Management of Osteoporosis Stephanie Fegley, FNP Department of Orthopaedic Surgery Christiana Care Health Services March 28, 2014

Objectives: Identify populations at risk for low bone density or osteoporosis. Recognize when it is appropriate to order a Bone Density Scan (DXA) with or without Vertebral Fracture Assessment (VFA). Select appropriate pharmacologic agent for osteoporosis management based on past medical history and side effect profile. Utilize “fragility fracture panel” to help rule out secondary causes of osteoporosis.

Nearly an epidemic Reflects the amount of FF per year in the U.S. More than MI, CVA & breast cancer combined.

Cast Mountain

Statistics At least 44 million Americans are affected by osteoporosis or low bone density. Due to an aging population, the number of Americans with osteoporosis or low bone density is expected to increase significantly. Up to ½ of all women will suffer a FF during their lifetime Up to ¼ of all men will suffer a FF during their lifetime

NOF 2 Million 2 Many Campaign

Cost of Osteoporosis Direct care expenditure from osteoporosis-related fractures exceeds $19 billion annually. By 2025, the annual cost of fractures is projected to grow to more than $25 billion, as annual fractures surpass 3 million.

Painful, yet undertreated Approximately 80% of patients do not receive recommended osteoporosis care following a fragility fracture. Men, who account for 30% of fractures & 25% of cost, are particularly undertreated.

“No one’s ever died from osteoporosis” Nearly 25% of patients who suffer a hip fracture die within a year. Those who do survive experience significant morbidity, as many experience a loss of independence & may require long-term nursing home care. Others never return to their baseline mobility, and will have to ambulate with a walker or cane & are at increased risk of future falls & fractures.

Provide a “Teachable Moment” According to AOA, a fragility fracture should be treated as a sentinel event. This will provide opportunities or clinicians to educate patients, fellow physicians & other healthcare providers about the importance of bone health and osteoporosis treatment. The best time to talk to your patient about a fragility fracture and the likelihood of Osteoporosis is while the fracture is fresh.

Fracture Cascade About 50% of people with one fracture due to Osteoporosis will have a repeat fracture. The risk of fracture rises with each new fracture, hence the “cascade effect” Women who have a vertebral fracture are 4x more likely to have another fracture within the next year, compared to women who have never fractured.

Pathophysiology Age-related changes in bone microarchitecture: Decreased bone volume Decreased trabecular thickness Decreased trabecular number Decreased connectivity Decreased mechanical strength Increased cortical porosity

Populations at risk… HIV/AIDS Ankylosing spondylitis Blood & bone marrow disorders Breast cancer Cushing’s syndrome Eating disorders Emphysema Female athlete triad Gastrectomy Gastrointestional bypass procedures Hyperparathyroidism Hyperthyroidism Idiopathic scoliosis Inflammatory bowel disease Diabetes mellitus Kidney disease Lupus Lymphoma & leukemia Malabsorption syndromes (i.e.- Celiac & Crohn’s disease) Multiple myeloma Organ transplants Parkinson’s disease Poor diet

More at Risk Populations… Post-polio syndrome Premature menopause Prostate cancer Rheumatoid arthritis Severe liver disease Spinal cord injuries Cerebral Vascular Accident Thalassemia Thyrotoxicosis Weight loss

Medications that will Increase Risk… Oral glucocorticoids Anticonvulsants PPIs SSRIs TZDs Lithium Aromatase Inhibitors Gonadotropin-releasing hormone agonists Chemotherapy Heparin Depo-Provera

Other Factors that Increase Risk Low dietary Calcium intake Vitamin D Insufficiency or Deficiency Tobacco use in the past 12 months Consuming > or = 3 units of alcohol per day Sedentary lifestyle 2 or more falls in the past year Moderate to high caffeine intake

Cheap ways to tell if your patient is at an increased risk for fragility fracture: Prior history of fracture after age 50 or >, at fall from standing height or less One of the “At risk populations” Is/has been taking one of the medications that increase risk Tobacco abuse Drinks > or = 3 units of alcohol per day Sedentary lifestyle History of > or = 2 falls in the past year Check a FRAX http://www.shef.ac.uk/FRAX/tool.aspx?country=9

Fracture Risk Assessment Tool (FRAX) Tool developed by the World Health Organization (WHO) to calculate fracture risk in patients, by combining clinical risk factors with BMD, to generate a 10 year probability of fracture. 10 year probability of hip fracture 10 year probability of major osteoporotic fracture (spine, forearm, or shoulder fracture)

When not to use FRAX: When the patient has already had a hip fracture When they have been on treatment for Osteoporosis in the past 2 years Less than 40 years old Most DXA reports will include a FRAX score at the end, if not contraindicated. This is to help the provider determine if treatment is necessary.

DXA Report with Inappropriate use of FRAX

Recommendations for when to order a DXA: Women age 65 years and older and men age 70 and older. Women under 65 and men age 50-69 about whom there is concern based on clinical risk factor profile or FRAX score. Women and men of any age who have suffered a low-impact fracture. Women and men of any age who are at increased risk as a result of selected medical conditions or treatment with specific medications.

DXA Guidelines DXA should be “Central DXA”, with lumbar spine & hips (preferably both hips) scanned. DXA should be interpreted in accordance with International Society for Clinical Densitometry (ISCD) The final diagnosis from DXA is based on the lowest t-score from the spine, proximal femur, or femoral neck, whichever is lowest. Diagnosis from DXA in premenopausal women and men under age 50 is based on z-scores and is reported as normal or low bone density for age.

DXA Guidelines (cont.) Evaluation of the forearm(s) should be performed if the evaluation of the spine or hip(s) is limited or nondiagnostic. Absolute fracture risk assessment using FRAX should be included in DXA reports for appropriate patients.

Vertebral Fracture Assessment (VFA) Lateral spine imaging with densitometric VFA is indicated when lowest t-score from DXA is <1.0 and or more of the following is present: Women age >/= 70 years or man age >/= 80 years Historical height loss > 4cm (> 1.5 inches) Self-reported but undocumented prior vertebral fracture Glucocorticoid therapy equivalent to >/= 5mg prednisone or equivalent per day for >/= 3 months.

How should you write your script? Write to perform a “DXA with VFA” or “DXA with VFA, if indicated” Things to consider: The patient has to lay on their side to have the VFA performed, so if they have a recent fracture, this may be too difficult/painful. Insurance coverage

Guidelines for follow-up DXA Insert Table 1 from CMG

Defining Osteoporosis by BMD Insert table 2 from CMG

Deciding when to treat using FRAX: According to the WHO, you should consider a pharmacologic agent if: 10 year probability of a hip fracture is > 3% 10 year probability of major osteoporotic fracture (spine, forearm, or shoulder fracture) is > 20%

Important Physical Exam Findings Eyes- Sclera Mouth- Teeth~ In OI can be normal or soft & translucent. Also if you are considering bisphosphonate or Prolia therapy you want to evaluate their dentition to determine increased risk for ONJ. Musculoskeletal- Postural changes such as kyphosis, “lengthening of the arm-trunk axis” (describes shortening of the trunk w/ comparatively long extremities) & tenderness of the spinous processes Gait- Try and sneak a peek at them walking in or out of the exam room. Can they get up from a chair without using their hands? Scars- Fracture repairs they have forgotten about BMI < 18 increases risk Height at every office visit!

Determining the cause… Once you make the diagnosis, don’t forget to rule out secondary causes! Fragility Fracture Panel: Serum Creatinine Calcium Albumin Phosphorus Alkaline phosphatase (ALP) Thyroid Stimulating Hormone (TSH) Vitamin D 25-OH Intact Parathyroid Hormone (iPTH)

Vertebral Compression Fractures Approximately two-thirds are never diagnosed, because they are written off as pain associated with aging or arthritis. Think about the cascade Loss of height (more than 3cm/just over 1 inch) Sudden severe back pain in the mid & lower spine Increased stoop or ‘dowager’s hump’

Conservative Treatment for Compression Fxs Self-Care at home: Rest Pain relief with NSAIDs May also need muscle relaxants Ice for 20 minutes every 60 minutes for the first week, then can do heat or ice, which ever feels better. Physical therapy, when permitted~ with emphasis on stretching & strengthening program to decrease risk for further osteoporosis and strengthen muscles supporting the back.

Conservative Treatment for Compression Fxs Hospital Admission: Inpatient treatment dependant upon pain control, weakness, ambulatory dysfunction, urinary retention, & cauda equina syndrome. TLSO (Thoracolumbosacral Orthosis) brace as needed, when out of bed for comfort. Rest Pain relief with opiates (usually hydrocodone or oxycodone) May also need muscle relaxants Ice for 20 minutes every 60 minutes for the first week, then can do heat or ice, which ever feels better. Physical therapy, when permitted~ with emphasis on stretching & strengthening program to decrease risk for further osteoporosis and strengthen muscles supporting the back.

Kyphoplasty

Vertebral Compression Fracture Posture

Consequences of Vertebral Compression Fractures Kyphosis Loss of height Bulging abdomen Acute & chronic back pain Breathing difficulties Depression Reflux & other GI symptoms Limitation of spine mobility (affecting ADL & ambulation) Need to use walking aid

Own the Bone Launched by the American Orthopaedic Association (AOA), to help providers drastically improve efforts of fracture prevention. Christiana Care Health System have been participating in the Own the Bone Registry since January 1, 2012. OTB focuses on 10 measures for the patient with a history of a fragility fracture

10 Own the Bone Measures Calcium supplementation Vitamin D supplementation Weight-bearing & muscle-strengthening exercise Fall prevention education Smoking cessation Limiting excessive alcohol intake Pharmacotherapy Ordering DXA Physician referral letter to report the patient’s fragility fracture, risk factors, & recommendations for treatment. Patient education latter to explain bone health risk factors & recommendations for treatment.

Which is the best Calcium? The majority of these patients should be told to consume 1200mg of calcium per day between diet and supplement combined. Dietary intake of calcium from food sources should be encouraged as much as realistically possible & fill the gap with a Ca supplement when necessary.

Food Sources of Calcium Lowfat & non-fat dairy products are high in calcium while certain green vegetables and other foods contain calcium in smaller amounts. Calcium fortified foods- Orange juice, cereals, soymilk, English muffins, waffles, breads, snacks, & bottled water.

Foods that Reduce the Absorption of Calcium Foods with high amounts oxalate & phytate reduce the absorption of Ca contained in those foods. Foods high in oxalate= spinach, rhubarb & beet greens Foods high in phytate= legumes (pinto beans, navy beans, peas), 100% wheat bran* (*space >/= 2 hours after eating foods that contain bran) You can reduce the phytate level to get more Ca from legumes by soaking them in water for several hours, discarding the water, & then cooking them in fresh water.

Calcium Side Effects Gas or constipation may occur from Ca supplements Some patients complain of nausea Patient’s should increase fluids & fiber in their diet, but if that does not help, they should try another type or brand of Ca. When starting a new Ca supplement, start with smaller amounts & drink an extra 6-8 ounces of water with it, then gradually add more Ca each week.

Calcium Supplementation There are many different types of calcium salts (i.e. glubionate, gluconate, lactate, citrate, acetate, phosphate, & carbonate) Calcium Carbonate (40% elemental Ca) Viactiv, Caltrate, Oscal, Tums, numerous store brands 300-600mg of calcium per pill Requires hydrochloric acid for best absorption, therefore remind patients to take with meals. Calcium Citrate (21% elemental Ca) **May need 2 pills per dose Citracal, some store brands 200-300mg of calcium per pill Does not requires hydrochloric acid for absorption, so it can be taken with or without food. Calcium Phosphate (39% elemental Ca) Posture Absorption is very similar to Calcium Carbonate

Is There a “Best” Calcium Salt? The data suggests that both Calcium carbonate & Calcium citrate, taken with meals, have equivalent bioavailability. If you have a patient on a H2 blocker, PPI, or you know has achlorhydria and supplements won’t be taken with meals, Calcium citrate is a better choice. Calcium carbonate is cheaper Calcium phosphate is equivalent to Calcium carbonate in supporting bone building. Study suggests that Calcium citrate has better availability than Calcium carbonate after roux-en-Y gastric bypass.

Calcium Supplements Most important factors are those predicting long-term use: palatability, cost, tolerance Advertised “differences” more apparent than real Magnesium may be helpful with constipation Calcium chews contain Vitamin K- ** Caution in patients taking Coumadin

Why is Vitamin D so Important? Vitamin D is essential for adequate gastrointestinal absorption of calcium. Insufficient amounts of vitamin D over time reduces serum calcium levels and can trigger a compensatory release of parathyroid hormone. This may produce secondary hyperparathyroidism, resulting in mobilization of calcium from the bone and a reduction in bone mineral density.

What is the Best Level to Check for Vitamin D Status? 25-OH Vitamin D level is best 1,25 OH2 Vitamin D levels are useful in chronic kidney disease, primary hyperparathyroidism, sarcoidosis, oncogenic osteomalacia, vitamin D-resistant rickets, pseudo- vitamin D deficiency rickets, and hypophosphatemic rickets

What Do the Results Mean? <10ng/mL Severe Vitamin D Deficiency 10-19ng/mL Vitamin D Deficiency 20-29ng/mL Vitamin D Insufficiency 30ng/mL Normal 40-60ng/mL Target range for someone with history of Osteoporosis with or without fracture

Health Risk Associated with Vitamin D Deficiency Ricketts Osteomalacia Precipitates & exacerbates Osteoporosis Increased risk of: deadly cancers, cardiovascular disease, Multiple Sclerosis, Rheumatoid Arthritis, & Type I DM Can also cause muscle weakness & increased risk for falls

Sources of Vitamin D Sunlight Food Supplements & Medications NOF recommendations: Adults < 50 years old: 400-800IU/day Adults >/= 50 years old: 800-1,000IU/day

Sunlight Solar ultraviolet B photons are absorbed by 7-dehydrocholesterol in the skin, leading to its transformation to previtamin D3, which is rapidly converted to vitamin D3. Season, latitude, time of day, pigmentation, aging, sunscreen use (even SPF of 8 reduces preduction by 95%), & glass all influence the cutaneous production of vitamin D3. People with fairer skin make more Vitamin D than people with darker skin. Once formed, vitamin D3 is metabolized in the liver to 25-hydroxyvitamin D3 and then in the kidney to its biologically active form, 1,25-dihydroxyvitamin D3.

Food Sources of Vitamin D It is extremely difficult to get all the Vitamin D you need from diet alone. Foods high in Vitamin D: fatty fish (i.e. mackerel, salmon, tuna, eel), egg yolks, & liver Vitamin D is added to the following foods: milk, some brands of orange juice, soymilk & cereals There is no Vitamin D in other dairy products like cheese, yogurt, or butter.

Cholecalciferol (Vitamin D3) Fat soluble; made from irradiation of 7-dehydrocholesterol from lanolin & the chemical conversion of cholesterol. Cholecalciferol 50,000IU is available from at least 1 manufacturer, it is often challenging to find in retail outlets. Mean time to peak= 14 days Also, these metabolites have a superior affinity for vitamin D-binding proteins in plasma, relative to ergocalciferol.

Ergocalciferol (Vitamin D2) Made from ultraviolet irradiation of ergosterol in yeast. Clinical studies indicate that vitamin D2 is much less potent & has a shorter duration of action than cholecalciferol. Ergocalciferol has been used historically to treat Vitamin D deficiency out of convention, or perhaps because high-dose ergocalciferol is more widely available in doses up to 50,000IU per softgel capsule from multiple manufacturers. In patients with severe deficiency, it is often difficult to raise 25-hydroxy vitamin D levels with ergocalciferol. Is 30% less potent than vitamin D3 & has markedly shorter duration of action Mean time to peak= 3 days

Populations at Risk for Low Vitamin D People who spend little time in the sun Sunscreen, clothing, hats, shade People with very dark skin Elderly people People living in nursing homes or other institutions People with certain medical conditions such as serious diseases of the nervous system or digestive systems People who are obese

Osteoporosis Treatment Osteoporosis medications can be classified into two main categories: Antiresorptives~ slow down bone destruction Bisphosphonates Calcitonins Estrogen agonists/antagonists Estrogen therapy (ET) & hormone therapy (HT) Receptor activator of nuclear factor KappaB ligand (RANKL) inhibitor Anabolics~ bone-building medication Parathyroid hormone

A Little Pathophysiology… Bone resorption by Osteoclasts Cells release an acid which dissolve collagen & the mineral coating of the bone Bone formation by Osteoblasts Cells that lay down new collagen to aide in formation of new bone tissue

Antiresorptives Most drug therapies work by decreasing the reabsorption of bone. At any given time there is bone that has been reabsorbed but not replaced & this accounts for 5-10% of bone mass. By decreasing reabsorption of bone, a gain in bone density of 5-10% is possible, taking about 2-3 years. However, no drug therapy will restore bone mass to normal.

Bisphosphonates Most commonly prescribed non-estrogen therapy; acts as an inhibitor of osteoclastic activity. May be beneficial in women who cannot tolerate ET. They are effective in inhibiting bone loss after menopause, since they slow down bone turnover. Unfortunately, this is also what puts these patients at risk for Atypical Femur Fracture (AFF)

Bisphosphonate Options Alendronate (Fosamax) Ibandronate (Boniva) Risedronate (Actonel) The 3 oral agents above must be taken on an empty stomach, 1st thing in the morning with no other medications. You must take with a full 8oz glass of water and remain upright for at least 30 minutes after swallowing pill. Risedronate (Atelvia) Zolendronic Acid (Reclast)

Alendronate (Fosamax) Dosing: 70mg weekly (osteoporosis men & women tx), 5mg daily (steroid-induced osteoporosis), 35mg weekly (osteoporosis prevention) Is available in a liquid 70mg/75mls weekly FDA approved for: 1) the prevention and treatment of Osteoporosis in postmenopausal women and men & 2) treating steroid-induced osteoporosis in men and women. Fracture prevention: Spine, hip & other bones Possible s/e: Joint, bone or muscle pain. Nausea, reflux, gastritis, or dysphagia. Hypocalcemia, Atrial Fibrillation, AFF, & ONJ. Renal dosing: CrCl <35; avoid use

Fosamax Plus D Dosing: 70mg/2800IU cholecalciferol, 70mg/5600IU cholecalciferol 1 tablet weekly for the treatment of osteoporosis in men or postmenopausal women. Fracture prevention: Spine, hip & other bones Possible s/e: Joint, bone or muscle pain. Nausea, reflux, gastritis, or dysphagia. Hypocalcemia, Atrial Fibrillation, AFF, & ONJ. Renal dosing: CrCl <35; avoid use

Ibandronate (Boniva) Dosing: 150mg pill monthly, 3mg IV every 3 months FDA approved for preventing and treating Osteoporosis in postmenopausal women only Fracture prevention: Spine only Possible s/e: Joint, bone or muscle pain. Nausea, reflux, gastritis, or dysphagia. Hypocalcemia, Atrial Fibrillation, AFF, & ONJ. After IV infusion flu-like symptoms, fever & headaches. Renal dosing: CrCl <30; avoid use (po), contraindicated (IV)

Risedronate (Actonel) Dosing: 35mg weekly (male & postmenopausal osteoporosis), 5mg daily (steroid-induced osteoporosis) FDA approved for: 1) the prevention and treatment of Osteoporosis in postmenopausal women and men & 2) treating steroid-induced osteoporosis in men and women. Fracture prevention: Spine, hip & other bones Possible s/e: Joint, bone or muscle pain. Nausea, reflux, gastritis, or dysphagia. Hypocalcemia, Atrial Fibrillation, AFF, & ONJ. Renal dosing: CrCl <30; avoid use

Risedronate (Atelvia) Dosing: 35mg DR weekly **Give with 8oz of water AFTER breakfast, remain upright x 30 min. FDA approved for preventing and treating Osteoporosis in postmenopausal women and men. Fracture prevention: Spine, hip & other bones Possible s/e: Joint, bone or muscle pain. Hypocalcemia, Atrial Fibrillation, AFF, & ONJ. Renal dosing: CrCl <30; avoid use

Zolendronic Acid (Reclast) Dosing: 5mg IV every 12 or 24 months FDA approved for preventing (24 mo) and treating (12 mo) osteoporosis in postmenopausal women and men. Treating steroid-induced osteoporosis in women and men. Fracture prevention: Spine, hip & other bones Possible s/e: Joint, bone or muscle pain. Nausea, reflux, gastritis, or dysphagia. Hypocalcemia, Atrial Fibrillation, AFF, & ONJ. Renal Dosing: CrCl <35; or acute renal impairment contraindicated Tip: If your patient has never been on prior bisphosphonate therapy, they will likely experience flu-like chills & body aches up to 48-72 hours after their first two infusions. This can easily be treated by taking Tylenol 650mg po every 4-6hrs ATC.

Denosumab (Prolia) Receptor activator of nuclear factor-KappaB ligand inhibitor (RANKL) Dosing: 60mg/ml SC every 6 months Nurse can inject in abdomen, thighs or upper arms FDA approved: Treating osteoporosis in postmenopausal women and men at high risk of fracture. Fracture prevention: Spine, hip & other bones Possible s/e: May increase risk of infection, rash, hyperlipidemia , AFF & ONJ Renal dosing: None; a great consideration for your patient with CRI or CKD, who is not on HD/PD.

Prolia Injection Sites

Other Prolia Tips Depending on the patient’s insurance, you may choose for them to bring their own medication from their pharmacy, go to an infusion center, or do a “buy & bill” from your office. Medication should be kept refrigerated, however once removed from the fridge it must be administered or discarded within 2 weeks Must be out of the fridge a minimum of 30 minutes before administration. Use of a specialty pharmacy will make the prior authorization process much easier Still takes about a month & numerous faxes/phone calls Cost= $856-1026.09 per injection

Osteonecrosis of the Jaw (ONJ) A confirmed case is defined as an area of exposed bone in the maxillofacial region that does not heal within 8 weeks after identification by a health care provider, in a patient who is currently receiving or has been exposed to a bisphosphonate, and has not had radiation therapy to the craniofacial region.

ONJ in Osteoporosis Patients Prevalence of ONJ in oral bisphosphonate users 0.10% Frequency of ONJ~ 0.01-0.04% of oral bisphosphonate users, if extraction 0.09-0.34% 60% of ONJ cases have a preceding history of tooth extraction, but only 0.5% of extractions result in ONJ ONJ has also been reported in patients taking Prolia (Denosumab) Studies have shown that adequate Vitamin D levels may be associated with improved peridontal health & critical for post-surgical oral wound healing.

Why the Jaw? Thin mucosa overlying osseous tissue Frequent site of microbial colonization and infection Common site of surgical intervention or trauma Does the bone turnover differ than other skeletal sites?

ONJ Prevention Good oral hygiene- brush teeth BID & floss Inspect teeth & gums daily & look for sore spots/open areas Notify your dentist that you started treatment (bisphosphonates or Prolia) Routine dental cleanings Avoid dental procedures while on above medications Wear properly fitting dentures Smoking cessation Notify prescriber of non-healing ulcers

Atypical Femur Fracture (AFF) 73 y.o. caucasian female w/ history of Osteoporosis on Boniva for nearly 5 years with a previous ankle fx. Presented to ED on 3/16/14 s/p trip & fall over a cord in her bedroom, when she was filling up her water bed. She tripped, fell forward and landed on her knees. The patient immediately felt excruciating pain and her husband called 911.

Initial X-ray Reveals a L subtrochanteric fracture Patient admits to having “constant cramps” in her L upper thigh 2 weeks prior to her fall, causing her to require a cane for ambulation Chance of a AFF 0.05% with bisphosphonate use.

Surgical Repair of AFF

Drug Holiday Duration of treatment should be based on: Patient’s risk of fracture Pharmacokinetics of the agent prescribed Patient preference (shared decision-making) At the 5-year treatment period, reassess the need for continuing treatment based on fracture history, BMD and clinical risk factors For those at low or moderate risk, stopping therapy is a possibility For those at higher risk, consider continuing therapy, consider drug holiday, or consider alternative medication during drug holiday Ending drug holiday Consider fractures, BMD, biochemical markers, FRAX

CCHS CPG “Medication Follow-up” For bisphosphonate therapy

Calcitonin (Miacalcin) Amino acid peptide hormone that inhibits bone resorption by osteoclasts, inhibits uptake of calcium from the intestines, & inhibits resorption of calcium from the kidneys Drug first approved in 1975 for the treatment of Paget’s Disease Dosing: Nasal spray 200IU/spray in one nostril QD or 100IU IM/SC injection QOD-QD FDA approved for treating osteoporosis in women who are at least 5 years past menopause. Fracture prevention: Spine only Sometimes used to help with the pain associated with hip fractures in the acute post-operative period. Possible s/e: Injectable form~ nausea, skin rash, frequent urination, & warmness. Nasal spray~ Runny or irritated nose, headache & backache. Also, recent studies have shown association w/ malignancy, so CCHS will be removing from formulary. Renal dosing: None

Calcitonin vs. Placebo ~1% improvement in the BMD of the spine & most studies show the the results in the hip and wrist are the same as placebo or slightly better. 0.7% Cost= $52.85 per bottle of nasal spray

Raloxifene (Evista) Classification: Estrogen agonist/Antagonist An oral selective estrogen receptor modulator (SERM) that has estrogenic actions on bone and anti-estrogenic actions on the uterus & breast Dosing: 60mg pill daily FDA approved for preventing and treating osteoporosis in postmenopausal women only. Fracture prevention: Spine only Possible s/e: Hot flashes, leg cramps, edema, & DVT/PEs. Renal dosing: None

Estrogen Therapy Estrogen has a protective effect on the bones prior to menopause, which is why a woman’s risk increases after menopause & women that have premature menopause are at increased risk. Estrogen reduces bone resorption & increases bone formation Dosing: varies depending on drug; pill and patch forms Climara, Estrace, Estraderm, Estratab, Ogen, Ortho-Est, Premarin, Vivelle FDA approved for preventing osteoporosis in postmenopausal women Fracture prevention: Spine, hip & other bones Possible s/e: May increase risk of DVT/PE, CVA, MI, breast & ovarian cancer. Vaginal bleeding, breast tenderness, mood changes, & gallbladder disease Renal dosing: None Hepatic Dosing: Contraindicated

Hormone Therapy Women past menopause with accelerated bone loss may benefit from hormonal therapy using estrogen with progesterone. The estrogen retards bone resorption and thus diminishes bone loss. This effect is the most prominent in the first years after menopause, while risks from HRT increase. Dosing: varies depending on drug; pill and patch forms Activella, Femhrt, Ortho-Prefast, Premphase, Prempro FDA approved for preventing osteoporosis in postmenopausal women Fracture prevention: Spine, hip & other bones Possible s/e: May increase risk of DVT/PE, CVA, MI, breast & ovarian cancer. Vaginal bleeding, breast tenderness, mood changes, & gallbladder disease. Renal dosing: None Hepatic Dosing: Impairment/Disease; Contraindicated

Teriparatide (Forteo) Parathyroid Hormone Dosing: 20mcg SC daily for up to 2 years Can self-inject in abdomen or thighs FDA approved for treating osteoporosis in postmenopausal men and women at high risk of fracture Fracture prevention: Spine and other bones Possible s/e: Nausea, dizziness & cramps Renal dosing: None Contraindications: Paget’s Disease (unexplained elev. ALP), young patients with open epiphyses, prior external beam or implant radiation involving the skeleton, & patient’s w/ current or h/o bone malignancies/metastases Monitoring considerations: After 4 months of therapy, repeat serum Ca, albumin & Vit D 25-OH levels. Do not check a iPTH it will be elevated & do not repeat a DXA in 1 year, wait at least 18 months.

Forteo Pen

Forteo Black Box Warning

Forteo Insurance approval will require patient to have a prior fragility fracture or have a t-score of </= -2.5 (Osteoporosis). Use of a specialty pharmacy will make the prior authorization process much easier Still takes about a month & numerous faxes/phone calls Your Forteo sales representative will gladly put you in touch with an educator who works for Lilly, but will (at no cost to you) meet with your patient at a location and time of your choosing, and talk to your patient one on one about Forteo & teach them how to inject. The patient does not need to even be 100% sold on the drug yet. Medication must be kept refrigerated at all times. Lilly also distributes cooler pack/travel kits to patient starting on Forteo for travel. Cost= $1,507.09 per pen; 1 pen lasts 28 days (does not include needles)

Please remember….. Osteoporosis is a chronic, but treatable disease & fragility fractures are preventable.

Questions Please feel free to contact me: sfegley@christianacare.org (302)733-5594