A quantitative analysis of publication trends in Iranian medical ethics and a comparison with EMRO countries.

BACKGROUND: Evaluating publication trends in a research area helps assess organised scientific efforts in the particular academic field. This study aims to evaluate and compare trends in medical ethics publications in the Eastern Mediterranean Region (EMRO) countries. METHODS: A scoping review was conducted to identify publication trends of Iranian and EMRO medical ethicists. Databases were searched, including Web of Sciences, Scopus, and PubMed for English language articles, which were published by countries in the World Health Organization EMRO regions. Iranian articles were searched in Persian and English language databases. The search strategy for the bioethics filter created by the Kennedy Institute of Ethics. Duplicate entries, tertiary publications and grey literature were excluded. All retrieved articles were categorised into ten main groups. Citavi software® was used for categorising and extracting articles' information. RESULTS: A total of 1835 English and Persian articles were obtained. Most (1211, 66%) Iranian publications in medical ethics were in Persian, and the rest (624, 34%) were in English. Most (306, 64.42%) of the published English articles in the EMRO region were authored by Iranian scholars, followed by those from Saudi Arabia (52, 10.95%), Oman (40, 8.42%), Pakistan (28, 5.89%), Lebanon (13, 2.74%), and Egypt (12, 2.53%). CONCLUSION: The results of this study show that the trend of publication of EMRO countries, especially Iranian publications, is insufficient to respond to national demands in medical ethics. A concept map has been presented to determine research needs in medical ethics. Focusing on national and regional research potentials could synergistically affect medical ethics progress in the EMRO region.

Off-label prescription: developing a guideline and validating an instrument to measure physicians' and clinical pharmacists' knowledge and attitudes toward off-label medication use.

Purpose: Off-label medications have been challenging in healthcare systems, and their significance is emphasized throughout pandemics. The study was designed to develop an ethics guideline for prescribing off-label medications and also aimed to develop a valid instrument for evaluating physicians' and clinical pharmacists' knowledge and attitudes regarding off-label medication use. Methods: In 2021, the two-phase study was done. A gap analysis study and a review of relevant guidelines and peer-reviewed papers were conducted in the first phase. There were three hybrid expert panel discussions with nine specialists until a consensus was reached. In the second phase, a questionnaire was developed to assess physicians' and pharmacists' knowledge and attitudes toward off-label prescribing medications. An expert panel of nine ethicists, physicians, and pharmacists determined the face and content validity. To evaluate the reliability and construct validity of the instrument, 201 physicians and clinical pharmacists participated. Results: This guideline provides 24 recommendations classified into seven themes to assist clinicians, pharmacists, and policymakers in managing off-label medication use. The preliminary questionnaire contained 72 items. Items were removed if their I-CVI and CVR were less than 0.79 and 0.78, respectively. The S-CVI/Average ratio was 0.937. The Cronbach α was 0.848. Ten factors were identified through exploratory factor analysis. These ten factors comprised 64.652% of the variance. There was no significant difference between general physicians, specialist physicians, and clinical pharmacists in one-way ANOVA [F = 0.584, P = 0.559]. Conclusion: We developed an ethical guideline for off-label medication use that can integrate ethical principles into related practice. Moreover, our valid and reliable questionnaire can evaluate the ethical adherence of physicians and pharmacists to scientific and ethical challenges of off-label medications in the country, especially during pandemics. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-023-01288-0.

Presenting a Comprehensive Definition of Unnecessary Healthcare Services and Their Drivers: A Systematic Review and Meta-synthesis.

Background: Providing unnecessary healthcare services is a major common problem in every health system. The scope and cause of healthcare services must be identified in order to be managed and controlled. Finding the most complete definition of the problem and its causes are the goals of this meta-synthesis. Methods: A comprehensive search strategy was performed using a wide range of keywords and databases. Based on the defined inclusion and exclusion criteria, 22 articles were selected for content analysis and meta-synthesis. The Graneheim and Lundman method was used for content analysis. The MAXQDA software Version 18.2.0 was used for the first round of content analysis. Content analysis and meta-synthesis were used to comprehensively define the term "unnecessary healthcare services" and find the etiologic factors driving healthcare providers to unnecessary healthcare services. Results: The term "unnecessary healthcare services" is defined as "overproviding healthcare services that could be harmful, low-value, insufficient, and inappropriate." The etiologic pattern of unnecessary healthcare services shows intrinsic and extrinsic factors as a driving force for unnecessary healthcare services. Conclusion: A multilayer strategy for efficient management and prevention of unnecessary healthcare services is appropriate due to the multifaceted character of these services. This approach consists of the modification of the intrinsic factors and extrinsic drivers.

Designing and psychometric evaluation of pharmacists' attitude toward ethical challenges questionnaire in pharmacy practice: A mixed­method study.

PURPOSE: Knowledge advancement exposes the pharmacists to new ethical and professional challenges in providing pharmaceutical care. The pharmacist's attitude towards the ethical challenges of pharmacy practice could be of great help in assessing pharmacist's ethical sensitivity. This study aimed to design a valid and reliable questionnaire for measuring pharmacists' attitudes. METHODS: The present study is the second phase of a sequential exploratory mixed­method study for designing and psychometric evaluation of the questionnaire. In the first phase the questionnaire was developed using semi-structured interviews followed by content analysis. The psychometric evaluation of the questionnaire was performed examining the validity (face, content, and construct), and reliability (internal consistency and Intraclass Correlation Coefficient and Standard Error of Measurement) in a sample of pharmacists practicing in community pharmacies in Tehran and Tabriz, Iran (n = 504). The construct validity of the questionnaire was determined using exploratory and confirmatory factor analysis. RESULTS: The Scale­Content Validity Index/Average (S­CVI/AVE) was calculated at 0.84. The results of exploratory factor analysis supported 22 items in four factors including regulations and rules, professional communications, providing and supplying medicine, and consultation and providing pharmaceutical care that are explained by a total of 49.50% of the variance. Also, confirmatory factor analysis confirmed goodness of fit indices and model fit. Cronbach's alpha Coefficient was 0.919 and ICC was 0.914. CONCLUSIONS: The psychometric evaluation of the present questionnaire shows a native, valid and reliable instrument to assess pharmacists' attitudes toward ethical challenges which could be a mirror of pharmacists ethical sensitivity.

The Association of Coronary Artery Calcium Score and Osteoporosis in Postmenopausal Women: A Cross-Sectional Study.

BACKGROUND: The association between osteoporosis, a common metabolic bone disorder, and atherosclerosis has been reported in different studies. In this study, we aimed to investigate the association between the coronary artery calcium score (CACS) and bone mineral density (BMD) at different sites and bone biomarkers in postmenopausal women. METHODS: A total of 184 participants were enrolled in this study. The CACS and BMD at different sites, including the spinal, total hip, and femoral neck, were measured using computed tomography angiography and dual energy X-ray absorptiometry, respectively. Serum levels of osteocalcin, ß-C-terminal telopeptide (ß-CTX), parathyroid hormone, and 25-hydroxy-vitamin D were measured. RESULTS: A negative association between CACS and bone biomarker levels (osteocalcin, P=0.021; ß-CTX, P=0.013) was noted. The univariable model showed an association between CACS and osteoporosis of the femoral neck (P=0.03). It was found that with an increase of 10 U in CACS, the odds of osteoporosis at the femoral neck escalates by 2% (odds ratio=1.02, 95% confidence interval, 1.002-1.03) using the multivariate logistic regression model, while such an association with osteoporosis could not be found at the spinal site. The best cutoff point of the calcium score was estimated to be 127. CONCLUSIONS: The results suggest that in postmenopausal women, coronary atherosclerosis is independently associated with osteoporosis of the femoral neck, but such an association could not be detected with spinal osteoporosis. The importance of screening for osteoporosis in patients with cardiovascular disease and the implications of preventive measures in the primary care setting were highlighted considering the common risk factors.

Evaluating the association between amino acid and acylcarnitine profiles and different levels of coronary artery disease risk in postmenopausal women using targeted metabolomics technique.

OBJECTIVES: Postmenopausal women are at increased risk of developing coronary artery disease (CAD). Metabolomic approaches aim at discovering more helpful biomarkers of CAD to reduce the disease burden in the future. Here, we intend to find potential blood biomarkers, amino acids, and acylcarnitines in postmenopausal women with different severity of CAD by using high-throughput methods. METHOD: This cross-sectional study was performed on postmenopausal women ( n = 183) who underwent coronary CT scans. Coronary artery calcium scoring (CACS) was assessed to detect plaque burden and degree of coronary artery obstruction. The participants were divided into three groups based on the score as follows (i) "low CACS" ( n = 96); a score of 0 to 10, (ii) "medium CACS" ( n = 35); a score between 11 and 100 and (iii) "high CACS" ( n = 52); a score greater than 100. Metabolites, including amino acids and acylcarnitines, were quantified using a targeted mass spectrometry method in serum samples. The association between metabolites and disease status was evaluated using univariate and multivariate regression analyses with adjustment for confounding factors. Factor analysis was used to deal with multiple comparisons. RESULTS: Metabolites, including proline, glutamic acid, and phenylalanine, were significantly lower in the high CACS group than the low CACS one. Also, a lower level of lysine and phenylalanine in high CACS compared with medium one was observed. Concerning acylcarnitines, it was found that C4 and C8:1 significantly were higher in women with high CACS. The logistic regression analysis revealed that the circulating levels of these metabolites (except C4) were associated with the presence of coronary artery calcification independently of age, body mass index, and time of menopause. Also, the amino acids were associated independently of medication and diabetes. CONCLUSIONS: The present study indicated that circulating levels of amino acids and acylcarnitines profile in postmenopausal women are partly associated with the severity of CAD in these participants.

Circulating amino acids and acylcarnitines correlated with different CAC score ranges in diabetic postmenopausal women using LC-MS/MS based metabolomics approach.

BACKGROUND: Diabetes mellitus (DM) and its cardiovascular disease (CVD) complication are among the most frequent causes of death worldwide. However, the metabolites linking up diabetes and CVD are less understood. In this study, we aimed to evaluate serum acylcarnitines and amino acids in postmenopausal women suffering from diabetes with different severity of CVD and compared them with healthy controls. METHODS: Through a cross-sectional study, samples were collected from postmenopausal women without diabetes and CVD as controls (n = 20), patients with diabetes and without CVD (n = 16), diabetes with low risk of CVD (n = 11), and diabetes with a high risk of CVD (n = 21) referred for CT angiography for any reason. Metabolites were detected by a targeted approach using LC-MS/MS and metabolic -alterations were assessed by applying multivariate statistical analysis. The diagnostic ability of discovered metabolites based on multivariate statistical analysis was evaluated by ROC curve analysis. RESULTS: The study included women aged from 50-80 years with 5-30 years of menopause. The relative concentration of C14:1, C14:2, C16:1, C18:1, and C18:2OH acylcarnitines decreased and C18 acylcarnitine and serine increased in diabetic patients compared to control. Besides, C16:1 and C18:2OH acylcarnitines increased in high-risk CVD diabetic patients compared to no CVD risk diabetic patients. CONCLUSION: Dysregulation of serum acylcarnitines and amino acids profile correlated with different CAC score ranges in diabetic postmenopausal women. (Ethic approval No: IR.TUMS.EMRI.REC.1399.062).

Ethics Education in Medical Sciences; A National Descriptive Survey.

Background: Historically, teaching medical ethics was always an important educational objective; however, the educational strategies to fulfill this goal varied in different times and areas. In the past two decades, teaching ethics has become an important part of the core curriculum of medical sciences in IRAN; however, ethics is relatively a newcomer to the undergraduate curriculum of medical sciences. This study aimed to evaluate the current status of teaching ethics in medical sciences in Iran. Methods: This descriptive survey was quantitatively conducted in two phases; evaluation of the curricula and syllabus of all undergraduate programs and surveying medical ethics teaching in all medical universities and/or schools using a questionnaire. The course title, content, hours (units), the recommended references, the teaching and students' assessment methods, and the information of ethics teachers were reviewed and analyzed. Results: The study showed some features about the current status of ethics teaching in medical sciences, including 1) no incorporation of ethics in 10 BS and MSc curricula; 2) different course titles, course contents and course units in similar programs; 3) non-adherence to the curriculum in terms of the core content, the references, and teaching and assessment methods; 4) non-adherence to the ethics core content especially in medical, dentistry, and pharmacy schools; 5) lack of qualified ethics teachers; and 6) no horizontal or vertical integration in ethics teaching. Conclusion: Taken together, to overcome shortcomings in teaching ethics, the authors suggest a four-phase approach for strengthening and reforming ethics education in medical sciences including determining the core content for ethics teaching by experts consensus, revising curricula in all undergraduate programs of medical sciences, training ethics teachers, and amending infrastructures for teaching ethics.

COVID-19 and the "Stay at home" recommendation: An ethnographic study.

BACKGROUND: Facing a devastating infectious outbreak like COVID-19, the command of "stay at home" was recommended by some officials as a self-voluntary quarantine strategy for controlling the outbreak, but the people perceived and act differently. In this study, we aimed at ethnographic evaluation of public response to this command. MATERIALS AND METHODS: This research used ethnography for observing the public response to the recommendation of "stay at home" in the COVID-19 outbreak. Data were collected via observing public behavior and documentation; then, the data were qualitatively analyzed. RESULTS: Our findings showed 10 different ignored dimensions in this moral statement including lack of legal and administrative support, diverse perception and contradictory reactions of the people to the epidemiological forecasting and recommendations, different response to moral statements, various perceptions of the people about health and wellbeing, feeling exhausted of staying at home, not including justice and fairness in the moral statement, not clarifying the meaning of necessary matters, not considering the COVID-19 infected patients and their requirements, assigning the responsibility of government to the public, and halting other scientific activities and investigations in charge of COVID-19. CONCLUSIONS: Taken together, the officials should take an active role in implementing this moral statement by strict regulations, public education about the disease, its control, and the importance of quarantine, considering justice and fairness in implementation.

Exploring medical ethics' implementation challenges: A qualitative study.

BACKGROUND: Adherence to medical ethics principles by medical professionals is required to improve health-care system's quality. Recognizing medical ethics' challenges and attempting to resolve them are important in the implementation of medical ethics in practice. This study aimed to explore such challenges at Iran's medical sciences universities in 2018. MATERIALS AND METHODS: This descriptive, qualitative study utilized a conventional content analysis approach for data analysis. This study was conducted using purposeful sampling from participants with experience in teaching or practicing of medical ethics field, and by considering maximum variety of disciplines (e.g., gynecology, internal medicine, surgery, and medical ethics). The data were gathered using semi-structured interviews. The interview guide was designed based on previous research findings by two members of the research team and contained the main interview questions and participants had the opportunity to express their perspectives in detail. Participants were chosen from clinical and ethical faculty members as well as managers. The data collection process continued until the data saturation stage, beyond which no new information or concept achieved by continuing interviews. RESULTS: After interviewing 14 faculty members and managers, findings were classified into 4 themes, 9 categories, and 42 sub-categories; four main categories of medical ethics challenges are affected by cognitive, educational, practical, and structural factors, respectively. CONCLUSION: This study suggested that medical ethics' cognitive and educational challenges can alleviate using educational programs intended for improving qualitative and quantitative aspects of medical ethics teaching for medical professionals ranging from students to faculty members. Medical ethics' structural and practical challenges are within policymaking and scheduling activities dealt with through future researches by health-care system's managers and planners.

Publication Trend in Islamic Medical Ethics in Iran and the World: Designing a Road.

This study aimed at determining the publication trend in Islamic medical ethics; finally, a road map was designed. All published English and Persian papers in Islamic medical ethics were searched until June 2017. Finally, 971 English papers and 204 Persian papers were analyzed. Our results show that publication in Islamic medical ethics started in 1973. The beginning of life was considered the most favorable subject followed by public health and biotechnology by both Iranian and non-Iranian scholars. Taken together, the publication trend in Islamic medical ethics has experienced ups and downs and is not as satisfactory as it should be.

The ethical challenges in pharmacy practice in community Pharmacies: A qualitative study.

BACKGROUND: Pharmacists as a group of health care professionals, face different types of ethical challenges in their everyday routine that may impede pharmaceutical care. OBJECTIVES: In this study, we aimed at evaluation and recognition of the ethical challenges of pharmacy practice in community pharmacies. METHODS: This exploratory study was conducted as a qualitative study consisting of open-ended in-depth interviews and focus group discussions followed by content analysis. The study participants were chosen from pharmacists with PharmD degree who had at least 4 years work experience and were the founders or technical managers of community pharmacies, either as governmental or private. Interviews continued until data saturation and transcribed verbatim. The content analysis was done by Graneheim and Lundman method. The codes were generated, and categorized. After assessment and final modifications, the results of the study were discussed and confirmed in a focus group discussion conducted by 7 experts who teach medical ethics and/or pharmacy ethics. RESULTS: Overall, 40 pharmacists were interviewed (mean age 46 ± 11.3 years). The extracted ethical challenges of pharmacy practice were categorized into 3 main themes, 11 subthemes and 102 codes. The themes were achieved as challenges related to professionalism and professional practice, challenges related to professional communications and challenges related to regulations and policies. CONCLUSION: Taken together, it seems that most of the challenges of pharmacy practice are related to professionalism and professional commitment; however, the regulations and policies provide serious obstacles for pharmacy practice and pharmaceutical care. More efforts towards teaching professionalism and modification of regulations and policies are recommended.

Priority setting for research in the field of medical ethics in the Islamic Republic of Iran: a Delphi study.

BACKGROUND: Priority-setting is one way to develop research in a particular field. AIMS: We aimed to identify and prioritize the most important medical ethics issues for research in the Islamic Republic of Iran. METHODS: A 3-round Delphi survey was conducted using a questionnaire covering 77 medical ethics topics in 10 categories and subcategories (extracted from literature review); this was emailed to 40 experts in medical ethics. The participants rated categories and subcategories for importance on a 5-point Likert scale and ranked the topics based on their research priorities. The highest Likert score showed the most important issue and the lowest priority score indicated the first priority. RESULTS: After consensus, the panel identified 6 categories as the highest priority and most important areas: professionalism [priority score = 2.66, standard deviation (SD) 2.63, importance score = 4.45, SD 0.72], education (priority score=3.12, SD 1.89, importance score = 4.25, SD 0.84), end of life (priority score = 3.79, SD 1.91, importance score = 4.47, SD 0.66), beginning of life (priority = 4.62, SD 1.68, importance score= 4.26, SD 0.61), public health (priority score = 5.20, SD 2.39, importance score = 4.29, SD 0.75), and ethics in research (priority score = 5.33, SD 1.97, importance score = 4.34, SD 0.64). CONCLUSION: The rankings for priority and importance was not the same. Our results highlight a lack of applicable knowledge in the areas of professionalism and end of life. This study could be used as a foundation for developing further investigations by ensuring the most appropriate use of limited resources.

COVID-19 and off label use of drugs: an ethical viewpoint.

BACKGROUND: The COVID-19 outbreak is rapidly spread over the world and kills infected patients. There is no proven medication for its treatment, so, all of the medications used for treatment are considered to be off-label. Off-label uses are not under regulation in the outbreak because there is no specific regulation for this condition. OBJECTIVES: In this short communication we aim at describing two ways of off-label use as clinical practice or investigational use. Further, we will describe the third way of off-label use, we named it pseudo-research and then we will state the most possible ethical challenges of off-label use for better perceptions and responsibility. RESULTS: The WHO considers off-label uses as country-specific. All international regulatory bodies consider off-label prescription as the physician's responsibility and legal by necessitating some requirements. There is no international guideline for regulating investigational off-label uses as clinical practice. CONCLUSION: There are different types of approaches, none of them is comprehensive and conclusive. Furthermore, respecting the four ethical principles necessitates codification and strict regulation of off-label uses either as clinical practice or investigational. Besides, compilation of a special guideline based on ethical principles especially non-maleficence and autonomy for investigational off-label uses in disasters is highly recommended.

Challenges of Confidentiality in Clinical Settings: Compilation of an Ethical Guideline.

BACKGROUND: Respecting patients confidentiality and privacy are considered as the patients' rights. Confidentiality is the key virtue for trust building in physician-patient relationship. While law considers confidentiality as absolute except for legal situations, despite efforts to maintaining confidentiality, sometimes breaching confidentiality is unavoidable but not necessarily unethical. There is no Iranian unified ethical guideline to define clear approaches to patient confidentiality in clinical setting. To keep all medical data confidential it is necessary to identify the scope of the problem. In this study, we aimed at identifying the scope of the problem. METHODS: This study was conducted in three phases including literature review, qualitative study (semi-structured interview) and focus group discussion. The literature review provided a framework for the second phase. RESULTS: The content analysis of the interviews presented 3 main themes indicating problems in maintaining confidentiality in clinical setting including management issues, organizational ethics and physician-patient relationship. CONCLUSION: Based on the results a draft guideline in confidentiality in clinical setting was prepared and finalized in focus groups discussions.

Assessment of Pharmacists Experiences and Attitudes Toward Professionalism and its Challenges in Pharmacy Practice.

Nowadays pharmacists should be involved in patients care and providing pharmaceutical care more than before, but still there is a gap between standard of care and pharmacy practice in pharmacies. In this study we aimed at evaluating the pharmacists experiences and attitudes about ethical professional practice in pharmacies. The study was conducted in the Tehran University of Medical Sciences, Tehran, Iran. This study performed as a mixed method study including 12 semi-structured interviews and two focus group discussions (FGDs). All interviews and FGDs were recorded verbatim. The study evaluates the pharmacy practice based on the Code of Ethics for National Pharmaceutical System requirements. Our study presents the pharmacists ethical challenges in 14 areas of practice such as lack of proper pharmacists-patients and inter and intra-professional relationship; poor management of medication error; lack of pharmacists awareness about their responsibilities, professional rules and regulations; non-OTC drug dispensing without prescription; no collaboration with custodian organizations; dissatisfaction from profession; financial problems; mismanagement in confronting with ads and offers of pharmaceutical companies, and conflict of interest; and uneven drug distribution during shortage. For providing standard pharmaceutical care modification of infra structures, educational system and regulations in pharmaceutical system is highly recommended.

To Tell, or Not to Tell; Confidentiality in an Iranian HIV Positive Patient: A Viewpoint.

Confidentiality is a basic concept in medical ethics and protecting confidentiality is considered as physicians' duty. In some occasions, this protection is in conflict with the right of the patient's sexual partner, who should be informed about the possibility of being infected. The sexual partner being pregnant, the situation is going to be more complicated. In this paper, we present a case discussion with special ethical, legal, social, cultural, and religious aspects. According to this informing sexual partner with the patient's assent, opt-out Human immunodeficiency virus (HIV) screening in pregnant women and enhancing psychosocial and family support are highly recommended. Strategic changes in health system policies and regulations seem to be necessary as well.

Ethical Issues Surrounding Personalized Medicine: A Literature Review.

More than a decade ago, personalized medicine was presented in modern medicine. Personalized medicine means that the right drug should be prescribed for the right patient based on genetic data. No doubt is developing medical sciences, and its shift into personalized medicine complicates ethical challenges more than before. In this review, we categorized all probable ethical considerations of personalized medicine in research and development and service provision. Based on our review, extensive changes in healthcare system including ethical changes are needed to overcome the ethical obstacles including knowledge gap and informed consent, privacy and confidentiality and availability of healthcare services. Furthermore social benefit versus science development and individual benefit should be balanced. Therefore guidelines and regulations should be compiled to represent the ethical framework; also ethical decision making should be day-to-day and individualized.

Coronary Artery Calcium Score and Bone Metabolism: A Pilot Study in Postmenopausal Women.

BACKGROUND: Since 1991 many studies evaluated the link between cardiovascular diseases and osteoporosis, two age-related conditions, but the main common pathologic pathway has not been determined yet. The histological similarity between arterial calcified plaque and bone matrix and involvement of similar cells and mediators provide a special field of research. Therefore in the present study, we aimed to evaluate the relationship between coronary artery calcium score (CACS) as a surrogate marker of atherosclerosis and bone mediators and parameters in postmenopausal women. METHODS: Eleven postmenopausal women who had CACS higher than 80 were enrolled into the study and underwent bone densitometry. In addition, their serum and urine samples were taken for measuring osteoprotegerin, osteocalcin, and ß cross laps. Patients' 10-year probability of fracture was calculated by the World Health Organization fracture-risk assessment tool (FRAX). RESULTS: The regression analysis of our results showed the association between CACS and OC (std ß=0.66, 95% confidence interval [CI] 5.47-72.27, P=0.027), femoral bone density (std ß=-0.6, 95% CI -6864.34-14.27, P=0.05) and T-score (std ß=-0.6, 95% CI -773.08-1.28, P=0.05) which remained significant after adjustment for age, weight, years since menopause and body mass index. No association was found between CACS and osteoprotegerin, spinal bone density and FRAX score. CONCLUSIONS: In conclusion, this pilot study with small sample size showed the potential association between CACS and osteocalcin, femoral bone density and T-score. However, the relationship between CACS and osteoprotegerin, receptor activator of nuclear factor-kappa B ligand, FRAX score and other bone parameters remain to be clarified in larger sample size studies.

New horizons in treatment of osteoporosis.

BACKGROUND: Prevalence of osteoporosis is increasing both in developed and developing countries. Due to rapid growth in the burden and cost of osteoporosis, worldwide, it seems reasonable to focus on the reduction of fractures as the main goal of treatment. Although, efficient pharmacological agents are available for the treatment of osteoporosis, there still remains a need to more specific drugs with less adverse effects. MAIN BODY: This review article provides a brief update on the pathogenesis, presenting current pharmacological products approved by the US Food and Drug Administration (FDA) or Europe, and also newer therapeutic agents to treat osteoporosis according to the clinical trial data available at PubMed, UpToDate, International Osteoporosis Foundation (IOF), and clinical practice guidelines. As well, the effect of combination therapy and recommendations for future research will be further discussed. SHORT CONCLUSION: The use of current antiresorptive and anabolic agents alone or in combinations for the treatment of osteoporosis entails several limitations. Mainly, their efficacy on non-vertebral fracture reduction is lower than that observed on vertebral fracture. In addition, they have potential adverse events on long time usage. Development of newer agents such as cathepsin k inhibitor and strontium ranelate not only have increased the available options for treating osteoporosis, but also have opened doors of opportunity to improvements in the effective treatment. However, the high cost of new agents have restricted their usage in selective patients who are at high risk of fracture or whom failed response to first line treatment options. Thus, personalized medicine should be considered for future evaluation of genetic risk score and also for environmental exposure assessment. In addition to permanent attention to early diagnosis of osteoporosis and understanding of the pathophysiology of osteoporosis for novel approach in drug discovery, there seems a need to more well-designed clinical trials with larger sample sizes and longer duration on current as well as on newer agents. Also, continuous research on plant-derived components as the source of discovering new agents, and conducting more clinical trials with combination of two or more synthetic drugs, plants, or drug-plant for the treatment of osteoporosis are recommended. Summary of treatment modalities for osteoporosis.