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Osteoporosis is largely a preventable disease. Its prevention, however, requires proactive efforts and education. Pharmacists are well-equipped to provide the necessary education and help people take those prophylactic steps.
Osteoporosis is not limited to elderly people. If prophylactic steps are not taken early in life, bone loss will occur early. According to the National Osteoporosis Foundation (NOF), 10 million Americans have osteoporosis, and 18 million more have low bone mass, which puts them at increased risk of osteoporosis. That’s 28 million Americans affected by osteoporosis. Unless awareness of the disease is raised and preventive measures taken, that number is expected to increase to 41 million Americans affected by 2015.1
Osteoporosis itself is not life-threatening. It progresses without symptoms, characterized by bone loss and deterioration of the skeleton. "However, osteoporosis leads to fractures, especially of the hip, spine, wrist, and ribs," says Lynn Chard-Petrinjak, NOF communications coordinator. "The mortality rate is high in elderly suffering from hip fracture," Chard-Petrinjak tells Drug Utilization Review. In fact, a staggering 24% of hip-fracture patients who are 50 years and older die in the year following their fracture, according to the NOF.
Furthermore, the rate of hip fracture is two to three times greater in women than in men, but twice as many men die in the year following hip fracture as women. According to the NOF, while women are four times more likely than men to develop the disease, men also suffer from osteoporosis. One-fourth of those who were ambulatory prior to the fracture require long-term care afterward. Although everyone loses some bone with age, the stooped posture of kyphosis and a loss of height greater than one to two inches are caused by vertebral fractures due to osteoporosis.
A study performed by Friedman and published last year in the Journal of Bone and Joint Surgery shows that fewer than one-fourth of women older than 55 with risk factors for osteoporosis are screened for osteoporosis or are followed up with drug therapy, according to Chard-Petrinjak. "Osteoporosis is responsible for 250,000 wrist fractures per year," she says. "Nontraumatic wrist fracture is often the first indication of osteoporosis. There are no overt symptoms until a bone is broken."
Patients need to be made aware of the effects that corticosteroids, some cancer medications, and other medications and diseases have on bones. "Pharmacists who dispense medication for the pain associated with bone fractures can help lead patients to ask their physicians about the need for screening and treatment of osteoporosis."
"Low bone mineral density and existing fractures are the two greatest risk factors for fractures," says Kelly Reith, senior marketing communications specialist at Hologic Inc., in Bedford, MA, manufacturer of bone densitometry, mammography, and general radiography systems. "We have technology that allows physicians to look for vertebral fractures. With the same instrument used to determine bone density, we can generate an image of the spine to find and assess fractures. This leads to better determination of fracture risk."
According to the NOF, bone density tests can measure bone density at various sites of the body and can:
"The gold standard in determining bone mineral density is dual X-ray absorptiometry, or DXA," says Reith. "DXA provides an accurate measure of BMD and sensitive measures of bone loss or gain over time." Third-party payers will reimburse for DXA tests in many situations, she says. Through the efforts of the NOF, Medicare now covers bone-density tests for those who are at risk of osteoporosis. Coverage remains to be standardized for both men and women under age 65. The National Osteoporosis Foundation has published physician guidelines for the diagnosis and treatment of osteoporosis. Patients who should be screened include:
There are no guidelines specific to men, according to Chard-Petrinjak. "However, some of the same principles for screening would apply, such as men who are on steroid therapy and those suffering nontraumatic fractures as adults."
Beyond these conditions for screening in men, there is a question about whether third-party payers reimburse for the tests.
"Patients and friends who fit into any of these categories for screening but who are not screened, should be encouraged to ask their physicians to order the appropriate test for them." Osteoporosis doesn’t fall under any one particular specialty. Many physicians treat patients for osteoporosis, including endocrinologists, gerontologists, and generalists, according to Chard-Petrinjak. By inquiring about the screening history of patients, pharmacists can help patients get a jump on osteoporosis treatment.
Despite educational efforts from the NOF and others, lack of awareness remains a problem, according to Reith — and not only among patients. "Health care providers are also sometimes unaware," she says. Occasionally, patients are hospitalized because of hip fractures, yet are discharged without ever being assessed or counseled for osteoporosis," she says. Patients may undergo orthopedic surgery and fail to question whether osteoporosis played a role in their fracture. Better communication across disciplines can help improve diagnosis.
Where one link in the health care chain fails to question or be educated, another link must be strong. "Pharmacists are in the perfect position to step in on the patient’s behalf in this kind of scenario," says Reith. "Pharmacists who are attentive to the patient’s full drug regimen as it relates to disease states can intervene and query physicians about the potential need for osteoporosis assessment and treatment."
"Pharmacists are an important part of the education process," Reith says. "Their role in today’s medicine is a lot more than distributive. They can do a lot toward teaching patients about both the prevention and treatment of osteoporosis. Educating about the risk factors to watch for helps raise awareness. Low bone mineral density is a primary risk factor and evidence has established that existing fracture is another."
Other risk factors for osteoporosis include:
The role of pharmacists is especially important for patients on high-dose corticosteroids, according to Reith. "These patients often get overlooked as being at risk for osteoporosis," she says. "You can have a young person on steroids with bone loss, who is at risk of fracture. Osteoporosis therapy can prevent such bone loss. Too often, patients initiating short-term treatment end up on long-term therapy with steroids and are at high risk of bone loss and subsequent fracture."
One step pharmacies can take in preventing osteoporosis in this patient population, according to Reith, is to flag high-dose steroids in the pharmacy computer so that pharmacists will check the patient profile for drugs to counter bone loss. In the absence of any such drugs, the pharmacist should follow up with a note to or conversation with the patient’s physician about treatment, or at least an assessment, for osteoporosis.
Several brochures are available for health care providers and for patients through the NOF Web site at www.nof.org. Some might serve to augment inservices that pharmacists perform for house staff. They would make good giveaways to patients as they are discharged from the hospital following hip surgery. In addition, you can subscribe to the NOF newsletter by e-mail.
The estimated national expenditures to hospitals and nursing homes for osteoporotic and associated fractures was $13.8 billion in 1995, representing $38 million each day, and the cost is rising. If nothing is done to reduce the incidence of osteoporosis, the cost of the disease will be an estimated $60 billion by the year 2020.1
"Primary prevention is extremely important," Reith says. "The No. 1 population where we make a difference is with young girls. If we can make sure they have a good supply of calcium in their diet, their peak bone density will be high. The peak is all you get," says Reith. "The higher the peak, the better head start you have for the rest of your life."
By around 20 years old, most women have acquired 98% of their total skeletal mass. Building strong bones during the early years, then, can be the strongest defense against development of osteoporosis later in life. Bone loss begins around age 30. The decline is gradual at first for both men and women. Once women hit menopause, though, their decline accelerates significantly, while that of men continues its gradual decline.
Components of a program to help prevent osteoporosis include:
Prevention of osteoporosis is important because, while there are treatments for osteoporosis, currently there is no cure. Prevention is important throughout life, but the steps listed above may not be sufficient once a woman goes through menopause. Estrogen replacement therapy or other drug therapy for osteoporosis may be required to help protect against bone loss. A woman may lose as much as 20% of bone mass in the first five to seven years after menopause. Many physicians recommend hormone replacement therapy (HRT) in postmenopausal patients no matter what the woman’s bone density because of its potential cardioprotective effects.
"Calcium and vitamin D alone are not enough," Reith continues. "Some might believe that calcium with D constitutes treatment. They’re not. Calcium and vitamin D are an important part of any good diet, whether or not you have osteoporosis. They should be part of your diet and part of any prevention measure, in addition to whatever the physician may prescribe on top of that."
Reith refers to a recent study by Robert Lindsay and colleagues, published in the Jan. 17, 2001, issue of the Journal of the American Medical Association.2 In this study, 2,725 postmenopausal women randomized to placebo in previous osteoporosis trials were evaluated. In the previous studies, all of the women had received calcium supplementation (1,000 mg/d) and vitamin D supplementation if their serum levels were low). Lindsay found that, within the first year following a vertebral fracture, one in five women will suffer another fracture. The results of this study point to the great need for identification of osteoporosis and intervention in these patients. "It can be a downhill cascade of events with osteoporosis," says Reith.
Although pharmacists are fully capable of educating patients about disease states, risk factors, and prevention, drug information is their specialty. "This is an area that patients need a lot of help with for both information and compliance," notes Reith.
According to NOF, national nutrition surveys show that many women and young girls consume less than half the amount of calcium recommended to grow and maintain healthy bones. Depending a person’s your age, an appropriate calcium intake falls between 1,000 and 1,300 mg a day. If a patient gets inadequate amounts of calcium through normal dietary habits, a calcium supplement can help compensate.
Patients who take calcium supplements must know that calcium needs vitamin D for proper absorption. Without adequate vitamin D, the body is unable to absorb calcium from foods and resorts to taking calcium from the bones. Vitamin D is available from two natural sources: through the skin following exposure to sunlight and through the diet. The recommended daily intake of vitamin D is 400 to 800 IU per day. Those with inadequate natural sources of vitamin D must take supplemental D or ingest fortified dairy products, egg yolks, saltwater fish, or liver.1
Many patients aren’t aware of all the potential benefits of HRT. Pharmacists can provide the necessary patient education. Counseling about potential side effects also fills an important gap, because a large percentage of women who start HRT discontinue it due to real or perceived side effects. Many women on HRT don’t realize their bones are benefiting from the therapy. Better knowledge of the benefits of therapy may lead to better patient compliance.
Although there is no cure for osteoporosis, there are steps that can be taken to prevent it or to retard its progress. The following medications are approved by the FDA for use in postmenopausal women for the prevention and/or treatment of osteoporosis.1
• Estrogens: Estrogen replacement therapy (ERT) is approved for the prevention and management of osteoporosis. This therapy reduces bone loss, increases bone density in both the spine and hip, and reduces the risk of hip and spinal fractures in postmenopausal women. ERT is available both in pill form and as a patch. This therapy is effective even when started in patients older than 70. Estrogen taken alone can increase the risk of endometrial cancer. To eliminate this risk, progestin is combined with the estrogen (HRT) for women with an intact uterus. ERT/HRT relieves symptoms associated with menopause and has shown beneficial effects on both bone and cardiovascular health. Side effects may include nausea, bloating, breast tenderness, hypertension, and formation of blood clots. Studies on the relationship between estrogen and breast cancer risk have been inconclusive.
• Alendronate (Fosamax): a bisphosphonate approved for the prevention and treatment of postmenopausal osteoporosis, treatment of male osteoporosis, and treatment of glucocorticoid-induced osteoporosis in men and women. In October 2000, the FDA approved two dosage strengths of alendronate for once-weekly dosing. The 70 mg dose was approved for the treatment of postmenopausal osteoporosis, the 35 mg dose for the prevention of postmenopausal osteoporosis.
"Once-weekly dosing may help increase patient compliance," says Reith. In postmenopausal women with osteoporosis, alendronate reduces bone loss, increases bone density in both the spine and hip, and reduces the risk of fractures of both the spine and hip. Side effects are uncommon but can include abdominal or musculoskeletal pain, nausea, heartburn, or esophageal irritation. Like all bisphosphonates, alendronate must be taken on an empty stomach. It is best taken with a full glass of water first thing in the morning, followed by at least a half-hour wait until the first food, beverage, or medication of the day. To minimize side effects, patients must remain in an upright position for at least half an hour after taking the drug.
"One could argue that bisphosphonates reverse or prevent the process because they build or maintain bone mineral density," Reith adds. Focusing on the consequence of osteoporosis —fracture — bisphosphonates are the only drugs proven in double-blind clinical trials to reduce vertebral fractures, nonvertebral fractures as a whole, and hip fractures."
• Calcitonin (Miacalcin): approved for treatment of postmenopausal osteoporosis only. Calcitonin is a hormone that occurs naturally and is involved in calcium regulation and bone metabolism. In women who are at least five years beyond menopause, calcitonin slows bone loss, increases spinal bone density, and, according to anecdotal reports, relieves the pain associated with bone fractures. Calcitonin reduces the risk of spinal fractures but does not appear to have a significant effect on non-vertebral fractures. Studies on fracture reduction are ongoing. Because calcitonin is a protein, it cannot be taken orally (it would be digested before it could be effective). Calcitonin is available as an injection or a nasal spray. While it does not affect other organs or systems in the body, injectable calcitonin may cause an allergic reaction and unpleasant side effects such as flushing of the face and hands, urinary frequency, nausea, and a skin rash. The only side effect reported with nasal calcitonin is rhinorrhea.
• Raloxifene (Evista): approved for the prevention and treatment of postmenopausal osteoporosis. Raloxifene is classified a selective estrogen receptor modulator (SERM) and appears to prevent bone loss at the spine, hip, and body. It also produces small increases in bone mass. After three years of use, raloxifene reduces the risk of spine fractures by about 50%. Like estrogens, SERMs produce changes in blood lipids that may protect against heart disease, although the effects are not as potent as those of estrogen. Unlike estrogens, SERMs do not appear to stimulate uterine or breast tissue. While side effects are not common, those reported include hot flashes and deep vein thrombosis, the latter of which is also associated with estrogen therapy. Research on raloxifene is ongoing.
• Risedronate (Actonel): a bisphosphonate approved for prevention and treatment of postmenopausal osteoporosis and for the prevention and treatment of glucocorticoid-induced osteoporosis in men and women. A daily dose of 5 mg slows bone loss, increases bone density, and reduces the risk of spine and non-spine fractures. As with alendronate, risedronate must be taken on an empty stomach, first thing upon rising in the morning, with a glass of plain water. Patients should remain upright for at least a half hour following the dose and refrain from eating, drinking, or taking other medications during that time. Side effects including stomach upset, constipation, diarrhea, bloating, gas, or headache were reported for risedronate with similar incidence as with placebo.
• Other therapies under investigation include sodium fluoride, vitamin D metabolites, parathyroid hormone, other bisphosphonates, and other SERMs.
Pharmacists know that compliance is a significant issue with HRT. Anything pharmacists can do to promote patient compliance will potentially help in the fight against bone loss. With bisphosphonates, patients have to take them correctly for proper absorption and to avoid potential side effects. "The more pharmacists educate their patients — both those at risk for osteoporosis and those undergoing treatment — the more patients will benefit," Reith says.
1. National Osteoporosis Foundation. Web site: www.nof.org.
2. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. JAMA 2001; 285:320-3.