The Spine Journal 15 (2015) 281–289

Clinical Study

Low clinical relevance of a prevalent vertebral fracture in elderly men—the MrOs Sweden study orn E. Rosengren, MD, PhDa, Ralph Hasserius, MD, PhDa, Mehrsa Kherad, MDa,*, Bj€ Jan- Ake Nilsson, BSca, Inga Redlund-Johnell, MD, PhDa, Claes Ohlsson, MD, PhDb, Mattias Lorentzon, MD, PhDc, Dan Mellstr€ om, MD, PhDc, Magnus K. Karlsson, MD, PhDa a

Clinical and Molecular Osteoporosis Research Unit, Departments of Orthopedics and Clinical Sciences, Lund University, Sk ane University Hospital, Stortorget 9, 211 22 Malmo, Sweden b Center for Bone and Arthritis Research, Institute of Medicine, Gothenburg University, Sahlgrenska University Hospital, Sahlgrenska I.C., Box 7163, SE-402 33 G€oteborg, Sweden c Geriatric Medicine, Institute of Medicine, Gothenburg University, Sahlgrenska University Hospital, Sahlgrenska I.C., Box 7163, SE-402 33 G€oteborg, Sweden Received 12 February 2014; revised 3 July 2014; accepted 15 September 2014

Abstract

BACKGROUND CONTEXT: The epidemiology, the fracture pattern, and the clinical relevance of prevalent vertebral fractures in old men are debated wherefore we set out to clarify these issues. METHODS: Mister Osteoporosis (MrOs) Sweden is a population-based cohort of communityliving men aged 69–81 years that includes 3,014 men. Out of these, 1,453 men underwent a lateral radiograph of the thoracic and lumbar spine of which 1,427 were readable and classified by a radiologist, that is the sample size in this study. The men also answered a questionnaire evaluating back pain and limitation in activities of daily living (ADLs) because of back pain during the preceding 12 months in addition with fracture history and life style. RESULTS: Fifteen percentage of the men had at least one prevalent vertebral fracture, but only 1/ 10th of these were aware of their fracture. Among the men with a fracture, 58% had one, 21% two, 9% three, and 11% four or more fractures. In men with only one fracture, 70% of the fractures were located in the thoracic and 30% in the lumbar spine, 85% had a wedge, 13% a biconcave, and 2% a crush-type configuration; one-quarter had a maximum vertebral body compression degree of less than 24% and one-quarter of more than 38%. Among the men with one or several vertebral fracture, 57% reported back pain compared with 55% in those without a fracture (p5.53). Most ADL functions were similar in the men with or without a prevalent vertebral fracture. In the men with one fracture, there was no difference in the occurrence of back pain depending on the fractured region (p5.49), type of the fracture (p5.77), or degree of compression (p5.85). In men with one or several fractures, there were no significant differences in the presence of back pain in any ages (p5.08), nor there were differences in presence of back pain regarding type (p5.08) or number of fractures (p5.21). CONCLUSIONS: A prevalent vertebral fracture is common in old men but has low clinical relevance. There does not seem to be a specific fracture pattern that predisposes for back pain. Ó 2015 Elsevier Inc. All rights reserved.

Keywords:

Vertebral fracture; Vertebrae; Back pain; Old men; Population-based cross-sectional study; MrOSstudy

FDA device/drug status: Not applicable. Author disclosures: MK: Nothing to disclose. BER: Nothing to dis Nothing to disclose. IR-J: Nothing close. RH: Nothing to disclose. J-AN: to disclose. CO: Nothing to disclose. ML: Nothing to disclose. DM: Nothing to disclose. MKK: Nothing to disclose. http://dx.doi.org/10.1016/j.spinee.2014.09.016 1529-9430/Ó 2015 Elsevier Inc. All rights reserved.

There were no specific study funding sources or study-specific conflicts of interest. * Corresponding author. Department of Orthopedics, Sk ane University Hospital, SE-205 02 Malmo, Sweden. Tel.: (46) 403-31000; fax: (46) 403-36200. E-mail address: [email protected] (M. Kherad)

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Context While the association between osteoporosis, senile compression fractures and elderly women is well known, the prevalence of vertebral fractures in elderly men is not as well understood. The authors set out to examine the epidemiology of vertebral fractures in a cohort of community-living elderly Swedish men. Contribution The study included 1,427 individuals evaluated using radiographic techniques. Of these, 15% were found to have one or more vertebral fractures. The incidence of back pain was not higher among those with vertebral fractures and most ADL functions were comparable to the control group without vertebral fractures. Implications This study is essentially a cross-sectional analysis, meaning it is unable to comment on the longitudinal effects (on health or physical function) of the fractures identified. There is also the potential for recall bias, as the study used questionnaires asking participants to rate their performance as far back as a year prior to the survey. As this study was conducted among Swedish men, cultural and socio-ethnic characteristics unique to that population could limit the reproducibility of findings among more diverse populations, or those of substantially different ethno-cultural backgrounds. —The Editors

Introduction The number of vertebral fractures has increased during recent decades; probably, because it gradually becomes a larger and larger proportion of old individuals in society and because age is correlated to osteoporosis, there will be a higher prevalence of osteoporosis in community [1]. An acute vertebral fracture is associated with increased morbidity and mortality [2–5] and is an important marker for future fracture risk [6]. But the general clinical relevance of a prevalent fracture is debated. The 10-year fracture probability for radiographic vertebral fracture increases in men from 3% at the age of 50 years to 8% at 85 years and in women from 7% to 27% in the same ages [4]. The European Vertebral Osteoporosis Study suggests that 12% of men and women aged 50–80 years have a radiographic vertebral fracture, with higher prevalence found in higher ages [7]. Other reports support an increasing prevalence by aging in both genders [8–10]. However, although the prevalence seems to be higher in young adult men than in young adult women [11], incident fractures are more common in old women than in old men

[7,12,13]. The fracture epidemiology in men is uncertain as the majority of prevalence and incidence studies have been undertaken in women [14,15] and only few in men have been population based [11,16]. For vertebral fractures, it is important to distinguish between clinical and radiographic vertebral fractures as only 25% to 33% of individuals with a radiographic vertebral fractures seek medical attention at the time of the fracture [11,17,18] and only 40% of postmenopausal women with a radiographic vertebral fracture seem aware of their fracture [19]. If the same applies to men is has to our best knowledge not been evaluated. In a patient with acute trauma, acute back pain, and a spine radiograph with an acute fracture, a causal relationship seems probable [11]. But, in those many patients with long-standing back pain and a prevalent radiographic vertebral fracture, it is difficult to determine if the fracture is new or old and its relevance to the clinical symptoms. The aims of this study were therefore to, in a populationbased cohort of community-living old men, determine vertebral fracture epidemiology, compare fracture prevalence of today with the older published data, estimate the clinical relevance of prevalent vertebral fractures, and evaluate if any specific facture pattern is associated to back pain.

Materials and methods Mister Osteoporosis (MrOs) Sweden is a prospective multicentre observational study including 3,014 men aged 69–81 years recruited at the medical centers in Gothenburg (n51,010), Malm€o (n51,005), and Uppsala (n5999) with the primary aim to prospectively evaluate risk factors for osteoporosis and fractures, the study in detail described previously [20,21]. The men were randomly selected from the national population register, that is they had to be registered in the national Swedish files with a contact address, had to be able to walk without assistance, and could not have bilateral hip replacements to be eligible for participation. The included men were then addressed by a letter that included a prepaid response letter where they had to answer if they wanted to participate, that is so they did not have to have a phone, and with this approach, we achieved an attendance rate of 45%. At baseline, all participants answered a questionnaire including fracture history, life style, and clinical symptoms with special reference to back pain history and limitations in activities of daily living (ADLs) because of back pain during the preceding 12 months (Table 1). Back pain was defined as pain in the thoracic or lumbar region and disability in ADL because of back pain by asking if the men because of back pain had difficulties in bending down, lifting a 5-kg object, reaching objects above the head, putting socks on either foot, getting in and out of a car, standing or walking more than 2 hours, and sitting in a chair for 30 minutes. Back pain was assessed in terms of a general

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Table 1 Baseline characteristics in 1,427 Swedish men aged 69–81 years, with and without a radiographic vertebral fracture in the thoracic or lumbar spine

Characteristics Anthropometry Age (y) Height (m) Weight (kg) BMI (kg/m2) Life style factors Daily exercise walking distance (km/d) Smoking (yes/no) Alcohol (drinks per wk) 0 drinks per wk O0 to !2 drinks per wk $2 drinks per wk History of osteoporosis Ever had fracture (yes) Ever had spine a fracture (yes) Presence of back pain and disability Back pain Difficulty bending down to pick up light things Difficulty lifting a 5-kg object Difficulty reaching object above head Difficulty putting socks on either foot Difficulty getting in or out of car Difficulty standing or walking for 2 h Difficulty sitting in a chair for 30 min

Men with vertebral fractures (n5215)

Men without vertebral fractures (n51,212)

No with adequate data

No with adequate data

p Value

215 215 215 215

1,212 1,212 1,212 1,212

74.863.0 1.860.1 81.2612.0 26.563.6

!.01 !.001 !.01 .05

819 821 1,039

3.762.4 114 (13.9%)

.15 .02

56 400 583

.16

135 163 174

75.463.0 1.760.1 78.2612.4 26.063.6 4.160.2 34 (20.9%) 16 67 91

215 214

103 (47.9%) 22 (10.3%)

1,211 1,206

408 (33.7%) 28 (2.3%)

214 213 214 215 215 214 212 215

122 49 33 21 45 44 98 25

1,207 1,199 1,200 1,202 1,205 1,204 1,153 1,206

660 292 118 69 283 277 515 129

(57.0%) (23.0%) (15.4%) (9.8%) (20.9%) (20.5%) (46.2%) (11.6%)

(54.7%) (24.4%) (9.8%) (5.7%) (23.5%) (23.0%) (44.7%) (10.7%)

!.001 !.001 .53 .67 .02 .03 .41 .41 .68 .69

BMI, body mass index. Note: Back pain and disability were evaluated during the preceding 12 months. Data are provided as means6standard deviations or as numbers with proportions (%) within brackets. Group comparisons were done with Student’s t tests, c2, or Fisher exact tests with statistically significant differences reported in bold.

question if the subject suffered from back pain during the preceding 12 months. Height and weight were measured using standard equipment [20,22]. We performed two consecutive measurements of height in the same session and used the average of these. In the case of a discrepancy of 5 mm or more between the measurements, we performed a third measurement and used the average of the two nearest values. Body mass index was calculated as the weight divided by the square of the height (kg/m2). All the men in Malm€ o and the latter half of the men in Gothenburg were also offered a standard radiological lateral examination of the thoracic and lumbar spine. A total of 1,453 men (988 in Malm€ o and 465 men in Gothenburg) accepted the offer, but 26 radiographs could not be read from the fourth thoracic to the fifth lumbar vertebra and were

excluded rendering 1,427 radiographs to be classified for prevalent vertebral fractures by a senior skeletal radiologist (IR-J), blinded to the clinical status of the patient. Fracture evaluation was conducted by a modified semiquantitative method developed by Genant et al. [23], a method widely used in the clinical research [15,24–27]. The reproducibility of the method for the diagnosis of vertebral fracture is high, with intraobserver agreement of 93% to 99% and interobserver agreement of 90% to 99% [28]. The method uses visual determination of the vertebral shape and degree of reduction in vertebral height in the anterior, middle, and/ or posterior dimension. In this study we considered a fracture if visual inspection indicated a reduction in vertebral height and/or compression of 10% or above of the estimated vertebral body height, and other causes of the deformity, such as congenital abnormality, hemivertebrae, and

Fig. 1. Wedge, biconcave, and crush type of vertebral fracture [23].

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Fig. 2. Distribution of vertebral fractures in 215 men aged 69–81 years with total 398 radiographic vertebral fractures in the thoracic and lumbar spine (some men had several fractures). Data are provided as the number of fractured vertebrae at each vertebral level in the thoracic (Th) and lumbar (L) spine.

developmental abnormalities, such as Scheuermann disease, and degenerative abnormalities, such as Schmorl noduli, were excluded [29]. For a fractured vertebra (index vertebra), the radiologist measured the anterior, mid-, and posterior heights that were compared with estimates of the normal height derived by the average heights of the first adjacent normal vertebrae cranially and caudally (reference vertebrae). In cases with a fracture in the fifth lumbar vertebra, we only used the fourth lumbar vertebra as reference and correspondingly used only the fifth thoracic vertebra as reference for fractures in the fourth thoracic lumbar vertebra. Fractures were also classified by type and were considered as wedge type if the anterior height was most compressed and the posterior height unaffected, as uni- or biconcave type (in the following parts referred to biconcave type) if the mid-height was most compressed and the anterior and posterior heights unaffected, and as crush type if the compression involved the entire vertebral body (Fig. 1) [16,23,26,27]. The ethics committee, the radiological committee, and the institutional review board at each center approved the study. All participants gave written informed consent before study start, and the study was performed in accordance with the declaration of Helsinki. Statistical Package of Social Sciences (SPSS, version 19, IBM, Armonk, NY, USA) was used for statistical analyses. For group comparisons, we used the c2 test for categorical variables and Student t test between means for continuous variables. Data are presented as numbers (n) and proportions (%) for categorical variables, as means with standard

deviations for normally distributed continuous variables, and medians with upper and lower quartile limits (25th and 75th percentiles) for non-normally distributed continuous variables. We considered group differences as statistically significant different at a level of .05.

Results Epidemiology Background data in men with and without prevalent vertebral fractures are presented in Table 1. In the 1,427 classified radiographs, we found, in total, 398 vertebral fractures in 215 men (15.1%) (Fig. 2) with increasing prevalence with increasing age (p5.01) (Table 2). Only 10% of men with a vertebral fracture were aware of their fracture. The distribution of the maximal compressed vertebral body in each man with a fracture is shown in Fig. 3, and the number, location, and type of the fractured vertebrae are presented in Fig. 4. In men with fractures, 126 (58.6%) had 1 fracture and 89 (41.4%) had several fractures (Table 3). In men with only 1 fracture, 89 (70.6%) had a thoracic fracture and 37 (29.4%) a lumbar fracture (Table 2). In those with several fractures, 32 (36.0%) had only thoracic fractures, 4 (4.5%) only lumbar fractures, and 53 (59.6%) fractures in both regions (Fig. 3). The most common type of fracture was the wedge type, found in 107 men (84.9%) with only 1 fracture and in 52 men (58.4%) with several fractures (Table 3).

Table 2 Proportion of individuals with and without radiographic vertebral fractures in 1,427 Swedish men aged 69–81 years Age groups (y)

Number of individuals

Vertebral fracture (n5215)

No vertebral fracture (n51,212)

p Value

69–72 73–75 76–78 79–81

458 545 253 171

51 85 43 36

407 460 210 135

!.01

(11.1%) (15.6%) (17.0%) (21.1%)

(88.9%) (84.4%) (83.0%) (78.9%)

Note: Data are provided as numbers with proportions (%) within brackets. Group comparisons were done with c2 test with a statistically significant difference reported in bold.

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Fig. 3. Maximal grade of compression in any fractured vertebrae in each of 215 men aged 69–81 years with at least 1 radiographic vertebral fracture. Compression was calculated as the proportion (%) of compression of the most compressed vertebrae in each subject in relation to the height of normal adjacent vertebrae in the same individual.

Clinical presentation There were anthropometric differences in men with and without prevalent vertebral fracture, but history of back pain was similar (Table 1). Among the men with one or several vertebral fracture, 57% reported back pain compared with 55% in those without a fracture (p5.53) (Table 1).

Compared with men without vertebral fractures, men with any fracture reported more fractures in the past (p!.001), including spine fractures (p!.001) (Table 1). Although current smoking was more common in men with prevalent vertebral fractures (p!.05), there were no group differences in alcohol intake (Table 1). Men with any prevalent vertebral

Fig. 4. Number of fractured (fx) vertebrae, fracture location, and fracture type in 215 men aged 69–81 years with any radiographic vertebral fracture in the thoracic or lumbar spine.

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Table 3 Back pain (during the preceding 12 months) in 214 Swedish men (1 individual with a fracture did not answer whether he suffered from back pain) aged 69–81 years with a radiographic vertebral fracture Subgroups

Number of individuals

Vertebral fracture and back pain

Vertebral fracture and no back pain

Numbers Age groups (y) 69–72 73–75 76–78 79–81 Number of fractures 1 2 3 4 $5 Fracture location Men with one fracture Thoracic spine Lumbar spine Men with several fractures Thoracic spine Lumbar spine Both in thoracic and lumbar spine Type of fracture Men with one fracture Biconcave Crush Wedge Men with several fractures Biconcave Wedge Several different Compression grade Men with one fracture Q1 (0.33–0.62) Q2 (0.62–0.69) Q3 (0.69–0.76) Q4 (0.76–0.87) Men with several fractures Q1 (0.21–0.52) Q2 (0.52–0.63) Q3 (0.63–0.68) Q4 (0.68–0.83)

214

122 (57.0%)

92 (43.0%)

p Value

51 84 43 36

32 44 20 26

(62.7%) (52.4%) (46.5%) (72.2%)

19 40 23 10

(37.3%) (47.6%) (53.8%) (27.8%)

.08

125 46 19 17 7

65 27 12 11 7

(51.6%) (58.7%) (63.2%) (64.7%) (100%)

60 19 7 6 0

(47.6%) (41.3%) (36.8%) (35.3%) (0%)

.21

125 88 37 89 32 4 53

65 (51.6%) 44 (49.4%) 21 (56.8%)

60 (47.6%) 44 (49.4%) 16 (43.2%)

.49

16 (50.0%) 2 (50.0%) 39 (73.6%)

16 (50.0%) 2 (50.0%) 14 (26.4%)

.08

9 (56.2%) 1 (33.3%) 55 (51.4%)

7 (43.8%) 2 (66.7%) 51 (47.7%)

.77

1 (25.0%) 31 (59.6%) 25 (75.8%)

3 (75.0%) 21 (40.4%) 8 (24.2%)

.08

16 15 18 16

(51.6%) (46.9%) (56.3%) (51.6%)

15 17 13 15

(48.4%) (53.1%) (40.6%) (48.4%)

.85

15 13 13 16

(68.2%) (59.1%) (56.5%) (72.7%)

7 9 10 6

(31.8%) (40.9%) (43.5%) (27.3%)

.64

125 16 3 107 89 4 52 33 125 31 32 31 31 89 22 22 23 22

Note: Grade of compression was estimated as the height of the most compressed vertebrae in relation to normal adjacent vertebrae stratified in quartiles (Q). Data are provided as numbers with proportions (%) within brackets. For fracture location, fracture type and grade of compression data are reported in two subgroups, with only one fracture and with several fractures. Group comparisons were done with c2 or Fisher exact test with statistically differences reported in bold.

fracture also reported more difficulties in lifting heavy objects (p!.05) and reaching objects above the head (p!.05). No other group differences were found in the ADL function (Table 1). Finally, we could not find any subgroup of men with vertebral fractures in respect of age, number of fractures, fracture location, type of fracture, or grade of compression that had significantly more back pain than others (Table 3), even if all men with five or more fractures (n57) reported back pain. Discussion This study shows that 15% of community living men aged 69–81 years have at least one prevalent vertebral

fracture. The clinical relevance of such a fracture seems low because we found similar prevalence of back pain in men with and without fracture and only 10% of men with a vertebral fracture were aware of their fracture, an even lower proportion being reported in postmenopausal women [19]. The prevalence of vertebral fractures in our cohort is in the lower range compared with the 13% to 26% prevalence figures reported in historical cohorts of Caucasian male populations [1,2,24,29,30] and also in the lower range of the 17% to 27% prevalence, depending on ages, reported in men in our city more than two decades ago [7]. It should be noted that Scheuermann disease was not considered in the European Vertebral Osteoporosis Study;

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hence, the prevalence of vertebral fracture might have been overestimated. Also from other perspectives, the present results seem to agree with the previous studies, as the prevalence increased by age [16,26,31–33], the majority of men had only one vertebral fracture [1,2,16], and the prevalence was lower than reported in women [1,2,7,8]. Hence, no substantial changes in the pattern or prevalence of vertebral fractures in old men seems evident during the recent decades. We found that only 10% of men with a vertebral fracture were aware of their fracture, even lower than the 40% of women who have been reported to be aware of a prevalent vertebral fracture [19]. These together with the similar prevalence of back pain in men with and without vertebral fractures indicate that a prevalent vertebral fracture is of low clinical relevance. Although this notion is supported by some studies reporting that only 30% of individuals with vertebral fractures seek medical attention at the time of the fracture [1,11,14], it is opposed by others reporting increased likelihood of back pain and reduced health-related quality of life with increasing compression grade and number of vertebral fractures [17,31,34,35]. In our study, we could find no such association. It has also been reported that disability from back pain is greater in patient with lumbar than thoracic fractures [35,36], another view that we could not find support for as others [14]. These differences comparing the different studies could depend on heterogeneous inclusion criteria resulting in different cohorts in respect of gender, age, exposure to trauma, physical activity, and proportion of acute fractures included. The most common loci of vertebral fractures in our and other studies [11,16,37,38] are the mid-thoracic and thoracolumbar regions. This can be referred to biomechanical conditions as the natural kyphosis is greatest around the eighth thoracic vertebra, resulting in higher bending forces in this region during mechanical loads and in the region where the rigid thoracic spine meets the more mobile lumbar segments [11]. There are limitations of semiquantitative grading of vertebral fractures. From the morphometric data on normal subjects, we know that vertebrae in the thoracolumbar junction especially in men are slightly more wedge shaped than in other regions [23]. This may result in a misclassification of normal vertebrae as mild deformity, possibly increasing the estimated prevalence of vertebral fractures . To minimize errors in interpretation, all films were examined by an expert radiologist. In our study, back pain was similar in men with and without any prevalent vertebral fractures, thereby opposing some previous studies that have found an association between vertebral fractures and back pain [39–41]. Leidig et al. [39] reported that the intensity of pain and physical limitations were significantly correlated to severity of radiographic vertebral fractures in 70 patients with osteoporotic vertebral fractures. Ettinger et al. [41] found that in a cohort of 204 women aged 55–75 years, those with the

287

most severe deformities suffered from both back pain and disability interfering with ADLs, whereas mild deformities did not add to the physical disability. There are, however, also studies that support our results [7,13]. The findings of O’Neill et al. [7] suggested that in women aged 50–75 years, there were no increase in back pain or disability after identification of prevalent radiographic vertebral fracture if no new fracture occurred during follow-up. Cockerill et al. [13] could not find any association between prevalent vertebral fractures and back pain in European men. Also the grade of the fracture compression and the number of fractures have in some studies been associated to back pain and reduced quality of life [34,40,42]. We, however, found no such association. It should, however, clearly be stated that only few individuals in our study had many fractures or great deformity, and we must thus acknowledge the risk of a Type II error. In fact, among those with five or more fractures (n57), all reported back pain. Finally, our study supports the previously found association between smoking and vertebral fractures [20,43] but not between alcohol intake and fractures [44]. Weaknesses of the study include the simultaneously evaluation of prevalent vertebral fractures and back pain. With this approach, temporal and causal relationships are not possible to establish, or in other words, we can state the proportion of recent or old fracture or any time between fracture event and the evaluation in this study. The inclusion of only ambulant elderly men without bilateral hip replacements and the attendance rate of 45% may result in selection bias. It is possible that the unhealthiest individuals declined participation to a higher extent than others that could lead to an underestimation of the prevalence of vertebral fractures and back pain. It must also be questioned if the results can be generalized to men of different ethnic background, living in other regions, or under different social circumstances. Although the sample size was large, some subgroup analyses still suffer the risk of a Type II error. The strengths include the large sample size, the population-based sample, and the radiological analyses conducted by a single expert radiologist. In conclusion, 15% of community-living Swedish men aged 69–81 years have a prevalent vertebral fracture. Men with prevalent vertebral fracture had not more back pain than those men without vertebral fracture. The fracture pattern and prevalence are similar historical cohorts, and the clinical relevance of prevalent vertebral fracture must be regarded as low.

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Low clinical relevance of a prevalent vertebral fracture in elderly men--the MrOs Sweden study.

The epidemiology, the fracture pattern, and the clinical relevance of prevalent vertebral fractures in old men are debated wherefore we set out to cla...
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