Since its discovery, a century ago, we have advanced in the knowledge of what was erroneously called “vitamin” D. We now know that it is not a vitamin, but we continue to call it that out of custom and tacit consensus. In fact, it is an endocrine system, the vitamin D endocrine system (VDES), similar to that of other steroid hormones. Cholecalciferol or “vitamin” D3, is the threshold (physiological) nutrient of the system, synthesized from 7-dehydrocholesterol in the skin, by the action of ultraviolet B (UVB) solar radiation. This route represents about 80-90% of the contribution to the body, the rest is obtained from the diet (10-20%) . There is another isoform, of nutritional contribution, called ergocalciferol or “vitamin” D2 that is found in small quantities in foods of vegetable origin, yeasts and fungi, not commonly used in Spain [2,3].Read More
Category: Special Documents
A proposal for reorganizing the world of scientific publications which would save Spain millions of euros
At the beginning of the twentieth century few scientific journals existed and their range of diffusion was limited. In the field of medicine, two publications stood out: in the United States, The New England Journal of Medicine, which was established in 1812, and The Lancet in Europe, which dates back to 1823. The main objective of the authors, most of whom were researchers, was to report important findings to their scientific community. These findings were often expected, as, for example, with Watson and Crick’s publication of the breakthrough in the structure of DNA in Nature 1 or Fleming’s discovery of penicillin 2, milestones in medicine that became known through their publication as scientific articles or simply as a letter, as in the case of the discovery of DNA 1.
More than 30 years ago, everything changed. Eugene Garfield’s impact factor for scientific journals 3 was initially conceived as an index to assess the quality of journals and to provide orientation for librarians (the essence of the impact factor is to list the frequency with which a given article is cited in other quality journals as well as the number of articles that the magazine publishes)4. The impact factor suffered a malevolent distortion in its use and, by extension, began to be used as an index of quality of the scientific articles published in the journals with an impact factor. From that point on, it conditioned the professional attitude of publishers, scientific journals, researchers and even of research institutes, universities and ministries, a phenomenon that has been recognized and lately called into question5.
Review of the scientific evidence regarding clinical use of the Trabecular Bone Score (TBS) SEIOMM official position (2018)
The incorporation of new technological applications in the medical field entails a prolonged period of evaluation of the scientific evidence generated in the clinical validation process.
Over the past 5 years, numerous publications, communications in congresses and meetings of scientific societies have been generated. The application of the Trabecular Bone Score (TBS) has also received the attention of the International Society for Clinical Densitometry (ISCD), which has integrated it into its official positions.
The concept of Evidence-Based Medicine (EBM) was developed by a group of internists and clinical epidemiologists led by Gordon Guyatt of McMaster University School of Medicine in Canada. The concept of EBM was defined by its creators as the conscious, explicit and judicious use of the best available clinical evidence to make decisions about the care of individual patients. In essence, EBM aims to have the best available scientific information, the evidence, to apply it to clinical practice.
In 2014, the Spanish Society of Bone Research and Mineral Metabolism (SEIOMM) began a project that facilitated its partners TBS software assessment, through a competitive call. The project ended in 2017. This application requires densitometry images with DXA (Dual X-ray Absorptiometry) of the lumbar spine, and by analyzing the image texture, offers information related to the microstructural quality of the trabecular bone. The project had the logistical support of Medimaps, a French developer, which distributed 20 TBS licenses among the partners that proposed their use in certain clinical and therapeutic settings.
Current perspectives on the role of vitamin D and calcium in the patient care for osteoporosis: An expert panel discussion
Background: A better knowledge of the wide variety of actions of vitamin D is an essential step to improve the quality of osteoporosis care. This review of the current evidence of the binomiun ‘vitamin D-osteoporosis’ is the result of a one-day expert panel meeting held in Madrid in 2008. The panel consisted of experts in osteoporosis and mineral bone metabolism pertaining to a range of clinical disciplines and drawn from throughout Spain.
Method: A literature search was performed on the MEDLINE database for clinical trials, randomized clinical trials, systematic reviews and meta-analyses for articles published between 2007 and 2008, using the terms osteoporosis, vitamin and calcium. The resulting articles were the material used for small-group discussions at the meeting.
Findings: Oral alendronate and risedronate are the aminobisphosphonates of choice because of their proven efficacy in vertebral, nonvertebral and hip fractures. The adequate dose of vitamin D could be defined as 800 IU/day for healthy adults and as 1000 IU/day for osteoporotic patients, and the adequate amount of calcium intake is 1000-1200 mg/day. The dose required for correct functioning of extraskeletal actions of vitamin D may be higher. Calcium supplementation could be secured through the diet but drug administration is required when vitamin D supplementation is given.
Conclusions: Optimization of the nutritional supply of vitamin D and calcium is the first step in the care of the patient with osteoporosis. Vitamin D supplementation does not exclude the intervention on other factors that may influence the risk of falls.
OP is a generalised disease of the skeleton characterised by low bone mass and an alteration in bone micro-architecture, with an increase in its fragility and consequently, a greater tendency to fracture1. Primary OP is that in which the reduction in bone mass can be explained by the changes brought about by aging, such as the hormonal changes produced in the menopause; the concept of secondary OP is reserved for that which can be caused or exacerbated by other pathologies or medications2. The prevalence of secondary OP is highly variable, depending on age, sex, racial group, etc. In addition, it is not always possible to talk of an isolated cause as the origin of many cases of osteoporosis, rather, a multifactorial etiology is quite frequently found. Thus, while the prevalence of cases of secondary OP in males reaches 64%3, in perimenopausal women the prevalence is around 50%, diminishing after the menopause to a not insignificant level of 20 to 30%2.
OP is a multifactorial disease to whose genesis contribute numerous genetic and environmental factors; each factor carries a relatively small weight in the development of the disease, with the exception of ageing and the menopause. The causes of secondary OP are multiple, from genetic, endocrinal, gastrointestinal and haemetologicial diseases, to nutritional and pharmacological factors.
Although the diagnosis of OP is established through densitometric criteria, supported on occasions by clinical criteria4, there are alterations in other imaging tests –conventional X-ray, computerised tomography (CT) and magnetic resonance (MR)– which should make us suspect this diagnosis. Thus, many cases of OP may be suspected in a casual way through an X-ray examination for another reason, or in subjects with fractures and risk factors for the disease.
The fact which drives the publication of this clinical case in our environment is based on three fundamental aspects: 1) the importance of specific X-ray examinations distinct from bone densitometry in the diagnosis of OP, 2) a review, in practical terms, of the epidemiology of secondary OP and 3) the necessity of maintaining clinical suspicion in selected patients, with negative results in the usual screening tests, which allow us to establish an early diagnosis of potentially curable diseases whose late diagnosis can result in high morbimortiality.
Consensual conclusions of the I Multidisciplinary Forum on the management of patients with High Risk of osteoporotic Fracture (HRF)
On the 12th and 13th of February this year the first Forum on High Risk of Fracture was held in Madrid, coordinated by Prof. Díaz Curiel under the auspices of SEIOMM, and with the sponsorship of Nycomed. Around 100 specialists in rheumatology, traumatology, rehabilitation, geriatrics, units of bone metabolism, internal medicine and endocrinology discussed, from a multidisciplinary perspective, the presentations prepared by the group coordinators based on the review of data published and having been previously discussed in two meetings by the members of the scientific committee.
With the difficulties consequent to tackling such a complex theme, a consensus document was developed to reflect the clinical and multidisciplinary reality of the concept of “high risk of osteoporotic fracture”. An extract of this document is presented here in summary, with the aim of bringing together the views from the different specialisms involved in the management of disease in this type of at risk patient in our country
Consensus document of the Spanish Society for Bone and Mineral Metabolism Research (SEIOMM) in conjunction with: Spanish Association for the Study of the Menopause (AEEM), Hispanic Foundation for Osteoporosis and Metabolic Diseases (FHOEMO), Spanish Society of Mouth Surgery (SECIB), Spanish Society of Oral and Maxillofacial Surgery (SECOM), Spanish Society of Orthopedic Surgery and Traumatology (SECOT), Spanish Society of Endochrinology and Nutrition /SEEN), Spanish Society of Osteoporotic Fractures (SEFRAOS), Spanish Society of Geriatrics and Gerontology (SEGG), Spanish Society for Family and Community Medicine (SEMFyC), Spanish Society of Internal Medicine (SEMI), Spanish Society of Oral Medicine (SEMO), Spanish Society of Doctors in Primary Medicine (SEMERGEN), Spanish Society for Rehabilitation and Physical Medicine (SERMEF), Spanish Society of Rheumatology (SER), Ibero-American Society for Bone and Mineral Metabolism Research (SIBOMM).
Our objective has been to write a position statement on the risk of developing maxillary osteonecrosis (ONJ) in patients receiving bisphosphonates for the treatment of osteoporosis, and identifying and evaluating the extent of the evidence which supports the recommendations. In order to do this we have reviewed the published studies on the definition, epidemiology, physiopathology, clinical manifestation, diagnosis and treatment of ONJ, producing, after their analysis, the current recommendations. These have been developed after a pre-agreed and reproducible process, which included an accepted model for the evaluation and citing of the evidence which supports them. The document, once produced by the co-ordinators, was reviewed and discussed by all the members of the panel, who produced draft recommendations which were finally studied and approved by the experts of the medical societies concerned with bone mineral metabolism, listed in Annex 2.Read More
Since the first, the Journal of Savançs, was published in 1665, scientific reviews have been the vehicles par excellence for the spreading of information and scientific knowledge, and instruments of communication between researchers from the same field. In the general framework of scientific communication “authors resort to the scientific journals with intention of ensuring ownership of their ideas (a public register) and with the certainty that the knowledge published is valid, is scientifically verified and respects the academic norms of scientific method, and this because it has been evaluated fairly and impartially by the members of the scientific community themselves, thus becoming an instrument of certification, validation and knowledge”1.
The importance of scientific reviews reaches its greatest expression in the case of medicine, where they are the medium most used for the interchange of ideas, to review and to update knowledge, making them a true reflection of the evolution of this scientific community.
Since their appearance in the 17th century, the evolution of scientific reviews has been linked with the changes in the way science is conducted and especially, to the events in the purely technological realm. In recent years, especially since the appearance and spreading use of the internet in the 90s, and after its consolidation as the main medium for searching for information and spreading content, we are experiencing great transformations in the process of scientific communications which directly affect the way in which reviews are written and published: the step from the printed form to the electronic, the appearance and consolidation of the Open Access movement which has modified the way scientific knowledge is published, spread and visualised, and the incorporation in the scientific reviews of the technologies of the so-called Web 2.0, “a system of applications on the internet which can be integrated to facilitate the publication of content by the users”2, turning it into more attractive products for the final user. All this has produced significant changes in the editorial guidelines of scientific publications, as well as in the way of consulting with, and participating in, these journals. I think that these conditions make this the time for reflexion and to try to give a response to questions such as: Will the print media survive or will the digital format definitely take over? Will the reviews be accessible by subscription or free access? Will the reviews be 2.0?
Taking into account how, and by how much, the scientific communication scene has transformed in recent years, the difficulty associated with predicting how scientific reviews will be in just a few years will have escaped no one, but we attempt here to give some broad brushstrokes to give us a glimpse, at least, of the general picture.
When the last version of the “Clinical Practice Guidelines for Posmenopausal, Esteroid and Male Osteoporosis”, Society of Bone and Mineral Metabolism Research1 was produced it was agreed that it should be revised at least every 5-6 years, by editing a new version of the same document. At an intermediate point –at around 2-3 years– an update should have been produced, to include issues which could not wait for the editing of the new version, especially taking into account the fact that even as the second version was written the introduction to market of the new drugs was already being foreseen. The following document includes this update. It should be stressed that this should not be treated as an entire revision of the guides, rather only of some aspects –fundamentally therapeutic issues– considered most urgent.
Given that this should not be treated as a complete revision of the guides, rather only its update, we have considered it proper to take into account solely information relevant from the practical point of view; specifically, information related to the efficacy of the drugs in reducing the incidence of fractures. We have not assessed data related to substituted variables, such as Bone Mineral Density (BMD) or markers for bone turnover. However, we have included comparative studies or non-inferiority studies regularly carried out with BMD as a variable of efficacy, given that they definitely constitute an indirect way of establishing the usefulness of a particular drug –or in a particular way of administering them– for fractures.
A systematic search of the bibliography in PubMed was carried out, with two different approaches: a) a search under “Theraputics”, of the “Clinical Enquiries” section, using the names of the various drugs; b) a search starting with the MeSH terms, using the names of the various drugs, plus the terms “fracture” or “osteoporosis”. The names of the drugs used in the searches were the following: etidronate, alendronate, risedronate, ibandronate, zoledronate, strontium ranelate, oestrogens, hormone replacement therapy, raloxifene, tibolone, calcitonin, PTH, parathormone, PTH 1-34, teriparatide, PTH 1-84, fluoride. The period of the bibliographic search started in January 2006, the point at which the systematic search for the second version of the guides ceased, and ended in December 2008. In addition to the works found in the systematic search over the aforementioned period, we also considered for this update information based on personal knowledge gained through regular handling of the bibliography related to this subject, and data presented at conferences; this information was included even though it was collected after the systematic search had been completed.
In order to assess efficacy in relation to fractures we analysed only works designed as clinical trials or meta-analyses, rejecting observational studies.
A first draft was written by the co-ordinator of guides (JGM), which was distributed among all the members of the Committee of Experts of the SEIOMM charged with producing the second version. They proposed changes to the document, according to which a second draft was produced, which again was sent to the members of the Committee. Finally, with the comments on this second draft the final, definitive version was produced, which was approved by the Committee. The document was submitted for the consideration of the scientific societies interested in osteoporosis.
In the last few years there has been a notable interest in vitamin D, not only due to its crucial importance in bone mineral metabolism, but also for its effects outside the bone, which, every day, are becoming better known.
Similarly, the existence of low blood levels of vitamin D, lower than what is desirable, has been found in different populations, both healthy and sick, and there is a discussion as to what would be the optimum levels of vitamin D in the blood.
For all these reasons, the Spanish Society of Bone and Mineral Metabolism Research (Sociedad Española de Investigación Ósea y Metabolismo Mineral – SEIOMM), jointly with all the scientific societies involved in the study of bone metabolism, have produced this position document on the requirements and optimum levels of vitamin D.
Material and method
The content of this document was developed in the following stages:
a) Meeting of a group of experts in osteoporosis to discuss and agree the relevant clinical questions related to vitamin D (Table1).
b) Creation of a systematic review team, formed by two experts in bone mineral metabolism who carried out the search, a standardised review, critical analysis and tabulation of the articles which had been published in Spanish and English between January 2000 and May 2010. The search was carried out using the MeSH (Medical Subject Headings) terms of the National Library of Medicine of the US National Institutes of Health, related to the topic. Using these terms, the following databases were consulted: PubMed, Medline Plus, Cochrane Library, Up to Date and OVID. Similarly, an ascending search was made of the previously published guides to clinical practice relevant to the topic, as well as articles suggested by the group of experts.
c) Those articles which provided the best level of evidence for each of the questions raised were included (Table 2).
d) Subsequently, following on from the results obtain in the search, a draft of the position document was put together by the group of clinical experts to respond to the questions previously formulated and to provide a consensus on recommendations, taking into account social, economic and health repercussions. In cases of disagreement, a majority opinion was formed, leaving the absence of unanimity on record.
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