Talking to patients with osteoporosis about initiating therapy Deborah Sellmeyer, MD Director, Johns Hopkins Metabolic Bone Center Dept of Medicine, Division of Endocrinology Disclosure DSMB member for denosumab in glucocorticoid treated subjects study Page 1
General Approach: Assessment of Risk H & P assess for patient specific risk factors assess patient preferences factors that affect medication choices Walk the patient through DXA results spine hip forearm FRAX Developing a Plan Assess for causes of secondary osteoporosis Nutrition Calcium Vitamin D Protein (0.8g/kg/day) Overall good nutrition: lean protein/meet goals for fruit and vegetables Exercise: weight bearing activity, resistance training, posture, balance Does patient meet guidelines to consider medication BMD bone loss FRAX fragility fracture Page 2
Medication Need hip/non-spine protection bisphosphonates denosumab anabolic Risk limited to spine calcitonin raloxifene Particularly high risk/fractured on treatment teriparatide abaloparatide Glucocorticoids bisphosphonate teriparatide Medication specifics Bisphosphonates fracture risk 50-60% spine, 40-50% hip Oral ~20% of pts UGI side effects difficult to absorb: review dosing instructions IV 25% acute phase reaction after 1 st dose may be reduced with acetaminophen pre-tx mortality after hip fracture Both <0.5% risk of ONJ 1:50,000 risk atypical fracture with long term treatment protection after stopping medication holidays Page 3
Medication specifics denosumab fracture risk 60% spine, 40% hip skin side effects rashes, eczema <0.5% increased risk of serious skin infections UTI risk may be increased similar risk of rare side effects to bisphosphonates <0.5% risk of ONJ 1:50,000 risk atypical fracture with long term treatment unlike bisphosphonates, rapidly reversible need to receive doses on schedule need to change to bisphosphonate prior to medication holiday or use continuous therapy Medication specifics calcitonin 25% spine fractures, no data for other fractures early agent clinical trials less robust than other options 6% mild nose irritation raloxifene 35% spine fractures, does not reduce fx at other sites risk invasive breast CA risk of thrombosis similar to OCP risk of death due to stroke in postmenopausal women with CAD hold for 72 hrs prior to air travel/immobility hot flashes need to take continuously; no ONJ or AFF Page 4
Case #1 70 y/o woman, known low bone density for 8 years, concerned about medication side effects No fractures No family history of osteoporosis or hip fracture + celiac disease, on gluten free diet, + reflux, constipation Consumes 2-3 servings Ca rich food/day Walks 10,000 steps/day Meds: Vit D 2000 IU, statin, H 2 blocker, ASA PE: mild thoracic kyphosis Case #1 DXA Lumbar spine T-score -3.1 Femoral neck T-score -2.0 Total hip T-score -1.6 FRAX hip fracture risk = 1.6% Recommendations? Page 5
Nutrition: Calcium: OK Vitamin D: OK Protein: OK Gluten free: OK Case #1 Physical activity: Weight bearing activity: OK Consider adding resistance activities Exercise program to reduce kyphosis Stand Tall: Anthony.Casino@ucsf.edu PT referral Assess for secondary osteoporosis, ensure TTG IgA low Vertebral imaging Case #1: Medication? Meets guidelines for pharmacologic therapy based on lumbar spine T-score of -3.1 Options: calcitonin raloxifene oral bisphosphonate IV bisphosphonate denosumab anabolic Page 6
Case #2 60 y/o woman, low bone density dx 2009 risedronate 2009-2011, stopped due to concern about side effects no fractures type 1 DM, insulin pump, A1C 7.8%, + nephropathy frequent UTIs, one episode nephrolithiasis FH: maternal aunt kyphosis,? vert fx Meds: vitamin D 1000-2000 IU/day, calcium 500 mg bid, insulin, ACE 1-2 servings calcium rich food/day Body Pump class at gym three times/week PE: unremarkable Case #2 DXA Lumbar spine T-score -0.5 Femoral neck T-score -2.5 Total hip T-score -1.9 FRAX: Major osteoporotic fx: 11% Hip fx: 2% Recommendations? Page 7
Case #2 screen for causes of secondary osteoporosis urine calcium 172 mg/24 hrs serum Cr 0.78, egfr 83 Ca 9.2, phos 3.7 PTH 53 Nutrition: calcium: high, decrease suppl to 500 mg/day vitamin D: OK protein: OK glycemic control: review with diabetologist Physical activity: consider 30 mins walking on days not at the gym Case #2: Medication? Meets guidelines for pharmacologic therapy based on femoral neck T-score of -2.5 FRAX estimated risk low uses femoral neck BMD does not include DM as a risk factor Options: calcitonin raloxifene oral bisphosphonate IV bisphosphonate denosumab anabolic Page 8
Case #3 88 y/o woman, known low bone density since 2001 previously tried alendronate and risedronate discontinued due to UGI symptoms no fractures no FH osteoporosis or hip fracture PMH: GERD, CAD, HTN, arthritis, glaucoma meds: vitamin D 600 IU, calcium 500 mg, MVI, beta blocker, eye drops participates in senior exercise class 2-3x/week 1 serving calcium rich food/day PE: unremarkable Case #3 DXA: Lumbar spine not available due to DJD Femoral neck T-score -3.3 Total hip T-score -2.4 1/3 forearm T-score -4.2 Recommendations? Page 9
Case #3 Nutrition: Calcium: prob OK, check calcium content of MVI Vitamin D: OK Protein: OK Review general goals for fruit/veg Physical activity: Encouraged continued participation in Senior exercise classes Fall prevention strategies Assess for causes of secondary osteoporosis, particularly PTH given 1/3 forearm BMD Case #3: Medication? Meets guidelines based on femoral neck and 1/3 forearm BMD values Options: calcitonin raloxifene oral bisphosphonate IV bisphosphonate denosumab anabolic Page 10
Case #4 59 y/o woman, low bone density since 2006 wrist fracture 2016 with fall from standing height hx breast cancer, on aromatase inhibitor, planning for 3 more years of tx vegetarian, consuming 1 serving Ca fortified almond milk, 3-4 servings/day cruciferous vegetables +FH osteoporosis: mother, no fractures Meds: vitamin D 2000 IU, calcium 500 mg, aromatase inhibitor Torn meniscus limited weight bearing activity Tooth being watched, may need procedure/extraction PE: unremarkable Case #4 DXA: lumbar spine T-score -2.1 ( 6% over 2 years) femoral neck T-score -2.8 ( 8% over 2 years) total hip T-score -2.2 ( 8% over 2 years) Recommendations? Page 11
Case #4 Nutrition: Calcium: OK Vitamin D: OK Protein: low recommended increased protein to meet RDA of 0.8 g/kg/day Vegetarian/vegan: ensure B12 adequate Physical activity: limited at present, recommended walking program and resistance exercises as able Assess for causes of secondary osteoporosis, B12 level Case #4: Medication? Meets guidelines for pharmacotherapy by BMD, also has ongoing bone loss Needs to continue aromatase inhibitor Possible dental procedure Options: calcitonin raloxifene oral bisphosphonate IV bisphosphonate denosumab anabolic Page 12
Case #5 64 y/o woman with known low bone density for five years no fractures, no FH osteoporosis or fractures PMH: RA and CREST, on glucocorticoids since 2005, currently on prednisone 10 mg/day previously tx with biologics: infections including parotid consuming goat yogurt, almond milk 16 oz/day, greens meds: vitamin D 15,000 IU/day, calcium 100 mg/day, amlodipine, vitamin B, vitamin C, PPI, NSAID, prednisone, L-thyroxine, biotin PE: findings consistent with RA, palpable subcutaneous calcifications extensor surfaces UEs, facial fullness Case #5 DXA Lumbar spine: T-score -1.7 ( 12% over 3 years) Femoral neck: T-score -2.3 ( 9% over 3 years) Total hip: T-score -2.1 ( 7% over 3 years) FRAX: Major osteoporotic fx: 13% Hip fx: 2.8% Recommendations? Page 13
Case #5 Nutrition: Calcium: d/c supplements Vitamin D: check level, likely will need to decrease Protein: OK Review general recommendations for fruit/veg Physical activity: walking program, resistance exercises as tolerated Assess for causes of secondary osteoporosis Case #5: Medication? Ongoing bone loss, on glucocorticoid therapy Options: calcitonin raloxifene oral bisphosphonate IV bisphosphonate denosumab anabolic Page 14
Questions? Page 15