2008 official positions of the Brazilian Society for Clinical Densitometry - SBDens

With the evolution of bone densitometry, differences in technologies, acquisition techniques, reference databases, reporting methods, diagnostic criteria and terminology have developed and the International Society for Clinical Densitometry (ISCD) periodically holds Position Development Conferences, the latest in 2007. The Brazilian Society for Clinical Densitometry (SBDens), with support from many Brazilian societies interested in bone health, gathered numerous specialists to discuss the ISCD proposals and to evaluate the validity of the extension of those norms to Brazilian population. The SBDens reunion of consensus made a very utile document to help the understanding and interpretation of bone densitometry and other methods of bone assessment.A evolução dos métodos de avaliação da massa óssea trouxe diferentes tecnologias, modos de aquisição de imagens, bancos de dados de referência, terminologias, critérios diagnósticos fez com que a International Society for Bone Densitometry (ISCD) tomasse a iniciativa de promover reuniões periódicas de consenso, a última em 2007. A Sociedade Brasileira de Densitometria Clínica (SBDens), com apoio de várias sociedades brasileiras ligadas ao estudo da saúde óssea, reuniu diversos especialistas para discutir as propostas da ISCD e validar a aplicação destas normas à população brasileira. A reunião de Posições Oficiais da SBDens produziu um documento extremamente útil para a compreensão e interpretação da densitometria e de outros métodos de avaliação da massa óssea.Sociedade Brasileira de Densitometria ClínicaSociedade Brasileira para o Estudo do Metabolismo Ósseo e MineralUniversidade Federal de São Paulo (UNIFESP)Universidade Federal de Minas Gerais Hospital Mater DeiSociedade Brasileira de ReumatologiaSociedade Brasileira de OsteoporoseUniversidade de São Paulo Faculdade de Medicina Hospital das ClínicasAssociação Brasileira de Medicina Física e ReabilitaçãoUniversidade Federal do Espírito SantoUNIFESPColégio Brasileiro de RadiologiaSociedade Brasileira de Ortopedia e TraumatologiaUNIFESPSciEL

A prevenção da osteoporose levada a sério: uma necessidade nacional

Rad se sastoji od dva dijela, teoretskog i eksperimentalnog dijela. U teorijskom dijelu rada su opisana nova tehnološka rješenja i premazi koji se danas uvode u proizvodne procese u cilju skraćivanja vremena prevlačenja automobila, ali i veće otpornosti na različite eksploatacijske uvjete. Posebna pozornost u ovome radu je dana završnome bezbojnom premazu otpornom na ogrebotine. U eksperimentalnom dijelu rada proveden je niz ispitivanja sustava premaza, koji su nanijeti na pločice od niskougljičnog konstrukcijskog čelika i aluminija. Ispitana su fizikalna i korozijska svojstva sustava premaza u slanoj, vlažnoj i UV komori, te su dane ocjene učinkovitosti zaštite. Sustavi premaza također su ispitani elektrokemijskom impedancijskom spektroskopijom kako bi se odredio otpor premaza.This study consists of two parts, first is theoretical and the second is experimental. Theoretical part of the paper describes the new technological solutions and coatings that are being introduced today in production processes in order to reduce the time of car coatings, but also greater resistance to different exploitation conditions. Particular attention in this paper is given to the finished scratch-resistant clear coat. In the experimental part of the work a series of system tests were carried out, which were applied on low-carbon steel and aluminum plates. Physical and corrosion properties of the coating system in salt spray, humidity and UV chamber were evaluated, and values of protection efficiency are provided. The coating systems were also tested by electrochemical impedance spectroscopy to determine the resistance of the coating

An updated hip fracture incidence rate for Brazil : the Brazilian Validation Osteoporosis Study (BRAVOS)

Hip fracture incidence rates in three representative geographic areas in Brazil over a period of 2 years (2010-2012) were assessed for the first time. Estimated incidence rates varied regionally, and markedly differed from those previously reported. Thus, national guidelines as well as FRAX Brazil should be revised in light of this new data. Purpose: To determine the annual incidence of hip fractures in individuals aged 50 years and over, living in 3 cities located in different regions of the country. To investigate the age, gender, and regional differences in fracture rates. Based on the obtained data, to estimate the national incidence of hip fractures resulting from osteoporosis, in order to improve prevention strategies. Methods: Retrospective, observational study including all patients aged ≥ 50 years admitted in hospitals because of a hip fracture in three cities (Belem, Joinville, and Vitoria) from representative geographic areas in Brazil from 2010 to 2012. Data were obtained from medical records in those cities. We analyzed incidence rates (crude and age- and gender-standardized rates) for hip fractures. Results: There were 1025 (310 in men and 715 in women) hip fractures in the over 50-year-old merged population from the three cities. The crude incidence rate for hip fracture was 103.3/100,000 (95% confidence interval [CI = 97.0; 109.7), in men 77.4/100,000 (95% CI = 68.8; 86.0), and in women 125.2/100,000 (95% CI = 116.0; 134.4). Incidence standardized for age and gender was 105.9 cases per 100,000 persons per year (95% CI = 99.4; 112.4); 78.5 cases per 100,000 (95% CI = 69.8; 87.3) in men and 130.6 cases 100,000 in women (95% CI = 121.0, 140.2) per year. Belem, located in the equatorial region (latitude 1° 27' S), had significantly lower crude and age-adjusted incidence than Joinville (latitude 26° 18' S) and Vitoria (latitude 20° 19' S), which were no different from each other. The incidence of fractures increased exponentially with age, and women had about twice the risk of fractures than men. Conclusions: Hip fracture mainly affects elderly women and presents great variability in incidence between the different regions in Brazil. The incidence of hip fractures in Brazil differed markedly from that reported previously, so that national guidelines and the FRAX model for Brazil should be revised

Impact of denosumab on the peripheral skeleton of postmenopausal women with osteoporosis: Bone density, mass, and strength of the radius, and wrist fracture

Objective: The aim of this study was to report the effects of denosumab on radius cortical and trabecular bone density, mass, and strength, and wrist fracture incidence in the FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months) study. Methods: In the FREEDOM study, postmenopausal women with osteoporosis (N = 7,808) received placebo or 60 mg of denosumab every 6 months for 36 months. Radius bone mineral density (BMD), bone mineral content, and strength (polar moment of inertia) were evaluated in two prespecified substudies using dual-energy x-ray absorptiometry (placebo, n = 209; denosumab, n = 232) or quantitative CT (placebo, n = 48; denosumab, n = 62). Prespecified analysis assessed wrist fracture incidence in all FREEDOM participants (placebo, N = 3,906; denosumab, N = 3,902), and post hoc subgroup analyses evaluated those with higher fracture risk (baseline femoral neck T-score ≤−2.5; placebo, N = 1,406; denosumab, N = 1,384). Results: Denosumab significantly increased areal BMD (assessed by dual-energy x-ray absorptiometry) and volumetric BMD, bone mineral content, and polar moment of inertia (assessed by quantitative CT), compared with placebo, in radius cortical and trabecular bone at all time points evaluated (all P < 0.05). Wrist fracture incidence was 2.9% for placebo and 2.5% for denosumab (relative risk reduction, 16%; P = 0.21) on month 36. Participants with a femoral neck T-score of −2.5 or lower were at increased risk for wrist fracture, and denosumab significantly reduced wrist fracture incidence compared with placebo (placebo, 4.0%; denosumab, 2.4%; relative risk reduction, 40%; absolute risk reduction, 1.6%; P = 0.03). Conclusions: Denosumab significantly improves radius bone density, mass, and strength compared with placebo. In higher-risk women, denosumab significantly reduces wrist fracture risk

Is it ethical to use placebos in osteoporosis trials?

The use of placebo control groups (e.g., subjects using calcium and vitamin D) in osteoporosis trials with subjects at high risk for fracture has been systematically questioned by institutional review boards (IRBs). Regulatory agencies, on the other hand, continue to not only recommend but also require that placebo-controlled trials be presented for the registration of new drugs for osteoporosis treatment. the Declaration of Helsinki and its updates have upheld the principle that protection of research subjects' rights is of primary concern. Nevertheless, even the Declaration keeps clearly opening the possibility of using placebo-control designs if it is justified for compelling and scientifically sound methodological reasons. the use of intermediary endpoints or surrogates to establish the efficacy or safety of new medications in the management of osteoporosis is currently considered scientifically insufficient. This concept has led regulatory agencies, such as the Food and Drug Administration in the United States and the European Medicines Agency in the European Union, to require fragility fracture reduction as the primary endpoint in clinical trials for the registration of new drugs. Superiority or noninferiority trials are alternatives to placebo-controlled designs. However, factors such as sample size, cost, and statistical limitations render these models impractical for the registration of new medications for osteoporosis. We recommend collaboration among regulatory agencies, IRBs, scientists, and ethicists on the design of clinical trials for the registration of new medications for reduction of fracture risk. Delay in developing mutually acceptable models may impair scientific development in the field and possibly deprive patients of potentially beneficial treatments.Osteoporosis Diag & Res Ctr Espirito Santo, BR-29055450 Vitoria, ES, BrazilHosp Heliopolis, CEPIC, São Paulo, BrazilPontificia Univ Catolica Campinas, São Paulo, BrazilUniv Fed Pernambuco, Recife, PE, BrazilClin Res Ctr, Rio de Janeiro, BrazilUniv Fed Goias, Fac Med, Goiania, Go, BrazilUniv Brasilia, BR-70910900 Brasilia, DF, BrazilPUC RS, Porto Alegre, RS, BrazilUniversidade Federal de São Paulo, São Paulo, BrazilNew Mexico Clin Res & Osteoporosis Ctr, Albuquerque, NM USAUniversidade Federal de São Paulo, São Paulo, BrazilWeb of Scienc

Densitometria clínica: posições oficiais 2006 Clinical densitometry: official positions 2006

Descrevemos as posições oficiais da Sociedade Brasileira de Densitometria Clínica (SBDens) para a realização e o relato do exame de densitometria óssea. Essas posições foram obtidas por consenso em encontro realizado em São Paulo no ano de 2006. A SBDens contou com o apoio de várias sociedades científicas descritas no texto.<br>We describe the official positions of the Brazilian Society for Clinical Densitometry (SBDens) for the performance and report of the bone mineral density testing. These positions were obtained by consensus in a meeting at São Paulo in 2006. SBDens positions were supported by other scientific societies described in the text

Official Positions for FRAX® clinical regarding international differences from Joint Official Positions Development Conference of the International Society for Clinical Densitometry and International Osteoporosis Foundation on FRAX®.

Osteoporosis is a serious worldwide epidemic. Increased risk of fractures is the hallmark of the disease and is associated with increased morbidity, mortality and economic burden. FRAX® is a web-based tool developed by the Sheffield WHO Collaborating Center team, that integrates clinical risk factors, femoral neck BMD, country specific mortality and fracture data and calculates the 10 year fracture probability in order to help health care professionals identify patients who need treatment. However, only 31 countries have a FRAX® calculator at the time paper was accepted for publication. In the absence of a FRAX® model for a particular country, it has been suggested to use a surrogate country for which the epidemiology of osteoporosis most closely approximates the index country. More specific recommendations for clinicians in these countries are not available. In North America, concerns have also been raised regarding the assumptions used to construct the US ethnic specific FRAX® calculators with respect to the correction factors applied to derive fracture probabilities in Blacks, Asians and Hispanics in comparison to Whites. In addition, questions were raised about calculating fracture risk in other ethnic groups e.g., Native Americans and First Canadians. In order to provide additional guidance to clinicians, a FRAX® International Task Force was formed to address specific questions raised by physicians in countries without FRAX® calculators and seeking to integrate FRAX® into their clinical practice. The main questions that the task force tried to answer were the following: The Task Force members conducted appropriate literature reviews and developed preliminary statements that were discussed and graded by a panel of experts at the ISCD-IOF joint conference. The statements approved by the panel of experts are discussed in the current paper