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Osteoporosis in the Nursing Home:
Screening and Interventions for Fracture Prevention
By
Linda D. Ward, RN, BSN
A manuscript submitted in partial fulfillment of the requirements for the degree of
MASTER OF NURSING�
Intercollegiate College ofNursing� Washington State University College ofNursing�
December, 2002�
To the faculty of Washington State University:
The members of the committee appointed to examine the Intercollegiate College of Nursing research requirements and manuscript of Linda Ward find it satisfactory and recommend that it be accepted.
Cynthia Corbett, Ph.D., R.N., C., Chairperson
Alice E. Dupler, M.S.N., R.N.
2~)~ Bronwynne Evans, Ph.D., R.N.
Stephen M. Setter, Pharm.D., C.G.P., C.D.E., D.V.M
2 Osteoporosis in the Nursing Home
Osteoporosis in the Nursing Home:
Screening and Interventions for Fracture Prevention
Abstract
More than 80% of nursing home residents are believed to have osteoporosis, which leaves them
susceptible to debilitating and life-threatening fractures. Vertebral fractures occur most
commonly, causing pain, deformity and functional impairment. Fractures at other sites are
associated with falls. Nursing home residents have a 60% risk to fall each year, with a hip
fracture rate of 5-6%, nearly ten times that of community-dwelling persons the same age. Hip
fracture in a nursing home resident is associated with a 41 % mortality rate within four months,
more than twice the rate for older persons who fracture a hip at home. Nursing home admission
provides a critical opportunity to screen for osteoporosis and offer il1terventions to reduce the
likelihood of fracture. A number of safe and effective therapies are available to improve bone
health in nursing home residents, btlt no fOffilal guidelines exist for preventing fractures in this
most vulnerable population. A research-based analysis, that includes clinical, economic, and
humanistic implications of available non-pharmacological and pharmacological interventions for
osteoporosis, is presented. The analysis is synthesized as an algorithm for screel1ing, preventing,
and treating osteoporosis in l1ursing home residents.
Osteoporosis in the Nursing Home 3
Osteoporosis in the Nursing Home:
Screening and Interventions for Fracture Prevention
Osteoporosis is a disease that primarily affects older persons. Similar to other
chronic diseases, it progresses insidiously for years before becoming apparent in the form of a
fracture. Ten million Americans already have osteoporosis, and 18 million have osteopenia, or
low bone mass (National Institutes of Health [NIH], 2001). Half of all white women will
experience an osteoporotic fracture in their lifetime (National Osteoporosis Foundation [NOF],
1999), along with 13% of white men (Messinger-Rapport & Thacker, 2002). In 1995,
osteoporosis caused 1.5 nlillion fractllres in the United States at a cost of$14 billion. That cost
may increase to as much as $240 billion over the next 50 years, as the population of Americans
over age 85 increases (Osteoporosis Task Force, 2001).
Over 90% of osteoporotic fractures occur in persons aged 65 and older, and those at
highest risk are the nearly two million residents of nursing homes. With a mean age of 84 years,
nursing home residents have high rates of functional and cognitive impairment, chronic disease,
and polypharmacy. It is no surprise, then, that falls are common in the nursing home; in fact,
60% of nursing home residents fall each year (Fuller, 2000). Most of these frail individuals also
have osteoporosis. Studies of white female nllfsing home residents showed from 80% to 95% to
be osteoporotic by World Health Organization (WHO) criteria (Chandler et aI., 2000; Ekman,
Michaelsson, Ljunghall, & Mallmin, 2001; Kanis, 1994; Wallace, 2000). The combination of
high fall risk and weak bone results in a fracture rate among nursing home residents that is nearly
ten times that of healthy comnllmity-dwelling elders (ChaIldler et aI.)
Osteoporotic fractures occur most often at the spine, hip, and wrist. Vertebral fractures
are most common and usually occur with normal activity. Many vertebral fractures go unnoticed,
4 Osteoporosis in the Nursing Home
about half are associated with back pain, 8% require hospitalization, and 2% result in long-term
nllrsing care (Office of Disease Prevention, 2000). Hip and wrist fractures are usually associated
with a fall. Hip fracture has such high morbidity and mortality that it is often a ternlinal event in
older persons. Within a year of fracturing a hip, 20% of community-dwelling women and 40% of
men die, about 60% never return to prefracture function, and 40% require long-term care (Field
Munves, 2001). The mortality rate following hip fracture in nursing home residents is twice as
high; 41 % of residents die within four months of fracture, and 46% die within one year (Baran et
aI., 1998).
Osteoporosis has been recently recognized as an important public healtll issue. Healthy
People 2010 set goals to reduce the incidence of osteoporosis and hospitalizations for vertebral
fractures by 20% and to reduce deaths and injuries from falls, including hip fracture, among
elderly perSOl1S (Office of Disease Prevention, 2000). The purpose of this paper is to discuss
current best practices in the management of osteoporosis in the nursing home population. The
focus will be on clinical interventions, primarily screening, nutritional supplementation, and
pharmacologic treatments, to prevent and treat osteoporosis.
Theoretical Framework
The Economic, Clinical, and Humanistic Outcomes (ECHO) model provides an
integrated framework for evaluating osteoporosis treatment alternatives (Kozma, Reeder, &
SchlLlz, 1993). The ECHO model differs from a traditional medical model by requiring
systematic evaluation of economic and humanistic outcomes as well as traditional clinical
outcomes in determining the best pharmaceutical treatment. Developed to guide
pharmacoeconomic decision-making, the ECHO model is also useful in comparing non
5 Osteoporosis in the Nursing Home
pharmaceutical treatments, and is particularly well suited to nursing home care, for reasons
detailed below.
Components ofthe ECHO Model
The ECHO nl0del (Figure 1) has tllfee components. The first component, clinical
variables, consists of clinical indicators and clinical outcomes. Clinical indicators are data
gathered from resident assessment that indicate the degree of disease and guide the decision to
treat. With osteoporosis, clinical indicators include risk factors for osteoporosis and radiographic
measurenlents of bone health. Clinical outcomes are medical events that occur (or do not occur)
as a result of the disease or treatment. Such outcomes include fracture, pain, and medication side
effects.
The second component, economic outcomes, includes the total direct, indirect and
intangible costs compared with the consequences of treatment alternatives. For example, the cost
of hospitalizing a resident for a gastrointestinal bleed related to bisphosphonate treatment is
included in determining the economic outcome of prescribing that medication. Likewise, dollars
saved by preventing a hip fracture are also counted.
The final component of the model, humanistic outcomes, includes the consequences of
both the disease and the treatment on the resident's functional status and quality of life. Physical
and social functioning, generalllealth and well-being, and satisfaction with treatment are
systematically assessed. For example, residents may object to having to swallow three large
calcium tablets, or to being awakened early for their alendronate (Fosamax®) dose. Application
of the ECHO model requires consideration of these patient responses to treatment.
6 Osteoporosis in the Nursing Home
Application ofthe ECHO model
The ECHO model is philosophically congruent with the way in which nursing home care
is provided. In addition to traditional medical treatment (clinical variables), quality of life issues
(hllmanistic outcomes) have long been emphasized in the nursing home. In fact, nursing 110nles
are required to implement individualized care plans and to involve residents and families in the
plan of care. Facilities also strive to acllieve a home-like atmosphere with diligent attention to
resident rights and autonomy. Implementation of a prospective payment system in 1998 provided
an increased incentive to provide cost-effective care (econonlic outcomes). All three components
of the ECHO model are thus integral to making treatment decisions in the nursing home.
Review of the Literature
Osteoporosis
Osteoporosis is defined by WHO in terms of bone mineral density (BMD). There is
currently no accurate measurement of overall bone strength, but BMD accounts for
approximately 70% of bone strength (NIH, 2001). Diagnostic criteria for osteoporosis are
expressed in terms ofT-score, or the number of standard deviations by which an individual BMD
differs from the nlean value for a young adult of the same sex. Osteopenia (low bone mass) is
defined as having a T-score between -1 and -2.5, while osteoporosis is diagnosed when the
T-score is less than -2.5 (Kanis, 1994). The baseline BMD of an individual correlates fairly well
with fracture risk, in that a T-score of -1 at the lumbar spine predicts a two-fold increase in risk
of vertebral fracture (Sharpe, Noble, & Spencer, 2001).
Determination of hip BMD is preferred for diagnosis of osteoporosis because of the
severe consequences of hip fractllre and the close correlation between low hip BMD and hip
fracture. Spine BMD is often used for monitoring treatment, because vertebral response to
7 Osteoporosis in the Nursing Home
antiresorptive agents occurs relatively quickly. Peripheral measurements ofBMD are easier to
obtain, but do 110t reliably predict fracture risk (Broe et aI., 2000).
Osteoporosis Prevention and Treatment
Many studies have been conducted in recent years regarding osteoporosis prevention and
treatment, however they have important limitations. Most interventional studies measured
change in BMD as an endpoint. While low BMD certainly contributes to fracture risk, a more
useful endpoint is actual fracture. However, in order for fracture studies to have sufficient power,
they must include large numbers of subjects and/or proceed for a lengthy time. A limited number
of studies used fracture as an endpoint, and these provide tIle strongest evidence for intervention
efficacy or lack thereof.
Evidence-based guidelines for nursing llome residents are limited because most findings
are based on studies of healthy, community-dwelling postmenopausal women. Very few trials
have focused on nursing home residents. Consequently, the published clinical guidelines for
osteoporosis treatment, most notably by the National Osteoporosis Foundation (NOF) and the
American Association of Clinical Endocrinologists (AACE), are directed at the management of
healthy postmenopausal women. Furthermore, the risk factors that form the basis of these
treatnlent guidelil1es have not been demonstrated to independently predict fracture in nursing
home residents (Chandler et aI., 2000). It may be that risk factors for community-dwelling,
"younger" elders are so common in the nursing home that they do not distil1guish fracture risk.
Finally, the pathophysiology of bone formation and resorption in older persons is not
clearly delineated. While osteoporosis is a chronic disease which typically progresses 20 to 30
years before fractllre occurs, most clinical trials have lasted only three or four years (Lindsay &
Meunier, 1998). Researchers commonly believed that bone loss occurred at a high rate beginning
8 Osteoporosis in the Nursing Home
with menopause, remained elevated for a few years, then slowed or ceased in older women.
However, recent studies indicate that bone turnover remains elevated into old age and may
accelerate rather than slow after age 65 (Villareal et aI., 2001).
There is no question that bone health must be addressed in the nursing home, but the lack
of research and treatment guidelines specific to this population nlakes treatment decisions
difficult. Despite the challenges identified above, there are a number of cost-effective
interventions that can reduce fractures among nursing home residents.
Assessment and Intervention: Application of the ECHO Model
Screening
Osteoporosis is both underdiagnosed and undertreated. Less than one-third of American
women with osteoporosis have been diagnosed, and only one-seventh of those diagnosed receive
treatment (Osteoporosis Task Force, 2001). A study of934 wonlen aged 60 and older who had
chest x-rays during hospitalization showed 14% had significant vertebral fractures, however,
only 1.8% had a discharge diagnosis of vertebral fracture. Of those, only 18% were prescribed
medication or dietary supplements to increase or maintain bone density (Gehlbach et aI., 2000).
A study of 170 patients hospitalized with a new hip fracture revealed only 5% were discharged
on a new medication to prevent subsequent fracture (Kamel, Hussain, Tariq, Perry, & Morley,
2000). Patients who have sustained one osteoporotic fracture are at high risk to refracture and
clearly should be offered treatment to improve or maintain bone strength.
Nursing home admission provides a critical opportunity to screen for osteoporosis,
especially since recent fracture often precipitates nursing home admission. Every l1ew resident
should be screened for bone health, despite their age or anticipated length of stay. Routine
measurement of BMD, which is recommended for healthy older persons, is controversial in the
9 Osteoporosis in the Nursing Home
nursing home. Application of the ECHO model to risk factor assessment and BMD measurement
is illustrative.
Risk Factor Assessment: Clinical, Economic and Humanistic Impact
Risk factor assessment is designed to determine which residents are likely to have
osteoporosis and benefit from therapy. The clinical utility of assessing risk factors depends on
counting those factors that actually predict fracture risk. While the risk factors listed in Table 1
were developed specifically to assess fracture risk in nursing home residents, there are no
specific studies to document their predictive value. In order to maximize the accuracy of
osteoporosis screening, more information about fracture risk in nursing home residents must be
collected. Fracture risk assessment llas minimal economic impact, requiring only time on the part
of the admitting nurse to complete the assessment. From a humanistic standpoint, assessment of
risk factors offers potential benefit without harm to the resident.
Guidelines for osteoporosis screening are well established for healthy older persons, and
both the NOF and the AACE have published specific risk factors for fracture in that population.
While no formal guidelines exist for screening nursing home residents, Baran et al. (1998)
utilized an expert panel and available research to develop a step-wise approach for evaluating
fracture risk in nllrsing home residents. The authors developed an algorithm intended for use by
primary care providers. However, with nlinimal adaptations to the algorithm, the admitting nurse
at the nursing home can complete a similar evaluation (Figure 2). Steps include determining
intention to treat, carefully reviewing tIle resident's medical history for evidence of osteoporosis,
and assessing clinical risk factors for fracture (Table 1). The nurse should then present the
findings to the primary care provider for consideration of specific therapies to promote bone
health and prevent fracture.
10 Osteoporosis in the Nursing Home
Bone Mineral Density: Clinical, Economic and Humanistic Impact
Osteoporosis is defined in terms of bone mineral density, and BMD is the single best
predictor of fracture risk. Both the NOF alld AACE recommend BMD testing for all women over
age 65 and specifically warn that treatment decisions should not be based on risk factors alone.
However, these guidelines were written for commllnity-dwelling older persons. Bone density
screening is probably not indicated for most nursing home residents, as application of ECHO
criteria demonstrates.
In terms of clinical indicators, there is no doubt that determination of hip BMD provides
useful information. In addition to confirming a diagnosis of osteoporosis and measuring baseline
bone density, BMD meaSllrement is useful in determining the cost effectiveness of expensive
treatments. Nomograms developed by the NOF help providers make rational and cost-effective
prescribing decisions for various antiresorptive agents by plotting a resident's age, number of
risk factors, and hip BMD (Lindsay & Meunier, 1998). However, the clinical utility of a
"screening" test for bone density is limited in the nursing home population, where at least 80%
of individuals are expected to have positive tests.
The economic impact of BMD measurement is substantial in the nursing home. The
measurement that provides the best correlation with fracture risk is hip BMD determined by
dual-energy x-ray absorptiometry (DEXA) of the hip. This scan requires the use of stationary
equipment and costs approximately $250. Under the current payment system, the nllrsing home
is usually required to pay for both the scan and tIle cost of transporting the patient to the testing
site. Portable systems are available to determine peripheral BMD at less cost, but those
measurements do not reliably predict fracture risk (Broe et aI., 2000).
11 Osteoporosis in the Nursing Home
The humanistic impact of hip BMD testing on nursing home residents is substantial,
requiring that residents be transported from the nursing home to the testing site, be positioned
correctly for the scan and lie still'for as long as ten minutes. Many residents cannot tolerate
scanning, due to impaired mobility or cognition. Even peripheral measurements of BMD
utilizing portable equipment are not easy to obtain in this population. In a large Maryland study,
34% of nursing home residents were unable to complete a portable BMD test of the distal
forearm, due to cognitive or physical impairment (Zimmerman et aI., 1999).
In light of clinical, economic and humanistic factors, routine BMD screening of nursing
home residents is not indicated. Given the higll incidence of osteoporosis in this population,
BMD screening loses much of its clinical utility, and the economic and humanistic factors
provide compelling reasons not to routil1ely measure bone density. Careful evaluation of each
resident's history and risk factors associated with osteoporosis provides a more rational approach
to identifying those likely to benefit from further evaluation and treatment.
Treatment of Osteoporosis: Application of the ECHO Model
The primary goal of osteoporosis treatment is fracture prevention through reducing bone
loss, increasing bone mass, and preventing falls. A multidisciplinary approach including dietary
interventions, phamlaceuticals, physical conditioning, and fall prevention provides the best
opportunity to improve bone health and reduce fractures in nursing home residents. Dietary
supplements and pharmaceuticals that have been shown to improve bone density and/or reduce
fracture risk include calcillm and vitamin D, bisphosphonates, estrogens, selective estrogen
receptor modulators and calcitonin. In addition, hip protectors have demonstrated efficacy in
reducing hip fractures in nursing home residents. These interventions will be examined within
the framework of the ECHO model.
12 Osteoporosis in the Nursing Home
Calcium
The role of calcium in bone health is well established. The skeleton stores 99% of the
body's calcium, and when insufficient calcium is present in the diet, bone is demineralized to
maintain serum levels. The average American diet provides less than 600 mg/d of elemental
calcium, about half the recommended daily allowance (NOF, 1999), and only about 50% to 60%
of older adults are believed to consume adequate calcium to maintain bone health (NIH, 2001).
Calcium supplementation is widely recommended for older persons. While the NOF
recommends at least 1200 mg/d dietary calciunl for all patients with risk factors for osteoporosis,
the NIH specifies an optimal calcium intake for women over age 65 to be 1500 mg/d.
The clinical benefits of adequate calcium for nursing home residents are well
demonstrated. Lindsay and Meunier (1998) summarized randomized trials of calcium
supplementation in about 1800 postmenopausal women, demonstrating a lower rate of bone loss
in women receiving supplemental calcium. Bone density was 1%-3% higher in the treatment
groups, with a greater effect noted in women who were more than five years postmenopausal.
Fewer studies have evaluated the effect of calcium on fracture. Four randomized,
controlled trials in community-dwelling postmenopausal women demonstrated modest but
clinically significant reductions in fractures, primarily vertebral fractllres, with calcium
supplementation (Chevalley et aI., 1994; Orimo et aI., 1994; Recker et aI., 1996; Reid et aI.,
1995). In a classic study, Chapuy, Arlot, Delmas and Meunier (1994) demonstrated a 43%
reduction in overall fractures among nursing 110me residents with calcium and vitamin D
supplementation over three years. Hip fractures were reduced by 29%. It is unknown whether the
protective effect was from calcium or vitamin D, or was a result of both in combination.
13 Osteoporosis in the Nursing Home
The economic impact of providing supplementary calcium is minimal. The NOF, while
admitting that tIle precise effect of calcium on fracture risk is unknown, estimates it is "highly
probable" that calcium supplementation reduces fractllre rates by 10%. At that level of
effectiveness, calciunl is cost-effective ifpurchased inexpensively (at a cost of about $50/year),
even for women who have high BMDs (Lindsay & Meunier, 1998).
There are some humanistic considerations in providing routine calcium supplements.
Calcium supplementation at the recommended level is safe, with few side effects if the doses are
provided with meals (Lindsay & Meunier, 1998). However, residents sometimes complain about
the size and/or number of calcium tablets, because two or three large tablets are required for a
1200-1500 mg dose. Dividing doses enhances absorption, but requires residents to take calcium
tablets two or three times a day. Residents sometimes have difficulty swallowing the pills.
However, chewable antacids that contain calcium are an economical alternative and may be
better tolerated. Chewable antacids are also easily crushed and can be added to applesauce or
pudding.
Applying the ECHO model to calcium supplementation reveals little reason to deviate
from the recommended l~vel of supplementation. Nursing home residents should conSlIDle 1200
to 1500 mg of elemental calcium per day unless there is a specific contraindication. Calcium
supplements should be used to augnlent dietary calcillm to the target level.
Vitamin D
Like calcium, vitamin D is essential for bone health. Vitamin D is not a true vitamin
because it can be synthesized in the skin with adequate ultraviolet exposure. Vitamin D is
required for absorption of dietary calcium and for bone mineralization. Insufficiency leads to
hyperparathyroidism, which in tum causes high bone turnover, bone loss, and increased fracture
14 Osteoporosis in the Nursing Home
risk (Fairfield & Fletcher, 2002). Vitan1in D insufficiency is widespread, especially among older
persons who are institutionalized or homebound. There is general agreement that sunlight
deprived people, particularly those in nursing homes, commonly have vitamin D deficiency.
LeBoff et al. (1999) found 50% of postmenopausal women with hip fractures to be vitan1in D
deficient. The NOF recommends 400 to 800 IV daily of vitamin D for nursing home residents,
while the AACE guidelines call for 800 IV per day.
Clinical outcomes show clear benefit with vitamin D supplementation. The largest trials
among elderly persons revealed il1creased hip BMD and fewer upper-extremity fractures, but no
reduction in hip fractures with vitamin D supplementation (Heikinheimo et aI, 1992; Lips,
Graafmans, Ooms, Bezemer, & Bouter, 1996). Pfeifer and Minne (1999) demonstrated improved
neuromuscular coordination and body sway with vitamin D supplementation, proposing that
vitamin D can reduce fall risk. Most studies of vitamin D and fracture risk included supplen1ental
calcium as well, and the efficacy of vitamin D alone in preventing fracture has not been clearly
demonstrated. Supplements in the recon1mended amount (up to 800 IV per day) are safe
(Fairfield & Fletcher, 2002).
Vitamin D supplementation incurs little economic in1pact. Milk and cereals that are
fortified with vitamin D can provide a large part of the daily reqllirement. Most multivitamins
contain vitamin D, as do n1any calcium supplements. Vitamin D supplements are also available.
These are all inexpensive interventions. Vitamin D in the amounts recommended is well
tolerated, and there are 110 compelling hllmanistic reasons to deviate from these
recommendations. All nursing home residents without specific contraindications to vitamin D
should receive 400 to 800 IV per day.
15 Osteoporosis in the Nursing Home
Bisphosphonates
The bisphosphonates are a group of medications that bind to bone and inhibit osteoclast
mediated bone resorption. In 1995, alendronate (Fosamax®) was the first bisphosphonate to be
labeled by the FDA for the prevention and treatment of osteoporosis. Risedronate (Actonel®), a
second-generation bisphosphonate, was approved in 2000. Application of the ECHO model to
these powerful antiresorptive agents is revealing.
Clinical outcomes associated with bisphosphonate therapy are positive in terms of
fracture prevention. Bisphophonates increase BMD irrespective of degree of underlying
osteoporosis and reduce fractures in patients with documented osteoporosis (Hodsman, Hanley,
& Josse, 2002). In randomized trials among community-dwelling elderly females, botll
alendronate and risedronate were found to significantly increase BMD at the lumbar spine and
hip (Black et aI., 2000; Hodsman et aI.; McClung et aI., 2001; Sharpe et aI., 2001). More
importantly, alendronate use over three years in the Fracture Intervention Trial (FIT) decreased
the incidence of new vertebral, hip, and wrist fractures by 50% (Black et aI.). Trials with
risedronate showed 30% to 50% reductions in fractllres at all sites over three years compared to
placebo (Harris et aI., 1999; McClung et aI.). With both bispllosphonates, fracture reduction
occurred only among women with BMD-documented osteoporosis; those with osteopenia
fractured at the same rate as the placebo groups (Black et aI.; Harris et aI.).
While clinical trials have firmly established the efficacy of bisphosphonates in treating
community-dwelling osteoporotic women, only a single, nluch smaller trial (N=327) with
nursing home residents has been published. Greenspan et aI. (2002) fOllnd significantly increased
BMD at the spine and hip after 2 years of alendronate treatnlent among ambulatory female
nursing home residents. The treatment group had a lower fractllre rate, but this was not
16 Osteoporosis in the Nursing Home
statistically significant. However, the small size of this study severely limited its ability to
demonstrate fracture reduction.
While the clinical efficacy of bisphosphonates in reducing fractures among nursing home
residents has not been clearly demonstrated, there is strong evidence to support their use.
Alendronate produced a pronounced reduction in fracture in women with very low BMD (Black
et aI., 2000). Nursing home residents as a group have significantly lower BMD than participants
in the FIT trial, and may have greater treatment benefit than community-dwelling elderly
persons.
Bisphosphonates are expensive, costing approximately $600 per year (Vestergaard,
Rejnmark, & Mosekilde, 2001), and specific dosing requirements increase the cost of
administration. Bisphosphonates must be administered apart from other medications, witll a full
glass of water, at least 30 minutes before the first food or drink of the day. Taking the drug with
liquid other than water, with other medications, or with food reduces the bioavailability (which is
<1 % at best) by 40%-90% (Sharpe et aI., 2001). After taking the drug, residents must remain
upright for 30 minutes to prevent esophageal irritation. The need to separate bisphosphonates
from the regular medication pass and to nlonitor that residents remain upright after the dose is
labor intensive, but failure to comply destroys the bioavailability of the drug, risks serious
gastrointestinal side effects, or both (Sharpe et aI.). The FDA recently approved weekly dosing
of bisphosphonates, which greatly reduces cost of administration.
The cost effectiveness of bisphosphonate therapy is dependent upon careful selection of
residents likely to benefit from treatment and by vigilant attention to administration instructions.
Bisphosphonates have been demonstrated to reduce fractures only in individuals with
documented osteoporosis, and limited knowledge of hip BMD makes it difficult to know which
17 Osteoporosis ill the Nursing Home
residents are actually osteoporotic. The NOF nomograms, which are useful in determining the
cost-effectiveness of treatment in individual patients, rely heavily on hip BMD measurements.
However, because the increase in BMD with bisphosphonates is greater in older than in younger
postmenopausal women (Greenspan et aI., 2000), and because nursing home residents in general
have been denlonstrated to have a very high incidence of osteoporosis, bisphosphonates may be
more cost effective in the nursing home than in the community. Still, because these drugs have
not yet been demonstrated to reduce fractures in randomized nursing home trials, their efficacy
and cost effectiveness truly remain unknown.
Humanistic factors associated with bisphosphonate use include administration
requirements and safety. These dosing reqllirements are not always appreciated by residents.
Most residents must be awakened early in the morning to take their bisphosphonate. They must
then remain upright for half an hour before their morning coffee, juice, or breakfast. The advent
of weekly dosing was a blessing to nursing staff and residents alike, greatly reducing the burden
related to dosing reginlen.
Esophageal safety with bisphosphonates has economic, clinical and humanistic
implications. Gastrointestinal side effects with alendronate, including occasional serious
esophageal injllry, have been more commonly reported in practice than in clinical trials (Sharpe
et aI., 2001). However, a high proportion of those reports are associated with failure to follow
dosing recommendations (Watts, Freedholm, & Daifotis, 1999). Endoscopic studies have not
shown gastrointestinal erosions or ulcers related to weekly alendronate (Lanza et aI., 2002).
Fewer problems have been reported with risedronate (Greenspan et aI., 2000). Bisphosphonates,
which quickly bind to bone and thus have little systemic effect, are otherwise well tolerated.
18 Osteoporosis in the Nursing Home
Bisphosphonate therapy should be considered for all nursing home residents who are at
high risk for fracture. Because of the high cost, both bone 11ealth and fall risk should be carefully
considered when deciding ifbisphosphonate therapy is indicated. Residents who can participate
in treatment decisions should have a voice regarding this therapy, because of the stringent dosing
requirements. Nursing staff must scrupulously follow the recommended dosing protocol. The
clinical efficacy, cost, and dosing implications for alendronate and risedronate are similar, and
there is little to recommend one over the other.
Estrogen
Estrogen has been widely believed to prevent osteoporotic fractures and is approved by
the FDA for prevention of osteoporosis in postmenopausal women. Historically, estrogen was
approved for osteoporosis treatment as well, however the FDA removed that indication because
estrogen was never demonstrated to reduce fracture risk. Controversy about estrogen's role in
osteoporosis management has been ongoing.
There is little dissent regarding estrogen's efficacy in preventing the rapid loss of bone
density that normally occurs in the immediate postnlenopausal period. The Study of Osteoporotic
Fractures was a large (N=9704) observational study that linked estrogen use to reduced fracture
risk in women over age 65 (Cauley et aI., 1995). The protective effect of estrogen appeared to
cease if therapy was stopped. The Postmenopausal Estrogen/Progestin Intervention (PEPI) trial
demonstrated that estrogen actually increases bone density, not merely slows bone loss or
maintains BMD. The authors noted that older women and those with lower initial BMD gained
significantly nl0re bone than women who were YOllnger and/or had higher BMD (PEPI Writing
Group, 1996).
19 Osteoporosis in the Nursing Home
While few studies focused on older women, a small (N=67) randomized trial involving
women over age 75 showed an increase in hip and spine BMD after only nine months of
estrogen therapy compared to the control group. The magnitude of the increase in both lumbar
spine and total hip BMD was equal to or greater than that found in studies of younger women
(Villareal et aI., 2001).
The issue of fracture reduction with estrogen was not demonstrated in randomized trials
until preliminary results from the Women's Health Initiative (WHI) were released in 2002. This
large trial of 16,608 healthy women aged 50-79 years showed a 33% reduction in the rate of hip
fracture with hormone replacement therapy (HRT) versus placebo. However, the study was
terminated early (after 5.2 years) by the National Institutes of Health, when the breast cancer risk
in the treatment group reached a prespecified upper boundary. The allthors concluded that HRT
caused net harm when used for 5.2 years, with reductions in fracture risk and colorectal cancer
outweighed by increased risk of cardiovascular disease and breast cancer (Writing Group for the
WHI, 2002). While the protective effect of estrogen on bone was clearly denlonstrated by the
WHI, the use of HRT for extended periods of time for the primary prevention of chronic disease
was determined not to be justified.
The clinical impact of HRT on the bone of nursing home residents is unknown. While
significant fracture reduction was achieved in the WHI, that population was younger and
healthier than the nursing home population. The small Villareal study demonstrated a favorable
effect of estrogen on bone, but no study has denl0nstrated estrogen to reduce fractures in the
nursing home. Because of estrogen's widespread systemic effects and potential adverse clinical
outcomes related to cardiovascular and breast disease, it has an overall negative clinical profile
for osteoporosis prevention.
20 Osteoporosis in the Nursing Home
Estrogen has a relatively low direct cost. Hormone replacement therapy costs
approximately $300 per year, about half the cost ofbisphosphonates. While Vestergaard et al.
(2001) claim HRT to be cost effective in terms of fracture prevention in women over the age of
70, application of the ECHO model requires that indirect costs also be considered, including
those costs related to potential adverse effects. Overall, HRT is not a cost-effective therapy for
fracture reduction in most nursing home residents.
Humanistic impact of HRT on nursing home residents is primarily related to potential
medication side effects and satisfaction with treatment. The single daily dose has no special
administration requirements. Some older females are quite convinced that estrogen confers a
number of benefits and are not interested in stopping therapy. Application of the ECHO model
requires providers to consider such patient preferences in making clinical decisions.
While estrogen has a significant protective effect on bone in younger wonlen, it has never
been demonstrated to increase bone density or prevent fractures in women long past menopause
(Baran et aI., 1998). Therefore, and because a wide range of adverse effects are associated with
prolonged therapy, estrogen should not be used for osteoporosis prevention.
Selective Estrogen Receptor Modulators
Raloxifene (Evista®) is one of a new class of drugs, selective estrogen receptor
modulators (SERMs), which bind to estrogen receptors but exhibit tissue-specific effects that are
distinct from estradiol. For example, raloxifene acts as an estrogen agonist on bone and on lipid
metabolism, but as an antagonist on breast and uterine receptors (Khovidhunkit & Shoback,
1999). The FDA approved raloxifene for the prevention of osteoporosis in postmenopausal
women in 1997. The health risks demonstrated with estrogen in the WHI fueled increased
21 Osteoporosis in the Nursing Home
interest in SERMs. The hope is that the tissue specificity of SERMs can produce benefits
associated with HRT without sonle of the risks.
The clinical efficacy of raloxifene been explored in a number of large randomized trials.
Trials involving 1800 healthy postnlenopausal women demonstrated raloxifene's positive effect
on bone and were cited in the FDA approval. Fracture was not an endpoint in these studies,
however significant increases in BMD at all sites were demonstrated in the treatnlent versus
placebo groups (Delmas et aI., 1997; Johnston et aI., 2000).
The largest American raloxifene study, the Multiple Olltcomes of Raloxifene Evaluation
(MORE), demonstrated significal1t risk reduction for vertebral fracture with raloxifene (RR 0.5
to 0.7) compared to placebo in healthy postmenopausal women. There was no risk reduction for
nonvertebral fractures, although BMD at the hip increased by 2.1 % with raloxifene. Thus,
raloxifene is less effective than both HRT and bisphosphonates in preventing fracture (Scott,
DaCamara, & Early, 1999). The mean age of participants in the MORE trial was 54 years, aIld
no raloxifene studies have focused on nursing home residents. The MORE trial demonstrated a
significantly lower incidence of breast cancer (RR 0.3 compared to placebo) and a 12%
reduction in serum LDL in the treatment group (Ettinger et aI., 1999). Raloxifene increased the
risk of venous clots, with a risk similar to estrogen.
Raloxifene is expensive, with a cost equivalent to the bisphosphonates. In light of its
lower clinical efficacy, it is significantly less cost-effective than otller agents. Raloxifene has a
favorable humanistic profile. Dosing involves taking a single pill daily, without regard to food.
Raloxifene was generally well tolerated in studies, in fact pooled data from several studies
showed that raloxifene was discontinued less often than placebo (Scott et aI., 1999).
22 Osteoporosis in the Nllrsing Home
Applying the ECHO model to raloxifene illustrates a favorable humanistic profile, but
poorer clinical outcomes and cost effectiveness as compared to bisphosphonates. Raloxifene is
an appropriate second-line drug for residents who are unable to tolerate bisphosphonates.
Calcitonin
Calcitonin is a hormone produced by the parafollicular cells of the thyroid gland.
Calcitonin is normally secreted in response to elevated serum calcium, whereupon it inhibits the
activity of osteoclasts, the cells responsible for resorbing bone. The resulting slowing of bone
resorption is thought to preserve, or even increase, bone density. While endogenous calcitonin
levels have little influence on bone mass, randomized trials in postmenopausal women showed
an increase in bone density with the use of subcutaneous or intranasal calcitonin. Salmon
calcitonin (Miacalcin®) was approved by the FDA in 1984 in its injectable form, and in 1995 as
a nasal spray.
The clinical efficacy of calcitonin was best demonstrated in the Prevent Recurrence of
Osteoporotic Fractures Study (PROOF), a large, five-year, randomized trial of calcitonin nasal
spray among women with osteoporosis. PROOF demonstrated a modest increase in lurrlbar spine
BMD and a 36% reduction in vertebral fractures with calcitonin compared to placebo (Chestnut
et aI., 2000). While the results are encouraging for patients at risk for vertebral fracture, no
protective effect against hip fracture was demonstrated. A major flaw in the study was that 59%
of the original participants dropped out before the study was completed and were "lost" to
follow-up. Critics of the PROOF trial claim the study leaves uncertainty about the value of nasal
calcitonin and suggest calcitonin should be reserved for patients who are unable to take agents
with demonstrated efficacy (Cummings & Chapurlat, 2000).
23 Osteoporosis in the Nllrsing Home
The cost of calcitonin is approximately the same as the bisphosphonates or raloxifene,
while its protective effect on bone is considerably less. Calcitonin is not associated with
significant indirect costs, having few side effects and being administered as a once-daily nasal
spray without regard food or other medications. Its cost effectiveness is limited by its marginal
effect on bone.
Calcitonin has a positive humanistic profile. The single daily administration of the nasal
spray is well tolerated. Occasional reports of nasal irritation are avoided by alternating nostrils,
and residents rarely complain about calcitonin. Another benefit of calcitonil1 is its demonstrated
analgesic effect in some patients with vertebral fractures. In the form of suppository, a
particularly dramatic analgesic effect was achieved in patients with acutely painful vertebral
fractures (Lyritis et al., 1999).
Calcitonin has limited usefulness in the nursing home. It may be helpful in residents with
vertebral fractures, especially if back pain is present. But the bisphosphonates and raloxifene,
with their demonstrated greater beneficial effect on both bone del1sity and fracture risk, have
greater efficacy.
Hip Protectors
A great deal of effort in nursing home care is directed toward fall protection. Overall,
nursing home residents have a hip fracture rate of about 5-6% per year, and 90% of these
fractllres are associated with falls. The most dangerous are falls to the side, with direct trauma to
the hip. About 24% of those falls result in hip fracture (Lauritzen, 1997). Biomechanical studies
reveal that a fall from standing height causes impact with a force that exceeds the proximal
femur strength in half of elderly men and women (Greenspan et aI., 1998). While dietary
24 Osteoporosis in the Nursing Home
supplements and antiresorptive agents improve bone strength, interventions to prevent falls
and/or reduce injury associated with falls are necessary to reduce hip fractures.
Hip protectors are shallow, shell-shaped devices that cover the greater trochanter and are
designed to shunt impact energy away from the bone to surrounding soft tissues. The protectors
fit into pockets sewn onto a stretchy undergarnlent. Hip protectors have been used in botll
community-dwelling elders and nursing home residents to reduce the incidence of hip fracture
with some success.
The clinical efficacy of hip protectors has been demonstrated in a number of controlled
trials, in which the protectors reduced hip fractures in elderly persons from 50% to 80%. A
finding common to these studies was that most fractures that did occur happened when the
protectors were not being worn (Harada et aI., 2001; Kannus et aI., 2000; Lauritzen, Petersen, &
Lund, 1993; Parker, Gillespie, & Gillespie, 2001).
The cost of a hip protector is between $100 and $200, and with some care in handling the
overall cost is relatively low. Vestergaard et aI. (2001) estinlate the cost-effectiveness of hip
protectors to exceed that of calcium and vitamin D. Indirect costs include monitoring that the
resident wears the protector, and assisting with donning the garment, if needed.
The hunlanistic aspect of hip protector use appears to be the most significant, because
compliance with the protectors has been an ongoing problem. Cameron et aI. (2001) achieved
orily 57% compliance with hip protector use in an Australian study, and all fractures in their
study occurred when protectors were not in place. In a Swiss study of 548 nursing home
residents, only one third of residents were still wearing the protectors after 10 months (Hubacher
& Wettstein, 2001). However, in a Finnish nursing home, hip protectors were introduced with a
short training sessions for caregivers. The caregivers then helped select residents at high risk for
25 Osteoporosis in the Nursing Home
fracture, and protectors were offered to those residents. Use of the protectors was carefully
monitored over six months. With this program, residents wore the protectors for more than 90%
of their active hours. At the end of the study, most of the commel1ts made by staff and residents
regarding the hip protectors were positive (Parkkari, Heikkila, & Kannus, 1998). Education and
motivation of nursing home staff nlay have been the crucial difference in achieving this excellent
level of compliance.
Hip protectors can be a useful and cost-effective adjunct to fracture prevention in the
nursing home. Selected residents, particularly those who are either ambulatory or at high risk to
fall, sl10uld be offered hip protectors and encouraged to use them regularly. Efforts to enlist staff
support in the use of these devices may be critical to success.
Best Practice Recommendations
Research demonstrates that a number of effective therapies are available to decrease
osteoporotic fracture risk. These interventions have been discussed in terms of the ECHO model,
which served as a framework for evaluating the clinical, economic and humanistic impact of the
various treatments on nursing home residents. Based on that that analysis, the following
guidelines are advocated to promote bone health and prevent fractures in the nursing home:
1.� Nursing home residents sl10uld be screened for osteoporosis on admission and on a regular basis thereafter.
2.� Nursing home residents should be offered calcium and vitamin D supplementation to bring total calcium intake to 1200 to 1500 mg/day of elemental calcium, and total vitamin D intake to 400 to 800 IU/day.
3.� Residents should be screened for fall risk on admission and on a regular basis thereafter. Those found to be at high risk for fracture should be considered for antiresorptive therapy with a bisphosphonate.
4.� Residents who have contraindications to bisphosphonates, or who are unable to tolerate thenl, should be offered a second-line treatment in the form ofraloxifene or calcitonin.
5.� Ambulatory patients at risk to fracture, as well as nonambulatory residents who are at risk to fall through self transferring, should be encouraged to use hip protectors.
26 Osteoporosis in the Nllrsing Home
6.� Nursing home staff should receive training in the proper administration of bisphosphonates and in the use of hip protectors to maximize the efficacy of these therapies.
Routine screening and therapeutic interventions to promote bone health are necessary to
protect nursing home residents from painful and debilitating fractures. Nurses who care for this
vulnerable population can make a real difference by implementing admission procedures that
include osteoporosis screening and dietary supplementation of calcium and vitamin D for all
residents, and by advocating for antiresorptive medications for at-risk residents. Nurses should
maximize the efficacy of these measures by carefully following dosing recommendations and
pronl0ting the use of hip protectors. Finally, l1urses should attend to new developments in the
area of fracture prevention, including pharmaceuticals now being evaluated, such as bone-
building medications and a bisphosphonate that is given with an annual injection. Using the
ECHO model to ensure positive clinical, economic, and humanistic outcomes for nursing home
residents maximizes systematic attention to these issues and provides early opportunities for
prevention and intervention in the older population, the group most likely to suffer from
osteoporosis.
27 Osteoporosis in the Nursing Home
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35 Osteoporosis in the Nllrsing Home
Figure 1� Economic, Clinical and I-Iumanistic Outcome (ECHO) Model�
(adapted from Kozma, et aI., 1993)�
Humanistic Outcomes
Osteoporosis� Dosing requirements Medication side effects Pain Mobility Satisfaction with treatment
Clinical Indicators Clinical Outcomes
Intention to treat Fracture History of fracture Mobility Clinical risk factors Pain Kyphosis/loss of height Skeletal changes Bone mineral density Medication side effects
Medications Medication administration Treatment of medication
side effects Hip protectors Hip protector monitoring Fracture treatment
Treatment Alternatives
Prophylactic nleasures ·calcium ·vitamin D Economic Outcomes
Bisphosphonate Raloxifene/calcitonin Savings related to fracture
preventionHip protectors Cost per quality-adjusted
life-year savings
36 Osteoporosis in the Nllrsing Home
Figure 2� Algorithm for Risk Factor Assessment for Osteoporosis Prevention and Treatment�
among Nllrsing Home Residents� (Adapted from Baran, et aI., 1998)�
Nursing home admission
Identify appropriate candidates:
Issues exist that Consider: No issues exist that preclude intervention
• Life expectancy • Terminal illness
.... 1-------1l1li"""'"..
preclude intervention
• Resident preferences regarding treatment
Stop� (exclude from diagnosis�
and treatment)�
Review of resident history Negative history Positive history of• Previous diagnosis of osteoporosis
.... osteoporosis diagnosis • Antiresorptive therapies r---~
" or fragility fracture • X-ray findings • Information from hospital records
Complete risk factor assessment • Review of history • Resident interview • Family interview
oto 5 risk factors 6 or more risk (see Table 1) factors (see Table 1)
• Calcium and vitamin D� • Calcium/vitamin D supplementation supplementation • Fall prevention
• Fall prevention� • Advocate for further interventions by • Re-evaluate in 1 year� primary care provider
·evaluation for causative factors ·pharmacological therapy •hip protectors ·physical conditioning
-----
37 Osteoporosis in the Nursing Home
Table 1� Risk Factors Associated with Fracture in Nursing Home Residents�
(Adapted from Baran, et aI., 1998)�
Female
Age 80 years or greater
Maternal history of hip fracture
Fractllfe after the age of 50
History of fragility fracture (i.e. fracture without significant trauma)
Poor general health
Previous hyperthyroidism
Severe cognitive impairment
Current weight in lowest 25% for age group (per nutritional assessment)
BMD with T score <-2.5
No walking exercise
Ambulatory status (either independently or with assistance)
Inability to rise from chair without using arms
Reported height loss >4 cm (1 ~")
History of falls, or at high risk to fall using standardized fall risk assessment
Visual acuity worse than 20/30
Anticonvulsant use
Current therapy with long-acting benzodiazepine, tricyclic antidepressant, or antipsychotic medication�
Caffeine intake> equivalent of 2 cups coffee per day�
Total number of risk factors:
To score fracture risk, count number of risk factors: Presence of 0-5 risk factors indicates low risk for fracture Presence of six or more risk factors indicates high risk for fracture