Romosozumab in postmenopausal women with low bone mineral density.

BACKGROUND: Sclerostin is an osteocyte-derived inhibitor of osteoblast activity. The monoclonal antibody romosozumab binds to sclerostin and increases bone formation. METHODS: In a phase 2, multicenter, international, randomized, placebo-controlled, parallel-group, eight-group study, we evaluated the efficacy and safety of romosozumab over a 12-month period in 419 postmenopausal women, 55 to 85 years of age, who had low bone mineral density (a T score of -2.0 or less at the lumbar spine, total hip, or femoral neck and -3.5 or more at each of the three sites). Participants were randomly assigned to receive subcutaneous romosozumab monthly (at a dose of 70 mg, 140 mg, or 210 mg) or every 3 months (140 mg or 210 mg), subcutaneous placebo, or an open-label active comparator--oral alendronate (70 mg weekly) or subcutaneous teriparatide (20 µg daily). The primary end point was the percentage change from baseline in bone mineral density at the lumbar spine at 12 months. Secondary end points included percentage changes in bone mineral density at other sites and in markers of bone turnover. RESULTS: All dose levels of romosozumab were associated with significant increases in bone mineral density at the lumbar spine, including an increase of 11.3% with the 210-mg monthly dose, as compared with a decrease of 0.1% with placebo and increases of 4.1% with alendronate and 7.1% with teriparatide. Romosozumab was also associated with large increases in bone mineral density at the total hip and femoral neck, as well as transitory increases in bone-formation markers and sustained decreases in a bone-resorption marker. Except for mild, generally nonrecurring injection-site reactions with romosozumab, adverse events were similar among groups. CONCLUSIONS: In postmenopausal women with low bone mass, romosozumab was associated with increased bone mineral density and bone formation and with decreased bone resorption. (Funded by Amgen and UCB Pharma; ClinicalTrials.gov number, NCT00896532.).

Frailty and bone health in European men.

Background: frailty is associated with an increased risk of fragility fractures. Less is known, however, about the association between frailty and bone health. Methods: men aged 40-79 years were recruited from population registers in eight European centres for participation in the European Male Aging Study. Subjects completed a comprehensive assessment which included quantitative ultrasound (QUS) scan of the heel (Hologic-SAHARA) and in two centres, dual-energy bone densitometry (dual-energy x-ray absorptiometry, DXA). Frailty was defined based on an adaptation of Fried's phenotype criteria and a frailty index (FI) was constructed. The association between frailty and the QUS and DXA parameters was determined using linear regression, with adjustments for age, body mass index and centre. Results: in total, 3,231 subjects contributed data to the analysis. Using the Fried categorisation of frailty, pre-frail and frail men had significantly lower speed of sound (SOS), broadband ultrasound attenuation (BUA) and quantitative ultrasound index (QUI) compared to robust men (P< 0.05). Similar results were seen using the FI after categorisation into 'high', 'medium' and 'low' levels of frailty. Using the Fried categorisation, frail men had lower femoral neck bone mineral density (BMD) compared to robust men (P < 0.05), but not lower lumbar spine BMD. Using the FI categorisation, a 'high' level of frailty (FI > 0.35) was associated with lower lumbar spine BMD (P < 0.05) when compared to those with low (FI < 0.2), but not lower femoral neck BMD. When analysed as a continuous variable, higher FI was linked with lower SOS, BUA and QUI (P < 0.05). Conclusions: optimisation of bone health as well as prevention of falls should be considered as strategies to reduce fractures in frail older people.

Low vitamin D and the risk of developing chronic widespread pain: results from the European male ageing study.

BACKGROUND: The association between low levels of vitamin D and the occurrence of chronic widespread pain (CWP) remains unclear. The aim of our analysis was to determine the relationship between low vitamin D levels and the risk of developing CWP in a population sample of middle age and elderly men. METHODS: Three thousand three hundred sixty nine men aged 40-79 were recruited from 8 European centres for a longitudinal study of male ageing, the European Male Ageing Study. At baseline participants underwent assessment of lifestyle, health factors, physical characteristics and gave a fasting blood sample. The occurrence of pain was assessed at baseline and follow up (a mean of 4.3 years later) by shading painful sites on a body manikin. The presence of CWP was determined using the ACR criteria for fibromyalgia. Serum 25-hydroxyvitamin D (25-(OH) D) was assessed by radioimmunoassay. Logistic regression was used to determine the relationship between baseline vitamin D levels and the new occurrence of CWP. RESULTS: Two thousand three hundred thirteen men, mean age 58.8 years (SD = 10.6), had complete pain and vitamin data available and contributed to this analysis. 151 (6.5%) developed new CWP at follow up and 577 (24.9%) were pain free at both time points, the comparator group. After adjustment for age and centre, physical performance and number of comorbidities, compared to those in upper quintile of 25-(OH) D ( ≥36.3 ng/mL), those in the lowest quintile (<15.6 ng/mL) were more likely to develop CWP (Odds Ratio [OR] = 1.93; 95% CI = 1.0-3.6). Further adjustment for BMI (OR = 1.67; 95% CI = 0.93-3.02) or depression (OR = 1.77; 95% CI = 0.98-3.21), however rendered the association non-significant. CONCLUSIONS: Low vitamin D is linked with the new occurrence of CWP, although this may be explained by underlying adverse health factors, particularly obesity and depression.

Fracture risk and zoledronic acid therapy in men with osteoporosis.

BACKGROUND: Fractures in men are a major health issue, and data on the antifracture efficacy of therapies for osteoporosis in men are limited. We studied the effect of zoledronic acid on fracture risk among men with osteoporosis. METHODS: In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1199 men with primary or hypogonadism-associated osteoporosis who were 50 to 85 years of age to receive an intravenous infusion of zoledronic acid (5 mg) or placebo at baseline and at 12 months. Participants received daily calcium and vitamin D supplementation. The primary end point was the proportion of participants with one or more new morphometric vertebral fractures over a period of 24 months. RESULTS: The rate of any new morphometric vertebral fracture was 1.6% in the zoledronic acid group and 4.9% in the placebo group over the 24-month period, representing a 67% risk reduction with zoledronic acid (relative risk, 0.33; 95% confidence interval, 0.16 to 0.70; P=0.002). As compared with men who received placebo, men who received zoledronic acid had fewer moderate-to-severe vertebral fractures (P=0.03) and less height loss (P=0.002). Fewer participants who received zoledronic acid had clinical vertebral or nonvertebral fractures, although this difference did not reach significance because of the small number of fractures. Bone mineral density was higher and bone-turnover markers were lower in the men who received zoledronic acid (P<0.05 for both comparisons). Results were similar in men with low serum levels of total testosterone. The zoledronic acid and placebo groups did not differ significantly with respect to the incidence of death (2.6% and 2.9%, respectively) or serious adverse events (25.3% and 25.2%). CONCLUSIONS: Zoledronic acid treatment was associated with a significantly reduced risk of vertebral fracture among men with osteoporosis. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT00439647.).

Bone demineralisation in a large cohort of Wilson disease patients.

AIMS AND BACKGROUND: We compared the bone mineral density (BMD) of adult Wilson disease (WD) patients (n = 148), with an age- and gender-matched healthy control population (n = 148). Within the WD cohort, correlations of BMD with WD disease parameters, lab results, type of treatment and known osteoporosis risk factors were analysed. METHODS: Hip and lumbar spine absolute BMD and T-score were measured by dual-energy X-ray absorptiometry. Osteoporosis and osteopenia were defined as a T-score ≤ -2.5, and between -1 and -2.5, respectively. RESULTS: There were significantly more subjects with abnormal T-scores in the WD population (58.8%) than in the control population (45.3%) (χ(2) = 6.65, df = 2, p = 0.036), as there were 50.0% osteopenic and 8.8% osteoporotic WD patients, vs. 41.2% and 4.1%, respectively, in the controls. Especially L2-L4 spine BMD measurements (BMD and T-scores) differed significantly between the WD population and matched controls. L2-L4 spine BMD for WD patients was on average 0.054 g/cm(2) (5.1%) lower than in matched normal controls (0.995 ± 0.156 vs 1.050 ± 0.135; p = 0.002). We found no significant correlation between BMD values and any of the WD disease parameters (e.g. the severity of liver disease), lab results, type of treatment or known osteoporosis risk factors. Duration of D-penicillamine treatment was negatively correlated with femoral BMD value, but in a clinically irrelevant manner, compared to age and gender. Importantly, BMD remained significantly lower in WD patients (n = 89) vs. controls after excluding WD patients with cirrhosis (p = 0.009). CONCLUSIONS: Our study suggests that WD is intrinsically associated with bone demineralisation.

Low heel ultrasound parameters predict mortality in men: results from the European Male Ageing Study (EMAS).

BACKGROUND: low bone mineral density measured by dual-energy x-ray absorptiometry is associated with increased mortality. The relationship between other skeletal phenotypes and mortality is unclear. The aim of this study was to determine the relationship between quantitative heel ultrasound parameters and mortality in a cohort of European men. METHODS: men aged 40-79 years were recruited for participation in a prospective study of male ageing: the European Male Ageing Study (EMAS). At baseline, subjects attended for quantitative ultrasound (QUS) of the heel (Hologic-SAHARA) and completed questionnaires on lifestyle factors and co-morbidities. Height and weight were measured. After a median of 4.3 years, subjects were invited to attend a follow-up assessment, and reasons for non-participation, including death, were recorded. The relationship between QUS parameters (broadband ultrasound attenuation [BUA] and speed of sound [SOS]) and mortality was assessed using Cox proportional hazards model. RESULTS: from a total of 3,244 men (mean age 59.8, standard deviation [SD] 10.8 years), 185 (5.7%) died during the follow-up period. After adjusting for age, centre, body mass index, physical activity, current smoking, number of co-morbidities and general health, each SD decrease in BUA was associated with a 20% higher risk of mortality (hazard ratio [HR] per SD = 1.2; 95% confidence interval [CI] = 1.0-1.4). Compared with those in higher quintiles (2nd-5th), those in the lowest quintile of BUA and SOS had a greater mortality risk (BUA: HR = 1.6; 95% CI = 1.1-2.3 and SOS: HR = 1.6; 95% CI = 1.2-2.2). CONCLUSION: lower heel ultrasound parameters are associated with increased mortality in European men.

Risk factors and comorbidities in the preclinical stages of chronic obstructive pulmonary disease.

RATIONALE: There is little information about comorbidities and their risk factors in the preclinical stages of chronic obstructive pulmonary disease (COPD). OBJECTIVES: This study aims to investigate the prevalence of premorbid risk factors and comorbid diseases and its association with daily physical activity in subjects detected with COPD by spirometry screening. METHODS: Sixty subjects with preclinical COPD (63 ± 6 yr; 68% [n = 41] male) were compared with 60 smoking control subjects (62 ± 7 yr; 70% [n = 42] male) and 60 never-smoking control subjects (62 ± 6 yr; 57% [n = 34] male). Comorbidities (cardiovascular, metabolic, and musculoskeletal disease) and daily physical activity (by multisensor activity monitor) were measured objectively. MEASUREMENTS AND MAIN RESULTS: The prevalence of premorbid risk factors and comorbid diseases was significantly higher in preclinical COPD compared with age-matched never-smoking control subjects, but was similar to smoking control subjects not suffering from COPD. In preclinical COPD and smoking control subjects, the combination of cardiovascular disease and musculoskeletal disease was the most prevalent (15% [n = 9] and 12% [n = 7], respectively). In a multivariate logistic regression analysis, physical inactivity and smoking were found to be independent risk factors for having greater than or equal to two comorbidities. CONCLUSIONS: Premorbid risk factors and comorbid diseases were more prevalent in the preclinical stages of COPD and smokers without COPD. Physical inactivity and smoking were more strongly associated with the presence of comorbidities compared with airflow obstruction. Clinical trial registered with www.clinicaltrials.gov (NCT 01314807).

Characteristics of older adults admitted to the emergency department (ED) and their risk factors for ED readmission based on comprehensive geriatric assessment: a prospective cohort study.

BACKGROUND: Patients aged 75 years and older represent 12% of the overall emergency department (ED) population, and this proportion will increase over the next decades. Many of the discharged patients suffer an unplanned readmission in the immediate and midterm post-discharge period, suggesting under recognition of psychosocial, cognitive and medical problems. The aim of this study was to compare the characteristics of older patients admitted and discharged from the ED and to determine independent predictors for ED readmission 1 month and 3 months after ED discharge based on comprehensive geriatric assessment (CGA). METHODS: Cohort study in a Belgian university hospital. A CGA, including demographic and medical data (e.g. reason for admission, comorbidity, number of medications), functional (e.g. activities of daily living, falls), mental (i.e. cognition, dementia, delirium), and nutritional status, and pain, was performed in 442 ED patients aged 75 years or older. RESULTS: Patients discharged from the ED (n = 117, 26.5%) were significantly less dependent for ADL, mobility, shopping and finances compared with hospitalised patients. Hospitalised patients (n = 325, 73.5%) were significantly more at risk for having nutritional problems, had a higher comorbidity index, and a lower cognitive status compared with those discharged. Ninety-seven patients (82.9%) were discharged home from the ED. Of the latter, 18 (18.6%) and 28 patients (28.9%) suffered an ED readmission within 1 and 3 months, respectively. At one month post-discharge, nursing care at home, meals on wheels, and risk for depression; and at 3 months post-discharge previous hospitalisation in the last 3 months, physiotherapy and meals on wheels were found to be independent predictors for ED readmission, respectively. CONCLUSIONS: This study observed a geriatric risk profile in older adults at the ED and a high readmission rate of those discharged, and suggests the potential value of CGA in identifying older patients at high risk for ED readmission.

Effects of a Six-Month Local Vibration Training on Bone Density, Muscle Strength, Muscle Mass, and Physical Performance in Postmenopausal Women.

The aim of the study was to investigate the effect of 6 months' local vibration training on bone mineral density (BMD), muscle strength, muscle mass, and physical performance in postmenopausal women (66-88 years). The study was organized as a randomized controlled trial for postmenopausal women who lived in daily care service flats and rest homes. Thirty-five postmenopausal women were randomly assigned to either a vibration (n = 17) or a control group (n = 18). The vibration group received 6-month local vibration treatment with frequency between 30 and 45 Hz and acceleration between 1.71 and 3.58g. The vibration was applied on the midthigh and around the hip in supine-lying position once per day, 5 d·wk. The participants of the control group continued their usual activities and were not involved in any additional training program. The primary outcome variables were the isometric and dynamic quadriceps muscle strength and the BMD of the hip. We assessed the muscle mass of the quadriceps and physical performance. Additionally, the feasibility, side effects, and compliance were evaluated after 6 months of local vibration training. Overall, the results showed a net benefit of 13.84% in isometric muscle strength at 60° knee angle in favor of the vibration group compared with controls (p < 0.01). No changes in BMD, muscle mass, or physical performance were found in both groups (p > 0.05). Six months of local vibration training improved some aspects of muscle strength but had no effect on BMD, muscle mass, and physical performance in postmenopausal women. The specific vibration protocol used in this study can be considered as safe and suitable for a local vibration training program.

[Delayed neurological syndrome after CO intoxication of elderly female]. / Laattijdige neuropsychologisch syndroom na CO-intoxicatie bij een bejaarde vrouw.

This article discusses the case history of an 87-year old woman with loss of consciousness following accidental CO intoxication. A few weeks later, the patient's cognitive abilities progressively deteriorated. This is hence a case of Delayed Neurological Symptoms after CO intoxication. This condition occurs in 40% of patients with CO intoxication and manifests itself 3-240 days after apparent recovery. Symptoms can linger for a long time and are in some cases even permanent. Treatment of CO intoxication usually consists of administering normobaric oxygen and in certain cases hyperbaric oxygen. The role of treatment with hyberbaric oxygen in delayed neurological symptoms after CO intoxication remains controversial, however.

Remission over 3 years in patients with Paget disease of bone treated with a single intravenous infusion of 5 mg zoledronic acid.

Using data from the Belgian Paget's Disease Registry of 142 patients treated with a 5 mg intravenous infusion of zoledronic acid, we examined disease remission over 3 years in 98 patients with Paget disease of bone (PDB) seen in routine practice. Median age was 76 years, most patients (60.2 %) were male, and all were Caucasian. Median time since PDB diagnosis was 11.5 years, few patients (5.1 %) had a family history of PDB, and 32.6 % had received prior bisphosphonate and/or other treatments. The most common pagetic locations were pelvis, spine, femur, tibia, and skull. The most common symptoms included pain, impaired mobility, bone deformities, and joint disease: 36.7 % of patients had comorbid osteoarthritis and 16.3 % comorbid osteoporosis. Response rates were 93.3 % at 1 year, 89.5 % at 2 years, and 91.6 % at 3 years, statistically similar to an extension study of the original zoledronic acid trials. Twenty-one patients experienced a relapse over the 3-year period at a median of 20.7 months posttreatment; of these, 13 regained remission by the end of the observation period. Relapse was not associated with osteoarthritis, osteoporosis, or other comorbidities. Safety data were similar to those reported elsewhere. In summary, in this somewhat frailer sample of patients with PDB, effectiveness and safety data were similar to those observed in the original trial populations. These findings, which are the first on the use of zoledronic acid for PDB in routine clinical practice, underscore the therapeutic benefits and relative safety of zoledronic acid in the management of PDB in "real-world" clinical settings.

Vitamin D status and bone mineral density changes during alendronate treatment in postmenopausal osteoporosis.

Vitamin D supplementation is recommended for women with osteoporosis. In the FOCUS-D trial comparing the combination tablet alendronate plus vitamin D3 5,600 IU (ALN/D) with standard care (SC) prescribed by patients' personal physicians, ALN/D was more effective in improving serum 25(OH)D and bone turnover markers by 6 months and increasing spine and hip bone mineral density (BMD) after 1 year than SC. This post hoc analysis examined the relationship between BMD gain and 25(OH)D in women in SC receiving alendronate (SC/ALN, n = 134, 52% of the SC group) and in the ALN/D group (n = 257). At baseline, participants were of mean age 73 years and 72% were Caucasian, with a mean 25(OH)D of 14.9 ng/mL. In the SC/ALN group, most received vitamin D, although intake of vitamin D varied extensively (51% received <400 µg/day). In this group, end-of-study 25(OH)D correlated positively with mean percent increases from baseline in lumbar spine and femoral neck BMD [Pearson correlation coefficients (95% CI) = 0.23 (0.02-0.41) and 0.24 (0.03-0.41), respectively]. Baseline 25(OH)D correlated with increases in only lumbar spine BMD [Pearson correlation coefficient (95% CI) = 0.22 (0.01-0.40)]. No correlations between mean BMD change and 25(OH)D were seen with ALN/D. In conclusion, in postmenopausal women with osteoporosis and low 25(OH)D receiving alendronate and a wide range of vitamin D doses, the increase in lumbar spine and femoral neck BMD was positively correlated with serum 25(OH)D achieved by the end of the study and, to some extent, with 25(OH)D concentrations at baseline. The degree of success of alendronate therapy for osteoporosis may depend on the vitamin D status of patients.

Obesity, health-care utilization, and health-related quality of life after fracture in postmenopausal women: Global Longitudinal Study of Osteoporosis in Women (GLOW).

Fractures may be associated with higher morbidity in obese postmenopausal women than in nonobese women. We compared health-care utilization, functional status, and health-related quality of life (HRQL) in obese, nonobese, and underweight women with fractures. Information from the GLOW study, started in 2006, was collected at baseline and at 1, 2, and 3 years. In this subanalysis, self-reported incident clinical fractures, health-care utilization, HRQL, and functional status were recorded and examined. Women in GLOW (n = 60,393) were aged ≥55 years, from 723 physician practices at 17 sites in 10 countries. Complete data for fracture and body mass index were available for 90 underweight, 3,270 nonobese, and 941 obese women with one or more incident clinical fractures during the 3-year follow-up. The median hospital length of stay, adjusted for age, comorbidities, and fracture type, was significantly greater in obese than nonobese women (6 vs. 5 days, p = 0.017). Physical function and vitality score were significantly worse in obese than in nonobese women, both before and after fracture; but changes after fracture were similar across groups. Use of antiosteoporosis medication was significantly lower in obese than in nonobese or underweight women. In conclusion, obese women with fracture undergo a longer period of hospitalization for treatment and have poorer functional status and HRQL than nonobese women. Whether these differences translate into higher economic costs and adverse effects on longer-term outcomes remains to be established.

Low prolactin is associated with sexual dysfunction and psychological or metabolic disturbances in middle-aged and elderly men: the European Male Aging Study (EMAS).

INTRODUCTION: We previously reported that in male patients consulting for sexual dysfunction, low prolactin (PRL) levels were associated with metabolic syndrome (MetS), arteriogenic erectile dysfunction, and incident major cardiovascular events. AIM: The aim of this study is to assess the clinical associations of PRL levels in the European Male Ageing Study (EMAS). METHODS: EMAS is a prospective, observational cohort of community-dwelling men aged 40-79 years old (mean age 60 ± 11 years old). PRL was available for 2,948 men. MAIN OUTCOME MEASURES: Different parameters were evaluated including the Short Form-36 questionnaire, Becks Depression Inventory, the Adverse Life Events Scale, the Physical Activity Scale for the Elderly, and the EMAS sexual function questionnaire (EMAS-SFQ). RESULTS: After the adjustment for confounders, PRL levels were inversely related with worsening of sexual function as compared with the previous year, as derived from change in sexual functioning domain of the EMAS-SFQ (adj. r = -0.043; P = 0.029). The strongest correlation (Wald = 6.840; P = 0.009) was observed between lower PRL levels and reduced enjoyment of orgasmic experiences. Furthermore, an inverse relationship between PRL levels and stressful life events or depressive symptoms was observed. Low PRL was also negatively associated with an unhealthy metabolic phenotype as well as with the MetS (Wald = 5.229; P = 0.022). In line with these data, low PRL was associated with a lower level of physical activity and feeling unhealthier. CONCLUSIONS: Low PRL is related to several metabolic, psychological, and sexual unhealthy characteristics in European men. Checking PRL might be useful to stratify men for cardiovascular risk and to encourage appropriate lifestyle changes.

Association of 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D and parathyroid hormone with mortality among middle-aged and older European men.

BACKGROUND: vitamin D deficiency has been associated with an increased risk of mortality, but whether this relationship is causal or linked to co-existent comorbidity and adverse life factors remains uncertain. Our objective was to determine whether endogenous 25-hydroxyvitamin D (25(OH)D), 1,25-dihydroxyvitamin D (1,25(OH)2D) and parathyroid hormone (PTH) levels predicted all-cause, cardiovascular and cancer mortality independently of health and lifestyle factors. SETTING: : prospective cohort analysis within the European Male Ageing Study. PARTICIPANTS: : 2,816 community-dwelling men aged 40-79 years at baseline. METHODS: : Cox regression was used to examine the association of all-cause mortality with 25(OH)D, 1,25(OH)2D and PTH; cardiovascular and cancer mortality were modelled using competing-risks regression. Results were expressed as hazard ratios (HR) and 95% confidence intervals (CIs) for Cox models; sub-hazard ratios (SHR) and 95% CIs for competing-risks models. RESULTS: : a total of 187 men died during a median of 4.3 years of follow-up. Serum levels of 25(OH)D (per 1 SD decrease: HR = 1.45; 95% CI = 1.16, 1.81) and 1,25(OH)2D (per 1 SD decrease: HR = 1.20; 95% CI = 1.00, 1.44) were associated with an increased risk of all-cause mortality after adjusting for age, centre, smoking, self-reported morbidities, physical activity and functional performance. Only levels of 25(OH)D <25 nmol/l predicted cancer mortality (SHR = 3.33; 95% CI = 1.38, 8.04). CONCLUSION: : lower 25(OH)D and 1,25(OH)2D levels independently predicted all-cause mortality in middle-aged and older European men. Associations with cancer mortality were only observed among men with very low levels of 25(OH)D. These associations were only partially explained by the range of adverse health and lifestyle factors measured here.

Effects of intensive whole-body vibration training on muscle strength and balance in adults with chronic stroke: a randomized controlled pilot study.

OBJECTIVES: To investigate the effects of a 6-week whole body vibration (WBV) training program in patients with chronic stroke. DESIGN: Randomized controlled pilot trial with 6 weeks' follow-up. SETTING: University hospital. PARTICIPANTS: Adults with chronic stroke (N=15) were randomly assigned to an intervention (n=7) or a control group (n=8). INTERVENTIONS: Supervised, intensive WBV training. The vibration group performed a variety of static and dynamic squat exercises on a vibration platform with vibration amplitudes of 1.7 and 2.5mm and frequencies of 35 and 40Hz. The vibration lasted 30 to 60 seconds, with 5 to 17 repetitions per exercise 3 times weekly for 6 weeks. Participants in the control group continued their usual activities and were not involved in any additional training program. MAIN OUTCOME MEASURES: The primary outcome variable was the isometric and isokinetic muscle strength of the quadriceps (isokinetic dynamometer). Additionally, hamstrings muscle strength, static and dynamic postural control (dynamic posturography), and muscle spasticity (Ashworth Scale) were assessed. RESULTS: Compliance with the vibration intervention was excellent, and the participants completed all 18 training sessions. Vibration frequencies of both 35 and 40Hz were well tolerated by the patients, and no adverse effects resulting from the vibration were noted. Overall, the effect of intensive WBV intervention resulted in significant between-group differences in favor of the vibration group only in isometric knee extension strength (knee angle, 60°) (P=.022) after 6 weeks of intervention and in isokinetic knee extension strength (velocity, 240°/s) after a 6-week follow-up period (P=.005), both for the paretic leg. Postural control improved after 6 weeks of vibration in the intervention group when the patients had normal vision and a sway-referenced support surface (P<.05). Muscle spasticity was not affected by vibration (P>.05). CONCLUSIONS: These preliminary results suggest that intensive WBV might potentially be a safe and feasible way to increase some aspect of lower limb muscle strength and postural control in adults with chronic stroke. Further studies should focus on evaluating how the training protocol should be administered to achieve the best possible outcome, as well as comparing this training protocol to other interventions.

Restraint use in home care: a qualitative study from a nursing perspective.

BACKGROUND: Despite the growing demand for home care and preliminary evidence suggesting that the use of restraint is common practice in home care, research about restraint use in this setting is scarce. METHODS: To gain insight into the use of restraints in home care from the perspective of nurses, we conducted a qualitative explorative study. We conducted semi-structured face-to-face interviews of 14 nurses from Wit-Gele Kruis, a home-care organization in Flanders, Belgium. Interview transcripts were analyzed using the Qualitative Analysis Guide of Leuven. RESULTS: Our findings revealed a lack of clarity among nurses about the concept of restraint in home care. Nurses reported that cognitively impaired older persons, who sometimes lived alone, were restrained or locked up without continuous follow-up. The interviews indicated that the patient's family played a dominant role in the decision to use restraints. Reasons for using restraints included "providing relief to the family" and "keeping the patient at home as long as possible to avoid admission to a nursing home." The nurses stated that general practitioners had no clear role in deciding whether to use restraints. CONCLUSIONS: These findings suggest that the issue of restraint use in home care is even more complex than in long-term residential care settings and acute hospital settings. They raise questions about the ethical and legal responsibilities of home-care providers, nurses, and general practitioners. There is an urgent need for further research to carefully document the use of restraints in home care and to better understand it so that appropriate guidance can be provided to healthcare workers.

Vibration training for upper body: transmission of platform vibrations through cables.

The aim of the present study was to evaluate the vibration transmission from a vibration platform through Vectran cables to the upper body and its relationship to induced muscular activation. Fifteen clinically healthy participants performed 3 different arm exercises-biceps curl, triceps curl, and lateral raise. Vibration transmission to the upper body was assessed over a wide range of accelerations (from 1.90 to 5.98 g) and frequencies (from 25 to 40 Hz). To assess the vibration transmission, 7 triaxial accelerometers were attached from the hand up to the head, and the root-mean-square of acceleration signal of each site-specific body point was calculated. Muscular activity of biceps brachii, triceps brachii, deltoid, and upper trapezius was recorded. The results showed a significant attenuation of the platform accelerations transmitted through the Vectran cables to the upper body. Handle vibration ranged between 27 and 44% of the acceleration delivered by the platform depending on platform vibration parameters (acceleration/frequency). Vibration increased the muscle activity of biceps brachii, triceps brachii, deltoid, and upper trapezius muscles significantly only during biceps curl exercises. No frequency or acceleration effect was found on the size of the muscle response. The results of the present study suggest that a cable-pulley resistance system on a vibration platform channels the vibration safely from the platform to the arms and induces additional muscle activation in some arm muscles when biceps curl exercises are performed.

Staffing levels and the use of physical restraints in nursing homes: a multicenter study.

There is an unclear relation between staffing levels and the use of physical restraints in nursing homes (NHs). A survey design was used in 570 older adults (median age = 86; 77.2% women), living on 23 wards within seven NHs. Restraint use was high (50% of residents, of which 80% were restrained on a daily basis). Multivariate analysis was conducted at the level of the individual wards. Neither staff intensity nor staff mix was a determinant of restraint use. Bathing dependency, transfer difficulties, risk for falls, frequent restlessness/agitation, and depression were independent predictors of restraint use. Patient characteristics have significant greater impact on physical restraint use than staffing levels. Therefore, improving knowledge and skills of NH staff to better deal with restlessness/agitation, mobility problems, and risk for falls is encouraged to decrease the use of physical restraints in NH residents.

Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur.

BACKGROUND: A number of recent case reports and series have identified a subgroup of atypical fractures of the femoral shaft associated with bisphosphonate use. A population-based study did not support this association. Such a relationship has not been examined in randomized trials. METHODS: We performed secondary analyses using the results of three large, randomized bisphosphonate trials: the Fracture Intervention Trial (FIT), the FIT Long-Term Extension (FLEX) trial, and the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial (PFT). We reviewed fracture records and radiographs (when available) from all hip and femur fractures to identify those below the lesser trochanter and above the distal metaphyseal flare (subtrochanteric and diaphyseal femur fractures) and to assess atypical features. We calculated the relative hazards for subtrochanteric and diaphyseal fractures for each study. RESULTS: We reviewed 284 records for hip or femur fractures among 14,195 women in these trials. A total of 12 fractures in 10 patients were classified as occurring in the subtrochanteric or diaphyseal femur, a combined rate of 2.3 per 10,000 patient-years. As compared with placebo, the relative hazard was 1.03 (95% confidence interval [CI], 0.06 to 16.46) for alendronate use in the FIT trial, 1.50 (95% CI, 0.25 to 9.00) for zoledronic acid use in the HORIZON-PFT trial, and 1.33 (95% CI, 0.12 to 14.67) for continued alendronate use in the FLEX trial. Although increases in risk were not significant, confidence intervals were wide. CONCLUSIONS: The occurrence of fracture of the subtrochanteric or diaphyseal femur was very rare, even among women who had been treated with bisphosphonates for as long as 10 years. There was no significant increase in risk associated with bisphosphonate use, but the study was underpowered for definitive conclusions.