FRACTURE LIAISON SERVICE

Transcription

1 FRACTURE LIAISON SERVICE

2 Welcome TO THE FRACTURE LIAISON SERVICE We continually strive to assist you in reaching and maintaining bone health to help prevent future fractures. If you are older than 50 and have had a fracture, or if your orthopaedic specialist feels you will benefit from a bone health evaluation, our Fracture Liaison Service will contact you. This booklet will serve as a guide to help you understand more about osteoporosis and minimizing the risk of another fragility fracture and provide you basic information about maintaining bone health. Your active participation and positive attitude will help you reach your goals. At no time does this information replace your provider s advice and orders. If you have questions, please call your provider. Please bring this booklet to all your DMG appointments. initial visit During your first visit, we will review your medical history, history of recent fractures, evaluate you for another fracture and discuss treatment options. questions you may be asked: - Have you had a bone density test (DEXA) before? If so, please let us know when it was done, and bring a copy for our records. - Have you ever been told you have bone loss, osteoporosis or osteopenia? - Do you take calcium or vitamin D supplements? - Have you had any other broken bones after age 50? follow-up visits You will be scheduled for a follow-up one to three months after your initial visit. At that time, your provider will help evaluate your treatment and continue the planning process for your care. helpful links National Osteoporosis Foundation National Bone Health Alliance contact us dmg fracture liaison service 100 Spalding Dr. Suite 300 Naperville, IL patient financial service guidelines We understand your concerns about the costs of your health care. Insurance claims, along with doctor and hospital bills can be confusing. Hospital & Doctor Bills The services provided by the Fracture Liaison Service are considered a medical necessity by most insurance providers due to the risk of future fractures. Insurance generally covers these expenses. If you are uncertain, please contact your insurance provider to confirm which services are covered. Health Insurance If you do receive a bill, be sure to contact your insurance provider to have that portion paid first. Some insurers provide 100 percent of coverage for these preventive services. Patient Responsibility Deductibles, co-insurance, copays and other balances are due at the time of service. Payment Options Credit card American Express, VISA, MasterCard, Discover Check or money order Debit cards Cash page 1

3 To understand your current bone health, your provider will use a combination of the following methods: medical history Your provider will ask you questions in order to obtain a thorough and accurate medical history. In particular, you will be asked questions relating to any personal history of fracture, family history of fracture and other risk factors for osteoporosis. It is important to indicate any medications you have been taking during the last 10 years. Some are known to increase an individuals risk for low bone mass and fractures. bone density scan If your test results indicate probable loss of bone density, arrangements will be made for a bone density scan, if one has not been done in the past year. This will help your provider confirm a diagnosis of osteoporosis and document the severity of bone loss. During most types of bone density tests (DEXA) a person remains fully dressed. The test usually takes less than 15 minutes. Bone density tests are non-invasive and painless. This means no needles or instruments are placed through the skin or body. A DEXA uses very little radiation. medication There are two categories of osteoporosis medications: antiresorptive medications (Slow bone loss) Bisphosphonates, calcitonin, denosumab, estrogen and estrogen agonists/ antagonists are antiresorptive medicines. Because your bones are continually losing old tissue and replacing it with new tissue, these medications can help decrease the bone loss that occurs. The goal for patients is to slow bone loss and continue to make new bone at the same pace. These treatments can often help prevent worsening bone loss and will reduce the risk of fracture. what is osteoporosis? physical examination Your provider will perform a limited physical exam with emphasis on the spine. Many fragility fractures go unnoticed by patients. Loss of height is sometimes an excellent marker for the presence of vertebral fragility fractures. laboratory tests Some lab tests are specific to bone health. Your medical records will be checked to determine testing performed in the previous six months. Lab work may need to be performed based on your history. x-rays An X-ray can help your provider determine if you have had any fragility fractures of the spine. anabolic drugs (Increase the rate of bone formation) Anabolic drugs increase the rate of bone formation. They are in a distinct category of osteoporosis medicines called anabolic drugs. Currently, Teriparatide (a form of parathyroid hormone) is the only osteoporosis medicine approved by the FDA that rebuilds bone. There are other similar medications being researched, but currently not available for treatment. The goal of treatment with anabolic medication is to build a healthy bone bank account and reduce the risk of breaking bones. Please review the attached list of medications from the National Osteoporosis Foundation for more details. Osteoporosis is a bone disease in which the mesh-like structure inside the bone becomes damaged. It literally means porous bones. The bone structure may be thin if too much bone tissue has been lost. When the internal strands of the bone become too thin (loss of density), bones become weak and can fracture or break easily. When a bone with osteoporosis is broken, it is called a fragility fracture. Though fragility fractures can occur anywhere in the body, the most common fractures occur in the: - Wrist - Hip - Spine - Thigh/leg (femur) Bone Quality + Bone Density = Bone Strength

4 your bones Bones are made of living tissue; every cell in your bones is alive, and are continually changing. Old dead cells are carried away and replaced by new healthy cells. The cells that carry old bone away are called osteoclasts. The cells that replace old bone with new are called osteoblasts. how aging affects change When you were a child, your bones grew rapidly. In fact, children only need about two years to completely replace their bone cells. Bones continue to grow in density through your late 20s. At that time, the amount of old cells removed and new healthy cells replacing them are about the same. This keeps a healthy bone bank account. In your mid-30s, however, the removal and replacement of cells can become out of balance. Unlike children, adults can take seven to 10 years to replace bone cells. As you continue to age, your body becomes less capable of replacing lost cells, and bones become less dense. Bone loss is normal, and not everyone will develop osteoporosis. If you have osteoporosis, you are losing bone cells faster than you are replacing them. did you know? The interior of your bones are made up of bone fibers that crisscross each other in layers. The fibers are precisely aligned to withstand the forces of tension and compression. This allows your bones to be both lightweight and strong. When architect Gustave Eiffel was looking for a way to make his famous tower both strong and lightweight, he modeled it after the structure of the human femur (thigh bone). long-term effects of osteoporosis fragility fractures The most common result of having osteoporosis is a fragility fracture. More than 1.5 million people suffer a fragility fracture each year. The severity of the fracture depends on where it is located, with the most common locations being the wrist, spine and hip. spinal curvature Even if a fracture does not occur, the spinal bones (vertebrae) can become weak and crush together, called a compression fracture. As this happens, the spine curves, which can result in back pain, height loss and difficulty breathing due to less space under the ribs. loss of mobility Osteoporotic bones take longer to heal than healthy bones. Fragility fractures can have a dramatic effect on your quality of life. With time, medication and physical therapy, patients can often regain bone strength. factors affecting osteoporosis The following can increase your risk of developing osteoporosis: age The older you get, the greater the risk. race If you are white or of Asian descent, you are at increased risk. gender Contrary to popular belief, it s not only a women s disease. One out of two women and one out of four men are likely to develop osteoporosis. family history If someone in your family has had osteoporosis or a hip fracture, you are at increased risk. lifestyle Inactive lifestyle puts you at increased risk. diet A diet low in calcium and vitamin D increases your risk. frame size The smaller your frame, the greater your risk. certain medical conditions Type 1 diabetes, rheumatoid arthritis, and inflammatory bowel disease, among others, can increase your risk. sex hormones A reduction of hormones increases your risk. In women, estrogen loss occurs primarily during and after menopause; in men, testosterone loss occurs gradually. A diet rich in calcium and vitamin D becomes particularly important during these years. smoking Recent studies have shown a direct relationship between tobacco use and decreased bone density. In addition, most studies suggest that smoking increases the risk of fractures. smoking & osteoporosis The longer you smoke, the greater your risk of fracture in advanced age. Smokers who fracture may take longer to heal than nonsmokers and may experience more complications during the healing process. At least one study suggests that exposure to secondhand smoke during youth and early adulthood may increase the risk of developing low bone mass. Significant bone loss has been found in older women and men who smoke. Compared with nonsmokers, women who smoke often produce less estrogen and tend to experience menopause earlier, which may lead to increased bone loss. Quitting smoking appears to reduce the risk of bone mass and fractures. However, it may take several years to reduce a former smoker s risk.

5 ADVICE & SAFETY TIPS When your loved one or friend has osteoporosis, you can help. Family and friends can help in many ways. By becoming more knowledgeable about osteoporosis, you may actually be helping yourself. Because heredity is one of the risk factors of the disease, accompanying your family member to the doctor may give you important information about avoiding fragility fractures in the future. If possible, attend your loved one s initial appointment. This will help your understanding of osteoporosis, different treatment options and how you can help. Help your family member or friends by providing accountability regarding medication, exercise and diet. Help your family member or friends avoid falls. fall prevention indoors Keep walkways clear of cords, clutter, etc. Place items within easy reach. For items out of reach, use a long-handled grabber. For items in high places, use a step stool with hand rails. Use non-skid rubber backing on area rugs, bathroom rugs and shower mats. Place hand rails or grab bars in the shower and near the toilet. Place and use hand rails on both sides of all stairways. On hardwood or uncarpeted floors, avoid using slippery wax. Only wear shoes with non-skid soles. Only use shower/tub seats with non-skid soles. At night, turn on the lights. Place a night light between your bed and the light switch. Keep your phone with you at all times in case you need help. fall prevention outdoors Use handrails when taking stairs or escalators. Walk on grass if walkways look slippery. Wear boots in the winter and low-heeled shoes. Shoes with rubber soles provide better traction. Use an assistive device (walker or cane), as needed. Keep your hands free by wearing a shoulder bag, fanny pack or backpack. Keep walkways, porches and driveways free of leaves, snow, trash and clutter. In public places, watch out for polished marble or tile floors that may be slippery. For more tips, visit the National Osteoporosis Foundation website at PREVENTION With osteoporosis, the best defense is a strong offense: a healthy diet and exercise! diet & nutrition Nutrition and osteoporosis are closely linked. Two key nutrients in preventing osteoporosis are calcium and vitamin D. Calcium is a key building block for your bones, while vitamin D allows your bones to absorb calcium. See attached calcium guide to understand your body s requirement for calcium and vitamin D. exercise The amount of exercise your bones can handle will vary from person to person. Check with your health care provider before beginning an exercise regimen. Please read the attached Moving Safely guidelines from the National Osteoporosis Foundation. calcium Dairy products, such as milk, yogurt and cheese are all good choices for adding calcium to your diet, but other foods are rich in calcium as well. Fortified juices, cereals and oatmeal. Salmon and sardines with bones. Beans and legumes. Certain nuts, such as almonds. Dark leafy greens such as broccoli and bok choy. Vitamin D. Fish, such as salmon, tuna and herring. Milk and yogurt regardless of whether it s whole, nonfat, or reduced fat/fortified with vitamin D. dental care It is imperative that you let your dentist know if you are on any osteoporosis medications. Some medications that prevent bone loss may negatively affect healing after certain dental procedures. You and your dentist will want to discuss options based on your medications.

6 BONE BASICS moving safely Keeping Good Posture, Body Mechanics & Alignment Good posture and proper body mechanics are important throughout your life, especially if you have osteoporosis. Body mechanics refer to how you move throughout the day. Knowing how to move, sit and stand properly can help you stay active and prevent broken bones and disability. Keeping good posture can also help limit the amount of kyphosis, or forward curve of the upper back, that can result from broken bones in the spine. One of the most important things about body mechanics and posture is alignment. Proper alignment of the body puts less stress on the spine and helps you have good posture. Alignment refers to how the head, shoulders, spine, hips, knees and ankles relate and line up with each other. To keep proper alignment, avoid the following positions or movements: Having a slumped, head-forward posture. Bending forward from the waist with straight legs. Twisting or bending the torso (trunk) to an extreme. Twisting the torso (trunk) and bending forward when doing activities such as coughing, sneezing, vacuuming or lifting. Anything that requires you to reach far. An example is reaching up for items on high shelves when you could lose your balance and fall. Strenuous overhead lifts or carrying packages that are too heavy. Some exercises can do more harm than good. If you have osteoporosis or have broken bones in the spine, you should avoid exercises that involve bending over from the waist. Some examples of movements you should NOT do include toe touches, abdominal crunches and sit-ups. In addition to these movements, many exercises and activities such as yoga, Pilates, tennis and golf may need to be avoided or adjusted because they often involve twisting and bending motions. Bending forward during routine activities also puts stress on the spine and can increase the chance of breaking a bone in the spine. Since bending forward puts more strain on the spine, it s safer if you re able to keep your back flat. KEEPING GOOD POSTURE sitting When sitting in a chair, try to keep your hips and knees at the same level. Place your feet flat on the floor. Keep a comfortable posture. You should have a natural inward curve to your lower back and a tall, upright upper back. When tying your shoes or drying your feet, sit in a chair. Place one foot on a footstool, box or on your other leg. Lean forward at the hips to tie or dry. Do not bend over or slouch through your upper back. Keep the natural inward curve of your lower back and a straight upper back. Use a footstool or footrest when seated for long periods of time. When sitting in bucket seats or soft couches or chairs, use a rolled up towel or pillow to support your lower back. When sitting at a desk, prop up a clipboard so it slants toward you, like a drafting table. When reading, do not lean on pillows or your lap. When standing up from a chair, move your hips forward to the front of the chair, and use your leg muscles to lift yourself up. When driving, use the head rest. standing Keep your head high, chin in, shoulder blades slightly pinched together. Maintain the natural inward curve of your lower back as you flatten your abdomen (tummy) by gently pulling it in. Point your feet straight ahead with your knees facing forward. While standing in one place for more than a few minutes, put one foot up on a stool or in an open cabinet (if in kitchen). Switch to the other foot every so often. You ll find this much less tiring for your back and legs. walking Keep your head high, chin in, shoulder blades slightly pinched together. Keep your feet pointed straight ahead, not to one side. Your knees should face inward. Keep them slightly bent. Avoid letting your knees lock as you bring your weight over your feet. Wear rubber or other non-slip soles when walking, and land lightly on your foot. Don t wear loose slip-on shoes or slippers. climbing stairs Use the stairs for exercise and to help maintain your bone density, but only if your healthcare provider says it s safe for you. Build up gradually with this exercise. Keep your head high, chin in, shoulder blades slightly pinches together and abdomen (tummy) gently tucked in. Keep your feet pointed straight ahead, not to one side. Your knees should face forward. Keep your knees slightly bent. Instead of putting one foot directly in front of the other. Keep your feet a few inches apart, lined up under the hip on the same side. For safety, hold the rail while going up and down but try to avoid pulling yourself up by the railing. Be especially cautious going downstairs to avoid a serious fall.

7 GETTING IN & OUT OF BED getting into bed First, sit down on the side of the bed. Lean toward the head of the bed while supporting your body with both hands. Then, lie down on your side, bringing both feet up onto the bed at the same time. Keep your knees bent and arms in front of you. Then roll onto your back in one motion. Pull your abdomen (tummy) in as you roll to support your back and help prevent twisting. Keep nose, knees and toes pointing in the same direction. Do not lift your head and upper back to move in bed. This puts a great deal of strain on your spine and could cause breaks in the spine. lying down When lying on your side in bed, use one pillow between your knees and one under your head to keep your spine aligned and increase your comfort. When lying on your back in bed, use 1-2 pillows under your knees, and one under your head. Try to avoid using extra pillows to prop your head and upper back since this will put you in a rounded upper back position. But, if you have a rounded upper back posture with a forward head, you may need two pillows to support your neck comfortably. getting out of bed Keep both arms in front of you. Pull your abdomen (tummy) in and breathe as you roll on your side. Keep your abdomen (tummy) pulled in, and use your hand to raise your upper body as you carefully place your legs over the side of the bed in one motion. Sit on the edge of the bed for a moment or two before you stand up. When on your back, never lift your head and upper back to sit up in bed or get out of bed. DAILY ACTIVITY MOVEMENT lifting & carrying Don t lift or carry objects, packages or babies weighing more than 10 pounds. If you re unsure about how much you can lift, check with your healthcare provider. If you are picking up a heavy object, never bend over so that your back is parallel to the ground as this places a lot of strain on your back. To lift an object off the floor, first kneel on one knee. Place one hand on a table or stable chair for support if you need it. Bring the object close to your body at waist level. Gently pull your abdomen (tummy) in, support your back and breathe out when you are lifting an object or straightening up. Do not hold your breath. Stand using your leg and thigh muscles. When carrying groceries, request that your bags be packed lightly. Divide heavy items into separate bags. Hold bags close to your body. Balance the load by carrying the same amount in each hand. When unpacking, place bags on a chair or table rather than on a high counter or floor. This prevents extra lifting and twisting of the spine. Instead of carrying a heavy pocketbook or purse, consider a fanny pack. pushing & pulling When you vacuum, rake, sweep or mop, keep your feet apart with one foot in front of the other. Face your work directly to keep from twisting your back. bending & twisting Keep your feet flat and about shoulder-width apart from one another. Let both upper arms touch your ribs on the sides, unless you re using one hand for support. As you bend, keep your back upright and straight and shoulder blades pinched together. Bend only at the knees and hips. Do not bend at the waist since this will put your upper back into a rounded position which can cause broken bones in the spine. Even when standing to brush your teeth or wash dishes, try not to bend over at the waist, but rather bend at the knees and hips while keeping your back straight. When changing direction, move your feet with your body. Do not twist the spine. Pivot on your heels or toes with your knees slightly bent. Keep nose, knees and toes pointing in the same direction. coughing & sneezing Support your back with one hand whenever you cough or sneeze. Place your hand behind your back or on your thigh. This protects the spine from damage caused by a sudden bend forward. Shift your weight from foot-to-foot in a rocking movement. With knees bent and shoulder blades pinched together, move forward and back, or from side to side rhythmically. Do not bend forward from the waist.

8 osteoporosis medication medications for prevention & treatment Although there is no cure for osteoporosis, the U.S. Food and Drug Administration (FDA) has approved medicines to prevent, slow or stop its progress. Taking a prescribed osteoporosis medicine, along with other healthy lifestyle behaviors, including getting enough calcium, vitamin D and regular exercise, can help reduce the risk of broken bones (also called fractures) due to osteoporosis. The best way to determine if you have osteoporosis is with a bone density test by a DEXA machine. DEXA stands for dual energy X-ray absorptiometry. The T-score result on a bone density test falls into three categories: normal density, low density (osteopenia) and osteoporosis. If you have broken a bone at age 50 or older, or your DEXA scan shows bone loss, you may need to take an osteoporosis medicine. Some individuals have osteoporosis even when a bone density test indicated normal or low bone density. Talk to your healthcare provider so you can establish a plan based on your current and past health. risk factors to consider in treatment decision: Having parents who had osteoporosis or broken bones Being small and thin Taking certain medicines (such as steroids) History of broken bones or height loss of 1.5 inches or more from young adult height Smoking or drinking too much alcohol (e.g. more than two-three drinks per day) bone remodeling cycle Bone is living, growing tissue that constantly forms new bone while replacing older bone. Bone continuously renews and changes through a process called remodeling. The bone remodeling cycle consists of two distinct stages: stage 1 bone resorption (Breakdown or removal) during bone resorption, special cells (osteoclasts) on the bone s surface dissolve bone tissue and create small cavities. stage 2 bone formation During bone formation, other cells (osteoblasts) fill the cavities with new bone tissue. Usually, bone resportion and bone formation take place in close sequence and remain balanced. An imbalance in the bone remodeling cycle occurs with menopause, aging and certain medical conditions. An imbalance can lead to osteoporosis and broken bones. predicting fracture risk Some DEXA machines include a person s FRAX score. A FRAX score can also be computed using an online version of the FRAX tool. This report incorporates a person s bone density results, age and some of the major risk factors for osteoporosis and broken bones to estimate the risk of breaking a bone in the next 10 years. A FRAX score can help healthcare providers and patients decide when treatment with an osteoporosis medicine may be needed to reduce fracture risk. when to consider treatment with an osteoporosis medicine bone sensitivity category normal bone density low bone density (Osteopenia) osteoporosis severe osteoporosis When to Consider Treatment with an Osteoporisis Medicine in Postmenopausal Women and Men Age 50 and Older Most people with T-scores of -1 or higher do not need to consider a medicine. People with T-scores between -1.0 and -2.5 should consider a medicine when there are certain risk factors suggesting an increased chance of breaking a bone in the next 10 years. All people with osteopororis or a history of fragility fracture should consider a medicine to reduce the risk of broken bones. All people with severe osteoporosis should consider a medicine to reduce the risk of additional broken bones. Scores Range -1 and higher and lower -2.5 and lower plus a broken bone *National Osteoporosis Foundation (NOF) has presented the T-scores differently in Clinician s Guide to help make this information more understandable. T-Scores Possible Score

9 fda-approved medicines Antiresorptive medicines slow the bone loss that occurs in the breakdown part of the remodeling cycle. These drugs include bisphosphonates, calcitonin, denosumab, estrogen and estrogen agonists/antagonists. When people first start taking antiresorptive medicines, they stop breaking down bone as quickly as before, but still make new bone at the same pace. Therefore, bone density may increase. The goal of treatment with antiresporptive medicines is to prevent bone loss and lower the risk of breaking bones. Anabolic medicines rebuild bone. Teriparatide, a form of parathyroid hormone, is the only FDA-approved anabolic medicine available at this time. The goal of treatment with teriparapeptide is to build bone and lower the risk of breaking bones. Special Note: Information about FDA-approved osteoporosis medicines is intended solely for general information and should NOT be relied upon for any particular diagnosis, treatment or care. This information does not imply an endorsement by NOF of any particular medicine or manufacturer. For more detailed information on the actions, administration and possible side effects for each of the following medications, please refer to the instuction insert, available online and at pharmacies. antiresorptive medicines Bisphosphonates Alendronate Sodium or Aledndronate Sodium plus Vitamin D3 (brand name Fosamax, Fosamax Plus D, Binosto, generic available). alendronate is approved for: Prevention and treatment of osteoporosis in post-menopausal women. Treatment of osteoporosis in men. Treatment of glucocorticoid-induced osteoporosis in men and women as a result of long-term use of steroid medicines (such as prednisone and cortisone). Alendronate reduces bone loss, increases bone density and reduces the risk of fractures in the spine, hip and other bones. Alendronate is taken daily as a 5 mg or 10 mg tablet, or once weekly as a 70 mg tablet. Aldendronate is taken first thing in the morning after waking up and on an empty stomach. It needs to be swallowed whole with 6-8 ounces of plain water (no other liquid), at least 30 minutes before having anything to eat or drink. Patients must remain upright (sitting, standing or walking) during this 30-minute period. osteoporosis medicines Risedronate Sodium or Risedronate Sodium with Calcium Carbonate (brand name Actonel, Actonel with Calcium and Atelvia, generic available). risedronate is approved for: Prevention and treatment of osteoporosis in postmenopausal women. Treatment of osteoporosis in men. Prevention and treatment of glucocorticoid-induced osteoporosis in men and women as a result of long-tern use of steroid medicines (such as prednisone and cortisone). Risedronate reduces bone loss, increases bone density and reduces fractures in the hip, spine and other bones. Risedronate is taken daily as a 5 mg tablet, weekly as a 35 mg tablet, twice monthly as a 75 mg tablet (on two consecutive days) or monthly as a 150 mg tablet. Risedronate (Actonel ) tablets needs to be taken first thing in the morning after waking up and on an empty stomach. It needs to be swallowed whole with 6-8 ounces of water (no other liquid or additives), at least 30 minutes before having anything to eat or drink. Patients must remain upright (sitting, standing or walking) during this 30-minutes period. For the individuals taking Risedronate with calcium, the calcium must be taken at a different time of the day from the Risedronate tablet and with a meal or a snack. The Risedronate (Atelvia ) delayed-release tablet needs to be taken immediately after breakfast with at least 4 ounces of plain water (no other liquid). Patients must remain upright (sitting, standing or walking) for at least 30 minutes after taking Atelvia. zoledrinic acid (Brand name for Reclast, generic available). zoledronic acid is approved for: Treatment of osteoporosis in postmenopausal women. Treatment to increase bone mass in men with osteoporosis. Prevention and treatment of osteoporosis in men and women as a result of long-term use of steroid medications (such as prednisone and cortisone). Zoledronic acid reduces bone loss, increases bone density and reduces fractures in the hip, spine and other bones. Studies show that zoledronic acid reduced the risk of new fractures in people who recently broke bones in the hip due to osteoporosis. Zoledronic acid is given once a year as an IV infusion of 5 mg to treat osteoporosis or every two years as an IV infusion of 5 mg to prevent osteoporosis. A healthcare professional gives zoledronic acid as an intravenous (IV) infusion in a doctor s office or other outpatient setting. Patients need to have blood tests before each dose to establish a baseline, including creatinine, to confirm that kidney function is normal and that the blood calcium level is normal.

10 side effects of bisphosphonate medicines Side effects for all bisphosphonate medicines may include bone, joint or muscle pain. Side effects of oral tablets may include nausea, difficulty swallowing, heartburn irritation of the esophagus and gastric ulcer. Shortly after receiving an IV bisphosphonate, some patients have flu-like symptoms, fever, headache and pain in muscles or joints. These generally stop within two or three days and usually do not happen with future infusions. In rare cases, inflammation of the eye (uveitis) may occur. There have also been reports of osteonecrosis (death of bone cells or tissue) of the jaw (ONJ) in patients taking bisphosphonate. The risk of ONJ in people taking bisphosphonates for osteoporosis is minimal and is increased if you have poor dental hygiene, or have had external radiation to your jaw. In most cases, the benefit of the medication far outweighs any small risk of ONJ. Patients should practice good dental care and work closely with a doctor and dentist to reduce the risk of ONJ. An unusual fracture of the upper femur (thigh bone) has been associated with bisphosphonates, however this is also very rare. The risk of this complication can be minimized by taking a holiday from bisphosphonate medications after 5 to 7 years of use. Tell your healthcare provider if you have been taking bisphosphonates for several years or longer and have an unusual ache or pain in your thigh bone. Some people have a dull ache or pain in the thigh or groin area, sometimes for several weeks or longer, before having an unusual break in the thigh. Patients taking oral bisphosphonate tablets should stop taking the drug and contact their healthcare provider immediately when experiencing chest pain, new or worsening heartburn, or difficult or painful swallowing. It is important that patients report these or other side effects to their healthcare provider. Bisphosphonates are not recommended for people who have severe kidney disease or low blood calcium. People with certain problems of the esophagus may not be able to take the oral tablets. antiresorptive medicine: calcitonin Calcitonin-Salmon (brand names Fortical and Miacalcin ). Calcitonin medicine is a synthetic hormone for the treatment of osteoporosis in postmenopausal women who are at least five years beyond menopause. Calcitonin is also a naturally occurring hormone in the body that is involved in calcium regulation and bone metabolism. Calcitonin medicines slow bone loss, increase bone density in the spine and reduce the risk of fractures in the spine. Calcitonin is available as a nasal spray (200 IU daily) or an injection (dosage varies). Due to concerns about increased cancer risk, and the fact that there are more effective medications available for bone loss, calcitonin is not used as a first line medication and is limited to no more than 6 months. possible side effects of calcitonin medicines Common side effects with nasal calcitonin are a runny nose, headache, back pain and nosebleed (epistaxis). Injectable calcitonin may cause an allergic reaction and unpleasant side effects including flushing of the face and hands, urinary frequency, nausea and a skin rash. antiresorptive medicine: rank ligand (rankl) Inhibitor/Human Monoclonal Antibody Denosumab (brand name Prolia TM ). denusab is approved for: Treatment of osteoporosis in postmenopausal women at high risk of breaking a bone. Being at high risk includes any of the following: - Women who have broken a bone due to osteoporosis or have multiple risk factors for breaking a bone. - Women who cannot use other osteoporosis medicines or other osteoporosis medicines did not work well. Treatment to increase bone mass in men at high risk for breaking a bone. Treatment to increase bone mass in men taking androgen deprivation therapy to treat prostate cancer (such as Lupron and Zoladex ). Treatment to increase bone mass in women taking aromatade inhibitors for breast cancer (such as Arimidex, Aromasin and Femara ) who are at high risk of breaking a bone. Denosumab reduces bone loss, increases bone density and reduces the risk of fractures in the spine, hip and other bones. A healthcare professional gives denosumab by injection every six months. Patients need to have a blood test before each dose to confirm that their baseline blood calcium level is normal. possible side effects of denosumab medicine It is important to understand that if your doctor recommends taking Prolia, then the risks of side effects are strongly outweighed by the benefits it provides in preventing fractures. Denosumab may lower calcium levels in the blood. If blood calcium levels are low before receiving denosumab, the low calcium level must be corrected before giving the medicine or it will get worse. Signs of low calcium levels include spasms, twitches or cramps; or numbness and tingling in the fingers, toes or around the mouth. Patients should report any of these symptoms to their healthcare provider. Most patients with low calcium levels, however, do not show these signs. People who have weak immune systems or take other medicines that affect the immune system may have an increased chance of having serious infections with denosumab. Even patients who have no immune system problems may be at higher risk of certain infections such as those of the skin. Patients should contact their healthcare provider right away if signs of infection or abnormal skin-related symptoms occur. Infection signs may include fever, chills, red and swollen skin, skin that is hot or sore to the touch, severe pains in the abdomen, or pain or burning when passing urine or passing urine more frequently and in small amounts. Denosumab may also cause skin rashes. Other side effects can include pain in the back, arms and legs. ONJ and unusual fractures of the upper femur (thigh bone) have been seen in patients taking denosumab (refer to side effects of bisphosphonate medicines for additional details about ONJ and unusual femoral fractures).

11 antiresportive medicine: estrogen agonists/ antagonists (formerly called serms) Raloxifene (brand name Evista ). raloxifene is approved for: Prevention and treatment of osteoporosis in postmenopausal women. Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. Raloxifene increases bone density and reduces the risk of fractures in the spine. Raloxifene offers the beneficial effects of estrogens without some of the potential disadvantages. It is neither an estrogen nor a hormone. Raloxifene is taken daily as a 60 mg tablet with or without meals. side effects of raloxifene Side effects may include hot flashes, leg cramps, deep vein thrombosis (blood clots), swelling and temporary flu-like symptoms. Raloxifene is not associated with diseases of the uterus or ovaries and does not affect cognitive (mental) function. Raloxifene should not be given to women at increased risk for stroke, including women with previous strokes, transient ischemic attacks (TIAs), atrial fibrillation or uncontrolled high blood pressure. anabolic medicine: parathyroid hormone (PTH) (1-34), Teriparatide (brand name Forteo ). teriparatide is approved for: Treatment of osteoporosis in postmenopausal women at high risk of breaking a bone. Treatment to increase bone mass in men with osteoporosis at high risk of breaking a bone. Treatment of osteoporosis in men and women as a result of long-term use of steroid medications (such as prednisone and cortisone) who are at high risk of breaking a bone. Teriparatide, a type of parathyroid hormone, rebuilds bone and increases bone mineral density, especially in the spine. Teriparatide reduces the risk of fractures in the spine and other bones. Candidates for Teriparatide include patients who have broken a bone due to osteoporosis and those with very low bone mineral density (T-scores lower than 3.0). Teriparatide is also an option for patients who continue to lose bone density or break bones while taking other osteoporosis medicines. Teraparatide is self-administered as a daily injection. It can be taken for a maximum of two years. At the end of two years, to retain the benefits of treatment with Teriparatide, most experts recommend that patients take an antiresorptive medicine. side effects of teriparatide medicine Side effects include leg cramps and dizziness. Modest elevations in serum and urine calcium can occur, but there is no documented increase in the risk of kidney stones. Rats who received very high doses of Teriparatide for a long period of time had increased risks for osteosarcoma, a type of bone cancer. Although common in rats, this type of tumor is extremely rare in adult humans. For this reason, the FDA approved use for up to two years only. There has been no evidence of increased risk of osteosarcoma in humans taking Teriparatide. the following individuals should not take teriparatide: Patients with Paget s disease. Children with growing bones. Persons with unexplained serum alkaline phosphatase elevations. Anyone who has had radiation treatment involving the skeleton. Individuals with metabolic bone diseases like hyperparathyroidism or cancer that has spread to the bone. Those with certain abnormal blood tests, including increased calcium levels. response to treatment with osteoporosis medicines A medicine that is appropriate and effective for one person may not be the best choice for another person. People can respond differently to treatment with the same medicine. To be effective, an osteoporosis medicine must be taken as prescribed. If you decide that a particular treatment is not right for you, discuss your concerns with your healthcare provider before stopping or interrupting treatment. For your medicine to work, you also need to get enough calcium, vitamin D and exercise. With antiresorptive medicines (bisphosphonates, calcitonin, estrogen and estrogen agnostics/antagonists), the goal of treatment is to prevent further bone loss and reduce the risk of fractures. Fractures can cause deformities, disabilities, and serious, as well as life-threatening complications. A patient has favorable response to treatment when bone mineral density remains stable or improves and no broken bones occur. With anabolic medicine (Teriparatide) the goal of treatment is to rebuild bone, increase bone mass, repair microscopic defects in bone and reduce the risk of fractures. A patient s response to treatment is favorable when bone quality and bone density improve and no broken bones occur. monitoring treatment & length of treatment A bone density test (DEXA) should be repeated every two years to monitor the effectiveness of treatment with an osteoporosis medicine. Some patients may need to repeat a bone density test after one year. Some healthcare providers may also perform lab tests called biochemical markers of bone turnover tests to learn more about your response to a medicine. At this time, there is no easy way to measure bone quality.

12 There are currently no conclusive research findings to suggest how long most osteoporosis drugs remain safe and effective, except for Teriparatide (Forteo ). Teriparatide can be taken for no more than two years according to the FDA. After patients stop taking a bisphosphonate medicine, they may continue to experience some of the drug s benefits for several years or even longer. Other osteoporosis medicines like Deonosumab and Teriparatide stop working quickly which can lead to rapid bone loss in some patients when these medicines are stopped. Patients who have responded well to taking bisphosphonate medicines and are considered at low risk of fracture may be able to discontinue taking these medications after three to five years. During this break from treatment, it s important to work closely with a healthcare provider to monitor bone health and re-evaluate the need to restart an osteoporosis medicine each year. People who are considered at high risk for breaking a bone usually need to continue treatment with a bisphosphonate or another osteoporosis medicine to prevent fractures.there is no uniform recommendation that applies to all patients taking osteoporosis medicines. In the absence of clinical studies on duration of treatment, healthcare providers and patients should discuss options to determine the best course of action. The National Osteoporosis Foundation (NOF) encourages all healthcare providers to evaluate a patient on the basis of clinical risk factors, such as the presence or absence of broken bones, height loss, bone density, age, weight and other factors that affect fracture risk. Length of treatment should be individualized and based on the person s medical and fracture history, as well as the initial and most recent bone density test results.

13 osteoporosis medicines approved by the fda class & drug brand name form frequency bisphosphonates alendronate alendronate ibandronate ibandronate risedronate risedronate risedronate zoledronic acid calcitonin calcitonin calcitonin calcitonin denosumab (RANKL inhibitor/human monoclonal antibody) denosumab Binosto Fosamax *, Fosamax Plus D Boniva * Boniva Actonel * Actonel with Calcium Atelvia Reclast * Fortical Miacalcin Miacalcin Prolia Effervescent tablet Oral (tablet) Oral (tablet) Intravenous (IV) injection Oral (tablet) Oral (tablet) Oral (tablet) Intravenous (IV) infusion Nasal spray Nasal spray Injection Injection Weekly Daily/Weekly Monthly Four times per year Daily/weekly/ twice monthly/monthly Weekly Weekly One time per year Daily Daily Two times per year adverse events & drug company information When a patient has a serious reaction or problem with a drug, either the patient or the patient s healthcare provider should report the problem to the FDA. This can be done by calling 1 (800) or completing an online report at Patients can also notify the pharmaceutical manufacturer. The information below provides the phone numbers of the pharmaceutical manufacturers and the date each medicine was approved by the FDA as an oeteoporosis medicine. alendronate (Binosto, Fosamax, Fosamax Plus D ) Merck, (800) FDA Approval: 1995 Generic versions are available. calcitonin (Fortical, Miacalcin ) Usher-Smith, (800) (Fortical ) Novartis, (888) (Miacalcin ) FDA Approval: 1995 denosumab (Prolia ) Amgen, (800) FDA Approval: 2010 raloxifene (Evista ) Eli Lilly, (800) FDA Approval: 1997 risedronate (Actonel, Actonel with Calcium, Atelvia ) Warner Chilcott, (800) FDA Approval: 2000 Generic versions are available. teriparatide (Forteo ) Eli Lilly, (800) FDA Approval: 2002 estrogen* estrogen estrogen raloxifene parathyroid hormone teriparatide Multiple brands* Multiple brands* Evista Forteo Oral (tablet) Transdermal (skin patch) Oral (tablet) Injection Daily *Generic versions of these drugs may be available. Check with your healthcare provider and pharmacist to find out more information about dosages, pricing and availability. Twice Weekly/Weekly estrogen agonists/antagonists also called selected estrogen receptor modulators (serms) Daily Daily estrogen (et) & hormone therapy (ht) FDA Approval: 1997 Generic versions are available ibandronate (Boniva ) Roche, (800) FDA Approval: 2005 for Monthly Oral Dose and 2006 for Quarterly IV Dose Generic versions are available (oral only). zoledronic acid (Reclast ) Novartis, (888) FDA Approval: 2007 Generic versions are available.

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