Bone Health for Women: Current Research, Initiatives and Recommendations

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Page 1 BONE HEALTH FOR WOMEN: CURRENT RESEARCH, INITIATIVES AND RECOMMENDATIONS Dr. Melissa Kagarise This program has been brought to you by PharmCon PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity. Bone Health for Women: Current Research, Initiatives and Recommendations Accreditation: Pharmacists: 0798-0000-10-056-L01-P CE Credits: 1.0 contact hour Target Audience: Pharmacists Program Overview: This program will assist pharmacists in understanding current research, initiatives and recommendations regarding bone health for women. It will also enhance pharmacists knowledge of available options and inform of potential adverse effects of osteoporosis treatment. The program includes information on pharmacologic treatments, patient counseling, and a question/answer period. Objectives: Describe musculoskeletal epidemiology and pathophysiology as it relates to bone health, specifically osteoporosis. Outline emerging evidence of the role of Vitamin D in bone health Identify pharmacologic and non-pharmacologic interventions to support women s bone health, including potential adverse effects of osteoporosis treatment Describe the pharmacists role in supporting patients bone health through evidence based patient education strategies. This program has been brought to you by PharmCon Bone Health for Women: Current Research, Initiatives and Recommendations Objectives Speaker: Dr. Melissa Kagarise is a primary care physician assistant who practices at a free medical clinic in Altoona, PA. She obtained her physician assistant degree through SFU and completed her doctoral studies in health sciences through Nova Southeastern University. Speaker Disclosure: Dr. Kagarise has no actual or potential conflicts of interest in relation to this program This program has been brought to you by PharmCon PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity. Review musculoskeletal epidemiology and pathophysiology as it relates to bone health, specifically osteoporosis. Discuss emerging evidence of the role of Vitamin D in bone health. Identify pharmacologic and non-pharmacologic interventions to support women s bone health, including potential adverse effects of osteoporosis treatment. Review the pharmacists role in supporting patients bone health through evidence based patient education strategies.

Page 2 Bone Facts Definitions 206 33 12 5 12 20 65 200 M 1.7 M 6.3M $17 B $50 B Bones in the body Bones in the spine Thoracic vertebrae Lumbar vertebrae Weeks for bone to heal Age of peak bone mass Age for significant fracture risk Women diagnosed with osteoporosis Annual incidence of osteoporotic fx Expected incidence of hip fx by 2050 Annual cost Expected annual cost 2040 Bone Mineral Density (BMD) The average mineral concentration of a bone Osteopenia A decrease of BMD normally found (1-2.5 SD below) Osteoporosis Decreased bone mass predisposing to fracture (>2.5 SD below ) Pathophysiology Normal Bone vs. Osteoporotic Bone Osteoblast- build new bone mineral Osteoclast- dissolves bone mineral Bone Mass Age of occurrence Rapid Increase Puberty-teenage Peak Late 20 s to early 30 s Annual Loss of 0.5% - 1% Annual loss of 1%-3% Return of annual loss to 0.5% -1% Mid 30 s to early menopause 5-10 years around menopause Thereafter

Page 3 Risk Factors Risk Factors Risk Factors Clinical Medical Risk factors Aging Low body weight Low body fat Low serum estrodiol Hx of previous fracture Medications Glucocorticoids Anticonvulsants Benzodiazepines Heparin SSRI Rosiglitazone (Avandia) GI, hematologic and hypogonadal disorders Behavioral Nutritional Genetic Cigarette smoking Low physical activity Alcohol Dietary Calcium Diuretics Corticosteroids Anticonvulsants NSAID Antibiotics Vitamin D High protein, caffeine and sodium diet Women White and Asian Small body frame Maternal history of fx Diseases Fracture Risk Assessment Tools Case Study Fracture Risk Algorithm (FRAX) http://www.shef.ac.uk/frax/ FORE Fracture Risk http://riskcalculator.fore.org/ Women's Health Initiative (WHI) Hip Fracture Risk Calculator hipcalculator.fhcrc.org Mrs. Smith is a 57 yowf being seen for a regular check up. She states that she is doing well without complaints. PMHx: Type 2 DM controlled with Avandia 4mg qd; OA controlled with Motrin 400mg tid Social Hx: Smoker 1ppd x 40 years Past Surgical Hx: TAH/BSO at age 50 Fam Hx: Positive hip fx maternal mother

Page 4 Case Study Diagnosis Which of the following places Mrs. Smith at higher risk for osteoporosis? A. Smoker B. Avandia use for DM C. Maternal history of fracture D. All of the above Dual energy x-ray absorptiometry (DXA) T- score T-score Normal -1.0 Osteopenia -1.0 to -2.5 Osteoporosis < -2.5 Severe osteoporosis < -2.5 with fx Z- score Diagnosis Management Quantitative Ultrasound (QUS) Quantitative CT Non-Pharmacologic Pharmacologic Categories Calcium and Vitamin D Physical Activity Fall Prevention Social factors Physical medicine and Rehab Bisphosponates Calcitonin Estrogen SERMs Parathyroid Biologic

Page 5 Non-Pharmacologic Treatment Non-Pharmacologic Treatment Calcium 1,200 mg/day Vitamin D 800-1,200 IU per day Serum 25 (OH) D >30ng/ml Vitamin D fortified milk, cereal, egg yolks, salt-water fish and liver Sun exposure Weight bearing exercise Walking, jogging, Tai-Chi, stair climbing, dancing, tennis 30 minutes Avoidance of smoking and excessive alcohol Fall prevention Dietary Supplements : D 2 vs D 3 Interactions: Steroids, Xenical, alli, Questran, LoCholest, Prevalite, Dilantin Bisphosphonates Osteonecrosis of the Jaw Alendronate (Fosamax) Risedronate (Actonel) Ibandronate (Boniva) Drug Dose Side Effects 35-70mg po weekly 5-10mg po daily 30-35mg po weekly 5mg po daily 150mg po monthly 150mg po monthly 2.5mg po daily 3mg IV q3 months Esophagitis Myalgias Osteonecrosis of jaw Same as above Same as above Flu-like symptoms Jaw bone (osteo-) damage and death (-necrosis) occurs as a result of reduced local blood supply (ischemia) Dental extractions or trauma to the jaw d/c Bisphosphonate prior to dental surgery until healed Zoledronic acid (Reclast) 5mg IV yearly infusion Same as above Mild transient hypocalcemia Atrial fibrillation

Page 6 Calcitonin (Miacalcin or Fortical) Estrogen Inhibits osteoclast activity. Indicated in women who have been postmenopausal for >5years. Painful osteoporotic fractures 200 IU/day intranasal Slows bone loss after menopause Estrogen Therapy Climara, Estrace, Estraderm, Estratab, Ogen, Ortho-Est, Premarin, Vivelle Hormonal Therapy Activella, Femhrt, Premphase, Prempro Contraindications: Breast/uterine cancer Poor liver function or disease History of blood clots Selective Estrogen Receptor Modulator (SERM) Reloxifene (Evista) 60 mg once daily Targeted actions in bone, breast, endometrium and in lipid metabolism Risks Deep venous thrombosis Pulmonary embolism Parathyroid Hormone Teriparatide (Forteo) 20 µg/day SQ injection Treatment should not exceed 2 years duration Side Effects Mild transient hypercalcemia Nausea Headache

Page 7 Denosumab (Prolia) Case Study cont. Inactivates the body's bone-breakdown mechanism 60 mg SQ injection every 6 months Calcium 1000 mg daily and Vitamin D 400 IU daily Adverse reactions: Hypocalcemia back pain, pain in the extremities Hypercholesterolemia Cystitis Mrs. Smith had a score of -1.8 on her central DXA scan. Based on her score and history, which treatment should be initiated? A. No treatment required at this time B. Non-weight bearing exercise and regular NSAID use C. Calcium, Vit. D & Bisphosphonate therapy D. Forteo & Bisphosphonate therapy concurrently Therapy Monitoring Additional Research Central DXA Every 2 years Biochemical markers of bone turnover Formation and Resorption Markers Can monitor response to pharmacologic treatment Changes observed within 3-6 months of therapy Magnesium Statins Protein Oligofructose enriched inulin Wheat, onions, garlic, bananas, leeks, chicory root Vitamin B12 Vitamin C