Prevention of hip fractures by external hip protectors - A randomized controlled trial

Context: Several randomized controlled trials have been performed to examine the effectiveness of external hip protectors in reducing the incidence of hip fractures, but the results are controversial. Objective: To examine the effectiveness of hip protectors in reducing the incidence of hip fractures in an elderly high-risk population. Design, Setting, and Participants: Randomized controlled trial of elderly persons aged 70 years or older, who have low bone density, and are at high risk for falls. Participants lived in apartment houses for the elderly, homes for the elderly, and nursing homes in Amsterdam and surrounding areas in the Netherlands. They were enrolled in the study between March 1999 and March 2001; the mean follow-up was 69.6 weeks. Of the 830 persons who were screened, 561 persons were enrolled. Intervention: External hip protector. Both groups received written information on bone health and risk factors for falls. Main Outcome Measure: Time to first hip fracture. Survival analysis was used to include all participants for the time they participated. Results: In the intervention group, 18 hip fractures occurred vs 20 in the control group. Four hip fractures in the intervention group occurred while an individual was wearing a hip protector. At least 4 hip fractures in the intervention group occurred late at night or early in the morning. Both in univariate analysis (log-rank P=.86) and in multivariate analysis (hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.55-2.03), no statistically significant difference between the intervention group and control group was found with regard to time to first hip fracture. In addition, the per protocol analysis in compliant participants did not show a statistically significant difference between the groups (HR, 0.77; 95% CI, 0.25-2.38). Conclusion: The hip protector studied was not effective in preventing hip fractures

The Amsterdam Hip Protector Study: Compliance and determinants of compliance

Hip protectors appear to be effective in reducing the incidence of hip fractures. However, compliance is often poor. Therefore, the objective of this study was to examine the compliance and determinants of compliance with external hip protectors. A prospective study was performed in residents from apartment houses for the elderly, homes for the elderly and nursing homes with a high risk for hip fracture (n = 276). The study was performed within the framework of the Amsterdam Hip Protector Study, a randomized controlled trial examining the effect of external hip protectors on the incidence of hip fractures. Compliance was assessed by unannounced visits at 1, 6 and 12 months after inclusion in the study. During the visits, a member of the research team checked whether the participant was wearing the hip protector and, if so, whether it was worn correctly. Furthermore, data on potential determinants of compliance were collected by interviewing the participants or their nurses. Compliance was 60.8% after 1 month (n = 217), 44.7% after 6 months (n = 246), and 37.0% after 12 months (n = 230). Of those wearing the hip protector, 86.7%, 91.7% and 96.5% of the participants were wearing the hip protector correctly after 1, 6 and 12 months respectively; and 14.8%, 16.1% and 8.8% respectively reported wearing the hip protector at night. Compliance after 12 months was predicted by the compliance after 1 month (RR = 2.04; 90% CI: 1.05-3.96). Furthermore, people who experienced one or more falls in the half year before baseline had a lower probability of being compliant at 6 months (RR = 0.72; 90% CI: 0.52-0.99). In conclusion, compliance is a very important issue in hip protector research and implementation. Although, the compliance percentages were moderately high during the unannounced visits in this study, not everyone was wearing the protector correctly and most participants did not wear the hip protector during the night

Effects of a clinical decision support system and patient portal for preventing medication-related falls in older fallers:Protocol of a cluster randomized controlled trial with embedded process and economic evaluations (ADFICE_IT)

BackgroundFalls are the leading cause of injury-related mortality and hospitalization among adults aged ≥ 65 years. An important modifiable fall-risk factor is use of fall-risk increasing drugs (FRIDs). However, deprescribing is not always attempted or performed successfully. The ADFICE_IT trial evaluates the combined use of a clinical decision support system (CDSS) and a patient portal for optimizing the deprescribing of FRIDs in older fallers. The intervention aims to optimize and enhance shared decision making (SDM) and consequently prevent injurious falls and reduce healthcare-related costs.MethodsA multicenter, cluster-randomized controlled trial with process evaluation will be conducted among hospitals in the Netherlands. We aim to include 856 individuals aged ≥ 65 years that visit the falls clinic due to a fall. The intervention comprises the combined use of a CDSS and a patient portal. The CDSS provides guideline-based advice with regard to deprescribing and an individual fall-risk estimation, as calculated by an embedded prediction model. The patient portal provides educational information and a summary of the patient’s consultation. Hospitals in the control arm will provide care-as-usual. Fall-calendars will be used for measuring the time to first injurious fall (primary outcome) and secondary fall outcomes during one year. Other measurements will be conducted at baseline, 3, 6, and 12 months and include quality of life, cost-effectiveness, feasibility, and shared decision-making measures. Data will be analyzed according to the intention-to-treat principle. Difference in time to injurious fall between the intervention and control group will be analyzed using multilevel Cox regression.DiscussionThe findings of this study will add valuable insights about how digital health informatics tools that target physicians and older adults can optimize deprescribing and support SDM. We expect the CDSS and patient portal to aid in deprescribing of FRIDs, resulting in a reduction in falls and related injuries

Clinical osteoarthritis of the hip and knee and fall risk: The role of low physical functioning and pain medication

Objective: Several studies have found an increased fall risk in persons with osteoarthritis (OA). However, most prospective studies did not use a clinical definition of OA. In addition, it is not clear which factors explain this risk. Our objectives were: (1) to confirm the prospective association between clinical OA of the hip and knee and falls; (2) to examine the modifying effect of sex; and (3) to examine whether low physical performance, low physical activity and use of pain medication are mediating these relationships. Methods: Baseline and 1-year follow-up data from the European Project on OSteoArthritis (EPOSA) were used involving pre-harmonized data from five European population-based cohort studies (ages 65 85, n = 2535). Clinical OA was defined according to American College of Rheumatology (ACR) criteria. Falls were assessed using self-report. Results: Over the follow-up period, 27.7% of the participants fell once or more (defined as faller), and 9.8% fell twice or more (recurrent faller). After adjustment for confounding, clinical knee OA was associated with the risk of becoming a recurrent faller (relative risk=1.55; 95% confidence interval: 1.10 2.18), but not with the risk of becoming a faller. No associations between clinical hip OA and (recurrent) falls were observed after adjustment for confounding. Use of opioids and analgesics mediated the associations between clinical OA and (recurrent) falls, while physical performance and physical activity did not. Conclusion: Individuals with clinical knee OA were at increased risk for recurrent falls. This relationship was mediated by pain medication, particularly opioids. The fall risk needs to be considered when discussing the risk benefit ratio of prescribing these medicationsSources of support: The Longitudinal Aging Study Amsterdam (LASA) is financially supported by the Dutch Ministry of Health, Welfare and Sports (grant no 311669, grant recipient D.J.H. Deeg). The Pe~nagrande study was partially supported by the National Fund for Health Research (Fondo de Investigaciones en Salud) of Spain (grant no FIS PI 05/1898; FIS RETICEF RD06/0013/1013 and FIS PS09/02143, grant recipients A. Otero, M.V. Castell). The Hertfordshire Cohort Study is supported by the Medical Research Council of Great Britain, Versus Arthritis, the British Heart Foundation and the International Osteoporosis Foundation (grant no MRC_MC_UP_A620_1014, grant recipients C. Cooper, E. Dennison). The Italian cohort was supported by the National Research Council of Italy (CNR), Research Project “Aging: molecular and technological innovations for improving the health of the elderly population" (Prot. MIUR 2867, grant recipient: S. Maggi). The Swedish Twin Registry is managed by Karolinska Institutet and receives funding through the Swedish Research Council (grant no 2017-00641, grant recipient Karolinska Institutet

A Randomized Controlled Trial to Examine the Effect of 2-Year Vitamin B12 and Folic Acid Supplementation on Physical Performance, Strength, and Falling: Additional Findings from the B-PROOF Study

Elevated homocysteine concentrations are associated with a decline in physical function in elderly persons. Homocysteine-lowering therapy may slow down this decline. This study aimed to examine the effect of a 2-year intervention of vitamin B12 and folic acid supplementation on physical performance, handgrip strength, and risk of falling in elderly subjects in a double-blind, randomized placebo-controlled trial. Participants aged ≥65 years with elevated plasma homocysteine concentrations [12–50 µmol/L (n = 2919)] were randomly assigned to daily supplementation of 500 µg vitamin B12, 400 µg folic acid, and 600 I

Low vitamin D status is associated with more depressive symptoms in Dutch older adults

Purpose: The existence of vitamin D receptors in the brain points to a possible role of vitamin D in brain function. We examined the association of vitamin D status and vitamin D-related genetic make-up with depressive symptoms amongst 2839 Dutch older adults aged ≥65 years. Methods: 25-Hydroxyvitamin D (25(OH)D) was measured, and five ‘vitamin D-related genes’ were selected. Depressive symptoms were measured with the 15-point Geriatric Depression Scale. Results were expressed as the relative risk of the score of depressive symptoms by quartiles of 25(OH)D concentration or number of affected alleles, using the lowest quartile or minor allele group as reference. Results: A clear cross-sectional and pr

Long-term effects of folic acid and vitamin-B12 supplementation on fracture risk and cardiovascular disease: extended follow-up of the B-PROOF trial

Background & aims: In the initial B-proof, we found inconsistent results of B vitamin supplementation. However, the debate regarding the effects of B vitamins on age-related diseases continues. Therefore, our aim was to investigate the long-term effects (5-7 years follow-up) of an intervention with folic acid and vitamin-B12 supplementation on fracture and cardiovascular disease risk.Methods: Extended follow-up of the B-PROOF trial, a multi-center, double-blind randomized placebo controlled trial designed to assess the effect of 2-3 years daily supplementation with folic acid (400 mg) and vitamin-B12 (500 mg) versus placebo (n = 2,919). Primary outcome was verified self reported fracture incidence and secondary outcomes were self-reported cardiovascular endpoints, which were collected through a follow-up questionnaires Proportional hazard analyses was used for the effect of the intervention on risk of fracture(s) and logistic regression for the effect of the intervention on risk of cardiovascular disease.Results: A total of 1,298 individuals (4 4.5%) participated in the second follow-up round with median of 54 months [51-58], (n = 662 and n = 636, treatment versus placebo group). Median age at baseline was 71.0 years [68.0-76.0] for both groups. No effect was observed of the intervention on osteoporotic fracture or any fracture risk after a follow-up (HR: 0.99, 95% CI: 0.62-1.59 and HR: 0.77; 95% CI: 0.50-1.19, respectively), nor on cardiovascular or cerebrovascular disease risk (OR: 1.05; 95%CI: 0.80-1.44 and OR: 0.85; 95%CI: 0.50-1.45, respectively). Potential interaction by baseline homocysteine concentration was observed for osteoporotic-and any fracture (p = 0.10 and 0.06 respectively), which indicated a significantly lower risk of any fracture in the treatment group with higher total homocysteine concentrations (>15.1 mmol/l). No age-dependent effects were present.Conclusions: This study supports and extends previous null -findings of the B-PROOF trial and shows that supplementation of folic acid and vitamin-B12 has no effect on fracture risk, nor on cardiovascular disease in older individuals over a longer follow-up period. However, B-vitamin supplementation may be beneficial in reducing fractures in individuals with high total homocysteine concentrations, a finding which needs to be replicated. (c) 2020 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.Prevention, Population and Disease management (PrePoD)Public Health and primary car

Do Vitamin D Level and Dietary Calcium Intake Modify the Association Between Loop Diuretics and Bone Health?

Loop diuretics (LD) may afect bone health by inhibiting renal calcium reuptake. However, whether vitamin D status and dietary calcium intake modify the association between LD and bone outcome is unclear. Therefore, this study aimed to evaluate whether vitamin D level or calcium intake modify the association between LD and various indices of bone health including bone mineral density (BMD) and Trabecular Bone Score (TBS). From The Rotterdam Study, a prospective population-based cohort study, we used data from 6990 participants aged >45 year with a DXA scan (2002–2008), 6908 participants with femoral neck (FN)-BMD, 6677 participants with lumbar spine (LS)-BMD and 6476 participants with LS-TBS measurements. Use of LD was available from pharmacy dispensing records. Vitamin D (25(OH)D) level was measured in serum, and dietary calcium intake was measured with a validated food frequency questionnaire. Almost eight percent of the participants used LD. The association between LD (past-users compared to never-users) and LS-TBS was signifcantly diferent by 25(OH) D concentrations (P for interaction=0.04). A signifcantly lower LS-TBS among LD past-users was observed for 25(OH) D ≥50 nmol/l compared to ≤20 and 20–50 nmol/l (β=−0.036, 95% CI −0.060; −0.013 vs. β=−0.012, 95% CI −0.036; 0.013 and β=−0.031, 95% CI −0.096; 0.034, respectively). However, no other signifcant efect modifcation by 25(OH)D and dietary calcium intake was found in the associations between LD use and bone health outcomes (P-interaction>0.13). This study suggests that the association between LD use and indices of bone health is not consistently modifed by vitamin D or dietary calcium intake

Factors associated with functional decline in hand and hip/knee osteoarthritis after one year: data from a population‐based study

Public Health and primary careGeriatrics in primary car

Cognitive performance: a cross-sectional study on serum vitamin D and its interplay with glucose homeostasis in Dutch older adults

Objectives First, the association between serum 25-hydroxyvitamin D (25[OH]D) and cognitive performance was examined. Second, we assessed whether there was evidence for an interplay between 25(OH)D and glucose homeostasis in the association with cognitive performance. Design, Setting, and Participants Associations were studied using cross-sectional data of 776 (3 domains) up to 2722 (1 domain) Dutch community-dwelling older adults, aged 65 years or older. Measurements Serum 25(OH)D, plasma glucose, and insulin concentrations were obtained. Cognitive performance was assessed with an extensive cognitive test battery. Prevalence ratios (PRs) were calculated to quantify the association between 25(OH)D and cognition; poor performance was defined as the worst 10% of the distribution of the cognitive scores. Results The overall median MMSE score was 29 (IQR 28–30). Higher serum 25(OH)D was associated with better attention and working memory, PR 0.50 (95% CI 0.29–0.84) for the third serum 25(OH)D tertile, indicating a 50% lower probability of being a poor performer than participants in the lowest tertile. Beneficial trends were shown for 25(OH)D with executive function and episodic memory. Serum 25(OH)D was not associated with plasma glucose or insulin. Plasma insulin only modified the association between serum 25(OH)D and executive function (P for interaction: .001), suggesting that the improvement in executive function with high 25(OH)D concentrations is stronger in participants with high plasma insulin concentrations compared with those with low plasma insulin concentrations. Conclusion Higher 25(OH)D concentrations significantly associated with better attention and working memory performance. This study does not demonstrate an interplay between serum 25(OH)D and glucose homeostasis in the association with cognitive performance