Nonpharmacological prevention of osteoporotic fractures

Nonpharmacological prevention of osteoporotic fractures

Joint Bone Spine 70 (2003) 448–457 www.elsevier.com/locate/bonsoi Clinical lectures Nonpharmacological prevention of osteoporotic fractures Xavier D...

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Joint Bone Spine 70 (2003) 448–457 www.elsevier.com/locate/bonsoi

Clinical lectures

Nonpharmacological prevention of osteoporotic fractures Xavier Deprez a,*, Patrice Fardellone b a

Rheumatology Department, Valenciennes Hospital, avenue Désandrouin, 59322 Valenciennes cedex, France b Rheumatology Department, North Hospital Group, 80054 Amiens cedex 1, France Received and accepted 2 September 2003

Abstract In postmenopausal women, the nonpharmacological prevention of osteoporotic fractures pursues the dual objective of minimizing bone loss and preventing falls. In women with a low fracture risk, optimizing the dietary intake of calcium is the main nutritional goal. Regular sustained physical activity should be encouraged. In older women, the high risk of proximal femoral fractures warrants a number of preventive measures, including calcium and vitamin D supplementation, correction of protein deficiency if needed, and minimization of the risk of falls. Hip protectors may be useful in institutionalized women at high risk for falls. These nonpharmacological measures should be part of a comprehensive customized management program used to complement standard pharmacological therapy. © 2003 Éditions scientifiques et médicales Elsevier SAS. All rights reserved. Keywords: Osteoporotic fractures; Calcium; Phytoestrogens; Physical exercise; Falls; External hip protectors

1. Introduction Osteoporosis is of major concern as a source of potentially incapacitating or life-threatening fractures. Spinal misalignment produced by vertebral fractures can cause chronic pain that responds poorly to treatment. Reflex sympathetic dystrophy syndrome is not infrequent after wrist fractures. Proximal femoral fractures are the most feared complications of osteoporosis, as they can lead to institutionalization and death in older patients. Prevention of fractures is the only objective of prophylactic and curative treatments for osteoporosis. Because bone loss is a key risk factor for fractures, regular physical activity and an adequate dietary intake of calcium in childhood and adolescence should be recommended with the goal of achieving the highest possible peak bone mass. However, many young patients feel that the benefits of these measures are too far away in the future to deserve their attention. The early prevention of osteoporosis falls outside the province of the rheumatologist and will not be discussed in this work. Patients may request prevention or treatment for osteoporosis at cessation of menses. Unfortunately, many patients are seen later, after the occurrence of one or more * Corresponding author. E-mail address: [email protected] (X. Deprez). © 2003 Éditions scientifiques et médicales Elsevier SAS. All rights reserved. doi:10.1016/j.jbspin.2003.09.004

fractures. Several medications have been proved effective in reducing the fracture risk. However, nonpharmacological measures aimed at preventing fractures can or should be implemented, as appropriate. This review discussed the modalities and efficacy of nonpharmacological measures for preventing osteoporotic fractures.

2. Nutritional adjustments 2.1. Calcium: a vital nutrient Ninety-nine percent of the calcium in the human body is located in the skeleton as hydroxyapatite crystals. Intracellular calcium homeostasis must be maintained within very narrow margins. Prolonged calcium deficiency stimulates the release of parathyroid hormone (PTH), which increases bone resorption, thereby releasing calcium into the plasma. Postmenopausal women and elderly individuals in general tend to reduce their dietary intake of calcium, for a number of reasons (gastrointestinal discomfort upon ingestion of dairy products, inadequate cholesterol-lowering diet, decreased gastric acid production, and other factors). Among elderly individuals in France, only 25–50% have a daily dietary calcium intake of 800 mg or more [1]. The guidelines issued by the National Institutes of Health consensus conference [2] recommend a dietary calcium intake of 1 g/day in postmeno-

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pausal women on hormone replacement therapy (HRT) and 1.5 g/day in other postmenopausal women and in all individuals older than 65 years of age. Although the importance of calcium store repletion in preventing and treating osteoporosis is universally recognized, the role for calcium per se in preventing postmenopausal bone loss and reducing the fracture risk requires investigation. 2.1.1. Effect of calcium on bone mass in postmenopausal women In a 1990 literature review, Cumming reported the results of six prospective studies in women studied shortly after the menopause (mean age, 50–57 years). The women receiving supplemental calcium experienced a 0.8% decrease in the mean rate of bone loss, as compared to the control groups. This figure translated into a mean bone loss reduction of about 40% per year [3]. Findings obtained by Elders et al. [4] in 243 postmenopausal women aged 46–55 years confirmed these results: after 2 years of supplementation with 1–2 g of calcium per day, mean decreases in bone mineral density (BMD) at the lumbar spine were only 1.3% and 0.7%, respectively, as compared to 3.5% in the control group. Similarly, in a study of women who were investigated 3–6 years after the menopause, Aloia et al. [5] found that a calcium intake of 1700 mg/day was associated with a significant reduction in bone loss at the femoral neck, as compared to the controls. Calcium supplementation is similarly effective in elderly individuals. A randomized double-blind placebocontrolled study by Dawson-Hughes et al. [8] confirmed earlier findings [6,7] by showing that 500 mg/day of supplemental calcium was beneficial in women with a time since menopause of 6 years or longer and a daily dietary calcium intake of less than 400 mg. 2.1.2. Effıcacy of calcium supplementation in reducing the fracture risk Although Cumming [3] suggested that calcium supplementation for 10 years may reduce the risk of osteoporotic

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fractures, the results of the few controlled studies of calcium supplementation alone deserve careful discussion. In 1994, Chevalley et al. reported their findings from a double-blind therapeutic trial of 800 mg of supplemental calcium per day in 93 patients with a mean age of 72 years. Vitamin D stores were returned to normal prior to the study. The incidence of vertebral fractures during the study was 74/1000 patient/years in the calcium group without fractures at baseline, 106 in the placebo group, and 144 in the calcium group with fractures at baseline [9]. Recker et al. studied supplementation with 1200 mg of calcium per day in nearly 200 women older than 60 years with a mean dietary calcium intake of only 400 mg/day. A significant decrease in incident fractures was noted in the subgroup of 94 patients who had vertebral fractures at baseline, as compared to the placebo group [10]. Finally, a recent meta analysis by Shea et al. [11] based on six studies reported between 1987 and 1996 indicated that calcium supplementation for at least 2 years induced a modest decrease in the risk of vertebral fractures (relative risk (RR), 0.77; 95% confidence interval (95%CI), 0.54–1.09), although the effect on fractures at other sites was less convincing (RR, 0.86; 95%CI, 0.43–1.72). Calcium supplementation (1200 mg/j) in combination with vitamin D in physiological dosages reduced the incidence of hip fractures in institutionalized patients older than 75 years of age [12]. In contrast, vitamin D supplementation alone was not effective, suggesting a role for calcium per se [13]. Whether calcium and vitamin D supplementation is effective in free-living elderly individuals remains unclear [14]. In practice, in all age groups, ensuring that the calcium and vitamin D intakes meet recommended daily allowances is a valuable means of preventing osteoporosis and fractures [2]. The daily dietary calcium intake should be evaluated. The self-questionnaire developed by Fardellone et al. [15] is an accurate and well-validated tool for evaluating dietary calcium. Calcium deficiency is best treated by increasing the dietary intake of calcium, which requires detailed knowledge of the calcium content in dairy products (Table 1). For in-

Table 1 Mean calcium content in the main diary products Cheese Cheeses containing 900–1200 mg of calcium per 100 g (30 g = 270–360 mg of calcium) Cheeses containing 600–800 mg of calcium per 100 g (30 g = 180–240 mg of calcium) Cheeses containing 400–500 mg of calcium per 100 g (30 g = 120–150 mg of calcium) Cheeses containing 100–200 mg of calcium per 100 g (30 g = 30–60 g of calcium)

Other dairy products One liter of milk = 1300 mg of calcium One yogurt = 160 mg of calcium One serving of cottage cheese or custard = 100 mg of calcium per 100 g Cream cheese = 30–60 mg per serving (according to serving size)

Edam, Gouda, Comté, Cantal, Beaufort, Swiss cheese, Parmesan Roquefort, St Nectaire, Pyrénées, Bombel, Reblochon, Vacherin, Bleu, Cheddar, Morbier, St Paulin, Maroilles Camembert, Tome, Chaource, Rouy, Munster, Pont-Lévèque, Raclette, soft processed cheese Crottin, Selles/Cher, Brie, Pouligny, soft goat cheese, Coulommier, St Marcellin, St Maure, dry goat cheese, Carré de l’Est, Cottage cheese and cream cheese preparations

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Table 2 Calcium content (mg/l) of selected brands of bottled water Bottled water Tallians® Hepar® Courmayeur® Contrex® La Francaise® Salvetat® Wattwiller® Saint Amand (Orée Du Bois)® Quezac® Saint Amand (Source Vauban)® San Pellegrino® Vittel grande source® Badoit® Arvie® Pierval® Evian® Volvic®

Calcium content (mg/l) 596 555 517 467 354 295 288 280 241 230 206 202 190 170 103 78 9.9

stance, the calcium content of cheeses varies 10-fold according to the manufacturing process. Low-fat dairy products used by patients with dyslipidemia contain as much calcium as full-fat dairy products. Bottled water can be a useful source of calcium, with calcium contents of up to 600 mg/l, i.e., the equivalent of about 0.5 l of milk or four yogurts (Table 2). 2.2. Other nutritional measures In addition to calcium, other nutrients deserve attention. Several studies found evidence that older individuals with low protein intakes lost more bone and had an increased risk of fractures, most notably at the hip [16–18]. Dairy products are valuable in that they supply both protein and calcium. A high intake of salt increases the amount of calcium lost in the urine, and dietary salt should be kept sufficiently low to maintain the urinary calcium excretion at about 100 mmol/day. There is no convincing proof that caffeine adversely affects bone mass, particularly in patients with an adequate calcium intake [19]. Nevertheless, two recent studies found that high intakes of caffeine-rich beverages were associated with greater bone loss at the spine [20] and with a moderately increased the risk of fractures, most notably at the wrist [21]. Vitamin K is involved in the gammacarboxylation of osteocalcin, and a deficient intake may increase the risk of proximal femoral fractures [22], whereas administration of vitamin K2 may reduce bone loss in postmenopausal women [23,24]. Thus, although compelling evidence of beneficial effects on bone is not always available, a reasonable measure is to recommend a balanced and varied diet, together with smoking cessation and no more than a modest intake of alcohol. 2.3. Phytoestrogens Phytoestrogens constitute a vast family of plant components whose chemical structure similar to that of 17beta-

estradiol is responsible for estrogen-like effects on bone. Phytoestrogens fall into three main groups: isoflavones, lignanes, and coumestrans. The respective proportions and absolute amounts of these phytoestrogens vary across food sources, which include legumes, cereals, nuts, and berries. Isoflavones, most notably genisteine and daidzeine, are by far the most extensively studied phytoestrogens. They are found chiefly in soy bean and soy products. That phytoestrogens may have beneficial effects in humans, most notably in the treatment of the menopause, was suggested by epidemiological studies conducted among Japanese women, a population whose traditional diet is rich in soy products [25–27]. Soy-based food supplements introduced in the US and later in Europe have been marketed as alternatives to conventional HRT for the menopause. The popularity of so-called natural medicines among the public in western countries has fueled interest for these supplements. The number of women who use soy products has risen further since the recent publication of findings from the Women’s Health Initiative study [28], which has been widely publicized in the media. Among women who seek medical advice about osteoporosis or BMD testing, many are on phytoestrogens, and an even greater number have questions about the potential benefits of these compounds. Thus, physicians should be familiar with the scientific data on this issue. In oophorectomized rats, a soy protein-enriched diet prevents bone loss at the femur and spine [29], possibly as a consequence of the anabolic effect of genisteine documented by Ishimi et al. [30]. However, another effect of this diet is enhanced production of IGF-1 [31]. Controlled studies in women are scarce. In 1998, Dalais et al. [32] reported a BMD increase in postmenopausal women who ate soy-enriched bread instead of wheat bread. Chiechi et al. [33] conducted a 6-month study of bone turnover markers and BMD in 187 postmenopausal women allocated at random to HRT, daily addition to the diet of soy-based foods (e.g., tofu and soy milk), or no treatment. At study completion, a significant drop in trabecular BMD was found only in the control group. BMD values showed no significant change vs. baseline in the HRT or soy-enriched diet groups. The only significant change detected in the soy-enriched diet group was an elevation in serum osteocalcin levels consistent with an anabolic effect on bone. Acceptability of the soy-enriched diet was poor, and its isoflavone content was not known with precision. In contrast, studies reported in 1998 by Potter et al. [34] and in 2000 by Alekel et al. [35] used daily doses of purified soy protein containing a well-defined proportion of isoflavones. After 6 months of treatment, Potter et al. noted a 2.2% increase in lumbar spine BMD in 22 women given 90 mg of isoflavone per day; the difference was significant as compared to the control group. Similarly, Alekel et al. found that administration of 80 mg of isoflavone per day for 6 months maintained BMD at the baseline level, whereas significant decreases were noted in the control group. Although available data suggest a beneficial effect of phytoestrogens on bone, they come from a small number of

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studies characterized by limited sample sizes and short follow-up durations. No definite conclusions can be drawn about the potential of phytoestrogens for preventing postmenopausal bone loss in the medium or long term or for diminishing the fracture risk in women with low bone mass. Furthermore, by decreasing the incidence of hot flushes, regular use of phytoestrogens may mislead women into believing that they are protected from the adverse effects of estrogen deprivation [36]. 3. Physical activity Many cross-sectional or prospective studies have established that physical activity is associated with higher bone mass. However, these studies vary widely regarding the study populations, nature of physical activities, duration of training programs, and methods used to evaluate bone mass. This makes it difficult to determine which type and amount of physical activity is optimal for preserving bone mass in postmenopausal women. Nevertheless, published data suggest a few important rules of relevance to everyday clinical practice. Physical activities involving weight bearing and brief but repeated efforts (running, step, workouts, aerobic dancing) have been shown to slow bone loss at the spine [37,38] and hip [39,40]. One hour, three times a week seems appropriate. The osteogenic response is more marked at the sites with greater exposure to mechanical loads, suggesting possible benefits from dynamic exercises against resistance. Daily psoas training consisting in 60 hip flexions with a 5-kg on the knee has been reported to decrease bone loss at the lumbar spine [41]. Similar exercises at the wrist, forearm, and hip seem to improve bone mass [42,43]. However, the benefits last only as long as the exercise program is continued [44]. Therefore, the exercise program should be acceptable to the patient and appropriate to physical abilities. Walking may be the best option for many women. Hatori et al. [45] and Martin and Notelowitz [46] showed that walking 45–60 min three times a week was associated with a reduction in bone loss at the lumbar spine. The brisker the pace, the greater the protective effect. Ebrahim et al. [47] reported a positive effect on BMD at the femoral neck. A very recent study by Qin et al. [48] suggested that a Tai Chi Chuan program may improve bone mass in postmenopausal women, although this requires confirmation. Vibrating platforms are marketed for preventing osteoporosis, despite the absence of efficacy data supporting their use. In a very recent randomized controlled study reported by Torvinen et al. [49], no changes in BMD occurred in younger individuals after use of a vibrating platform for 8 months. Whether physical activity acts in synergy with pharmacotherapy remains controversial [50,51]. Nevertheless, in postmenopausal women, regular sustained physical activity seems to improve bone mass. Another favorable effect is maintenance of muscle strength and balance, which decreases the risk of falls [52–54].

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4. Fall prevention There is general agreement that falls occur at least once a year in 30% of individuals older than 65 years and in 50% of those older than 80 years of age. Higher rates are found among institutionalized individuals. Among falls, 5–6% cause fractures, the most common sites being the proximal femur (1–2% of falls) and the forearm or arm [55,56]. Conversely, 90% of proximal femoral fractures are caused by falls. It follows that fall prevention must be an integral part of the overall management of osteoporosis, since the main objective is protection against fractures. 4.1. Risk factors for falls Falls are multifactorial events that result from complex interactions linking an individual to an activity and to an environment. Factors leading to falls can be divided into environmental factors, which are mainly related to the physical environment (e.g., the terrain or obstacles), and patientrelated factors (e.g., muscle weakness and poor balance). Falls in younger patients are usually ascribable to environmental factors (e.g., patch of ice on the ground). With advancing age, environmental and patient-related factors become increasingly intertwined, and in very elderly individuals, patient-related factors predominate (e.g., fall while trying to get out of a chair). 4.1.1. Environmental risk factors 4.1.1.1. Physical environment. Environmental factors seem to predominate in 30–50% of falls [57,58]. They cover an extraordinarily wide spectrum from inappropriate clothing or footwear to uneven terrain (e.g., sidewalks and gardens) and obstacles at home [59,60]. Over 70% of falls occur at home [61]; the bedroom seems to carry the highest risk, followed by the bathroom and stairs. Waxed floorboards, wet tiles, a poorly secured rug, or a slippery bathtub or shower are commonly incriminated. However, the main hazard may stem from poor equipment that hampers the activities of daily living (dim lighting, inadequate heating, shelves out of easy reach, cluttering, and high or low seats and beds) [63,64]. 4.1.1.2. Medications. A long list of medications can promote falls. Hypnotic, anxiolytic, antidepressant, and neuroleptic agents are commonly incriminated [65]. In the study by Tinetti et al. [62], medication use was the main patientrelated risk factor for falls (RR, 3.1; OR, 28.3). Wayne et al. [66] reported that psychotropic agents with long half-lives increased the risk of proximal femoral fractures. Other medications that deserve special mention are antihypertensive drugs, most notably those with central effects, diuretics, and digitalis [67]. 4.1.2. Patient-related factors Falling indicates a deficiency in posture and musculoskeletal function, which depend on input from visual, vestibular,

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Table 3 Risk factors for falls and recurrent falls Tinetti et al. [62], 336 patients > 75 years, follow-up: 1 year OR for falls (95% CI) – – –

Graafmans et al. [68], 354 patients > 70 years, follow-up: 6 months OR for falls 2.2 (1.1–4.2) 2.7 (1.9–4.7) –

Weak lower limb muscles Unable to stand from a chair

3.8 (2.2–6.7) –

Balance and gait disorders Joint disease Vertigo Use of sedatives Cognitive impairment Urinary incontinence Parkinson disease Stroke-related impairments Postural hypotension

Female gender ≥ 1 fall within the last year Fear of falling

OR for multiple falls 1.9 (0.8–4.6) 3.5 (1.9–6.2) –

Luukinen et al. [69], 1016 patients > 70 years, follow-up: 2 years OR for ≥ 2 falls/year 2.14 (1.2–3.8) 2.61 (1.6–4.3) 2.16 (1.3–3.7)

Nevitt et al. [63], 325 patients > 60 years, follow-up: 1 year OR for ≥ 2 falls – 3.1 (1.5–6.4) –

1.6 (1.0–2.7) 2.5 (1.5–4.1)

2 (1.1–3.7) 4.8 (2.5–9.3)

– –

– 3 (1.2–7.2)

1.9 (1.0–3.7) – –

2.6 (1.6–4.3) – 2.3 (1.3–3.8)

5.3 (2.8–10) – 2.3 (1.2–4.3)

– – 1.82 (1.1–3.1)

2.7 (1.1–6.2) 2.7 (1.3–5.6) –

28.3 (3.4–239.4) 5 (1.8–13.7) – – – –

– 1.7 (0.9–3.2) 2.6 (1.6–4.3) – 1.8 (0.9–3.5) 1.4 (0.8–4.8)

– 3.2 (1.4–7.2) 2.8 (1.5–3.8) – 3.4 (1.6–7.1) 2 (1.0–4.2)

– – 1.56 (1.0–2.6) – – 1.65 (1.0–2.7)

– – – 9.5 (1.8–50.1) – –

neurological, vascular, metabolic, osteoarticular, and muscular sources. Abnormalities in any of these sources increase the risk of falls. Variable combinations of these numerous risk factors can occur in older individuals. Syncope and malaise are easy to identify, particularly when there is a witness to the fall; the cause may be a drop-attack, postural hypotension, a vagovagal reaction, or a paroxysmal rhythm disorder. The many neurological causes of falls include Parkinson’s disease, stroke-related residual impairments, cerebellar syndrome, peripheral neuropathy, Alzheimer’s disease, and other forms of dementia. Vestibular dysfunction, decreased visual acuity, and disturbances in accommodation may lead to falls. A number of musculoskeletal diseases may promote falls by impairing balance and walking; they include knee and hip osteoarthritis, spinal misalignment, and foot deformities. Muscle weakness, particularly at the lower limbs, frequently seems minor yet plays a key role in causing falls. Several studies have evaluated the predictive value of these risk factors [62,64,68,69] by calculating odds ratios for falls (Table 3). Tinetti et al. [62] reported that sedative agents and cognitive impairments, both responsible for decreased alertness, were the main risk factors, whereas muscle weakness and balance had a far smaller impact. In contrast, in a study by Graafmans et al. [68], balance or gait disorders, muscle weakness in the lower limbs, and an inability to get up from a chair were clearly the predominant risk factors, most notably for recurrent falls. The role for postural hypotension seemed fairly modest overall. 4.2. Influence of risk factors for falls on the fracture risk Although bone insufficiency is the underlying mechanism of osteoporotic fractures, the triggering factor is usually a fall

or other injury, except at the spine. Whether preventing falls can reduce the fracture risk to a meaningful extent depends on the contribution of falls to the genesis of fractures, as compared to bone loss. Two studies sought to identify factors associated with an increased likelihood that falling would result in a fracture or other injury [70,71]. In the study by Nevitt et al. [70], these factors consisted of female gender and age older than 80 years (OR, 2), a history of fracture within the last year (OR, 6.7), cognitive impairments (OR, 1.9), decreased visual acuity (OR, 1.8), and a long reaction time (OR, 1,8). In the other study, conducted by Tinetti et al. [71], cognitive impairments and balance disorders increased the risk of falls responsible for fractures or other injuries (OR, 2.2 and 1.8, respectively). Grisso et al. [72] compared women admitted for a first proximal femoral fracture to age-matched women admitted to a trauma unit for another reason. Median age was 80 years; there were 174 patients in each group. Five risk factors for falls were significantly associated with femoral neck fractures: Parkinson’s disease (OR, 9.4), long-term barbiturate therapy (OR, 5.2), history of stroke (OR, 4.5), decreased visual acuity (OR, 4.8), and impaired lower limb function (OR, 1.9). In 1996, the findings from the EPIDOS study (Table 4) confirmed that risk factors for falls contributed to the genesis of proximal femoral fractures to a similar extent as bone insufficiency [73] and showed a greater than twofold increase in the fracture incidence among the women who were prone to falls. Recent data indicate that selected risk factors predict fractures of the humerus [74] or osteoporotic fractures at any site [75]. These data strongly suggest that fall prevention in elderly individuals may be a major part of the overall management strategy for osteoporosis.

X. Deprez, P. Fardellone / Joint Bone Spine 70 (2003) 448–457 Table 4 Effects of four risk factors for falls and of femoral neck bone mineral density on the hip fracture risk in 7323 women Small calf perimeter Decreased walking speed Difficulty with heel-to-toe walking Decreased visual acuity 5–7/10 3–4/10 ≥ 2/10 Reduction by 1 standard deviation in femoral neck BMD

Relative risk (95% CI) 1.2 (0.8–1.7) 1.3 (1.1–1.6) 1.2 (1.0–1.5) 1.6 (1.0–2.6) 1.9 (1.1–3.1) 2.0 (1.1–3.7) 1.8 (1.5–2.2)

BMD, bone mineral density as measured by absorptiometry; 95% CI, 95% confidence interval.

4.3. Identification of fall-prone patients Patients with multiple comorbidities, a recent history of recurrent falls, or major difficulty with walking are clearly at risk for falling. However, in osteoporotic patients without these risk factors, the rheumatologist should use a validated clinical tool to evaluate the risk of falls. The Tinetti maneuver, a reliable and accurate method for evaluating gait and balance [76], is among the standards of reference used in geriatric practice. However, evaluation of the many parameters included in this instrument is time-consuming, which may be a limitation to use in everyday practice; The timed “get up and go” test [77] is simple and rapid: the patient is seated in an armchair and asked to stand up, to remain standing for a few moments, to walk 3 m, and finally to turn, walk around the armchair, and sit again. Patients who cannot accomplish this routine within 30 s can be considered at increased risk for falling. However, one-leg balance remains the simplest and fastest test for use during outpatient visits. The risk of falls responsible for injury is increased in patients who are unable to stand unassisted on one leg for at least 5 s [78]. 4.4. Fall prevention in practice Fall prevention requires that risk factors in the individual patient be identified and, if possible, corrected. Interventions range from information and advice to a comprehensive program of multidisciplinary management. The physiological age of the patient, the medical setting, the number and type of prior falls, and the severity of osteoporosis influence management decisions. Most patients will be somewhere between the two extreme scenarios described below. Patients with osteoporosis who are in good general health and have a moderate risk of fracture should be informed about how to identify and to correct physical factors likely to cause falls in the home: the home should be well lit and the rugs firmly fastened to the floor with no loose edges, slipproof mats should be placed in the bathtub or shower, seats should be at a manageable height, and shelves and cupboards should be within easy reach. These individuals are often

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active or even energetic and should therefore be encouraged to be careful during potentially hazardous activities about the home or yard, as well as during leisure activities (walking on damp or frozen ground, athletic pursuits). Physical activities should be strongly encouraged and may include daily walks, gentle work-outs, or sporting activities to maintain muscle strength, balance and flexibility. In addition, physical activity may promote bone formation. Sorock et al. [79] reported that regular physical activities such as walking 1.5 km three times a week significantly reduced the risk of proximal femoral fractures. A multifaceted prevention strategy, if possible involving a multidisciplinary team, is desirable in older patients with multiple comorbidities, particularly those with a history of fractures at the hip or at other sites. Risk factors should be detected by a detailed history and thorough physical examination. Pharmacotherapy for conditions likely to promote falls (e.g., Parkinson disease or painful knee or hip osteoarthritis) should be evaluated and intensified if needed. Medical prescriptions should be reviewed with care and all medications likely to impair alertness and to promote postural hypotension should be discontinued unless they are indispensable. Visual disorders should be detected and corrected if possible. The footwear should be examined. A podiatrist may be able to improve the fit of shoes and the quality of gait by treating corns and calluses. When technically feasible, minimization of environmental hazards in the home is effective [80]. Ideally, the patient should be evaluated at home by an occupational therapist, a physical therapist, or the usual physician. One of the various physical activities programs that have been proved effective should be chosen. The FICSIT [81] found evidence that a 12-week program of muscle strengthening, balance, and flexibility exercises was associated with a 21% decrease in the risk of falls after a mean follow-up of 18 months. In another arm of the FICSIT, Buchner et al. [82] showed that combining muscle strengthening, flexibility, and endurance exercises decreased, not only falls, but also fallrelated hospital admissions. In 2002, Robertson et al. reported the results of a vast prospective placebo-controlled trial in more than 1000 free-living men and women aged 65–97 years. The physical activity program consisted in three weekly 30-min sessions of exercises to strengthen the lower limb muscles and to improve balance; the patients were also encouraged to walk two to three times a week. Overall, this program decreased the number of falls and injuries by 35% and seemed particularly effective in patients aged 80 years or older and in those with a history of falls [83]. The effects of Tai Chi Chuan programs have been investigated [84]. To date, the most convincing evidence comes from a study by Wolf et al. [85], which included 200 patients older than 70 years of age; 65% were women and 35% had a history of falls. The Tai Chi Chuan group was composed of 72 patients who performed two 15-min sessions per week for 15 weeks. At completion of the 4-month study, the risk of falls was significantly decreased in the Tai Chi Chuan group

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as compared to the control group (RR, 0.525; TP = 0.01); however, the risk of falls was increased among the patients with a history of falls before the study. More recently, Lehtola et al. included Tai Chi Chuan in a 6-month program including walking and three weekly exercise sessions performed at home. A 40% decrease in the risk of falls was noted 4 months after the end of the activity program, as compared to the individuals who had not changed their physical activities [86]. These results suggest that Tai Chi Chuan used alone or in combination with conventional physical therapy may contribute to the primary prevention of falls. Multidisciplinary prevention programs combining elimination of hazards in the home, discontinuation of fallpromoting medications, and regular physical activity have been found effective, most notably in elderly individuals with a history of falls [87,88]. However, implementation of these complex programs is often difficult, particularly in patients with severe cognitive impairments. Thus, for many elderly or frail patients, falls are virtually inevitable. External hip protectors have been suggested to reduce the risk of proximal femoral fractures in this population. 4.5. Hip protectors Hip protectors are devices worn in specially designed underwear and positioned over the greater trochanters. They are designed to cushion the trochanter in the event of a fall. The kinetic energy is diverted toward the adjacent soft tissues (polypropylene shell) and/or absorbed by the protector (plastazote core). In 1993, Lauritzen et al. reported the results of a study of hip protectors used to prevent femoral neck fractures in elderly institutionalized individuals. During the 11-month study period, hip fractures occurred in eight of the 240 patients in the hip protector group and in 31 of the 318 patients in the comparison group. These figures indicate a 66% reduction in fracture risk (relative risk, 0.44; CI, 0.21–0.94). Furthermore, the eight fractures recorded in the hip protector group occurred at times when the patients were not wearing the device [89]. Subsequent studies produced less convincing results. Thus, in a study of 1801 frail patients, Kannus et al. [90] found that the device significantly reduced the hip fracture risk, by 60%, after 2 years, whereas Hildreth et al. [91] and Hubacher and Wettstein [92] found no proof of efficacy and reported poor acceptability and compliance. Two very recently published studies obtained conflicting results. Van Schoor et al. monitored 571 retirement home or nursing home residents with a mean age of 85 years, low bone mass, and a high risk of falls. Within 1 year, hip fractures occurred in 18 of the 276 patients in the hip protector group and in 20 of the 285 controls; the difference was not significant [93]. However, in the treated group, only 22% of the fractures occurred while the patients were wearing the device. Furthermore, only 16% of patients wore the device at night, and four of the 18 fractures in this group occurred at night or upon awakening. In contrast, Meyer et al. [94] studied two popu-

lations of patients older than 70 years of age and at high risk for falling: 459 patients in institutions where hip protectors were offered to residents together with an educational program (benefits of hip protectors, practical issues with using the device) and 483 residents in institutions where hip protector use was suggested but was not supported by an educational program. After more than 1 year of follow-up, 42 hip fractures had occurred in the control group and 21 in the intervention group; the difference was significant after adjustment on the risk of falls. These discrepancies can be ascribed to differences in randomization methods. Of the four studies that found no benefit, three used individual randomization [91–93], whereas most of the studies in which hip protectors were effective used the study centers as the randomization unit. Having an entire center use an intervention probably increases the likelihood that the caregivers regularly check the intervention. This point is crucial with hip protectors, which are effective only if properly positioned and worn day and night. However, patients have reported discomfort with the protectors, describing them as unpleasantly warm, bulky, irritating to the skin, and unbecoming. Furthermore, urinary incontinence is common in elderly patients and requires frequent changing of clothes and therefore availability of a large number of specially designed panties [95]. Thus, hip protectors seem to reduce the risk of proximal femoral fractures in elderly institutionalized patients provided they are worn at all times and properly positioned over the greater trochanters. This requires specific attention from a team of motivated caregivers who are aware of the benefits of hip protectors. In France, the decree of 18 June 2002, setting the retail price of the HIPS® (Mediris) and KPH (HRA Pharma) models at 123 Euros inclusive of VAT can be expected to encourage the use of hip protectors. These devices are reimbursed by the universal healthcare insurance plan in institutionalized patients older than 70 years of age.

5. Conclusion Selection of modalities for the nonpharmacological prevention of osteoporotic fractures in the individual patient is based on a host of factors, including patient age, fracture history, physical abilities, and severity of bone loss as assessed by absorptiometry. Overall, in recently postmenopausal women who are in good general health and are felt to have a fairly low fracture risk, optimizing the daily calcium intake and faithfully adhering to a program of athletic activities or workouts can help to maintain a satisfactory bone mass. In addition, physical activity maintains balance and muscle function, most notably at the lower limbs, thereby limiting the risk of falls. In elderly and very elderly patients, the main goal is hip fracture prevention. To achieve this goal, medications for osteoporosis may be appropriate. However, nonpharmacological measures probably play a key role also, although their impact on the fracture risk is difficult to evalu-

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ate. Ideally, these nonpharmacological measures should be part of a multidisciplinary program, together with optimization of calcium and vitamin D intakes and implementation of measures to decrease the risk of falls. This may require the involvement of many healthcare professionals, including physicians, physical therapists, and podiatrists. Nevertheless, in many very elderly and/or frail individuals, falls are inevitable and hip protectors should be considered. When used properly, hip protectors can protect against proximal femoral fractures. Thus, medications and nonpharmacological measures should be used in combination in a personalized global management program. Patient information and education play a key role in modifying potentially harmful behaviors and perhaps in improving compliance with treatment recommendations [96,97]. However, because of their high cost in human and financial resources, global programs cannot be offered to all patients with osteoporosis. Therefore further studies are needed to determine which patients are most likely to benefit and the size of the prophylactic effect.

Acknowledgements We are grateful to Carole Kosmowski for typing this manuscript.

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