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AbstractLocalized oral drug delivery offers several advantages for treating various disease conditions. However, drug retention at the disease site within the oral cavity is indeed a significant challenge due to the dynamic oral environment. The present study aimed to develop a mucoadhesive inner layer for a three-layer mucoadhesive bandage suitable for localized oral drug delivery. using gellan gum (GG) biopolymer. Gellan gum (GG) was modified using L-cysteine moieties via carbodiimide chemistry. Subsequently, gellan gum solution at different extents of thiolation was ionically cross-linked using aluminum ammonium sulfate. Thiolated gellan gum films of uniform thickness were prepared using a solvent casting method. The thickness of bare gellan gum film was 0.035 ± 0.0043 mm, whereas the thiolated gellan gum films, GG 1S and GG 2S showed a thickness of 0.0191 ± 0.0011 mm and 0.0188 ± 0.0004 mm respectively. A high work of adhesion was noted for thiolated gellan gum (GG 2S) with a value of 10 N.mm while using porcine buccal mucosa. An average tensile strength of 48.2 ± 2.46 MPa was measured for thiolated gellan gum films irrespective of the extent of thiolation. The high work of adhesion, favorable cytocompatibility, desirable mechanical properties, and free swell capacity in saline confirmed the suitability of ionically cross-linked thiolated gellan gum films as an inner mucoadhesive layer for the mucoadhesive bandage. [ABSTRACT FROM AUTHOR]

The obvious benefits of employing prebiotics as functional components in many foods and feed products have resulted in higher demand for their industrial production, necessitating the development of more efficient and cost-effective manufacturing procedures. As a result, the goal of this study was to synthesize confirmed prebiotics, namely fructo-oligosaccharides (FOS), using sucrose as a substrate, since it allows the synthesis of oligosaccharides with lower polymerization degree, and consequently, a more pronounced prebiotic effect. Due to its availability, low market price, and high stability under industrial conditions, a commercial enzymatic mixture, Pectinex® Ultra SP-L, is used as a source of enzyme - fructosyltransferase (FTase). By varying key experimental conditions such as pH, temperature, enzyme and substrate concentrations, as well as the duration of the process, the composition of the FOS mixture can be adjusted to fit the potential applications. It was found that by performing the reaction in an aqueous medium (pH 7), at a temperature of 50 °C using an enzyme concentration of 1% (v/v) and any sucrose concentration in the range of 200-700 g/L, it was possible to achieve maximum FOS yield of 60% of total carbohydrates within a 24 h. The produced syrup with a high content of FOS can be further used as an adequate food additive, or else, developed processes should be used for the transformation of various food products (such as juices, jams, fillings, candies, cakes, etc.) in which sucrose dominates, creating products with lower caloric and higher functional value.

Importance of hospital environment in patient-care has been recognized widely in infection prevention and control. Inappropriate antibiotic use led to emergence of resistant strains that are difficult to treat with the available antibiotics. Progress in nanotechnology led to enhancement of nanoparticles with physicochemical characteristics and functionality that overcomes the constraints of common antimicrobials. Aim was to investigate effective antimicrobial role of Silver nanoparticle (Ag-NPs) against clinically important bacterial strains and observe effects of varying storage temperatures on Ag-NPs antimicrobial activity. Different concentrations of Ag-NPs were tested against Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Acinetobacter baumannii using diffusion method. Zone of inhibition (ZOI) for each organism was directly proportional to concentration of Ag-NPs used. Mean ZOI values at different concentrations were significantly different for all organisms with p-value <0.001 for E. coli, S. aureus, P. aeruginosa and 0.004 for A. baumannii. Variation in storage temperature hardly showed any effects on the antimicrobial property of the Ag-NPs. Scanning electron microscopy (SEM) showed morphological and size variations in Ag-NPs exposed cells when compared to control strains, especially for S. aureus, E. coli and P. aeruginosa. Damaged cell membrane areas can be clearly distinguished in E. coli and P. aeruginosa thus suggesting bacterial membrane disruption. These finding can help design a larger study where Ag-NPs can be used in various medical instruments which are usually kept at room temperatures. Also, outcomes of this study may help in designing proper implants, prosthesis and equipment coated with minimum concentration of nanoparticles that might be considered safe for medical applications. [ABSTRACT FROM AUTHOR]

Irrigation Water Quality Index (IWQI) is applied based on the linear combination of the five different groups of irrigation water quality parameters: (a) salinity hazard, (b) permeability and infiltration problems, (c) specific ion toxicity, (d) trace element toxicity; and (e) miscellaneous problems that have potential negative impacts on soil quality and crop yield. A single index value is developed, which is then interpreted to determine the suitability of the irrigation water. Furthermore, the values of various quality parameters of sewage were compared with the quality of groundwater of villages in the Gandhinagar district of Gujarat State selected for the study. The comparison revealed that no significant difference had been observed among the values of water quality parameters analyzed for groundwater and sewage. Further, the IWQI calculated for sewage and groundwater was found to be in the moderate and high class of suitability for irrigation purpose. IWQI also considers the levels of trace heavy metals, therefore it serves as an excellent tool for monitoring their levels and assess their impact on human and animal health in future. Moreover, it is recommended to carry out continuous monitoring of sewage, crops, and soil for perpetual applications of sewage for irrigation. [ABSTRACT FROM AUTHOR]

Accurate magnetic-signature prediction is the most challenging task in the path of active magnetic-signature minimization. This article discusses the effect of the change in hull thickness, relative permeability, and radius of the object, considering the detailed understanding of the magnetic signatures. The traditional magnetic experiment-based method using a 12-coil structure is implemented for a double hull vessel. However, the time required and effort involved in predicting the magnetic signature is much higher. Hence, a multiple linear regression-based statistical machine-learning (ML) technique for the magnetic signature prediction is proposed. The nonlinear magnetic behavior of the naval vessel is assumed to be linear, because the hysteresis curve in the range of the earth’s ambient field is linear. Hence, a linear relationship is developed between the magnetic signatures and each component of the ambient earth’s magnetic field. The ML-based model also considers the crosstalk among the longitudinal, athwartship, and vertical signatures. The predicted magnetic signatures using the ML technique and the experiment-based techniques are compared. The ML method is found to be accurate, fast, and precise compared with the laboratory-based method, which has strict and continuous requirements for hardware magnetic facility. This method is very simple to implement and directly contributes to the development of the real-time degaussing current calculation algorithm. [ABSTRACT FROM AUTHOR]

This review presents a detailed overview of COVID-19 pandemic on dental practice. Guidelines issued by authorities/agencies for COVID-19 and identical guidelines that are applicable for similar outbreaks in the past are discussed. The outbreak has caused unexpected disruption to dental practice and has changed the way dentistry will be foreseen in the near future. It is therefore imperative to study the nature, characteristics and transmission of COVID-19 during emergency dental procedures. In addition to this, management of infection control, precautionary measures during preoperative, intraoperative and postoperative dental care and contingency management when contacted by virus are of prime importance not only for dental practice but also for dental education. [ABSTRACT FROM AUTHOR]

This paper proposes a fast and efficient method for magnetic signature reduction of underwater vessels. The magnetic signature reduction is required to protect the ferromagnetic vessels from magnetic anomaly detectors and mines. We propose a novel machine learning-based approach for degaussing of the vessel. This method adds a degree of bias to the evaluated coefficients in order to handle inherent multicollinearity issues. The proposed algorithm is efficient in terms of computational efforts, speed, and accuracy. More than 90% of signature reduction is achieved, assuming that the signature predicted is accurate. The proposed method is validated for a simulated model of prototype submarine. [ABSTRACT FROM AUTHOR]

This paper implements an open-loop controller for generating earth’s magnetic field in vessel’s co-ordinate frame. It also incorporates the rotational movements along the three axes, without physically moving the object. This has potential application in prediction of signature for ferromagnetic marine vessels in changing earth’s magnetic field experienced by the vessel due to change in location. It also considers the effect of roll, pitch and heading changes. Uniform magnetic field simulator is designed to generate the required magnetic field in the vessel’s coordinate frame. Simulation results are verified using experimental laboratory setup. [ABSTRACT FROM AUTHOR]

Background: In the United States, between one-third and two thirds of postmenopausal women do not begin treatment with a prescription osteoporosis medication after a diagnosis of osteoporosis. The objective of this study was to understand the reasons for this lack of treatment. Materials and Methods: Online physician and patient surveys were administered in 2013. The physician survey included a chart review of untreated postmenopausal women recently diagnosed with osteoporosis and gathered data on physicians' practices regarding the management of osteoporosis in postmenopausal women. The patient survey was given to untreated postmenopausal women with a recent osteoporosis diagnosis. Results: The physician survey was completed by 224 physicians, who also reviewed 811 patient charts. A total of 165 patients completed the patient survey. In the chart review, physicians reported that 19% of the postmenopausal women they diagnosed with osteoporosis were not prescribed an osteoporosis medication. The patient declined a physician's recommendation for pharmacological treatment in 81% and 52% of cases in the physician and patient surveys, respectively. The most frequent reasons for physicians not recommending treatment were: low calcium and/or vitamin D levels, patients potentially at risk of medication side effects, pre-existing gastrointestinal problems, and polypharmacy. The most frequent reasons for patients deciding against treatment were: concerns about side effects, considering nonprescription options and behavioral modifications, and questioning the potential benefit of taking the medication. Conclusions: Patients decided against pharmacological treatment of newly diagnosed osteoporosis in at least half of the cases of nontreatment. The principal reasons for not being treated with a prescription medication, given by both physicians and patients, were that there were alternatives and concern about the risks of prescription medications. [ABSTRACT FROM AUTHOR]

Objective: To estimate the rate of non-treatment among elderly women with osteoporosis (OP) and to examine the association between patient characteristics and receiving treatment.Research Design and Methods: This cross-sectional, retrospective, observational study utilized patient information and claims from the Humana database to identify Medicare covered women aged ≥65 years old and continuously enrolled with evidence of either an OP diagnosis or an OP-related fracture during 2007-2011. The main outcome was receipt of pharmacological treatment of OP during 2012 (follow-up). The percentage of non-treatment was calculated and a stepwise selection logistic regression model was employed to estimate the association between baseline demographic and clinical characteristics and receiving treatment.Results: A total of 109,829 patients were included. Mean age was 75.7 years and 79.4% were identified with OP through OP diagnosis codes and did not have evidence of a prior fracture. Approximately one-third (32%) of patients had used OP medications during the baseline period, and 39% had experienced at least one gastro-intestinal event during baseline. Among all patients, 71.4% did not receive OP therapy during follow-up. The strongest factor associated with receiving treatment was prior use of OP therapy (odds ratio [OR] = 31.3; p < .001). Among the subgroup of patients with baseline fractures, 75.9% did not receive OP therapy during follow-up and the strongest factor associated with receiving treatment remained prior use of OP therapy (OR = 20.4; p < .001). Those with high comorbidity burden were less likely to receive treatment in both the overall cohort and within the subgroup with baseline fractures.Conclusions: Among Medicare-eligible women aged ≥65 identified with OP between 2007 and 2011, 71.4% did not receive OP treatment during 2012, including 75.9% of the subgroup of patients with a prior fracture. The use of diagnosis and procedures codes to identify patients with osteoporosis is subject to variation in coding. [ABSTRACT FROM AUTHOR]

Background: A substantial portion of women diagnosed with osteoporosis (OP) do not initiate pharmacotherapy to reduce fracture risk. In clinical practice, gastrointestinal (GI) events have been linked with OP therapy discontinuation. However, there is limited research examining GI events as barrier to treatment initiation following an OP diagnosis. The objective of this study was to examine the association between gastrointestinal (GI) events and osteoporosis (OP) treatment initiation among post-menopausal women diagnosed with osteoporosis in France.Methods: A retrospective claims analysis of the Mediplus France database during 1997 to 2010 identified women aged ≥ 55 with an OP diagnosis and without prior OP treatment (first diagnosis date was defined as the index date). GI events were identified during the 1 year pre-index and up to 1 year post-index. OP treatment initiation post-index was identified based on the presence of claims for any bisphosphonate (BIS) or non-BIS OP medication within 1 year post-index. Multivariate models (logistic regression, Cox proportional hazards regression and discrete choice) adjusted for pre-index patient characteristics were used to assess the association of pre- and post-index GI events with the likelihood of initiating OP treatment, and the type of treatment initiated (BIS vs. non-BIS).Results: A total of 10,292 women (mean age 70.3 years) were identified; only 25% initiated OP treatment. Post-index GI events occurred in 11.5% of patients, and were associated with a 75.7% lower likelihood of initiating OP treatment. Among treated patients, a discrete choice model estimated that patients with post-index GI events were 34.6% less likely to receive BIS vs non-BIS as compared to patients without post-index GI events.Conclusion: Among women aged ≥ 55 years with an OP diagnosis, post-index GI events were associated with a lower likelihood of OP treatment initiation. [ABSTRACT FROM AUTHOR]

Objectives: To examine the rate of osteoporosis (OP) undertreatment and the association between gastrointestinal (GI) events and OP treatment initiation among elderly osteoporotic women with Medicare Part D drug coverage. Methods: This retrospective cohort study utilized a 20% random sample of Medicare beneficiaries. Included were women ≥66 years old with Medicare Part D drug coverage, newly diagnosed with OP in 2007-2008 (first diagnosis date as the index date), and with no prior OP treatment. GI event was defined as a diagnosis or procedure for a GI condition between OP diagnosis and treatment initiation or at the end of a 12-month follow-up, whichever occurred first. OP treatment initiation was defined as the use of any bisphosphonate (BIS) or non-BIS within 1 year postindex. Logistic regression, adjusted for patient characteristics, was used to model the association between 1) GI events and OP treatment initiation (treated versus nontreated); and 2) GI events and type of initial therapy (BIS versus non-BIS) among treated patients only. Results: A total of 126,188 women met the inclusion criteria: 72.1% did not receive OP medication within 1 year of diagnosis and 27.9% had GI events. Patients with a GI event were 75.7% less likely to start OP treatment (odds ratio [OR]=0.243; P<0.001); among treated patients, patients with a GI event had 11.3% lower odds of starting with BIS versus non-BIS (OR=0.887; P<0.001). Conclusion: Among elderly women newly diagnosed with OP, only 28% initiated OP treatment. GI events were associated with a higher likelihood of not being treated and, among treated patients, a lower likelihood of being treated with BIS versus non-BIS. [ABSTRACT FROM AUTHOR]

Purpose: To estimate the proportion of osteoporosis patients in whom initiating strontium ranelate treatment, under new EMA guidelines, should be contraindicated because of a history of cardiovascular events or risk for cardiovascular events. Materials and methods: This was a retrospective analysis of medical and pharmacy claims using the Clinical Practice Research Datalink database. Patients were included if they had ⩾1 prescription of strontium from September 1, 2008 to August 31, 2013, were aged ⩾50 as of the index date (the date of the first ever strontium ranelate prescription), and had ⩾1 year of medical records pre-index. Cardiovascular events occurring any time pre-index were identified, which included ischemic heart disease, cerebrovascular disease, uncontrolled hypertension, and peripheral arterial disease. Cardiovascular risk factors assessed included 1) diabetes or hypertension any time pre-index; 2) hyperlipidemia in the 12 months pre-index; or 3) obesity in the 12 months pre-index. Results: A total of 7,474 patients were included: 90.4% were women, with an average age of 76.5 years, and 84.5% used osteoporosis therapy, either bisphosphonates or non-bisphosphonates, prior to strontium initiation. A total of 23.6% of patients experienced ⩾1 cardiovascular event prior to strontium initiation; the rate was lower among female patients than in male patients (22.4% vs 35.3%, P<0.01). A total of 45.9% had risk factors for cardiovascular events (without cardiovascular event history). Conclusion: More than one-fifth of osteoporosis patients in the UK who used strontium had a cardiovascular event history, and one-half had cardiovascular risk factors prior to strontium initiation. [ABSTRACT FROM AUTHOR]

Background: Many women with osteoporosis do not initiate osteoporosis treatment. Objective: To examine patients' reasons for not initiating osteoporosis treatment among women with osteoporosis. Methods: Survey recipients were identified from a national US claims database and included women $55 years with an osteoporosis diagnosis from January 1, 2010 to March 31, 2012 as defined by: 1) osteoporosis diagnosis coupled with bone mineral density test within 183 days of diagnosis and/or 2) osteoporosis-related fracture. Eligibility required no claims for osteoporosis medication 1) at least 12 months and up to 5 years prior to osteoporosis diagnosis and 2) at least 6 months after osteoporosis diagnosis. Continuous enrollment for 18 months (6 months pre-osteoporosis and 12 months post-osteoporosis diagnosis) was also required. A total of 2,000 patients with the most recent osteoporosis diagnosis were mailed a survey. Respondents reporting that they did not initiate physician-recommended osteoporosis medication, after either their physician told them they had osteoporosis or they experienced a fracture since age 45 years, were asked for reasons why they did not initiate treatment. Results: There were 430 patients who returned a complete survey; mean age was 61% and 21.6% had a fracture. A total of 197 (45.8%) patients reported their physician diagnosed osteoporosis and 117 (59.3%) of those were recommended osteoporosis medication; 44 of the 117 patients (37.6%) did not initiate recommended osteoporosis medication by the time of survey. The primary reasons for not initiating osteoporosis medication were concern over side effects (77.3%), medication costs (34.1%), and pre-existing gastrointestinal concerns (25.0%). Conclusion: Among respondents, 41% of patients whose physician diagnosed osteoporosis were not recommended osteoporosis treatment and 38% of patients who were recommended osteoporosis treatment did not initiate treatment within approximately 2 years of diagnosis. Concerns with side effects of osteoporosis treatment, medication costs, and pre-existing gastrointestinal concerns were the most common reasons for not initiating recommended treatment. [ABSTRACT FROM AUTHOR]

The article focuses on a study related to noncompliance with osteoporosis (OP) treatment in women and associated healthcare burden. Topics discusses include higher risk of fracture, inpatient service utilization and medical care cost due to noncompliance, the use of alendronate in OP treatment and less compliance related to OP pharmacologic treatment.

The article presents a study on the examination of osteoporotic fracture rates in women who were going through bisphosphonate therapy since one year. Topics discussed include definition of adherence as a medication possession ratio (MPR), identification of higher comorbidity score and fragility fracture in the first year of treatment, identification of drawbacks as no information was available on calcium's supplement use, bone mineral density and reasons for initiation of oral bisphosphonates.

Background: Multiple therapies are approved for the treatment of osteoporosis (OP), but many patients with osteoporosis may not initiate treatment upon osteoporosis diagnosis. Objective: To characterize initiation of pharmacologic OP treatment among women within 1 year of OP diagnosis in a US managed care population. Research design and methods: The retrospective cohort study included women aged <55 years with a claims-documented diagnosis of OP who were naive to OP medications prior to OP diagnosis (index date) during 2001–2010. Continuous enrollment for 12 months before (baseline) and after (follow-up) the index date was required. Patients who received OP medications but did not have an OP diagnosis were excluded. Differences in baseline characteristics between the treated and untreated cohorts were compared using Wilcoxon rank-sum (continuous variables) and chi-square tests (categorical variables). Main outcomes measures: During the follow-up period, the percentages of patients treated with bisphosphonates (alendronate, ibandronate, risedronate, zoledronic acid) and non-bisphosphonates (calcitonin, raloxifene, teriparatide) were determined. Results: A total of 65,344 patients, mean age 65.7 years, met study inclusion exclusion criteria. During the follow-up period, 42,033 patients (64.3%) received no OP medication and 23,311 patients (35.7%) received OP treatment. A total of 20,200 patients (30.9% of total study population) received bisphosphonates and 3111 (4.8% of total) patients received non-bisphosphonates as their index medication. At baseline, untreated patients were slightly older and had higher rates of hypertension, chronic inflammatory joint disease, diabetes mellitus, and gastrointestinal events (p<0.01) compared with treated patients. Conclusions: Among women aged <55 years in a US managed-care population, 64.3% received no pharmacologic treatment within 1 year after being diagnosed with OP. The authors were not able to determine if untreated patients did not receive or did not fill a prescription. Further research is needed to understand the barriers to OP treatment and reasons for non-treatment. [ABSTRACT FROM AUTHOR]

Nosocomial infections, termed hospital-acquired infections (HAIs), are acquired from a healthcare or hospital setting. HAI is mainly caused by bacteria, such as Acinetobacter baumannii, Klebsiella pneumoniae, Escherichia coli, Enterococci spp., Methicillin-resistant Staphylococcus aureus (MRSA), and many more. Due to growing antibacterial resistance, nanotechnology has paved the way for more potent and sensitive methods of detecting and treating bacterial infections. Nanoparticles have been used with molecular beacons for identifying bactericidal activities, targeting drug delivery, and anti-fouling coatings, etc. This review addresses the looming threat of nosocomial infections, with a focus on the Indian scenario, and major initiatives taken by medical bodies and hospitals in spreading awareness and training. Further, this review focuses on the potential role nanotechnology can play in combating the spread of these infections. [ABSTRACT FROM AUTHOR]

Background: Osteoporotic fractures are important causes of morbidity, mortality, and increased health care costs. However, the risk of osteoporotic fractures can be decreased, with clinical studies supporting the use of calcium and vitamin D supplements to promote bone health. Vitamin D insufficiency is widespread, particularly among postmenopausal women with osteoporosis, and this indicates that dietary intake is suboptimal, even though vitamin D supplements are widely available. Methods: We conducted an observational study, using telephone surveys, to estimate vitamin D and calcium intake and the use of prescription osteoporosis medications in Spanish women aged ≥ 50 years with osteoporosis. Results: Among the study participants, mean dietary calcium intake was 1239 mg/day and generally appeared sufficient in terms of the recommended daily intake guidance documents. Participants aged ≥ 75 years had a significantly lower mean dietary calcium intake (988 mg/day), thus one-half were below the level advised by the World Health Organization. Daily calcium intake was also lower in participants who were not taking prescription medications for bone health. Dietary vitamin D intake was 167 IU/day, which is well below both the established target dose (400 IU/day) and the more recent, higher guideline recommended for postmenopausal women (800–1300 IU/day). Dietary vitamin D intake was even lower for participants aged ≥ 75 years (120 IU/day) and was not related to the use of bone health prescription medications. Conclusion: These results support the need for greater promotion of the benefits of higher vitamin D intake in Spanish women with osteoporosis. [ABSTRACT FROM AUTHOR]

Background: Gastrointestinal (GI) events are common in postmenopausal women treated for osteoporosis. The influence of GI events on treatment initiation and treatment compliance is the subject of ongoing research., Objective: The objectives of this study were (i) to determine the association of GI events with receipt of treatment in patients newly diagnosed with osteoporosis, and (ii) among treated patients, to determine the association of GI events with treatment compliance., Methods: This was a retrospective analysis of claims data carried out in Germany using the Mediplus database. Data were collected from January 1992 through December 2010. The dual-objective study design required two distinct cohorts. Cohort 1 comprised women aged ≥ 55 with a diagnosis of osteoporosis. GI events were recorded for the 12 month periods before and after the date of diagnosis. Time-varying Cox regression and discrete choice models were used, respectively, to assess the association of post-diagnosis GI events with the initiation of pharmacologic treatment (yes versus no) and the type of treatment initiated (bisphosphonates versus non-bisphosphonates). Cohort 2 comprised women aged ≥ 55 who initiated an oral bisphosphonate (alendronate, ibandronate, or risedronate). GI events were recorded for the 12 month periods before and after the date of bisphosphonate initiation, and a logistic regression model was employed to determine if pre-treatment or post-treatment GI events were associated with patient compliance, defined as a medication possession ratio (MPR) of ≥ 60%, with sensitivity analyses at MPR ≥ 80%., Results: In cohort 1 (N = 18,813), 13.8% of patients had GI events in the pre-diagnosis period, and 14.8% had GI events in the post-diagnosis period. Among the patients with post-diagnosis GI events, 93.2% remained untreated during the post-index year, 6.2% were treated with bisphosphonates, and 0.6% received non-bisphosphonates. The respective percentages in patients without post-diagnosis GI events were 81.3%, 16.7%, and 1.9%. A post-diagnosis GI event decreased the likelihood of receiving any osteoporosis treatment (versus no treatment) by 83% (HR 0.17, 95% CI 0.14-0.20) and also decreased the likelihood of receiving a bisphosphonate (versus a non-bisphosphonate) by 39% (OR 0.61, 95% CI 0.54-0.68). In cohort 2 (N = 6040), 17.1% of patients had GI events in the year before treatment initiation, and 19.1% had GI events in the year after treatment initiation. At 12 months post-treatment initiation, GI events were more frequent in patients with pre-treatment GI events (53.2%) than in those without pre-treatment GI events (12.0%). Post-treatment GI events decreased the likelihood of attaining compliance defined as an MPR ≥ 60% (OR 0.84, 95% CI 0.73-0.97) but not an MPR ≥ 80% (OR 0.91, 95% CI 0.79-1.06)., Conclusions: In German women newly diagnosed with osteoporosis, GI events decreased the likelihood of receiving treatment and were associated with the choice of treatment. In women initiating oral bisphosphonates, post-treatment GI events were associated with reduced patient compliance.

Background: Preexisting gastrointestinal (GI) events may deter the use of pharmacologic treatment in patients diagnosed with osteoporosis (OP). The objective of this study was to examine the association between preexisting GI events and OP pharmacotherapy initiation among women diagnosed with OP., Methods: The study utilized claims data from a large US managed care database to identify women aged ≥55 years with a diagnosis code for OP (index date) during 2002-2009. Patients with a claim for pharmacologic OP treatment in the 12-month pre-index period (baseline) were excluded. OP treatment initiation in the post-index period was defined as a claim for bisphosphonates (alendronate, ibandronate, risedronate, zoledronic acid), calcitonin, raloxifene, or teriparatide. During the post-index period (up to 12 months), GI events were identified before treatment initiation. A time-dependent Cox regression model was used to investigate the likelihood of initiating any OP treatment. Among patients initiating OP treatment, a discrete choice model was utilized to assess the relationship between post-index GI events and likelihood of initiating with a bisphosphonate versus a non-bisphosphonate., Results: In total, 65,344 patients (mean age 66 years) were included; 23.7% had a GI event post diagnosis and before treatment initiation. Post-index GI events were associated with a 75% lower likelihood of any treatment initiation (hazard ratio 0.25; 95% confidence interval 0.24-0.26). Among treated patients (n=23,311), those with post-index GI events were 39% less likely to receive a bisphosphonate versus a non-bisphosphonate (odds ratio 0.61; 95% confidence interval 0.54-0.68)., Conclusion: GI events after OP diagnosis were associated with a decreased likelihood of OP treatment initiation and an increased likelihood of treatment initiation with a non-bisphosphonate versus a bisphosphonate.

Purpose: To estimate the proportion of osteoporosis patients in whom initiating strontium ranelate treatment, under new EMA guidelines, should be contraindicated because of a history of cardiovascular events or risk for cardiovascular events., Materials and Methods: This was a retrospective analysis of medical and pharmacy claims using the Clinical Practice Research Datalink database. Patients were included if they had ≥1 prescription of strontium from September 1, 2008 to August 31, 2013, were aged ≥50 as of the index date (the date of the first ever strontium ranelate prescription), and had ≥1 year of medical records pre-index. Cardiovascular events occurring any time pre-index were identified, which included ischemic heart disease, cerebrovascular disease, uncontrolled hypertension, and peripheral arterial disease. Cardiovascular risk factors assessed included 1) diabetes or hypertension any time pre-index; 2) hyperlipidemia in the 12 months pre-index; or 3) obesity in the 12 months pre-index., Results: A total of 7,474 patients were included: 90.4% were women, with an average age of 76.5 years, and 84.5% used osteoporosis therapy, either bisphosphonates or non-bisphosphonates, prior to strontium initiation. A total of 23.6% of patients experienced ≥1 cardiovascular event prior to strontium initiation; the rate was lower among female patients than in male patients (22.4% vs 35.3%, P<0.01). A total of 45.9% had risk factors for cardiovascular events (without cardiovascular event history)., Conclusion: More than one-fifth of osteoporosis patients in the UK who used strontium had a cardiovascular event history, and one-half had cardiovascular risk factors prior to strontium initiation.

Purpose: The aim of this study was to estimate the rate of gastrointestinal (GI) events, and association between GI events and compliance with osteoporosis therapy among osteoporotic women., Methods: A retrospective cohort study using a large administrative claims database in the United States from 2001 through 2010 was conducted. We studied women ≥ 55 years old who were continuously enrolled in a health plan for at least 2 years, a baseline year before and a follow-up year after the date of the first prescription of oral bisphosphonate as the first oral osteoporosis treatment. Compliance with osteoporosis therapy was measured using the medication possession ratio (MPR), with compliance defined as MPR ≥ 0.8. Multivariate logistic regression was used to assess the association between occurrence of GI events and compliance with osteoporosis therapy after controlling for demographic and clinical characteristics., Results: A sample consisting of 75,593 women taking at least one oral bisphosphonate with mean (SD) age of 64 (8) years was identified. A total of 21,142 (28%) patients experienced at least one GI event during the follow-up period. Only 31,306 (41%) patients were compliant with osteoporosis therapy. Patients who experienced GI events after initiation of oral bisphosphonates were 29% less likely to adhere to osteoporosis therapy as compared to patients who did not experience GI events (odds ratio [95% CI], 0.71 [0.69-0.74]; P  < .001)., Conclusions: Less than half of the patients were compliant with osteoporosis therapy within one year after initiating oral bisphosphonates, and the likelihood of compliance was significantly lower by 29% among women with GI events.

Background: The burden of osteoporosis in the Asia-Pacific region is not well characterized. The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study in the Asia-Pacific Region (MUSIC OS-AP) was designed to better understand the association of gastrointestinal events with patient-reported outcomes in postmenopausal women of this region., Methods: MUSIC OS-AP is a prospective, multinational, observational cohort study of postmenopausal women ≥ 50 years of age diagnosed with osteoporosis. The study was conducted in five Asia-Pacific countries: Australia, New Zealand, Taiwan, Korea, and India. MUSIC OS-AP has three components: a physician questionnaire, a retrospective chart review, and a prospective cohort study. The physician questionnaire investigated the role of gastrointestinal events in physicians' pharmacologic management of osteoporosis. The retrospective chart review, also completed by physicians, recorded rate of osteoporosis treatment and the types of osteoporosis medications prescribed to osteoporosis patients. The prospective cohort study investigated the associations between gastrointestinal events and patient-reported outcomes among patients taking oral medications for osteoporosis as well as reasons for non-treatment in patients who remained untreated. The prospective cohort study enrolled two groups of patients: untreated, and treated with oral osteoporosis medications. Untreated patients completed only the baseline surveys, providing information on gastrointestinal event rates, quality of life, health care resource use, and reasons for non-treatment. Treated patients, who were either new to osteoporosis medication or continuing an ongoing medication course, completed surveys at baseline and 3, 6, and 12 months post-baseline. The evaluations recorded patient characteristics, gastrointestinal events, health-related and osteoporosis-specific quality of life, health care resource use, medication adherence, and satisfaction with treatment., Results: Physicians at 59 sites completed the physician questionnaire, and data for 300 patients from 26 sites were abstracted for the retrospective chart review. Enrollment and baseline data collection for the prospective cohort study were conducted between July 2013 and August 2014 for 301 untreated and 3287 treated patients, of whom 1416 were new users and 1871 were experienced users of oral osteoporosis medications., Conclusions: The results of MUSIC OS-AP will highlight the association of gastrointestinal events with patient-reported outcomes among postmenopausal women with osteoporosis and elucidate physicians' management of gastrointestinal events among this patient population in the Asia-Pacific region.

Background: Among patients on osteoporosis therapy, including oral bisphosphonates (BIS), upper gastrointestinal (GI) conditions have been linked with lower adherence to treatment and increased treatment discontinuation in clinical practice. Patients who are nonadherent to treatment have a higher risk of osteoporotic fractures and, consequently, have greater use of health care services. The burden of upper gastrointestinal events on health care resource utilization (HCRU) among women initiating oral BIS has not been well investigated., Objective: To examine the association of upper GI events and HCRU in women initiating oral BIS. , Methods: Using a U.S. national claims database, this retrospective study identified women aged ≥ 55 years who were prescribed oral BIS during 2001-2011 and had no history of GI events 12 months prior to treatment initiation. Patients with medical claims for an upper GI event ≤ 4 months posttreatment initiation were cases; all others were controls. The date of the first upper GI event among cases and a randomly assigned date ≤ 4 months posttreatment initiation among controls was the index date. Cases were matched 1:1 to controls by propensity scores derived from logistic regression of pre-index patient characteristics. Outcomes were all-cause and osteoporosis (OP)-related HCRU in the 6-month post-index period. Differences were assessed using McNemar's test., Results: Of the 62,863 eligible patients, 4,751 (7.6%) experienced an upper GI event ≤ 4 months posttreatment initiation (cases); 4,739 cases were matched with 4,739 controls. Compared with controls, cases had higher rates of all-cause HCRU (outpatient: 99.3% vs. 87.8%; inpatient: 20.2% vs. 6.4%; emergency room [ER]: 12.5% vs. 7.4%; all P  less than  0.0001) and OP-related HCRU (outpatient: 24.6% vs. 18.2%; inpatient: 3.4% vs. 1.0%; ER: 0.7% vs. 0.4%; all P  less than  0.05)., Conclusions: Patients with upper GI events had higher rates of all-cause and OP-related health care utilization. Upper GI events may pose an incremental HCRU burden among patients initiating BIS.

Objectives: The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC OS-EU) was designed to better understand the rate and burden of gastrointestinal (GI) events on clinical and health care outcomes among postmenopausal women with osteoporosis., Methods: MUSIC OS-EU is a prospective, multinational, observational cohort study of postmenopausal women ≥50 years of age diagnosed with osteoporosis and enrolled in physician clinics in six countries: France, Italy, the Netherlands, Sweden, the United Kingdom, and Canada. The MUSIC OS-EU study has three components: (i) a physician survey to describe their management of osteoporotic patients with GI events; (ii) a retrospective chart survey to describe the receipt and type of osteoporosis medication prescribed; and (iii) a prospective cohort study including untreated and treated patients diagnosed with osteoporosis to investigate the rate of GI events and association with osteoporosis medication use patterns, health-related quality of life, treatment satisfaction and resource utilisation among postmenopausal women with osteoporosis., Results: Physicians at 97 sites completed the physician questionnaire and data for 716 patients were abstracted for the retrospective chart review. Enrolment and the baseline data collection for the prospective cohort study were conducted between March 2012 and June 2013 for 292 untreated and 2,959 treated patients, of whom 684 were new users and 2,275 were experienced users of oral osteoporosis medications., Conclusions: The results of MUSIC OS-EU will illuminate the association of GI events with the management of osteoporosis and with patient-reported outcomes among postmenopausal women with osteoporosis in Europe and Canada.

Background: Many women with osteoporosis do not initiate osteoporosis treatment., Objective: To examine patients' reasons for not initiating osteoporosis treatment among women with osteoporosis., Methods: Survey recipients were identified from a national US claims database and included women ≥55 years with an osteoporosis diagnosis from January 1, 2010 to March 31, 2012 as defined by: 1) osteoporosis diagnosis coupled with bone mineral density test within 183 days of diagnosis and/or 2) osteoporosis-related fracture. Eligibility required no claims for osteoporosis medication 1) at least 12 months and up to 5 years prior to osteoporosis diagnosis and 2) at least 6 months after osteoporosis diagnosis. Continuous enrollment for 18 months (6 months pre-osteoporosis and 12 months post-osteoporosis diagnosis) was also required. A total of 2,000 patients with the most recent osteoporosis diagnosis were mailed a survey. Respondents reporting that they did not initiate physician-recommended osteoporosis medication, after either their physician told them they had osteoporosis or they experienced a fracture since age 45 years, were asked for reasons why they did not initiate treatment., Results: There were 430 patients who returned a complete survey; mean age was 61% and 21.6% had a fracture. A total of 197 (45.8%) patients reported their physician diagnosed osteoporosis and 117 (59.3%) of those were recommended osteoporosis medication; 44 of the 117 patients (37.6%) did not initiate recommended osteoporosis medication by the time of survey. The primary reasons for not initiating osteoporosis medication were concern over side effects (77.3%), medication costs (34.1%), and pre-existing gastrointestinal concerns (25.0%)., Conclusion: Among respondents, 41% of patients whose physician diagnosed osteoporosis were not recommended osteoporosis treatment and 38% of patients who were recommended osteoporosis treatment did not initiate treatment within approximately 2 years of diagnosis. Concerns with side effects of osteoporosis treatment, medication costs, and pre-existing gastrointestinal concerns were the most common reasons for not initiating recommended treatment.

Background: A large proportion of patients do not persist with osteoporosis (OP) therapy. Gastrointestinal (GI) events (e.g., gastroesophageal reflux disease and nausea/vomiting) are common among OP patients receiving OP therapy and may impact persistence with treatment., Objective: To examine the association of GI events and persistence with OP therapy., Methods: Using a large U.S. administrative claims database, we studied women aged ≥ 55 years who received oral bisphosphonate (BIS) as their first OP therapy from 2002-2009. The index date was the first pharmacy claim date recorded for oral BIS therapy; the baseline period was 12 months pre-index, and follow-up was 12 months post-index. Patients were considered persistent with therapy if they had continuous refills of the index drug class without additional drug therapy from a different drug class from the index date until the end of the follow-up period with no gaps in supply greater than 45 days. Discontinuation was defined as the first gap greater than 45 days during which there was no evidence of refills of OP medication. The association between post-treatment GI events and the risk of discontinuation or switching was modeled with Cox regression stratified by presence of baseline GI events and adjusted for baseline clinical and demographic characteristics., Results: Of the 75,593 women who met eligibility criteria, 59.9% discontinued BIS; 39.3% were persistent; and 0.5% switched to non-BIS. GI events were diagnosed in 20,073 patients (26.6%) during baseline and in 21,142 (28.0%) in the post-treatment period (12-month follow-up post-index). Patients with post-treatment GI diagnosis were 35.6% more likely to discontinue or switch treatment (HR = 1.356, 95% CI = 1.318-1.396) during the 12-month follow-up compared with those without post-treatment GI diagnosis. GI events that occurred closer to treatment discontinuation or switching were associated with a greater risk of discontinuation or switching: 37.9% (HR = 1.379, 95% CI = 1.338-1.421) for GI events within 6 months of discontinuation or switching and 45.6% (HR = 1.456, 95% CI = 1.408-1.505) for GI events within 3 months of discontinuation or switching., Conclusions: Among women aged 55 years or older in a U.S. managed care population, post-treatment GI events were associated with a higher risk of discontinuation of oral BIS or switching to non-BIS.

In the United States, an estimated 19% of older men and 30% of older women are at elevated risk of osteoporotic fracture and considered to be eligible for treatment. The burden of osteoporosis is similar in Europe and is projected to rise worldwide, with aging populations and increasing fracture rates accompanying urbanization. Notwithstanding its high prevalence, osteoporosis is often underdiagnosed and undertreated. Moreover, even when the diagnosis is made and the decision is taken to treat, there are remaining challenges in implementing therapy for osteoporosis. Several patient populations are particularly challenging for clinicians to treat and require further study with regard to osteoporosis therapy. These include the very elderly, who face challenges relating to adherence; men, in whom osteoporosis remains under-recognized; patients with glucocorticoid-induced osteoporosis or renal impairment, who are at increased risk of fracture; patients with preexisting gastrointestinal problems who cannot tolerate existing orally administered osteoporosis therapies; and high-risk patients who show inadequate response to therapy. Moreover, poor adherence and poor persistence with osteoporosis medications are common and result in an increased risk of fracture, higher medical costs, and increased hospitalizations. Once the decision to institute therapy is made, patient education about osteoporosis and fracture risk should be provided. This is particularly important for men, who may not be aware that osteoporosis can be a concern. Secondary prevention programs, including fracture liaison services and bone therapy groups, can help to improve adherence to therapy. Further study is needed to guide the treatment of men, the very elderly, patients with glucocorticoid-induced osteoporosis and renal impairment, high-risk patients not well-controlled despite therapy, and patients with preexisting gastrointestinal conditions. Moreover, therapies are needed that are viewed as effective and safe by both physicians and patients, and as convenient to take by patients.

Background: Osteoporotic fractures are important causes of morbidity, mortality, and increased health care costs. However, the risk of osteoporotic fractures can be decreased, with clinical studies supporting the use of calcium and vitamin D supplements to promote bone health. Vitamin D insufficiency is widespread, particularly among postmenopausal women with osteoporosis, and this indicates that dietary intake is suboptimal, even though vitamin D supplements are widely available., Methods: We conducted an observational study, using telephone surveys, to estimate vitamin D and calcium intake and the use of prescription osteoporosis medications in Spanish women aged ≥ 50 years with osteoporosis., Results: Among the study participants, mean dietary calcium intake was 1239 mg/day and generally appeared sufficient in terms of the recommended daily intake guidance documents. Participants aged ≥ 75 years had a significantly lower mean dietary calcium intake (988 mg/day), thus one-half were below the level advised by the World Health Organization. Daily calcium intake was also lower in participants who were not taking prescription medications for bone health. Dietary vitamin D intake was 167 IU/day, which is well below both the established target dose (400 IU/day) and the more recent, higher guideline recommended for postmenopausal women (800-1300 IU/day). Dietary vitamin D intake was even lower for participants aged ≥ 75 years (120 IU/day) and was not related to the use of bone health prescription medications., Conclusion: These results support the need for greater promotion of the benefits of higher vitamin D intake in Spanish women with osteoporosis.