Biomedical subjects

D Hans

Publications and source records attributed to D Hans.

At least 19 recordsLinked to original sources

PubMed2006

Which screening strategy using BMD measurements would be most cost effective for hip fracture prevention in elderly women? A decision analysis based on a Markov model.

INTRODUCTION: Hip fractures are responsible for excessive mortality, decreasing the 5-year survival rate by about 20%. From an economic perspective, they represent a major source of expense, with direct costs in hospitalization, rehabilitation, and institutionalization. The incidence rate sharply increases after the age of 70, but it can be reduced in women aged 70-80 years by therapeutic interventions. Recent analyses suggest that the most efficient strategy is to implement such interventions in women at the age of 70 years. As several guidelines recommend bone mineral density (BMD) screening of postmenopausal women with clinical risk factors, our objective was to assess the cost-effectiveness of two screening strategies applied to elderly women aged 70 years and older. METHODS: A cost-effectiveness analysis was performed using decision-tree analysis and a Markov model. Two alternative strategies, one measuring BMD of all women, and one measuring BMD only of those having at least one risk factor, were compared with the reference strategy "no screening". Cost-effectiveness ratios were measured as cost per year gained without hip fracture. Most probabilities were based on data observed in EPIDOS, SEMOF and OFELY cohorts. RESULTS: In this model, which is mostly based on observed data, the strategy "screen all" was more cost effective than "screen women at risk." For one woman screened at the age of 70 and followed for 10 years, the incremental (additional) cost-effectiveness ratio of these two strategies compared with the reference was 4,235 euros and 8,290 euros, respectively. CONCLUSION: The results of this model, under the assumptions described in the paper, suggest that in women aged 70-80 years, screening all women with dual-energy X-ray absorptiometry (DXA) would be more effective than no screening or screening only women with at least one risk factor. Cost-effectiveness studies based on decision-analysis trees maybe useful tools for helping decision makers, and further models based on different assumptions should be performed to improve the level of evidence on cost-effectiveness ratios of the usual screening strategies for osteoporosis.

Absorptiometry, Photon↗

PubMed2005

Quantitative ultrasound parameters as well as bone mineral density are better predictors of trochanteric than cervical hip fractures in elderly women. Results from the EPIDOS study.

RATIONALE: Hip fractures can be separated into cervical and trochanteric fractures. Trochanteric fractures have been associated with up to twice the short-term mortality of cervical fractures in the elderly. There is also evidence suggesting that the mechanisms are different. Evidence from the literature remains limited on the predictive power of bone mineral density (BMD) and quantitative ultrasounds (QUS) for both types of hip fractures. METHODS: 5703 elderly women aged 75 years or more, who were recruited from the voting lists in the EPIDOS study, and had baseline calcaneal ultrasounds (QUS) and DXA measurements at the hip and the whole body, were analyzed in this paper. Among those, 192 hip fractures occurred during an average follow-up of 4 years, 108 cervical and 84 trochanteric fractures. RESULTS: Femoral neck, trochanteric and whole body BMD were able to predict trochanteric hip fracture (RR's and 95% CI were, respectively, 3.2 (2.4-4.2); 4.8 (3.5-6.6); and 2.8 (2.2-3.6)) more accurately than cervical fractures (respectively, 2.1 (1.7-2.7); 2.3 (1.8-3.0); 1.2 (1.0-1.6)). All ultrasound parameters, SOS, BUA, and stiffness index (SI) were significant predictors of trochanteric (RR's respectively 3.0 (2.2-4.1), 2.5(2.0-3.1), and 3.5(2.6-4.7)) but not cervical fractures. After adjustment for femoral neck or trochanteric BMD ultrasound parameters were still significant predictors of trochanteric fracture, and stiffness tended to be a better predictor of trochanteric fractures than either BUA or SOS with a relative risk of 2.25 (1.6-3.1). CONCLUSIONS: A significant decrease of all bone measurements, BMD and QUS, was highly predictive of trochanteric fractures, whereas a decrease of femoral neck and trochanteric BMD were only associated with a slight increase in cervical fracture risk and a low total body BMD or QUS parameters were not significant predictors of cervical fractures. In women who sustained a hip fracture, the decrease of BMD and QUS values increases the risk of trochanteric fracture as compared to cervical fracture. Trochanteric fractures were mostly a consequence of a generalized low BMD and QUS, whereas other parameters might be involved in cervical fractures.

Aged↗

PubMed2005

Skeletal site selectivity in the effects of calcium supplementation on areal bone mineral density gain: a randomized, double-blind, placebo-controlled trial in prepubertal boys.

BACKGROUND: Calcium supplementation during childhood and adolescence is considered an early means of preventing osteoporosis in adults. Prepuberty is an opportune time for detecting the benefits of calcium in girls. OBJECTIVE: The objective was to assess whether calcium supplementation increases bone mass gain in prepubertal boys in a skeletal site-specific manner. METHODS: In a 12-month double-blind, placebo-controlled trial with 1-yr follow-up, 235 healthy prepubertal boys aged 7.4 +/- 0.4 yr (mean +/- sd) were randomized to receive two food products providing 850 mg/d calcium (calcium supplement group, n = 116) or an isocaloric placebo (n = 119). Areal bone mineral density (aBMD) was determined by dual-energy x-ray absorptiometry at radius (two sites), hip (two sites), femoral diaphysis (FDia), and L2-L4 vertebrae. RESULTS: At 12 months, aBMD gain was greater at the FDia and at the mean of the five appendicular skeletal sites in the calcium supplement group in both intention-to-treat analysis [76 +/- 32 vs. 64 +/- 33 mg/cm(2).yr; difference, 12.0 (95% confidence interval, CI, 3.6-20.3), P = 0.006; and 33 +/- 16 vs. 28 +/- 16 mg/cm(2).yr; difference, 5.1 (95% CI, 0.9-9.2); P = 0.018, respectively] and active treatment analysis [81 +/- 32 vs. 64 +/- 31 mg/cm(2).yr; difference, 17.2 (95% CI, 7.9-26.5); n = 174, P < 0.001; and 35 +/- 16 vs. 28 +/- 14 mg/cm(2).yr; difference, 7.5 (95% CI, 2.9-12.2); P = 0.002]. There was no beneficial effect of calcium on lumbar spine. The calcium effect was still detectable by ANOVA repeated measures analysis at the FDia (P = 0.004) and at the mean of the five appendicular skeletal sites (P = 0.002) 1 yr after the end of intervention (active treatment analysis). There was no change in bone size. CONCLUSION: In prepubertal boys, calcium-enriched foods increased aBMD at several appendicular skeleton sites, but not at the lumbar spine, and this without any bone size change. This effect was maintained 1 yr after treatment discontinuation.

Body Mass Index↗

PubMed2005

Longitudinal follow-up of body composition in hematopoietic stem cell transplant patients.

Patients with hematological malignancies are well nourished prior to allogeneic hematopoietic stem cell transplantation (HSCT). HSCT and associated complications can affect body composition. The study evaluated cross-sectionally the prevalence and longitudinally the changes in lean body mass index (LBMI) in HSCT patients. Patients (n=82) were classified as normal or low LBMI. Logistic regression analyses were used to estimate odds ratios (OR) for low vs normal LBMI, between healthy volunteers and patients; for limited or extensive vs no chronic graft-versus-host-disease (GVHD); and for decreased (Karnofsky <80) vs normal functional status (>80). Patients were significantly more likely to have low LBMI at 6, 12 months, 2-3, 4-6 and >6 years than volunteers. In all, 38% of patients were below pre-HSCT LBMI at 4-6 years post-HSCT. Low LBMI was significantly associated with steroid treatment (OR 2.6, confidence intervals (CI) 1.3-5.2, P=0.008); limited (OR 5.5, CI 1.7-18.5, P=0.005) or extensive chronic GVHD (OR 20.3, CI 5.7-71.6, P<0.001); and decreased performance status (Karnofsky scores of < or =80) (OR 2.7, CI 1.3-5.9, P=0.01). Patients were more likely to have low LBMI than volunteers. Chronic GVHD and low performance status were associated with low LBMI; thus, complications and/or treatment increase the likelihood of low LBMI.

Body Composition↗

PubMed2004

Appropriateness of internal digital phantoms for monitoring the stability of the UBIS 5000 quantitative ultrasound device in clinical trials.

In bone status assessment, proper quality assurance/quality control is crucial since changes due to disease or therapeutic treatment are very small, in the order of 2-5%. Unlike for dual X-ray absorptiometry, quality control procedures have not been extensively developed and validated for quantitative ultrasound technology, limiting its use in longitudinal monitoring. While the challenge of developing an ideal anthropometric phantom is still open, some manufacturers use the concept of the internal digital phantom mimicking human characteristics to check the stability of their device. The objective of the study was to develop a sensitive model of quality control suitable for the correction of QUS patient data. In order to achieve this goal, we simulated a longitudinal device lifetime with both correct and malfunctioning behaviors. Then, we verified the efficiency of digital phantoms in detecting those changes and subsequently established the in vitro/in vivo relationship. This is the first time that an attempt to validate an internal digital phantom has made, and that this type of validation approach is used. The digital phantom (DP) was designed to mimic normal bone (BUAP2) and osteoporotic bone (BUAP1) properties. The DP was studied using the UBIS 5000 ultrasound device (DMS, France). Diverse malfunctions of the UBIS-5000 were simulated. Several series of measurements were performed on both BUAP1 and 2 and on 12 volunteers at each grade of malfunction. The effect of each simulated malfunction on in vivo and in vitro results was presented graphically by plotting the average BUA values against the percentage change from baseline. The change from baseline in BUA was modeled using linear regression, and the in vivo/in vitro ratio was obtained from the model. All experimentations influenced the measure of BUAP1 and 2 as well as the measure of our 12 volunteers. However, the degree of significance varied as a function of the severity of the malfunction, and the results also differed substantially in magnitude between in vivo and in vitro. Indeed, the DP was about 10 times more sensitive to variations of the transfer function than was the in vivo measurement, which is very reassuring. The sensitivity of the digital phantoms was reliable in the determination of simulated malfunctions of the UBIS-5000. The digital phantoms provided an accurate evaluation of the acoustic performance of the scanner, including the fidelity of transducers. In light of these results, the QC approach of the UBIS-5000 will be extremely simple to implement compared with other devices. Indeed, since the digital phantom was automatically measured during every patient measurement, the QC approach could be built on an individual level basis rather than on an average basis.

Adult↗

PubMed2004

Special report on the official positions of the International Society for Clinical Densitometry.

The International Society for Clinical Densitometry (ISCD) periodically holds Position Development Conferences (PDCs) for the purpose of establishing standards and guidelines for indications, acquisition, and interpretation of bone density tests. Topics are selected for consideration by the ISCD Scientific Advisory Committee, reviewed by scientific working groups, and presented to an international panel of experts. Topic categories addressed to date include indications for bone density testing, selection of reference databases for T-scores and Z-scores, clinical applications for central and peripheral bone densitometry, serial bone density testing, instrument precision assessment, phantom scanning and calibration testing, requirements for a bone density report, nomenclature, and diagnosis of osteoporosis in postmenopausal women, premenopausal women, men, and children. Following an open session for public comment and discussion, the panel convenes for consideration of each topic and makes recommendations for positions to the ISCD Board of Directors. Recommendations that are accepted become the Official Positions of the ISCD. This Special Report summarizes the methodology of the ISCD PDCs and presents selected Official Positions of general interest.

Absorptiometry, Photon↗

PubMed2004

Risk factors for hip fracture in women with high BMD: EPIDOS study.

Hip fractures are common among older women. At the present time, major efforts are being made to identify women with low bone mineral density (BMD). However, more than half of hip fractures occur in women who would not classically be considered osteoporotic by BMD. This study aimed to identify factors associated with hip fracture in women with high BMDs. A total of 7598 French women aged over 74 participated in the EPIDOS study and had BMD measured by dual energy X-ray absorptiometry. Analysis was carried out comparing women with and without hip fractures over more than 3 years of follow-up. The participants were divided into three groups based on femoral neck BMD, so as to have equal numbers in each group (cut-off points=0.601 g/cm(2), and 0.683 g/cm(2)). Multiple risk factors thought to be associated with hip fracture were tested in the high and low BMD groups to search for those whose effect was stronger in the high BMD group. Age adjusted Cox regression was used. Results for continuous variables are reported per standard deviation change. Positive interaction between higher BMD, hip fracture and the following factors were found: age (P<0.01), ultrasound attenuation (P<0.05), urinary deoxypyridinoline (DPD) (P<0.05), left quadriceps strength (P<0.05) and right and left foot coordination (P<0.05). The following factors had a larger hazards ratio in those in the upper third of BMD than the low and were statistically significant: femoral neck BMD, nulliparity, age, ultrasound attenuation and speed, prior fracture, urinary deoxypyridinoline, left grip strength and foot coordination. Multiple factors appear to be more strongly associated with hip fractures in women with high BMD than low. They appear to cluster as factors that may relate to bone turnover and architecture and others which are more subtle measures of left-sided coordination.

Age Factors↗

PubMed2004

Should age influence the choice of quantitative bone assessment technique in elderly women? The EPIDOS study.

In a prospective cohort of 7,598 women aged 75 and over, we analyzed the effect of age on the ability of femoral neck bone mineral density (BMD) and of ultrasound (BUA and SOS) of the calcaneus to predict hip fracture. Unadjusted regression analysis showed that the risk of hip fracture was increased 1.7 times for one standard deviation increase in age (3.7 years). Overall, for a decrease of one standard deviation in quantitative bone measures, the risk was significantly increased by 2.2 times for BMD (1.9-2.5), 1.8 for BUA (1.6-2.1), and 1.9 for SOS (1.6-2.2). However the average relative risk associated with a decrease in BMD tends to diminish with advancing age, meaning that a smaller part of the risk is explained by BMD in the very elderly. This is confirmed by the areas under the ROC curves (AUC) of BMD that are significantly better before 80 years (0.75 [0.73-0.76]) than after (0.65 [0.63-0.67] in group 80-84 years and 0.65 [0.61-0.68] in group >/=85). On the other hand, as the absolute risk increases exponentially with age, the number of hip fractures attributable to a low BMD is still important in the very elderly, the risk difference between the lowest and the highest quartile of BMD is 25 hip fractures / 1,000 woman-years in the group >/=85 compared with 16 in the two other groups. Thus, after 80, quantitative assessment of bone may still be of interest for clinical decisions. Compared with quantitative ultrasound parameters, the ability of BMD to predict hip fracture was significantly superior to that of BUA and SOS only before the age of 80 (AUC of BMD 0.75 [0.73-0.76], BUA 0.67 [0.66-0.69], SOS 0.67 [0.65-0.69]). For patients older than 80, we did not observe significant differences in AUC between DXA and QUS to predict hip fracture.

Absorptiometry, Photon↗

PubMed2004

Does follow-up duration influence the ultrasound and DXA prediction of hip fracture? The EPIDOS prospective study.

While the potential of quantitative ultrasound (QUS) in the management of osteoporosis has been accepted, its interaction with follow-up time has never been investigated. The aim of our study is to prospectively evaluate the influence of follow-up time on the prediction of hip fracture by ultrasound parameters in the elderly as compared to bone mineral density (BMD) and to establish a long-term fracture prediction model. In the multicenter prospective study EPIDOS, 5898 Caucasian healthy women, aged 75 and over, had femoral dual-energy X-ray absorptiometry (DXA) and heel ultrasound measurements at baseline. A survey of fracture occurrence was conducted every 4 months. Statistical analyses were performed for three different average lengths of follow-up, namely, 1.5, 2.5 and 3.5 years. Relative risks per standard deviation decrease (RR) and the area under the receiver operating characteristic (AUC) curves were given. Estimates of the long-term hip fracture prediction by DXA and QUS were extrapolated. During an average of 3.5 years follow-up, 227 women sustained their first non-traumatic hip fracture. For the three categories of follow-up, low values of both calcaneal ultrasound and hip BMD were associated with a significant increased risk of hip fracture [e.g. ultrasound Stiffness index RR = 2.8 (2.1-3.8), 2.1 (1.7-2.6) and 1.9 (1.7-2.3) for 1.5, 2.5 and 3.5 years of follow-up, respectively]. The combination of femoral neck BMD with the Stiffness showed an improvement of the hip fracture prediction model. Using extrapolation, the prediction of hip fracture by the Stiffness remained significant up to 7.5 years [RR = 1.2 (1.03-1.41)], whereas the limit of significance was reached at 10 years for the femoral neck BMD [RR = 1.25 (1.04-1.52)]. Our results indicate that the Stiffness tends to be the best short- and long-term predictor of hip fracture among ultrasound parameters. This paper provides additional information on the long-term prediction of hip fracture, which has always been an important issue in routine clinical practice as it influences the management of the disease. Our model should give a relatively good estimation of the fracture risk prediction at 5 years with the ultrasound and 10 years for the femoral neck BMD.

Absorptiometry, Photon↗

PubMed2003

Device-specific weighted T-score for two quantitative ultrasounds: operational propositions for the management of osteoporosis for 65 years and older women in Switzerland.

The World Health Organization (WHO) criteria for the diagnosis of osteoporosis are mainly applicable for dual X-ray absorptiometry (DXA) measurements at the spine and hip levels. There is a growing demand for cheaper devices, free of ionizing radiation such as promising quantitative ultrasound (QUS). In common with many other countries, QUS measurements are increasingly used in Switzerland without adequate clinical guidelines. The T-score approach developed for DXA cannot be applied to QUS, although well-conducted prospective studies have shown that ultrasound could be a valuable predictor of fracture risk. As a consequence, an expert committee named the Swiss Quality Assurance Project (SQAP, for which the main mission is the establishment of quality assurance procedures for DXA and QUS in Switzerland) was mandated by the Swiss Association Against Osteoporosis (ASCO) in 2000 to propose operational clinical recommendations for the use of QUS in the management of osteoporosis for two QUS devices sold in Switzerland. Device-specific weighted "T-score" based on the risk of osteoporotic hip fractures as well as on the prediction of DXA osteoporosis at the hip, according to the WHO definition of osteoporosis, were calculated for the Achilles (Lunar, General Electric, Madison, Wis.) and Sahara (Hologic, Waltham, Mass.) ultrasound devices. Several studies (totaling a few thousand subjects) were used to calculate age-adjusted odd ratios (OR) and area under the receiver operating curve (AUC) for the prediction of osteoporotic fracture (taking into account a weighting score depending on the design of the study involved in the calculation). The ORs were 2.4 (1.9-3.2) and AUC 0.72 (0.66-0.77), respectively, for the Achilles, and 2.3 (1.7-3.1) and 0.75 (0.68-0.82), respectively, for the Sahara device. To translate risk estimates into thresholds for clinical application, 90% sensitivity was used to define low fracture and low osteoporosis risk, and a specificity of 80% was used to define subjects as being at high risk of fracture or having osteoporosis at the hip. From the combination of the fracture model with the hip DXA osteoporotic model, we found a T-score threshold of -1.2 and -2.5 for the stiffness (Achilles) determining, respectively, the low- and high-risk subjects. Similarly, we found a T-score at -1.0 and -2.2 for the QUI index (Sahara). Then a screening strategy combining QUS, DXA, and clinical factors for the identification of women needing treatment was proposed. The application of this approach will help to minimize the inappropriate use of QUS from which the whole field currently suffers.

Absorptiometry, Photon↗

PubMed2003

Fat-free mass change to weight change ratio during refeeding following lung transplantation.

Malnutrition occurs frequently prior to lung transplantation (LTR), but patients gain weight after LTR. The study aimed to determine the ratio changes of fat-free mass (deltaFFM): changes of body weight (deltaBW) during refeeding. A total of 37 LTR patients were measured for weight and FFM and body fat by bioimpedance analysis at 1 month post-LTR, then annually for 3 years. Linear regressions determined the ratio deltaFFM:deltaBW during refeeding. DeltaFFM was: year- 1=1.822+0.389* deltaBW, r(2)=0.397; yr-2=0.611+0.246* deltaBW, r(2)=0.441; yr-3=-0.17+0.208 * deltaBW, r(2)=0.319. Refeeding during year-1 in thin subjects resulted in a ratio deltaFFM:deltaBW of 0.389, whereas the change in ratio deltaFFM:deltaBW during year- 2 and 3 was 0.246 and 0.208, respectively. Refeeding resulted in a larger ratio deltaFFM:deltaBW in thin subjects versus normal and overweight subjects. Thus, refeeding in underweight LTR patients is geared to normalizing depleted FFM, whereas later FFM gains were similar to FFM gains in normal and overweight subjects.

Adipose Tissue↗

PubMed2003

Prevalence of low fat-free mass index and high and very high body fat mass index following lung transplantation.

The aim of this study was to determine the prevalence of low fat-free mass index (FFMI) and high and very high body fat mass index (BFMI) after lung transplantation (LTR). A total of 37 LTR patients were assessed prior to and at 1 month, 1 year and 2 years for FFM and compared to 37 matched volunteers (VOL). FFM was calculated by the Geneva equation and normalized for height (kg/m(2)). Subjects were classified as FFMI "low", 8.2 kg/m(2) in men and >11.8 kg/m(2) in women. In 23 M/14 F, body mass index (BMI) was 22.3+/-4.4 and 20.1+/-4.9 kg/m(2), respectively. The prevalence of low FFMI was 80% at 1 month and 33% at 2 years after LTR. Prevalence of very high BFMI increased and was higher in patients than VOL after LTR. The prevalence of low FFMI was high prior to and remained important 2 years after LTR, whereas BFMI was lower prior to and higher 2 years after LTR.

Adipose Tissue↗

PubMed2003

Validation of a bioelectrical impedance analysis equation to predict appendicular skeletal muscle mass (ASMM).

RATIONALE: Appendicular skeletal muscle mass (ASMM) is useful in the evaluation of nutritional status because it reflects the body muscle protein mass. The purpose of this study was to validate, against dual-energy X-ray absorptiometry (DEXA), a BIA equation to predict ASMM to be used in volunteers and patients. METHOD: Healthy men (n = 246 men, BMI 25.3+/-2.9 kg/m(2)) and women (n =198, 24.1+/-3.6 kg/m(2)), and heart, lung and liver transplant patients (213 men, BMI of 24.6+/-4.4 kg/m(2); 113 women, BMI 23.0+/-5.2 kg/m(2)) were measured by BIA (Xitron Technologies) and DEXA (Hologic QDR 4500). A BIA equation to predict ASMM (kg) that included height(2)/resistance, weight, gender, age and reactance, was developed by means of multiple regressions. [table: see text] Mean difference (Bland-Altman) for volunteers was 0.1+/-1.1 kg, r =0.95, SEE 1.12 kg and for patients -0.4+/-1.5 kg, r =0.91, SEE 1.5 kg. Best fitted multiple regression equation was -4.211 + (0.267 x height2 / resistance) + (0.095 x weight)+(1.909 x sex (men = 1, women = 0)) + (-0.012 x age) + (0.058 x reactance). CONCLUSIONS: BIA permits the prediction of ASMM in healthy volunteers and patients between 22 and 94 years of age. A slightly larger, though clinically not significant, error was noted in patients.

Absorptiometry, Photon↗

PubMed2002

Is time since hip fracture influencing the discrimination between fractured and nonfractured subjects as assessed at the calcaneum by three technologically different quantitative ultrasound devices?

Because quantitative ultrasound (QUS) instruments from different manufacturers have significant technical differences, it is difficult to assess whether all of them can discriminate similarly between osteoporotic fractures and age-matched controls. Thus, to avoid any bias, reliable comparative assessment of the QUS devices should be carried out on the same population. Few studies have fulfilled this condition. Another source of variability in cross-sectional studies in which fractured and nonfractured subjects are compared is the time since osteoporotic fracture. Our study evaluated the ability of three calcaneal QUS devices to discriminate patients with osteoporotic hip fracture from control subjects, using the same population. In addition, a subset of patients was re-measured about 9 months after the hip replacement surgery to check how the time since fracture affects the discriminatory ability of the different QUS devices. Fifty postmenopausal hip-fractured patients and 46 postmenopausal age-matched controls were included in this study and measured on three QUS devices, as well as 50 young healthy controls to calculate the T-score. Odds ratio results showed that a decrease in UBIS trade mark BUA of 1 SD was associated with a significant increase in fracture risk (odds ratio adjusted = 2.30) comparable with Sahara broadband ultrasound attenuation (BUA) (OR adj. = 2.30), and Achilles BUA (OR adj. = 3.5). However, given the large overlap between the 95% intervals of each OR and for the areas under ROC curves, no significant difference was found between them. In the subset of 15 hip-fractured subjects, no significant differences were found between ultrasound parameters of the first visit and 9 months after except for the heel width (soft tissue variation). Odds ratio and areas under the curve (AUC) tend to increase from visit 1 to 2 for the BUA and decrease substantially for the SOS for all but the Lunar Achilles+. Nonsignificant correlation was found between the absolute difference of the ultrasound parameters measured at the two visits and the time since fracture, except for the Sahara SOS (r = 0.45; P < 0.04). In conclusion, no significant differences between QUS technologies were observed in their positive and significant ability to discriminate hip-fractured patient from controls. However, this statement is shadowed when taking into account the time since fracture which seems to negatively influence results obtained on dry versus wet QUS systems. As a result, it is advisable that such parameters would be taken into account when designing a study aimed to demonstrate the discriminatory ability of heel ultrasound between normal and hip-fractured patients.

Adult↗

PubMed2002

Monitored impact loading of the hip: initial testing of a home-use device.

Many studies have been done involving exercise, impact loading, and the effect on BMD. In some of these studies, particularly those involving outpatient activity, compliance and the specific parameters of an individual's impact loading have been difficult to monitor effectively. In this study, an individual, home-use platform was used to record daily, specific, and reproducible impact forces generated during a heel drop exercise. At three centers over 24 months, we conducted a randomized, prospective study of 157 osteoporotic and osteopenic women, aged 60-85 years. A total of 99 patients used the home Osteocare device (OrthoGenesis Incorporated, Northborough, Massachusetts USA) to generate a reproducible and specific daily impact program (active group). Controls (32) performed a similar motion on the unit but without trying to trigger an impact force (sham group), and 26 patients did no prescribed heel drop exercise (control group). All groups had the same calcium and vitamin D supplementation. Hip DXA was performed at baseline and every 6 months during the entire study duration. Compliance with the 3-5 min routine was high, and patients were able to consistently achieve the specific targeted impact range. Pooled BMD results showed no significant differences between groups in overall BMD measurements. However, a classification model that looked at individual site-specific BMD changes showed that more than 75% of the active group responded (versus 62% for both the sham and the control groups) by maintaining or increasing site-specific hip BMD over the 2-year trial. In fact, at the end of the study, 45% of the actives were gainers versus 12% and 22% in the sham and control groups, respectively. This study suggests that hip BMD may be maintained through a brief, safe, at-home, monitored impact loading program.

Absorptiometry, Photon↗

PubMed2002

Longitudinal quality control methodology for the quantitative ultrasound Achilles+ in clinical trial settings.

Appropriate quality assurance (QA) and quality control (QC) procedures have been well developed and validated for dual X-ray absorptiometry (DXA), and are widely applied in multicenter clinical trials to monitor device stability used to check the treatment effects on bone mineral density. This is not yet the case for quantitative ultrasound (QUS) technology, for which no QC approaches have yet been fully tested. The first Achilles (GE-Lunar Corporation, Madison, WI, USA) has been on the market for 10 years (1991). The goal of this study was to develop the QC methodology for the QUS Achilles+ device using its past/current experience (log and maintenance files.) as well as by integrating the progress made over the last years in the ultrasound domain so as to better understand the influence of temperature on ultrasound parameters. Because of the lack of confidence in the external black rubber phantom used in daily QC with the Achilles+, to monitor the device stability, we selected several QC parameters known to be influenced by potential malfunctions as experienced by the maintenance department of GE-Lunar company as well as the physical approach. These are phantom temperature-adjusted speed of sound (PSOS-TC) and broadband ultrasound attenuation (PBUA-TC), water speed of sound error (WSE), water spectrum slope (WSS) and water gain (WG). We used four Achilles+ devices perfectly stable during their entire QC range, to calculate the optimum thresholds (based mostly on 95% confidence interval) for each of these parameters as well as the precision for the in vitro SOS and BUA. An additional not fully stable Achilles device has been used to run a QC procedure example. The precision expressed as the CV was 0.22% and 0.65% for the PSOS-TC and PBUA-TC, respectively. The alarm thresholds used for QC process are +/- 0.6%, +/- 1.9%, +/- 6.8 m/s, +/- 5.3% and +/- 7.3% for the PSOS-TC, PBUA-TC, WSE, WSS and WG, respectively. Applying a logical approach on the impact of each parameter on each other as well as their respective reactivity to malfunctions, we build a QC process flowchart meant to detect real malfunction in the daily QC. We found that in case of real malfunctions, the in vivo SOS should be decreased by 1.33 m/s for each 1 m/s increase in WSE. Unfortunately, in vivo BUA can not be adjusted when real malfunction occurs. Nevertheless, the BUA can be qualified as bad quality data and excluded from the medical interpretation. Using the currently available phantom and parameters, the best possible QC procedures to detect long-term drift in the daily QC of the Achilles+ was developed. To fully validate our approach and gain confidence in the defined limits it is our plan to apply this QC processing to a higher number of QUS devices.

Bone and Bones↗

PubMed2002

Influence of region of interest and bone size on calcaneal BMD: implications for the accuracy of quantitative ultrasound assessments at the calcaneus.

There is considerable technological diversity among quantitative ultrasound (QUS) devices used to assess osteoporosis. Because the distance between the transducer and the footplate remains constant, the location of the calcaneus measured will vary with foot size. This study was designed to quantify the variation in bone mineral density (BMD) between a manufacturer's region of interest (ROI_M), which is fixed relative to the footplate, and an anatomical region of interest (ROI_A), which is defined as 20% of calcaneal length. The effect of foot length and width on QUS variables measured using two Food and Drug Administration cleared QUS devices, the Sahara (Hologic) and the Achilles+ (Lunar) was assessed. 26 healthy subjects (12 male and 14 female), aged 22-54 years (35.6+/-10 years) and with foot lengths of 21.5 cm to 29.7 cm (25.1+/-2.3 cm) were recruited. QUS assessments were performed at the right calcaneus. In addition, a Hologic 4500 densitometer was used to measure the BMD of the calcaneus in the ROI_M and ROI_A. The sizes of the ROIs were approximated to the sizes of the transducers of the Sahara and Achilles+ devices. The results showed a significant difference in BMD between the two ROI locations for the Sahara device (BMD 0.642+/-0.135 g cm(-2) vs 0.616+/-0.114 g cm(-2), p=0.014), but no significant difference was found in BMD between the two locations for the Achilles device (BMD 0.661+/-0.120 g cm(-2) vs 0.662+/-0.123 g cm(-2), p=0.818). At the ROI_A, there was a significant difference in BMD between the two QUS devices (p<0.001). The correlation between QUS variables and BMD was slightly higher for the ROI_M (r=0.68-0.79, since this is site-matched) than the ROI_A (r=0.59-0.70) for the Achilles device, while for the Sahara device the correlations were r=0.35-0.40 and r=0.51-0.54, respectively. The smaller ROI of the Sahara device resulted in more than 50% of the subjects having BMD differences of greater than 5% between the ROI_A and the ROI_M, compared with only 20% of the subjects on the Achilles device. ROIs containing cortical bone edge and other soft tissues were found in 58% of cases for the Achilles device and 46% of cases for the Sahara device. The greatest differences occurred in very small and very large feet. Calcaneal length correlated significantly with Sahara speed of sound (SOS), and heel width correlated significantly with Achilles SOS. Heel width also correlated significantly with Sahara broadband ultrasound attenuation (BUA) but not Achilles+ BUA. These results suggest that variation in ROI and bone size might affect the accuracy of QUS measurements, since the calcaneus is heterogeneous both in terms of its external geometry and its internal structure and density.

Adult↗

PubMed2002

Discriminatory ability of quantitative ultrasound parameters and bone mineral density in a population-based sample of postmenopausal women with vertebral fractures: results of the Basel Osteoporosis Study.

The discriminatory potential to classify subjects with or without vertebral fractures was tested cross-sectionally with different methods for the measurement of bone status in a population-based sample of postmenopausal women. Quantitative ultrasound (QUS) measurement at the calcaneus (Lunar Achilles, Hologic Sahara), the proximal phalanges (Igea Bone Profiler), and measurement of bone mineral density (BMD) with dual-energy X-ray absorptiometry (DXA; Lunar Expert) at several anatomic sites was performed in 500 postmenopausal women (aged 65-75 years) randomly selected from the population. In addition, 50 young female subjects (20-40 years old) had QUS measurements and served as controls to express QUS results as T-score values. Radiographs of the lumbar and thoracic spine were performed in the elderly women. Two independent radiologists reviewed the X-rays for the presence of vertebral fractures. Of 486 eligible study participants, no fracture was seen in 396 participants. Single vertebral fractures were observed in 71 subjects; 19 individuals presented multiple fractures. The overall prevalence of vertebral fractures was 18.5%. Participants without vertebral fractures were compared with subjects with vertebral fractures. Normal statistical distributions were found for all bone measurement results. Risk of vertebral fracture in subjects with no and multiple vertebral fracture was estimated using age adjusted odds ratios (ORs) for QUS and dual-energy X-ray absorptiometry (DXA) values. Each SD decrease in bone measurement increased the risk of multiple vertebral fracture by 3.0 (95% CI, 1.6-5.6) for the Achilles stiffness, by 3.8 (95% CI, 1.8-8.2) for the Sahara QUI, 2.1 (95% CI, 1.3-3.4) for the Bone Profiler amplitude-dependent speed of sound (AD-SOS), and 2.1 (95% CI, 1.2-3.9) and 2.4 (95% CI, 1.3-4.3) for DXA lumbar spine and for DXA total hip, respectively. Results of a discriminant analysis showed sensitivities between 84% and 58% and specificities between 72% and 58% for the respective DXA and QUS parameters. Optimum fracture thresholds for QUS measurements derived from this analysis were calculated also. Optimum T-score threshold values for QUS measurements tended to be higher than those for DXA measurements. However, the performance of QUS measurements is at least comparable with DXA measurements in identifying subjects with multiple vertebral fractures randomly selected from the population.

Aged↗