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Research and Reports

Objective: To develop a stepwise approach, or clinical guideline, to the diagnosis and treatment of osteoporosis in residents of long-term care facilities.

Design: Expert panel developed the guideline on the basis of existing research and consensus.

Setting: Long-term care facilities.

Conclusions: Use of this clinical guideline and algorithm for the diagnosis and treatment of residents in long-term care facilities may optimize resident outcomes and improve strategies for preventing falls.

Abbreviations: LTC = long-term care, SD = standard deviation, BMD = bone mineral density, ADL = activities of daily living, RDA = recommended dietary allowance, BTM = bone turnover marker.

Key Words: Osteoporosis, Long-term care, Falls, Fall prevention, Fracture risk, Elderly, Calcium, Vitamin D, Estrogen, Calcitonin, Outcomes.

Consult Pharm 1998;6: 685-99.

Information about the prevalence of osteoporosis complications and the outcomes of treatment in the long-term care (LTC) environment is virtually nonexistent. It is accepted, however, that osteoporosis is under-recognized and under-treated in nursing facility residents. Reasons for this include a lack of knowledge about osteoporosis on the part of clinicians and caregivers in nursing facilities; clinicians' belief that nursing facility residents are at the end of their life cycle and thus there may be no value to treatment; the profound absence of data supporting osteoporosis interventions in the nursing facility resident population; and multiple clinical problems that compete for the clinician's attention.

To address these issues, a guideline and an algorithm for assessment, diagnosis, and treatment of osteoporosis for LTC residents was developed to assist the clinician (e.g., physician, pharmacist, advanced practice nurse, physician assistant) in optimizing resident outcomes (Figure 1). The algorithm incorporates pharmacological and nonpharmacological treatments that improve or maintain bone health and maintain physical function. The algorithm also encourages fall prevention strategies to minimize risk of fracture.

A second algorithm (Figure 2) was developed to further guide pharmacotherapeutic selection. These algorithms are provided to facilitate guideline implementation, with the expectation that improved outcomes can be quantified as part of quality improvement initiatives.

The clinical guideline, algorithm, and supporting documentation were developed through the efforts of an expert panel coordinated by the Office of Professional Programs at the Philadelphia College of Pharmacy and Science. Each panel member contributed expertise from his or her respective experiences in geriatrics, osteoporosis management, and LTC administration. In addition, each panel member represents a professional organization with vital interests in the management of LTC residents. The members of the expert panel (and their affiliations) are listed in the box at right.

These guidelines are the first step toward addressing the unique demands of osteoporosis management in LTC facilities. The panel made its recommendations using existing LTC evidence whenever possible, extrapolating data from the research on community-dwelling elders when necessary and applying the opinions of leaders in the areas of geriatrics, endocrine disorders, and nursing facility administration. All decisions were guided by the primary goal of nursing facility care, which is to prevent the decline and to maintain the function of residents. The treatment recommendations of this guideline achieve this goal through risk identification and fracture prevention.

Osteoporosis and Fracture Risk

Low bone mass is an important predictor of fracture risk. In several prospective epidemiological studies, each decrease of one standard deviation (SD) in bone mineral density (BMD) from the age-matched mean was associated with approximately a twofold increase in the risk of vertebral fractures and a 2.6-fold increase in the risk of hip fracture.^2,3 The risk relationship between BMD and fracture is at least as strong as that between serum cholesterol and coronary heart disease.⁴

There are limited reliable data on the prevalence of osteoporosis in the residents of LTC facilities. Extrapolations from the community dwelling population to the LTC population are suggestive, but will likely underestimate the prevalence of osteoporosis. One large prospective epidemiological study estimated the distribution of low femoral bone density in older, non-institutionalized elderly women. The study found that in women 70-79 years of age, the estimated prevalence of osteoporosis (BMD > 2 SD below young adult mean) at the femoral neck was 55%, and the estimated prevalence in women older than 80 years was 73%.⁵

Long-Term Care Perspective

Fracture, Morbidity, and Mortality in LTC Facilities

Elderly persons are defined as those over 65 years of age. It is projected that by the year 2020, there may be two to three times as many patients over the age of 85 living in nursing facilities than there were in1989.⁶ Thus as the population ages, the nursing facility population, and hence cost of care, can be expected to rise sharply.

Nursing facility residents are among the most frail in our society and are at very high risk for osteoporotic fracture. In one limited study, research conducted in an Italian LTC facility demonstrated that the overall incidence of fractures in the population was as high as 7.8% per year.⁹ Most reports refer to hip or vertebral fractures associated with osteoporosis, where the annual age-adjusted incidence among nursing facility residents is estimated to be 8-9 times greater than among community-dwelling elderly people.¹⁰ Several factors appear to contribute to the increased incidence of fracture in this population, including high rates of co-morbidities and disabilities that may result in increased risk of falling.

Serious consequences such-as systemic infections, thromboses, dysfunction of other body systems, psychological deterioration, impairment in the individual's ability to perform normal activities of daily living, and a change in quality of life-are at least in part attributable to fractures resulting from osteoporosis. Several studies have discussed specific effects of hip fracture, including high rates of mortality.

One European study examined outcomes associated with 282 hospital admissions subsequent to hip (femoral neck or trochanter) fracture. Results indicated that the short-term mortality (four months or less) for hip fracture in nursing facility residents was 41%.11 The mortality rate increased to 46% at one year and was greater than twice the mortality rate for patients sustaining a hip fracture in their own home. Because of the serious clinical outcomes, nursing facility care providers should be educated about how to recognize of osteoporosis in LTC residents.

Economics and Health Care Utilization

In the United States, osteoporosis results in more than 1.5 million fractures annually, including more than 500,000 spine, 250,000 hip, and 240,000 wrist fractures.^1,12 The annual cost to the United States health care system is at least $13.8 billion.^1,13 Because of the aging of the population and increases over time in the incidence of fractures, these high costs will more than double over the next 30 years.¹³ One epidemiological study projected that the increasing numbers of elderly people in the United States will drive the total number of hip fractures in persons 50 years and older from 238,000 in 1984 to 347,000 by the year 2020, with a concomitant increase in deaths, disability, and medical costs.¹⁴ The total annual cost of hip fractures is projected to increase from approximately $7.2 billion in 1984 to $62 billion in 2020.¹⁴

Assessment

1-3. APPROPRIATE CANDIDATES FOR EVALUATION
Only residents who are candidates to receive a medical intervention should be evaluated for osteoporosis using this guideline. An initial assessment to identify appropriate candidates should be performed.

Whenever possible, all residents in a nursing facility should be provided general education on fall prevention and evaluated through nutritional assessment to ensure calcium and vitamin D adequacy in diet as per the Recommended Dietary Allowance (RDA). More intensive fall prevention and nutritional support should be reserved for appropriate patients after further evaluation (Item 9).

Most residents will benefit from general measures to ensure nutritional adequacy and to prevent osteoporosis or falls. General measures may apply even to clinically unstable residents. However, issues such as life expectancy, presence of terminal illness, and individual preferences for care may preclude a more formalized evaluation of the resident and may determine the intention to treat. Additional patient-focused measures addressing fall and fracture risk and dietary supplements may be reserved until the intention to treat has been established. All residents should be assessed for appropriateness, and identified residents should subsequently be evaluated by the health care team. Residents who are unable to benefit from intensive intervention because of extenuating clinical status may be considered inappropriate for formal evaluation.While no specific criteria defining such extenuating status are offered, it is prudent for clinicians to consider resident prognosis when the care of the frail elderly is managed.

4. ASSESS HISTORY FOR PRIOR EVIDENCE OR DIAGNOSIS
A review of the patient's medical history for evidence of a pre-existing diagnosis of osteoporosis is obligatory. The history can include notations of osteoporotic fracture (Colles', vertebral, hip, femur, other), previous pharmacological treatment for osteoporosis, kyphosis (dowager's hump) or height loss believed to be secondary to osteoporosis.¹⁵ Pre-existing diagnoses should be confirmed with current findings and warrant treatment consideration.

Previous radiography results may also provide evidence of prior vertebral fracture, which is also a risk factor for osteoporosis.^{16, 17} A reading of "thinning bones" on radiography should not be used as the sole justification for the initiation of medical therapy.

Many patients entering the LTC facility do so as a result of hip fracture. In a study conducted across four LTC institutions, it was found that 84% of residents institutionalized because of hip fracture also had multiple risk factors for further bone loss. However, no mention of osteoporosis or osteopenia was recorded in the medical problem list, and as a result, there was no intervention plan in place to maintain or increase bone mass to reduce risk of future fracture.¹⁶ For this reason, osteoporosis is likely to be under-reported because osteoporosis may not be diagnosed until a fracture occurs and in some cases not even diagnosed when a fracture occurs.

It is important to remember that the prevalence of osteoporosis increases with age after menopause. The Academy of Orthopaedic Surgeons has reported that the prevalence of moderate to severe osteoporosis, as evidenced in dorsolumbar radiographs in women over the age of 75 years, was 89%.^18,19

5. EVALUATE FOR CLINICALLY EVIDENT OSTEOPOROSIS
If a history review does not identify a pre-existing diagnosis of osteoporosis, then a clinical evaluation for evident signs or symptoms of osteoporosis is the next appropriate step in the determination of existing disease. Confirmed signs or symptoms warrant treatment consideration.

A clinically focused evaluation to detect evidence of osteoporotic fracture and other sequelae, such as height loss and kyphosis, will serve to identify a significant number of osteoporotic patients in the LTC population.

6. ASSESS RISK FOR FRACTURE
Since osteoporosis is under-diagnosed in the LTC environment, residents without a history or signs or symptoms of osteoporosis should still be assessed for risk of fracture.

An evaluation that takes into account clinical factors associated with increased risk of fracture and diagnostic tests (when available) should be performed.

Clinical Risk Factors

Risk factors are additive and cumulative. The panel suggests setting a threshold at six factors for high risk as a guideline only. Some factors may be weighted more heavily than others; therefore, a distinct dichotomy between high- and low-risk residents may not exist. Because the data on risk are not definitive and because a synthesis of sources has been invoked, clinical judgment plays a role in risk assessment.

Several studies have examined factors related to the risk of fracture.^20-25 One epidemiological study conducted over a four-year period with over 9,500 community-dwelling women aged 65 years or older examined potential risk factors for hip fracture.²⁶ Multivariate analysis identified factors associated with increased risk of fracture. These factors were extrapolated to the LTC population and augmented by the expert panel (Table 1).

Residents who are ambulatory (either independently or with assistance) are at greater risk of fall-related fracture than non-ambulatory (bedridden or chair-bound) patients.²⁷ However, non-ambulatory residents appear to be at greater risk for minimal trauma fracture and future bone loss.²⁸ It is believed that minimal trauma fractures occur during the lifting, moving, and transferring of bedridden or chair-bound LTC residents. A non-ambulatory status, therefore, should not lead the clinician to assume lower fracture risk.

7A. HIGH RISK
Presence of six or more factors indicates a higher risk for fracture. This risk assessment can be used to identify patients who should be further evaluated and considered for treatment.

7B. LOW RISK
Presence of zero to five factors indicates a lower risk for fracture. Residents with lower risk should be re-evaluated yearly as part of routine assessment to track changes in risk levels. More frequent assessment is warranted with significant changes in resident status.

Diagnostic Testing

Bone Mineral Density Testing: There is a direct correlation between BMD and fracture risk. Bone mineral density may therefore be used to help identify patients with osteoporosis. However, there is no universal agreement on a BMD threshold to define osteoporosis. Several publications define osteoporosis as BMD more than 2.0 SD below the mean of a young adult (30 years),^31-33 while the World Health Organization defines osteoporosis as 2.5 SD below the mean of young adults.³⁴

Several types of BMD measurements are available to aid the clinician in assessment of fracture risk, including single-energy photon absorptiometry, single energy x-ray absorptiometry, dual energy x-ray absorptiometry (DXA), peripheral-dual energy x-ray absorptiometry (p-DXA), quantitative computed tomography, ultrasonography, and radiographic absorptiometry. All of these measurement methods have diagnostic advantages and disadvantages and are described in detail elsewhere.^31-33,35-37 Currently, DXA is widely regarded as the preferred method for baseline and follow-up measurements but may not be widely available in a LTC setting. Based on availability, peripheral measurements by radiographic absorptiometry, or p-DXA may be more convenient.

Bone Turnover Marker (BTM) Testing: Information on BTM is relatively new, and thus clinicians should use caution when considering its use as a primary diagnostic tool. Several studies have discussed the relationship between various assays for bone loss and fracture risk.^38-40 These assays included urinary N-telopeptide, pyridinoline II, deoxypyridinoline, and pyridinium crosslinks.³² One recent study found that high concentrations of several urine assays were significantly associated with rapid bone loss from the total hip and high prevalence of low BMD, although they were not correlated with fracture incidence.^20,21 Pending the results of additional research and the development of improved assay techniques, these assays are not recommended at this time.

8. EVALUATION FOR SECONDARY CAUSES OF OSTEOPOROSIS
All residents either diagnosed with osteoporosis or at high risk of fracture should be screened for causes and markers of secondary osteoporosis prior to initiation of treatment.^32,41,42 If a bone density is available and there is extreme deviation from a normal value (e.g., more than 2.5 SD below an age-matched mean), then secondary causes should be investigated (note that an age-matched mean specifies comparison to a similarly aged cohort). If a secondary cause of osteoporosis is identified and is amenable to treatment, then that secondary cause should be a primary treatment goal. Treatment of osteoporosis should still be considered, as necessary. It is especially important to evaluate for secondary osteoporosis if there is an extremely low bone density. Table 2 provides a list of important causes/secondary osteoporosis.

Intervention

9. INTENSIVE PATIENT-FOCUSED EDUCATION AND FALL PREVENTION
Low-risk, high risk, and diagnosed residents should be counseled (educated) as appriopriate for their cognitive capacity, on modifiable risk factors for osteoporosis and falls. Residents in LTC facilities will determine their own willingness to modify such risk factors.

Numerous articles in the published literature have reported various factors associated with the risk of osteoporotic fracture.^{1-3,9,26,32,35,42,43} Programs that provide education and offer various forms of intervention may contribute to a decline in fracture incidence and result in reductions in morbidity and mortality in the LTC population. These modifiable factors are divided into two groups: factors that increase the risk of bone loss (Table 3) and factors that increase the risk of falls (Table 4).

Bone Loss

Cigarettes, Alcohol, and Caffeine: Cigarettes, alcohol, and caffeine have been implicated as risk factors for osteoporosis. Caffeine is associated with a decrease in BMD⁴⁷ and an increase in fracture risk.²⁹ The use of alcohol in moderation appears to be positively correlated with BMD,^30,48,49 while chronic alcoholism is associated with a decrease in BMD^50,51 and may result in an increased incidence of skeletal fractures.^52,53 Cigarette smoking is associated with a decrease in BMD at the lumbar spine and femoral neck.^54,55 Interventions in the form of education and cessation programs that address the effects of excessive alcohol use, excess caffeine intake, and cigarette smoking may assist in reducing use of these substances.

Malnutrition: Several studies report that malnutrition resulting from myriad etiologies ranging from depression to dental problems is frequently seen in LTC residents. Treatment of underlying depression and physical barriers to proper nutrition, and correction of protein, calcium, or vitamin D deficiencies, may improve the strength and functional status of LTC residents. (See Calcium and Vitamin D Intake, below.)^56,57

Inactivity or Sedentary Lifestyle: Lack of appropriate exercise and a sedentary lifestyle have been related to increased bone loss and risk of fracture.^1,26 Complete bed rest gives a negative calcium balance within a few days and a detectable reduction in bone density within a few weeks.⁵⁸

Numerous studies have evaluated the effect and appropriateness of therapeutic exercise on bone loss and overall fitness in elderly women.^{13,31,35,42,59-66} Published findings have determined that regular, appropriate exercise for the elderly can improve BMD;^59,61 reduce the risk of fractures by improving muscle tone, balance,^58,59,62,64 and ambulation;^60,61 improve general health and fitness;^59,62,64 help to maintain or improve functional status;^64,66 and enhance quality of life.⁶⁵

With modification, some of the exercise guidelines recommended by the expert panel for healthy adults may be appropriate for the elderly;⁶⁷ low-impact activities (i.e., less force on the musculoskeletal and joint structure) are recommended.^63,67 Exercise should be performed at low or moderate intensity and gradually increased.^62-64 Whether ambulatory or bedridden, most elderly patients can benefit from regular, properly designed exercise programs.⁶⁷

Falls

The list includes postural hypotension and impaired cognition and lethargy due to sedative-hypnotic use. Also, some drug regimens (often involving multiple drugs) may be responsible for impaired cognition in the elderly, which may manifest as confusion or psychiatric disorders.

Impaired balance, poor ambulation, and decreased muscle strength, coupled with the presence of environmental hazards, also increase the risk of tripping and falling. In addition, vision impairment may contribute to falls and may be an important risk factor for hip fracture, especially among elderly women. One study identified that elderly patients whose vision is moderately impaired (20/30 to 20/80) or poor (20/100 or worse) have a greater risk of fracture than elderly patients with good vision (20/25 or better).²²

Most falls are due to multiple factors such as environmental hazards (e.g., poorly lit hallways), and intrinsic factors (e.g., foot problems, conditions or medications that may cause muscle weakness, vision impairment, balance, and gait abnormalities).^68,69 Specific interventions for patients at risk for falls are provided in Table 5.

Educating patients regarding the possible side effects of medications is important, as per the Omnibus Reconciliation Act of 1992 (OBRA 92) requirements. As required in the nursing facility regulations set forth in OBRA 92, caregivers should consider tapering or discontinuing the use of sedatives/hypnotics when appropriate. Re-evaluating complex drug regimens to identify overlapping or unnecessary therapies may help to reduce falls while improving patient cognition and physical energy.^68,69 A pharmacy consult is recommended when advice on therapy modification is required.

Teaching residents to rise slowly and stand with support may help to decrease the incidence of postural hypotension. Training to assist in transferring, balance, ambulation, and accessibility of various mechanical assistive devices (e.g., geri-canes, handrails, walkers, and wheelchairs) should be available to the LTC resident. The importance of appropriate exercise to improve muscle strength, balance, and range of motion should be stressed.⁶⁹

Researchers are investigating the usefulness of hip pads to protect patients from the full impact of a fall. However, it has been noted that compliance is a problem and development of more acceptable devices is needed.^72,73

Safety may be improved in the LTC environment by taking care to remove trip hazards and to provide safer furniture, improved lighting, and grab bars.^68,69,74 Removal of environmental hazards is also an important issue to consider.⁷⁴ One institution reported that 16% of the falls occurred as a result of a wet floor.⁶⁸ Specific interventions may be also made available to patients based upon their functional status and individual needs.

Hip, vertebral, and distal radius fractures are associated with significant function impairments.^12,75 Patients who sustain osteoporotic fractures should be assessed to determine fracture-related impairments and should be referred for rehabilitation services.

9. CALCIUM AND VITAMIN D INTAKE
The recommended dietary and supplemental calcium intake is 1,500 mg daily for all patients over 65 years of age.^1,76 A total of 400-800 IU of vitamin D daily is recommended for all older individuals. The presence of absorption impairment or low laboratory measures of calcium or vitamin D, despite adequate dietary intake, may require supplementation at prescription doses. Reference to standard pharmaceutical compendia will guide prescribing.

Adequate calcium and vitamin D are essential to good bone health.Calcium is required for normal bone remodeling to occur, and vitamin D is involved with regulation of calcium uptake from the intestine and may be involved in the stimulation of bone formation.⁷⁷ Several studies have also noted that the dietary intake of calcium is below normal in many nursing facility residents.¹⁶

Research has shown that the skin tissue and kidneys of elderly women have reduced capacity to manufacture and activate vitamin D precursors.^78,79 Without either exposure to sunlight or multivitamin supplementation, the vitamin D intake levels of many nursing facility residents may be inadequate.⁸⁰ Several studies have demonstrated that many nursing facility residents may be deficient in vitamin D, and this deficiency may be an important factor in bone loss among the elderly.^16,81 One recent study in elderly women found that supplemental vitamin D increased bone mineral density at the femoral neck.⁸² Another study found that the number of hip fractures was 43% lower among those treated with vitamin D and calcium compared to placebo.⁸³

10. PHARMACOLOGICAL TREATMENT FOR HIGH-RISK PATIENTS
Pharmacotherapy should be instituted for residents either diagnosed with osteoporosis or who are at high risk of fracture. Further research is required to determine the benefits of combination therapy of estrogen, bisphos-phonates, and calcitonin.⁸⁴

This summary is not intended to be comprehensive. It is recommended that providers refer to the appropriate manufacturer's recommendations for complete details on indications, contraindications, warnings, precautions, adverse reactions, dosage, and administration. Recent reviews of therapy that provide an overview of options are also recommended (Eastell RN. N Engl J Med 1998; 338:736-46; Beaumont W. Postgrad Med 1997; 101(1):129-32,136-7,141-2).

Estrogen85

Although a great deal of data exist regarding use of hormone replacement therapy in younger women, a paucity of data are available to support new (de novo) use of hormone replacement therapy in women older than 75 years. In some situations, the relative benefits versus risks as assessed by the resident and physician may warrant initiation of therapy. Existing hormone replacement therapy, if effective and tolerated, should be continued.

Estrogen therapy is indicated for the prevention and management of osteoporosis. Estrogen reduces bone resorption and retards or halts postmenopausal bone loss. Observational studies have shown an approximately 60% reduction in hip and wrist fractures in women whose estrogen replacement was initiated within a few years of menopause. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as six years after menopause, estrogen may prevent further loss of bone mass for as long as the treatment is continued.

Considerations associated with the decision to initiate estrogen therapy include potential benefits such as relief of symptoms of estrogen deficiency and cardiac protection. However, there are risks associated with therapy, such as breast and endometrial cancer.^86,87

A majority of studies have shown a reduction in the risk of subsequent ischemic heart disease with postmenopausal estrogen therapy compared with no estrogen therapy. When estrogen therapy is discontinued, bone mass declines at a rate comparable to that in the immediate postmenopausal period. However, the cardiac protective effect after the cessation of therapy may be conferred for a period of time equal to the duration of therapy.⁸⁷

Current medical practice often includes the use of concomitant progestin therapy in women with an intact uterus to diminish the risk of endometrial cancer.^85,88 The effect of added progestins on the risk of breast cancer is unknown, although a moderately increased risk for those taking combination estrogen/ progestin therapy has been reported. Other studies have not shown this relationship. Women with a positive family history of breast cancer are at greatest risk.

Because vaginal bleeding may be a sign of malignancy, close clinical surveillance of all women taking estrogen is important. In postmenopausal women, compliance with estrogen has been reported to be low whether specifically prescribed for osteoporosis or for other reasons.

Bisphosphonates^89-93

In several controlled trials, therapy with alendronate increased total body BMD, suggesting that BMD increases in the spine and hip did not occur at the expense of other skeletal sites. In three-year trials, increases in BMD were apparent in as early as three months and continued throughout therapy. However, increases are not maintained following withdrawal of therapy, indicating that continuous daily treatment is required to maintain therapeutic effects. Analysis of pooled data indicated that alendronate was associated with a reduced incidence of vertebral fractures and with reduction in the frequency and severity of fractures. The relative hazard for hip fracture and wrist fracture in the alendronate group was 0.49 compared to placebo in patients with pre-existing vertebral fracture.^93,94

Alendronate is not recommended for patients with renal insufficiency (e.g., serum creatinine 2.5 mg/dL). Also, it is contraindicated for patients with the following conditions: abnormalities of the esophagus that delay esophageal emptying such as stricture or achalasia, untreated hypocalcemia, or inability to stand or sit upright for at least 30 minutes, or hypersensitivity to any component of the product.

Patients taking alendronate have reported severe esophageal adverse experiences such as esophagitis, esophageal ulcers, and esophageal erosion. To facilitate delivery to the stomach and to reduce the potential for esophageal irritation, alendronate should be swallowed with a full glass of water (at least 6 oz.) at least 30 minutes before the first food or drink of the day. Patients should not lie down for at least 30 minutes following the dose.

Calcitonin⁹⁵

Because calcitonin is protein, the possibility exists for a systemic allergic reaction, including bronchospasm, swelling of the tongue or throat, and anaphylactic shock. Skin testing should be considered prior to treatment with injectable calcitonin. Administration of injectable calcitonin could also lead to hypocalcemic tetany.

Intranasally administered calcitonin is indicated for the treatment of osteoporosis in women greater than five years postmenopause with low bone mass who refuse or cannot tolerate estrogens or for whom estrogens are contraindicated. Food and Drug Administration approval of intranasal calcitonin was based on studies inclusive of such patients. The intranasal formulation increased lumbar vertebral BMD relative to baseline and placebo in women with osteoporosis greater than five years postmenopause.^100,101 It produced statistically significant increases in lumbar vertebral BMD compared with placebo as early as six months after initiation of therapy, with persistence of this level for up to two years of observation. No effects on cortical bone of the forearm or the hip were demonstrated. However, in one study, BMD of the hip bone showed a statistically significant increase compared with placebo after one year of treatment, changing to a trend in two years that was no longer statistically significant.

Because of the incidence of rhinitis, nasal irritation, redness, and sores associated with intranasal calcitonin, periodic nasal examinations are recommended prior to initiating therapy and at any time nasal complaints occur.

Pharmacotherapy Selection

The panel recognized that drug selection for the treatment of osteoporosis in LTC facilities may be difficult to discriminate. However, the panel identified some selected clinical situations that suggest a preference of agents. The algorithm in Figure 2 offers a hierarchy of preferences for the selection of drug agents based on clinical presentations likely to been encountered in the LTC population. It should be noted that there is no comparative evidence to support the choice of agent; therefore, the algorithm is based on panel consensus.

11. OUTCOMES MEASUREMENT
The best measure of any osteoporosis prevention strategy is the number of averted osteoporotic fractures in the resident population.

The measurement of health outcomes begins with an individual resident; however, pooled outcome measurements are especially useful to assess prevention strategies for avoidable illnesses. In the case of osteoporosis, the expert panel preferred the outcome measurement of the number of averted osteoporotic fractures in the resident population. Each resident with multiple risk factors for fracture who survives a fall without serious injury is an important outcome. However, a pooling of outcome measures can best help institutions determine the effectiveness of the treatment plan.

Outcome studies should be based on a protocol that compares rates of fracture incidence in the institution before and after a clinical intervention. In particular, the intervention should include implementation of a program that promulgates clinical guidelines for the management and treatment of osteoporosis. No studies have been performed that examine the benefits of a comprehensive osteoporosis management program in long-term care facilities; therefore, protocols should be structured on basic outcome models. Many opportunities exist for the consultant pharmacist's role in such a protocol, primarily as an educator and an advocate of appropriate therapy.

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Robert W. Baran, PharmD, is Director, Clinical Outcomes, Office of Professional Programs, University of the Sciences, Philadelphia, Pennsylvania. Douglas P. Kiel, MD, MPH, is Assistant Professor of Medicine, Harvard Medical School, and Associate Director of Medical Research, Hebrew Rehabilitation Center for the Aged, Research and Training Institute, Cambridge, Massachusetts. Heather Patterson, PharmD, is a Fellow in Pharmacoeconomics, SmithKline Beecham, Collegeville, Pennsylvania. Joseph Doyle, RPh, MBA, Outcomes Fellow, Philadelphia College of Pharmacy, Thomas Jefferson University Office of Health Policy and Clinical Outcomes, Philadelphia, Pennsylvania. Becky Briesacher, MA, is a PhD candidate at the University of Maryland, College Park, Maryland. W. Gary Erwin, PharmD, FASCP, is Vice-President for Outcomes Research, Omnicare, Radnor, Pennsylvania.

Address for Reprints: Robert W. Baran, PharmD, Director, Clinical Outcomes, Office of Professional Programs, University of the Sciences, Philadelphia, PA 19104-4495.

Copyright © 1998, American Society of Consultant Pharmacists, Inc. All rights reserved.