A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people : protocol for the ASPREE-Fracture substudy

Background Disability, mortality and healthcare burden from fractures in older people is a growing problem worldwide. Observational studies suggest that aspirin may reduce fracture risk. While these studies provide room for optimism, randomised controlled trials are needed. This paper describes the rationale and design of the ASPirin in Reducing Events in the Elderly (ASPREE)-Fracture substudy, which aims to determine whether daily low-dose aspirin decreases fracture risk in healthy older people. Methods ASPREE is a double-blind, randomised, placebo-controlled primary prevention trial designed to assess whether daily active treatment using low-dose aspirin extends the duration of disability-free and dementia-free life in 19 000 healthy older people recruited from Australian and US community settings. This substudy extends the ASPREE trial data collection to determine the effect of daily low-dose aspirin on fracture and fall-related hospital presentation risk in the 16 500 ASPREE participants aged ≥70 years recruited in Australia. The intervention is a once daily dose of enteric-coated aspirin (100 mg) versus a matching placebo, randomised on a 1:1 basis. The primary outcome for this substudy is the occurrence of any fracture-vertebral, hip and non-vert-non-hip-occurring post randomisation. Fall-related hospital presentations are a secondary outcome. Discussion This substudy will determine whether a widely available, simple and inexpensive health intervention-aspirin-reduces the risk of fractures in older Australians. If it is demonstrated to safely reduce the risk of fractures and serious falls, it is possible that aspirin might provide a means of fracture prevention.

Higher dietary calcium intakes are associated with reduced risks of fractures, cardiovascular events, and mortality: a prospective cohort study of older men and women

The aim of this population-based, prospective cohort study was to investigate long-term associations between dietary calcium intake and fractures, non-fatal cardiovascular disease (CVD), and death from all causes. Participants were from the Melbourne Collaborative Cohort Study, which was established in 1990 to 1994. A total of 41,514 men and women (∼99% aged 40 to 69 years at baseline) were followed up for a mean (SD) of 12 (1.5) years. Primary outcome measures were time to death from all causes (n = 2855), CVD-related deaths (n = 557), cerebrovascular disease-related deaths (n = 139), incident non-fatal CVD (n = 1827), incident stroke events (n = 537), and incident fractures (n = 788). A total of 12,097 participants (aged ≥50 years) were eligible for fracture analysis and 34,468 for non-fatal CVD and mortality analyses. Mortality was ascertained by record linkage to registries. Fractures and CVD were ascertained from interview ∼13 years after baseline. Quartiles of baseline energy-adjusted calcium intake from food were estimated using a food-frequency questionnaire. Hazard ratios (HR) and odds ratios (OR) were calculated for quartiles of dietary calcium intake. Highest and lowest quartiles of energy-adjusted dietary calcium intakes represented unadjusted means (SD) of 1348 (316) mg/d and 473 (91) mg/d, respectively. Overall, there were 788 (10.3%) incident fractures, 1827 (9.0%) incident CVD, and 2855 people (8.6%) died. Comparing the highest with the lowest quartile of calcium intake, for all-cause mortality, the HR was 0.86 (95% confidence interval [CI] 0.76-0.98, ptrend  = 0.01); for non-fatal CVD and stroke, the OR was 0.84 (95% CI 0.70-0.99, ptrend  = 0.04) and 0.69 (95% CI 0.51-0.93, ptrend  = 0.02), respectively; and the OR for fracture was 0.70 (95% CI 0.54-0.92, ptrend  = 0.004). In summary, for older men and women, calcium intakes of up to 1348 (316) mg/d from food were associated with decreased risks for fracture, non-fatal CVD, stroke, and all-cause mortality.

New vertebral fractures after vertebroplasty: 2-year results from a randomised controlled trial

Summary: A randomised controlled trial of vertebroplasty (VP) versus placebo assessed the effect of VP on the risk of further vertebral fractures. While no statistically significant between-group differences for new or progressed fracture risk at 12 and 24 months were observed, we observed a consistent trend towards higher risk of any type of fracture in the group undergoing VP. Our analysis was underpowered, and further adequately powered studies are needed to be able to draw firm conclusions about further vertebral risk with vertebroplasty. Purpose: This study seeks to assess the effect of VP on the risk of further radiologically apparent vertebral fracture within two years of the procedure. Methods: We conducted a randomised placebo-controlled trial of VP in people with acute osteoporotic vertebral fracture. Eligible participants were randomly assigned to VP (n = 38) or placebo (n = 40). Cement volume and leakage were recorded for the VP group. Plain thoracolumbar radiographs were taken at baseline, 12 and 24 months. Two independent radiologists assessed these for new and progressed fractures at the same, adjacent and non-adjacent levels. Results: At 12 and 24 months, radiographs were available for 45 (58 %) and 47 (60 %) participants, respectively. There were no between-group differences for new or progressed fractures: 32 and 40 in the VP group after 12 and 24 months compared with 21 and 33 in the placebo group (hazard ratio (HR) 1.80, 95 % confidence interval (CI) 0.82 to 3.94). Similar results were seen when considering only adjacent (HR (95 % CI) 2.30 (0.57 to 9.29)) and non-adjacent (HR (95 % CI) 1.45 (0.55 to 3.81) levels. In all comparisons, there was a consistent trend towards higher risk of any type of fracture in the group undergoing VP. Within the VP group, fracture risk was unrelated to total (HR (95 % CI) 0.91 (0.71 to 1.17)) or relative (HR (95 % CI) 1.31 (0.15 to 11.48)) cement volume or cement leakage (HR (95 % CI) 1.20 (0.63 to 2.31)). Conclusion: For patients undergoing VP, our study did not demonstrate significant increases in subsequent fracture risk beyond that experienced by those with vertebral fractures who did not undergo the procedure. However, because of the non-significant numerical increases observed, studies with adequate power are needed to draw definite conclusions about fracture risk.

Patients presenting with fractures are likely to be vitamin D deficient: are we getting enough sun?

BACKGROUND: 25-Hydroxyvitamin D serves a crucial role in bone metabolism through its role on osteoclast and osteoblastic function. To assess the implication of vitamin D and its relationship to bone fracture and fracture force, we have examined vitamin D levels in patients requiring inpatient fracture management. METHODS: We performed serological testing of vitamin D levels, calcium, parathyroid hormone and liver function tests on patients admitted to our rural institution in southeastern Australia for inpatient fracture management. All participants completed a questionnaire designed to screen for potential contributing factors to bony fragility. Demographic data were also obtained including age, gender and body mass index. Fracture location and the type of inpatient management as well as the force of injury were included in our analysis. RESULTS: We recruited 100 patients to the study, with a median age of 72 (range 22-98) of whom 66 were women. Most had low-energy fractures (79%), treated by internal fixation (73%) or arthroplasty (9%) with 18 treated non-operatively. The majority of the patients were at best vitamin D insufficient, <75 nmol/L (77%), and 38% were vitamin D deficient (<50 nmol/L). Only 14 patients had a formal diagnosis of osteoporosis at presentation, with 63 patients claiming daily sun exposure in line with recommendations for vitamin D sufficiency. CONCLUSIONS: Our data suggest that the prevalence of vitamin D insufficiency and deficiency is common in patients presenting with fractures in southeastern Australia and is not confined to elderly patients. All patients with fractures should be assessed for vitamin D levels and treated in accordance with vitamin D deficiency guidelines.

Complications associated with operative fixation of acute midshaft clavicle fractures

The aim of this study was to review the complication rate and profile associated with surgical fixation of acute midshaft clavicle fracture in a large cohort of patients treated in a level I trauma centre.Patients and methods: We identified all patients who underwent surgical treatment of acute midshaft clavicle fracture between 2002 and 2010. The study group consisted of 138 fractures (134 patients). There were 107 males (78%) and 31 females (22%) and median age of 35 years (IQR 24-45). The most common mechanism of injury was a road traffic accident (78%). Sixty percent (n = 83) had an injury severity score of ≥ 15 indicating major trauma. The most common fracture type (75%) was simple or wedge comminuted (2B1) according to the Edinburgh classification. The median interval between the injury and operation was 3 days (IQR 1-6). Plate fixation was performed in 110 fractures (80%) and intramedullary fixation was performed in 28 fractures (20%). There were 85 males and 25 females in the plate fixation group with median age of 35 years (IQR: 25-45) There were 22 males and 6 females in intramedullary fixation group with median age of 31 years (IQR 24-42 years). Statistical analysis was performed using Independent sample t-test, Mann-Whitney test, and Chi-square test. Significant P-value was < 0.05.Results: The overall incidence of complication was 14.5% (n = 20). The overall nonunion rate 6%. Post operative wound infection occurred in 3.6% of cases. The incidence of complication associated with plate fixation was 10% (11 of 110 cases) compared to 32% associated with intramedullary fixation (9 of 28 cases) (P = 0.003). Thirty five percent of complications were related to inadequate surgical technique and potentially avoidable. Symptomatic hardware requiring removal occurred in 23% (n = 31) of patients. Symptomatic metalware was more frequent after plate fixation compared to intramedullary fixation (26% vs 7%, P = 0.03).Conclusions: Intramedullary fixation of midshaft clavicle fracture is associated with higher incidence of complications. Plate fixation is associated with a higher rate of symptomatic metalware requiring removal compared to intramedullary fixation. Approximately one in three complications may be avoided by attention to adequate surgical technique.

Bellwether procedures for monitoring and planning essential surgical care in low- and middle-income countries: caesarean delivery, laparotomy and treatment of open fractures

BACKGROUND: Surgical conditions represent a significant proportion of the global burden of disease, and therefore, surgery is an essential component of health systems. Achieving universal health coverage requires effective monitoring of access to surgery. However, there is no widely accepted standard for the required capabilities of a first-level hospital. We aimed to determine whether a group of operations could be used to describe the delivery of essential surgical care.

METHODS: We convened an expert panel to identify procedures that might indicate the presence of resources needed to treat an appropriate range of surgical conditions at first-level hospitals. Using data from the World Health Organization Emergency and Essential Surgical Care Global database, collected using the WHO Situational Analysis Tool (SAT), we analysed whether the ability to perform each of these procedures-which we term "bellwether procedures"-was associated with performing a full range of essential surgical procedures.

FINDINGS: The ability to perform caesarean delivery, laparotomy, and treatment of open fracture was closely associated with performing all obstetric, general, basic, emergency, and orthopaedic procedures (p < 0.001) in the population that responded to the WHO SAT Survey. Procedures including cleft lip, cataract, and neonatal surgery did not correlate with performing the bellwether procedures.

INTERPRETATION: Caesarean delivery, laparotomy, and treatment of open fractures should be standard procedures performed at first-level hospitals. With further validation in other populations, local managers and health ministries may find this useful as a benchmark for what first-level hospitals can and should be able to perform on a 24/7 basis in order to ensure delivery of emergency and essential surgical care to their population. Those procedures which did not correlate with the bellwether procedures can be referred to a specialized centre or collected for treatment by a visiting specialist team.

Non-hip and non-vertebral fractures : the neglected fracture sites

Summary: Non-hip, non-vertebral fractures (NHNVF) were compared with hip, vertebral and controls. NHNVF were younger and heavier than controls and hip/vertebral fractures in both men and women, respectively. Falls and prior fractures were less common in NHNVF than hip fractures. Glucocorticoid use was lower in NHNVF compared to vertebral fracture (VF) in men. Introduction: Although hip fracture (HF) and vertebral fractures (VF) receive the most attention in the literature and are the targeted sites for fracture prevention, non-hip, non-vertebral fracture (NHNVF) sites account for a greater proportion of fractures than the hip or vertebrae. This study aimed to assess risk factors for NHNVF and compare them with those for HF, VF and controls. Methods: Incident fractures during 2005–2007 for men and 1994–1996 for women were identified using computerised keyword searches of radiological reports, and controls were selected at random from electoral rolls for participation in the Geelong Osteoporosis Study. Participants aged 60+ years were included in this study. Results: Compared to controls, men and women with NHNVF were younger (ORs, 0.90, 95 % CI 0.86–0.94; and 0.96, 0.93–0.98, respectively) and had a lower femoral neck bone mineral density (BMD) T-score (age-adjusted; difference [men] 0.383, P = 0.002; [women] 0.287, P = 0.001). Compared to HF, men and women with NHNVF were heavier (difference [men] 9.0 kg, P = 0.01; [women] 7.6 kg, P < 0.001). Heavier weight was also a risk factor for women with NHNVF compared to VF (1.03, 1.01–1.06). In men with NHNVF, falls (0.37, 0.14–0.97) and prior fractures (0.38, 0.15–0.98) were less common compared to HF; and glucocorticoid use was less common for NHNVF (0.30, 0.11–0.85) compared to VF. Conclusions: Given the high numbers of NHNVF sustained by men and women in this study, fracture prevention strategies should focus on individuals with high risk of sustaining these types of fractures, as well as on individuals who are more likely to sustain a HF or VF.

When continuity of care breaks down: a systems failure in identification of osteoporosis risk in older patients treated for minimal trauma fractures

OBJECTIVE: Minimal trauma fractures may be the first indication of osteoporosis. Our aim was to determine the proportion of patients who underwent bone density testing for osteoporosis of those with a minimal trauma wrist fracture treated in the emergency department (ED).

DESIGN: This observational retrospective cohort study used explicit medical record review and scripted telephone interviews.

SETTING: EDs of three metropolitan hospitals in Melbourne in 2006.

PARTICIPANTS: Patients aged 50 years and over who were treated for wrist fracture due to minimal trauma. Data collected included demographic details, fracture details, causes of injury, any bone density testing and any osteoporosis-related medication change.

MAIN OUTCOME MEASURE: The proportion of patients who underwent bone density testing in the follow-up period.

RESULTS: 131 patients were studied; 83% were female, and the median age was 71 years. No patient was referred by an ED or fracture clinic for bone density testing (95% CI, 0-3.5%). Telephone follow-up data were obtained from 91 patients. Of these, 28 reported having bone density testing after their fracture, of whom 14 (50%; 95% CI, 32%-67%) were found to have osteoporosis. Seven were treated with a bisphosphonate and one with a selective oestrogen-receptor modulator.

CONCLUSION: Follow-up of patients suffering minimal trauma wrist fractures treated in the ED is poor. Systems to improve the identification and treatment of osteoporosis in this group are needed if future osteoporotic fractures and their consequences are to be avoided.

Prescribing exercise for Osteoporosis

Osteoporosis is a major public health problem because of the morbidity and mortality associated with fracture. Minimizing the risk of fracture is the primary objective of osteoporosis management. The role of exercise in osteoporosis management is to increase and maintain peak bone density and reduce the rate of bone loss and the risk of falling. This article provides recommendations focusing on a life-span approach to minimizing the risk of fracture associated with osteoporosis. Osteoporosis prevention begins in childhood, when exercise can increase peak bone strength. In young adults, it can maintain peak bone mineral density. In elderly individuals, physical activity can slow bone loss and improve fitness and muscle strength, helping prevent falls and lower the risk of fracture. Exercise goals for individuals with osteoporosis should include reducing pain, increasing mobility, and improving muscle endurance, balance, and stability in order to improve the quality of life and reduce the risk of falling. Thus, exercise plays a significant part in reducing fractures in later life.

The effect of mechanical loading on the size and shape of bone in pre-, peri-, and postpubertal girls: a study in tennis players

Exercise during growth results in biologically important increases in bone mineral content (BMC). The aim of this study was to determine whether the effects of loading were site specific and depended on the maturational stage of the region. BMC and humeral dimensions were determined using DXA and magnetic resonance imaging (MRI) of the loaded and nonloaded arms in 47 competitive female tennis players aged 8-17 years. Periosteal (external) cross-sectional area (CSA), cortical area, medullary area, and the polar second moments of area (I_p, mm⁴) were calculated at the mid and distal sites in the loaded and nonloaded arms. BMC and I _p of the humerus were 11-14% greater in the loaded arm than in the nonloaded arm in prepubertal players and did not increase further in peri- or postpubertal players despite longer duration of loading (both, _p < 0.01). The higher BMC was the result of a 7-11% greater cortical area in the prepubertal players due to greater periosteal than medullary expansion at the midhumerus and a greater periosteal expansion alone at the distal humerus. Loading late in puberty resulted in medullary contraction. Growth and the effects of loading are region and surface specific, with periosteal apposition before puberty accounting for the increase in the bone's resistance to torsion and endocortical contraction contributing late in puberty conferring little increase in resistance to torsion. Increasing the bone's rt.osistance to torsion is achieved hy modifying bone shape and mass, not necessarily bone density.

Application of very-high-frequency (VHF) method to ceramic insulators

A VHF method (30-300 MHz) is applied to identify faults and defects in ceramic insulators. Insulators which exhibit internal cracks and fractures are used as test samples. Different artificial conditions are introduced to the test samples according to the IEC 507 standard under wet and dry conditions. Using a cascading signal processing technique and analysis methods such as FFT and fractal analysis, VHF signals acquired by digital scope are processed and analyzed. This study indicates that the fractal dimension can be used as an effective tool to isolate the common faulty conditions found on the ceramic insulators. The results from this study strongly support the prospect of using a VHF method to monitor the physical condition of ceramic insulators.

Emergency nurse practitioner care and emergency department patient flow: case-control study

Objective: The present study aimed to compare ED waiting times (for medical assessment and treatment), treatment times and length of stay (LOS) for patients managed by an emergency nurse practitioner candidate (ENPC) with patients managed via traditional ED care. Methods: A case–control design was used. Patients were selected using the three most common ED discharge diagnoses for ENPC managed patients: hand/wrist wounds, hand/wrist fractures and removal of plaster of Paris. The ENPC group (n = 102) consisted of patients managed by the ENPC who had ED discharge diagnoses as mentioned above. The control group (n = 623) consisted of patients with the same ED discharge diagnoses who were managed via traditional ED care. Results: There were no significant differences in median waiting times, treatment times and ED LOS between ENPC managed patients and patients managed via traditional ED processes. There appeared to be some variability between diagnostic subgroups in terms of treatment times and ED LOS. Conclusion: Patient flow outcomes for ENPC managed patients are comparable with those of patients managed via usual ED processes.

Should older people in residential care receive vitamin D to prevent falls? Results of a randomized trial

Objectives: To determine whether vitamin D supplementation can reduce the incidence of falls and fractures in older people in residential care who are not classically vitamin D deficient.

Design: Randomized, placebo-controlled double-blind, trial of 2 years' duration.

Setting: Multicenter study in 60 hostels (assisted living facilities) and 89 nursing homes across Australia.

Participants: Six hundred twenty-five residents (mean age 83.4) with serum 25-hydroxyvitamin D levels between 25 and 90 nmol/L.

Intervention: Vitamin D supplementation (ergocalciferol, initially 10,000 IU given once weekly and then 1,000 IU daily) or placebo for 2 years. All subjects received 600 mg of elemental calcium daily as calcium carbonate.

Measurements: Falls and fractures recorded prospectively in study diaries by care staff.

Results: The vitamin D and placebo groups had similar baseline characteristics. In intention-to-treat analysis, the incident rate ratio for falling was 0.73 (95% confidence interval (CI)=0.57–0.95). The odds ratio for ever falling was 0.82 (95% CI=0.59–1.12) and for ever fracturing was 0.69 (95% CI=0.40–1.18). An a priori subgroup analysis of subjects who took at least half the prescribed capsules (n=540), demonstrated an incident rate ratio for falls of 0.63 (95% CI=0.48–0.82), an odds ratio (OR) for ever falling of 0.70 (95% CI=0.50–0.99), and an OR for ever fracturing of 0.68 (95% CI=0.38–1.22).

Conclusion: Older people in residential care can reduce their incidence of falls if they take a vitamin D supplement for 2 years even if they are not initially classically vitamin D deficient.

Men and osteoporosis

BACKGROUND: While strict criteria have been developed for defining osteoporosis in women (bone mineral density measurements more than 2.5 standard deviations below the mean for young adult normal women, i.e. t-score value < -2.5), there still remains a controversy regarding the definition in men. Spinal fractures occur in 5% and hip fractures in 6% of men older than 50 years. There are significant differences between men and women with respect to the pathogenesis of osteoporosis, underlying medical conditions and postfracture sequelae.

OBJECTIVE: To provide an overview of the pathogenesis, diagnosis and prevention of osteoporosis in men.

DISCUSSION: Osteoporosis is increasingly recognised. Data from the Dubbo Osteoporosis Epidemiology Study suggests that 30% of men in Australia aged over 60 years will suffer from an osteoporotic fracture. It is estimated that 30-60% of men presenting with spinal fractures will have another illness contributing to their bone loss. Osteoporotic fractures in men are associated with higher morbidity and mortality than in women. Lifestyle changes together with daily calcium supplementation should be implemented and vitamin D3 should be considered in men with osteopenia.