Feature Article
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Management of Osteoporosis in the Nursing Home Setting Ms. Lee is a Clinician 4 with the University of Virginia Health System, Charlottesville, VA, and a Nurse Practitioner with a part-time nursing home practice. Address for correspondence: Virginia K. Lee, APRN,BC, University of Virginia Health System, Charlottesville, VA 22908. E-mail: vkl@virginia.edu .
The basic interventions of smoking cessation, nutrition, and exercise all influence bone health and should be addressed in nursing home residents, despite the challenges they involve. Two studies of calcium and vitamin D in populations with inadequate intake of these nutrients have shown decreased fracture risk. Of the newer drugs for osteoporosis management, the bisphosphonates (alendronate in particular) have been studied most rigorously and are approved for use with men as well as women; alendronate is approved for glucocorticoid-induced osteoporosis. The research evidence is not as strong for the benefits of raloxifene or estrogen, and problems with side effects may limit their use in the nursing home setting. The efficacy of calcitonin nasal spray in the prevention of new vertebral fractures is still not clear, but calcitonin can be useful when other options are not viable, particularly for those with pain from acute fracture. (Annals of Long-Term Care: Clinical Care and Aging 2001;9[9]:32-42)
Background
Osteoporosis is a progressive, systemic skeletal disease characterized by reduction in bone mass and deterioration of the microarchitecture of the remaining bone, making it fragile and at risk for fracture with minimal trauma.1 More than 700,000 spine fractures, 200,000 wrist fractures, and 300,000 hip fractures occur each year in the United States, predominantly in postmenopausal women. 2 The personal cost of these fractures is high, with significant morbidity and a decreased quality of life. Between 18% and 33% of persons with hip fracture die within a year, and many more never regain their prior level of functioning. 3 In addition, more than $15 billion is spent annually in treatment. 4 There has been an explosion of information about osteoporosis in both lay and professional literature with the development of new methods to prevent, diagnose, and treat this disease. Limited attention, however, has been paid to the high-risk populations that reside in nursing homes. Approximately 1.6 million residents live in nursing homes in the United States. The majority of residents (91%) are elderly (> 65 years). About 72% are female and 85% are white.5 Two-thirds of elderly nursing home residents need help with three or four basic activities of daily living. Ninety-six percent use a wheelchair, walker, or cane at least some of the time. 6 When these statistics are compared to the risk factors for osteoporosis (Table I), it is clear that a large percentage of nursing home residents are at high risk for osteoporosis. Although white women are primarily affected, frail African-American, Hispanic, and Asian women as well as elderly men are also at significant risk. Few data exist for nonelderly nursing home residents, but most have significant mobility problems and should be evaluated.
Osteoporosis increases fracture risk. Osteoporosis, coupled with the high fall rate in nursing homes, makes this population particularly vulnerable. A 1999 study measured bone mineral density (BMD) in the dominant forearm of 1475 patients from randomly selected nursing homes in Maryland.3 Using the World Health Organization (WHO) definition of osteoporosis—a BMD 2.5 standard deviations (SD) below the BMD of a normal young adult (T-score at or below -2.5), 7 the prevalence of osteoporosis for white female residents ranged from 63.5% (for those 65-74 years) to 85.8% (for those > 85 years). Only 3% had a composite BMD within 1 SD of the young adult mean. These percentages were significantly higher than estimates from community-based studies. 3 Approximately one-half of nursing home residents fall at least once a year, and 11% sustain a serious fall-related injury.8 The rate of hip fracture in nursing home residents is three to 11 times that of age-matched community dwellers.
Basic Interventions
The management of osteoporosis in the nursing home setting includes pharmacologic and nonpharmacologic interventions, and both must be considered. Addressing modifiable risk factors is a challenge but should not be ignored. Coordinated educational efforts for staff, administration, and families may be required to ensure environmental and cultural support for changes in lifestyle. Smoking cessation, nutrition programs to promote weight gain and adequate calcium intake, and creative, well-developed exercise and activity programs will contribute to healthier bones and other benefits. Research in younger populations has identified smoking as an important risk factor for osteoporosis and fracture. In one study of female twins discordant for tobacco use, significant differences were found not only in bone density but also in serum concentrations of calcium, parathyroid hormone, and urinary markers of bone resorption. 9 Smoking adversely affects weight gain, health, and neuromuscular fitness and endurance for exercise. All of these factors are thought to increase fracture risk. 10,11 For a variety of reasons, smoking is often not addressed in elderly and nursing home populations. The patients’ right to decide must be honored, but in many, smoking cessation deserves attention. Repeated conversations, reinforcement of benefits, and encouragement to gradually reduce or to consider a nicotine patch trial are appropriate. In some environments, a lack of interesting, appropriate, diversionary activities contributes to heavy cigarette use. Exercise in the later years, in the presence of adequate calcium and vitamin D, probably has a modest effect on slowing BMD loss. It also has a positive effect on muscle strength and mass even into the later years, and some studies have shown associations between muscle strength and BMD.12 There is convincing evidence that exercise improves function, helps maintain independence, and promotes quality of life. A review of physical activity, falls, and fractures in older adults 13 concluded that studies evaluating the effectiveness of physical activity programs in preventing falls have been inconclusive. However, recent trials suggest that exercise, particularly involving balance and lower extremity strength training may reduce fall risk. The same review concludes that there is consistent evidence from prospective and case-controlled studies that physical activity is associated with a 20-40% reduced risk of hip fracture relative to sedentary individuals. Along with the emphasis on exercise, specific fall-prevention programs should be in place to increase staff, family, and patient awareness and to modify the environment to make it safer. A careful review of medications is also important. Drugs that contribute to dizziness, confusion, and falls should be used only when essential and in appropriate doses. Specific devices and interventions to improve safety and decrease fracture risk—such as bed and chair alarms, low beds, helmets, and padded hip protectors—should be considered in individual circumstances.
Drug Treatment Options
The National Osteoporosis Foundation recommends therapy for osteoporosis be initiated to reduce fracture risk in women with BMD T-scores below -2 SD in the absence of risk factors, and in women with BMD T-scores below -1.5 SD if other risk factors are present. Women over 70 years of age with multiple risk factors are at high enough risk that treatment is warranted without BMD testing.14 Those with secondary causes (chronic glucocorticoid use, use of anticonvulsants that interfere with vitamin D metabolism, hyperparathyroidism, and excessive thyroid hormone) should be carefully evaluated for treatment. Many clinical trials use percentage of change in BMD and bone turnover to evaluate the effectiveness of interventions. There is generally a strong association between BMD and the likelihood of fracture, but other factors influence fracture risk as well. Decreased fracture risk is the criterion of most importance to patients and primary care providers. There has been a great deal of research performed on osteoporosis in the last two decades. However, randomized, placebo-controlled trials that provide the most reliable evidence have been completed only in the last several years. Hochberg15 recently reviewed all the randomized, controlled trial evidence on the antifracture efficacy of the antiresorptive agents used in the treatment of osteoporosis (Table II). The most common drugs will be discussed.
Calcium and Vitamin D
Providing sufficient calcium and vitamin D is a basic intervention to help reduce fracture risk and slow bone loss, especially in nursing home patients, who often have inadequate intake of these elements. Unless there is clear contraindication, all residents should be taking recommended doses of calcium and vitamin D. Studies have been conducted with monotherapy of each supplement; however, since vitamin D is necessary for the absorption of calcium, both are generally recommended in institutionalized elderly. The absorption of calcium decreases with age, and bone loss occurs in men and women throughout adult life. Most American women have a dietary calcium intake below recommended levels, and supplementation is usually required to ensure adequate intake. The National Institutes of Health Consensus Development Panel on Optimal Calcium Intake recommends a daily intake of 1500 mg for everyone over the age of 65 years. 16 The recommended daily allowance (RDA) of calcium is 1200 mg/day for all persons over the age of 51 years.17 The RDA for vitamin D (vitamin D3 , cholecalciferol) is 400 IU daily, but 600-800 IU are recommended for institutionalized or homebound patients. Most therapeutic vitamins contain at least 400 IU. Adequate calcium and vitamin D have a modest slowing effect on BMD loss but do not completely prevent it or build bone. Two studies have shown that these supplements prevent fracture. A large study of nursing home residents with a mean age of 84 years who received 1200 mg of elemental calcium and 800 IU of vitamin D daily for 18 months were 43% less likely to fracture a hip and 32% less likely to sustain other nonvertebral fractures, compared with placebo.18 In another placebo-controlled study of 389 community-dwelling men and women over age 65, treatment group subjects received 500 mg of calcium and 700 IU of vitamin D daily for three years. At study completion, those who received supplements had a nonvertebral fracture rate 60% lower than the control group and a moderate decrease in the rate of bone loss.19 Generally, calcium and vitamin D supplementation should not be considered as an adequate intervention to prevent fractures in high-risk women who are candidates for other interventions. 20 Calcium is generally well-absorbed and well-tolerated and should be taken daily in three or four divided doses. Calcium supplementation at recommended levels has not been associated with kidney stone formation. The actual amount of elemental calcium varies by preparation, with calcium carbonate, calcium acetate, and calcium citrate providing 400, 253, and 211 mg/g of calcium, respectively. Some controversy exists about the best preparation for the frail elderly. Calcium carbonate provides the most elemental calcium and is the least expensive. However, its absorption may be diminished in those with decreased gastric acid (a significant portion of the elderly). Administration of calcium carbonate with food enhances absorption. Other preparations may be better absorbed, but more tablets will be needed to meet the dose requirement, and they are more costly. Generally calcium is well-tolerated, but complaints of constipation and flatulence are common.
Bisphosphonates
Of the treatments available for osteoporosis, the bisphosphonates are the most thoroughly investigated to date. Discussion will be limited to the two drugs, alendronate and risedronate sodium, approved by the U.S. Food and Drug Administration (FDA) for osteoporosis management. Alendronate was recently approved for the treatment of osteoporosis in men as well as women. Alendronate is available in 5-mg/day (prevention) and 10-mg/day (treatment) doses and also in recently approved once-a-week strengths—35 mg (prevention) and 70 mg (treatment). Studies looking at the weekly dosing have found efficacy comparable to the daily doses in suppressing bone turnover markers and on BMD, but no data are available on fracture rates. 21,22 Risedronate in the 5-mg dose was approved in 2000 for the treatment of osteoporosis in postmenopausal women and for glucocorticoid-induced osteoporosis.
Alendronate. Alendronate is a potent inhibitor of bone resorption. Data are available on patients with osteoporosis and low BMD from several large, randomized, controlled clinical trials of up to seven years’ duration.23-28 Alendronate was found to increase BMD by 5-11% at the hip and spine and to decrease new fracture risk at these sites by up to 50%. In the seven-year trial, there was evidence of continued increase in BMD throughout the time period. 28 A study of elderly long-term care residents with a mean age of 78 years was recently completed.29 Those treated with alendronate, 10 mg for two years, showed significantly greater increases in BMD at the hip (3.3% vs 0.1%) and lumbar spine (6.3 % vs 1.9%) than those taking placebo, and there was also a significant decrease in bone turnover. In two studies, subjects followed for two years after treatment was stopped maintained BMD, and accelerated bone loss did not occur;28,30 however, continuous treatment was more effective.28 This is in marked contrast to the rapid loss of BMD associated with discontinuation of estrogen replacement therapy. Trials have focused on women, but small-scale studies of men with osteoporosis have had similar results.31 Alendronate is also effective in treating osteoporosis caused by glucocorticoid treatment. 32 In trials comparing alendronate to other agents, alendronate was found to be more effective than intranasal calcitonin in increasing BMD. 33-34 Studies have also looked at the effects of alendronate and conjugated equine estrogen (CEE) in combination and separately in postmenopausal women with low BMD.35,36 A recent prospective study compared placebo, alendronate 10 mg daily, CEE 0.625 mg daily, or alendronate 10 mg plus CEE 0.625 daily. At two years, placebo-treated patients showed a mean loss of 0.6% in lumbar spine BMD, compared to mean increases in the other groups of approximately 6%. The corresponding changes in femur BMD were +4.0%, +3.4%, +4.7%, and +0.3% for the alendronate, CEE, CEE plus alendronate, and placebo groups, respectively.34 Clinical trials have shown alendronate 5 mg to be effective in increasing BMD in younger women, although data are not clear about its effectiveness in reducing fractures. There seems little reason to use this dose in nursing home residents.
Risedronate. Risedronate is less well-studied than alendronate. Two recent large trials looked at women with established osteoporosis. One studied the effects of risedronate 5 mg on vertebral fractures, and the other looked at fractures of both vertebral and nonvertebral sites.37,38 Risedronate reduced the spine fracture rate by 61-65% in the first year. After three years, the risk of new fracture, compared to placebo, was reduced by 41-49%. Nonvertebral fractures showed a 39% reduction in cumulative incidence after three years of treatment. 38 The dropout rate in both studies was high (40-50%), however, adding some uncertainty to the findings. Several issues need to be considered before prescribing these drugs for nursing home patients. The irritant effect bisphosphonates may have on the esophagus and stomach is an important consideration. In clinical trials, the incidence of side effects with both drugs was similar to that with placebo, but clinical experience with alendronate suggests a significant number of people experience upper gastrointestinal disturbance, particularly esophageal symptoms (chest pain, heartburn, and pain or difficulty swallowing). A rare reported complication of alendronate is esophageal or gastric ulceration. 39 Experience will show whether similar problems occur with risedronate. Contraindications to the bisphosphonates include esophageal stricture or achalasia, inability to stand or sit upright for at least 30 minutes, and hypocalcemia. These drugs are not recommended for persons with severe renal insufficiency.39,40 The safety and tolerability profile of the weekly dosing of alendronate is similar to the daily dosing. Because of poor absorption and risk of esophageal injury, the bisphosphonates must be taken with plain water immediately upon arising and at least 30 minutes before the first food, beverage, or medication of the day. Additionally, the person must not lie down for 30 minutes and until the food is eaten. Food, juice, coffee, and certain drugs, including iron and calcium, significantly interfere with absorption. A weekly dose should be taken on the same day each week.39,40 These requirements complicate the routine of morning care, necessitate supervision to ensure compliance, and often present a challenge for nursing home staff.
Hormone Replacement Therapy
Estrogen replacement therapy, either alone or in combination with progestin (HRT), is an established approach for osteoporosis prevention and management. In many situations, it is considered the best choice. HRT is now approved by the FDA to prevent and manage osteoporosis. Observational studies have consistently shown that the risk of fracture in postmenopausal women is reduced with estrogen, but there is limited evidence from large randomized, controlled trials with fracture as a primary outcome. A meta-analysis of 11 observational studies suggested a 25% decrease in the risk of hip fracture in women who reported using estrogen. 41 A number of observational and case-controlled studies have consistently reported reductions of up to 75% in the incidence of hip and wrist fractures among postmenopausal women receiving HRT, but the benefit varied widely depending on the duration of use and the time since discontinuation. 42-44 Studies have also shown that estrogen improves BMD. 45-47 Recent further analysis of data from the Heart and Estrogen-progestin Replacement Study (HERS), in which women were selected for cardiovascular disease but not osteoporosis, showed no reduction in the incidence of fractures or height loss.48 Although HRT provides clear benefit to the skeletal system, the effects on various other systems and disease entities are still not completely understood. Effects on cardiovascular health and breast cancer are of particular concern. The HERS trial found no overall cardiovascular benefit from HRT, at least in women with known disease. 49 The incidence of thromboembolic events was three times higher in the HRT group. There is no clear consensus on the optimal time to begin or discontinue HRT. Rapid bone loss occurs not only around menopause but also when HRT is discontinued. Beginning HRT at menopause and continuing for the rest of life has been generally recommended. Others suggest waiting to begin HRT until later (after age 65) as a more economical approach that provides nearly equal bone-conserving benefit in the later years when risk of fracture is highest.43,45 Few studies have included significant numbers of women over age 75, and none were found that looked specifically at HRT in nursing home populations; therefore, much of the information must be extrapolated from studies in younger populations. A 1996 prevalence study of HRT use by women 65 years and older found only 6.1% taking hormones. 50 Poor compliance among older women is usually thought to be related to bothersome side effects. The development of continuous HRT regimens tends to decrease the occurrence of uterine bleeding and to improve compliance among postmenopausal women.51 No statistics were found for the number of women in nursing homes taking these drugs. The numbers are probably low, and most of the women taking these drugs are likely to be continuing an HRT regimen in place prior to admission. There are several studies looking at the use of low-dose estrogens with and without progestin in postmenopausal women. Across studies, a positive effect on BMD or a decrease in bone resorption markers has been found.52-55 Several studies have looked at using unopposed estrogen in women with an intact uterus; two studies were in women over age 65. 52,55 One comparison of several doses of unopposed estrogen (0.3-1.25 mg/day) showed that the changes seen in BMD were dose-related. Clinically significant endometrial hyperplasia was seen only in the doses greater than or equal to 0.625 mg.55 In a three-year study that looked at subjects who received low-does estrogen and progestin, BMD of the spine increased by 3.5% (P < .001) in an intent-to-treat analysis aby by 5.2% among patients with a greater than 90% adherence to therapy. Significant increases were seen in total boday and forearm bone density (P < .001).55 These studies suggest that low-dose estrogen regimens may provide adequate protection from bone loss and fracture while avoiding endometrial hyperplasia and problematic side effects. Larger studies are needed to confirm these findings and to provide an additional treatment option.
Calcitonin
Calcitonin salmon is a synthetic hormone used for the treatment of postmenopausal osteoporosis. Parenteral calcitonin salmon is available, but the intranasal preparation, introduced several years ago, is a more useful treatment option. The efficacy of intranasal calcitonin for the treatment of osteoporosis has been evaluated in several controlled clinical trials. Results of clinical trials demonstrate that intranasal calcitonin is more effective than placebo in increasing BMD, but not as effective as alendronate;33,34,56,57 greater inhibition of bone turnover occurred with alendronate than with calcitonin.57 Calcitonin also decreased the rate of vertebral and nonvertebral fracture by one-third, compared with placebo.58 A large five-year randomized trial, the Prevent Recurrence of Osteoporotic Fractures (PROOF) Study, was designed to determine the efficacy of calcitonin nasal spray in the prevention of new vertebral fractures in postmenopausal women with established osteoporosis and a history of at least one prior spinal fracture.59 Subjects were assigned to four groups to receive intranasal calcitonin (100, 200, or 400 IU) or placebo daily. In subjects receiving the 200-IU dose, the risk of new fracture was 33% less than with placebo. This significant reduction in new fracture risk was not seen at other treatment doses. Lumbar spine BMD increased in all active treatment groups. However, the withdrawal of 59% of the subjects and other design issues kept the PROOF Trial from completely clarifying the value of calcitonin in preventing the recurrence of spinal fractures. Calcitonin is generally considered safe. The most frequent adverse effects of intranasal therapy are transient nasal symptoms and mucosal alterations such as crusts, erythema, itching, and bleeding. 60 The drug should be administered in alternating nostrils to decrease nasal irritation at the usual dose of 200 IU (one spray) daily. The ease of administration and minimal side effects make this agent attractive, and overall it seems as if calcitonin may prevent recurrent vertebral fractures, but the data are not conclusive. In regard to nonspine fractures, other options clearly provide more benefit. Calcitonin does, however, provide a significant analgesic effect for many women with acute vertebral fractures.61 This is an added benefit and an important consideration in these cases. Additional analgesic agents would likely be needed, and a lumbar support corset is often helpful.
Raloxifene
Raloxifene is a selective estrogen receptor modulator indicated for the prevention and treatment of osteoporosis in postmenopausal women. The exact mechanisms by which it exerts a positive estrogen-like effect on bone and lipid metabolism are not completely clear, but it seems to reduce bone turnover and improve the lipid profile by increasing high-density lipoprotein and reducing low-density lipoprotein (LDL). Raloxifene acts as an estrogen antagonist at breast and uterine tissue. 62,63 Several clinical trials have evaluated its effects on BMD in postmenopausal women, many with osteopenia. Results demonstrate that raloxifene increases BMD at the lumbar spine, hip, and femoral neck and in the total body.63,64 In addition, raloxifene reduced total and LDL cholesterol by 6.4% and 10.1%, respectively. There were also no differences in endometrial thickness between raloxifene- and placebo-treated patients. Results from the large, randomized, placebo-controlled Multiple Outcomes of Raloxifene Evaluation (MORE) study were recently published. 65 Postmenopausal osteoporotic women with either a BMD T-score of less than -2.5 or with low BMD and prior vertebral fractures were randomized to receive placebo, raloxifene 60 mg, or raloxifene 120 mg daily for three years. Overall and in each study group, the risk of new vertebral fracture decreased 30-50% in women receiving raloxifene, regardless of existing fractures at study initiation. There were no differences in outcomes between the two doses. In contrast to its clear effect on spinal fractures, however, raloxifene did not alter the risk of nonvertebral fractures. There was a modest but significant increase in BMD of the spine and the femoral neck. Breast cancer was statistically less frequent in the women receiving raloxifene. 65 Hot flashes are the most common side effect of raloxifene. The recommended daily dose is 60 mg for prevention and treatment. The drug decreases the effect of warfarin, so close monitoring of prothrombin time and international normalized ratio is necessary. The risk of venous thromboembolic events increases with raloxifene to a degree similar to that observed with estrogen.
Cost of Therapy
The cost of medications is a concern for individual nursing homes since medications are a service covered by Medicare, Medicaid, and most private payment plans. It is an additional issue practitioners should consider when making treatment decisions; the choice of a costly alternative should be the result of a thoughtful process documenting rationale and benefit. Table III displays the daily doses and monthly costs of agents used in the prevention and treatment of osteoporosis (personal communication with Procter & Gamble and Aventis Pharmaceuticals, April 2001). 66 Pharmacoeconomic studies of these agents have not been performed, making it difficult to determine the most cost-effective therapy, but, given the tremendous cost to society and individuals, it is important to treat this disease whenever possible.
Summary
The recognition of osteoporosis as a major health problem provides both challenges and opportunities to effectively address this disease in the nursing home setting. Health care providers should think about fracture prevention and management as part of routine preventive health care. Much has been learned in the last two decades, but too many patients still needlessly suffer the consequences of unrecognized and untreated skeletal fragility. Improving the environment of many nursing homes to consistently provide excellent basic programs in nutrition, exercise, and fall prevention is an important step in preventing the high cost of fractures. With the advent of new drugs, the options for osteoporosis treatment and prevention have increased, but there is little published information on the use of these drugs in patients over 70 years old, who comprise the majority of the nursing home population.
Acknowledgment I wish to express my thanks to Michelle W. McCarthy, PharmD, at the University of Virginia for her assistance with this article.
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Annals of Long-Term Care - ISSN: 1524-7929 - Volume 9 - Issue 09 - September 2001 |