consider a bisphosphonate holiday after 5 years of stability in moderate risk patients For oral bisphosphonates, consider a bisphosphonate holiday after 6-10 years of stability in higher risk patients For IV zolendronic acid, consider a drug holiday after 3 annual doses and in moderate risk patients, and after 6 doses in higher risk patients Teriparatide or raloxifene may be considered during bisphosphonate holidays A holiday is NOT recommended with Denosumab Resume therapy in those at high risk for fracture after two years of Drug Holiday Endocrine Practice Vol 22 (Suppl 4) September 2016

35 BMD Efficacy of Long-term Treatment* In long term trials, BMD continues to increase or remains stable Medication Pivotal Study Extended Treatment Duration (yrs) # of Participants % Change Lumbar Spine BMD Ŧ % Change Total Hip BMD Ŧ Risedronate 1 VERT-MN Alendronate 2 FLEX Zoledronic Acid 3 Denosumab 4 HORIZON ( Analysis of 9 year study) FREEDOM (Analysis 10 year study) / * Not head to head analyses: Results cannot be compared due to differing study populations and methodologies. Ŧ Represents % change from BL of Pivotal Trial. Represents 10 mg dose only. 1. Mellstrom D et al. Calcif Tissue Int 2004;75: Bone HG et al. N Engl J Med 2004;350: Black DM, et al. J Bone Miner Res. 2012; 27(2): Brown JP, et al ACR Annual Meeting. Presentation L8

36 AACE Osteoporosis Practice Guidelines-2016 Q9: What About Combination Therapy? AACE does not recommend combination therapy Estrogen given for menopausal symptoms or raloxifene for prevention of breast cancer may be used with other agents Combined Denosumab and teriparatide achieves greater BMD increases but no fracture data is available

37 AACE Osteoporosis Practice Guidelines-2016 Q10: Should sequential Therapy be considered? Treatment with teriparatide should always be followed by anti-resorptive agents to prevent BMD decline Consider IV Zolendronate dose if Denosumab is discontinued

38 AACE Osteoporosis Practice Guidelines-2016 Q11: Should Vertebral Augmentation be considered for Compression Fracture? Vertebroplasty and Kyphoplasty are NOT recommended as first line treatment of vertebral fractures There is an unclear benefit on overall pain And the potential increased risk of vertebral fractures in adjacent vertebrae

39 AACE Osteoporosis Practice Guidelines-2016 Q12: When to refer to an Osteoporosis Specialist? When patient with normal BMD fractures Recurrent fractures despite receiving appropriate therapy When osteoporosis is unexpectedly severe Patients who experience fragility fracture may benefit form specialist care When the patient has conditions complicating therapy CKD, hyperparathyroid, hyperthyroid

40 Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial JAMA. 2016;316(7):

41 Abaloparatide vs Placebo Nonvertebral and Major Osteoporotic Fractures JAMA. 2016;316(7):

42 Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis Saag KG et al. N Engl J Med 2017;377: Note: FDA approval denied July 2017 due to CV safety concerns

43 Osteoporosis: A Major Public Health Issue Osteoporosis is a major health problem Patients at risk can be identified Safe and effective therapy is available 2-million-2 is too Many!

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