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      Clinical practice guidelines on postmenopausal osteoporosis: *An executive summary and recommendations

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          Abstract

          For review on vitamin D: Michael F Holick, Professor of Medicine, Physiology and Biophysics and Molecular Medicine. Director, Vitamin D, Skin, and Bone Research Laboratory. Programme Director General Clinical Research Unit. Director, Biologic Effects of Light Research Centre, Director, Bone Healthcare, Boston. External Review Board: A Muruganathan, Anil K Jain, Dinesh K Dhanwal, G R Sridhar, Hema Divakar, K V Radha Krishna, Prof Nihal Thomas, N S Neki, P K Shah, S K S Marya, Sandhya Kamath, Sarita Bajaj, Thomas Paul. Advisory Board: Asha Kapadia, Atul Munshi, Duru Shah, Rama Vaidya, Saroj Srivastava, Sonia Malik, Sunila Khandelwal, Urvashi Prasad Jha. External Review Board: A Muruganathan, Anil K Jain, Dinesh K Dhanwal, G R Sridhar, Hema Divakar, K V Radha Krishna, Prof Nihal Thomas, N S Neki, P K Shah, S K S Marya, Sandhya Kamath, Sarita Bajaj, Thomas Paul. Resource Faculty: Alap Shah, Amita Pandey, Anil Mahajan, Ashok Vaidya, Beena Bansal, Bharti Kalra Prof. Dr C.V. Harinarayan, Dilip Mehta, Hemant Tiwari, I.V. Reddy, Jyothi Unni, Ketan Mehta, Manisha Sahay, Meeta, Nagamani, Neelam Agarwal, Rabindera Nath Mehrotra, Raghava Dutt Mulukutla, Rakesh Sahay, Major General (Dr) Raman Kumar Marwaha, Ram Prabhoo, Rama Vaidya, Ranu Patni, Rashmi Shah, Sanjay Bhadada, Sanjay Kalra, Sailesh. B, Seema Puri, Sharad Kumar, Shashank Joshi, Shushrut Babhulkar, Siddharth Sarkar, Sudha Sharma, Sunila Khandelwal, Sushil Gupta, Vishal R. Tandon, Vivek Arya, U.R.K. Rao, Yatan Pal Singh Balhara. INTRODUCTION Guidelines are a method of translating the best available evidence into clinical, communicable, organizational, and policy making statements in the hope of improving health care and or policies. Do we need country specific guidelines? Yes, we do. Given the fact that the model of health-care delivery system and the prevailing environment of one country may not be extrapolated to that of another. “Working with what you have, where you are and not with what you wish for” – is the principle each one of us follow in the clinical practice to give the best to our patients. This guideline hopes to bridge the gap between evidence based practice, backed by scientific evidence and experience based practice based on the published and unpublished Indian data and expert opinions. Unlike protocols, guidelines are meant to aid the clinician in decision making. The target readers of this guideline are the adult women, members of the Indian Menopause Society (IMS), allied professionals, health-care providers, and policy makers. India is a land of rich and diverse cultural heritage. It is a land of diversity in terms of, socioeconomic, religion, culture, beliefs, education, nutrition urban, rural, and geographical regions. The dilemmas and challenges are unique to different regions and solutions need to be planned accordingly. The specific issues pertaining to Indian women are an early age of natural menopause, genetic and environmental influences, nutritional deficiencies, and excesses resulting in physiologic differences. These factors contribute significantly to an increased incidence of diabetes, cardiovascular disease, osteoporosis, and thyroid dysfunction. Genetic components are likely to play a prominent role in these disorders for example, polymorphisms in estrogen receptors alpha and vitamin D receptor has been implicated in the pathogenesis of osteoporosis. The burden of morbidity from osteoporosis has significant medical, social, and financial implications. Osteoporotic fractures are preventable, yet diagnosed only after the event; a situation similar to the diagnosis of hypertension after myocardial infarction or stroke. It has a long incubation period and cost- effective treatment strategies currently available for this disease mandate that osteoporosis be diagnosed and treated early. OBJECTIVES To recognize post-menopausal osteoporosis (PMO) as a major health issue among health-care professionals, policy makers, and the public. To assist health-care practitioners in providing optimal care to post-menopausal women with the available resources. Osteoporosis is a costly debilitating disease, hence it is important to instill preventive measures, diagnose early, encourage modifications of risk factors associated with osteoporosis. Counseling on nutritional factors, abuse of tobacco, heavy alcohol consumption, and on life-style should be mandatory. Treat with pharmacologic agents only when indicated. To fill the lacunae of medical care after managing fragility fracture. To aid primary care physicians to decide when to refer patients with difficult problems to the relevant specialists. To stimulate interest in research on osteoporosis. METHODS The planning to publishing of the document took 24 months. The core committee was formed and a broad based multi-disciplinary list of experts were invited to write on the topic of their expertise. Majority of the reviews and deliberations wear by E-mail. A two day intensive contact program of the contributors was convened at Hyderabad on December 8th and 9th 2012. Each topic was presented and deliberated upon, and the consensus obtained by an automated response system. Later one day contact meeting of the Editorial Board was convened on January 11th, 2013. Finally, the document was validated by an External Review Board. Data were sourced from the electronic database PubMed, MEDLINE, Cochrane Database of Systematic Reviews and published guidelines on PMO management. The appraisal of Guidelines Research and Evaluation,[1] instrument was used to appraise published guidelines. Abstracts from papers and posters presented at the National Indian Menopause Society Meetings, published and unpublished studies, expert opinion was considered. Cost-effectiveness of diagnosis and treatment is based on the available market value. SYSTEM FOR GRADING: EVIDENCE USED IN THE DOCUMENT The quality of evidence and the level of recommendation was carried out using the grades of recommendation, assessment, development, and evaluation (GRADE),[2] system. Recommendations are based on strong evidence, suggestions on experience based evidence, this method is adapted to unite the diverse conditions of India with the best available data and the rich experience based evidence from the experts. GRADE: Grades of evidence: High quality – GRADE A: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality – GRADE B: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality – GRADE C: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality – GRADE D: We are very uncertain about the estimate. In terms of the strength of the recommendation, strong recommendations use the phrase “recommend,” and weak recommendations use the phrase “suggest.” Research questions are placed at the end of each chapter in the monogram of the book. BENEFITS OF USING THE GUIDELINE Benefits of using these guidelines are: (i) Improved early identification and better management of women at risk for fragility fractures; (ii) down grading the disease burden after an episode of fragility fracture by improving the assessment, management and follow-up of these women; (iii) understanding the urgent need of conducting preventive health programs by all stake holders related to women’s health; and (iv) in addition, in view of the paucity of Indian data it is hoped that this guideline will help stimulate interest in research in various aspects of PMO. CONCLUSIONS Osteoporosis has significant medical, social, and financial implications. The onus is on the Government and Non-Government Organizations to develop specialty menopause and osteoporosis clinics akin to antenatal clinics in the private and public sectors besides developing management of menopause as a medical specialty within obstetrics and gynecology care. The aim of the guideline is to provide a resource documentss to aid the busy clinician to give optimal care to the ageing woman. Limitations are the paucity of robust research evidence in India. This is one of the endeavors of the Indian Menopause Society to work toward the slogan “Fit @ Forty, Strong @ Sixty, Independent @ Eighty”. ACKNOWLEDGEMENTS We thank the experts who took time out of their busy family life, academics, and work to contribute to the document on PMO in India. A special thanks to Dr. Hemant Zaveri for sourcing the data. DISSEMINATION OF THE GUIDELINES A free copy of the guideline is for the members of the IMS and Jaypee Publishers are making the monogram available widely for purchase by the health-care providers and policy makers. The Guideline is available on the IMS website www.indianmenopausesociety.org.com and is published in the Journal of Midlife, official publication of the IMS. REVISION OF THE GUIDELINES It is recommended that the guidelines are upgraded every 2 years. EDITORIAL INDEPENENCE The views expressed are independent of any extraneous influences.

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          Hip fractures in the elderly: a world-wide projection.

          Hip fractures are recognized to be a major public health problem in many Western nations, most notably those in North America, Europe and Oceania. Incidence rates for hip fracture in other parts of the world are generally lower than those reported for these predominantly Caucasian populations, and this has led to the belief that osteoporosis represents less of a problem to the nations of Asia, South American and Africa. Demographic changes in the next 60 years, however, will lead to huge increases in the elderly populations of those countries. We have applied available incidence rates for hip fracture from various parts of the world to projected populations in 1990, 2025 and 2050 in order to estimate the numbers of hip fractures which might occur in each of the major continental regions. The projections indicate that the number of hip fractures occurring in the world each year will rise from 1.66 million in 1990 to 6.26 million by 2050. While Europe and North America account for about half of all hip fractures among elderly people today, this proportion will fall to around one quarter in 2050, by which time steep increases will be observed throughout Asia and Latin America. The results suggest that osteoporosis will truly become a global problem over the next half century, and that preventive strategies will be required in parts of the world where they are not currently felt to be necessary.
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            Predictive value of BMD for hip and other fractures.

            The relationship between BMD and fracture risk was estimated in a meta-analysis of data from 12 cohort studies of approximately 39,000 men and women. Low hip BMD was an important predictor of fracture risk. The prediction of hip fracture with hip BMD also depended on age and z score. The aim of this study was to quantify the relationship between BMD and fracture risk and examine the effect of age, sex, time since measurement, and initial BMD value. We studied 9891 men and 29,082 women from 12 cohorts comprising EVOS/EPOS, EPIDOS, OFELY, CaMos, Rochester, Sheffield, Rotterdam, Kuopio, DOES, Hiroshima, and 2 cohorts from Gothenburg. Cohorts were followed for up to 16.3 years and a total of 168,366 person-years. The effect of BMD on fracture risk was examined using a Poisson model in each cohort and each sex separately. Results of the different studies were then merged using weighted coefficients. BMD measurement at the femoral neck with DXA was a strong predictor of hip fractures both in men and women with a similar predictive ability. At the age of 65 years, risk ratio increased by 2.94 (95% CI = 2.02-4.27) in men and by 2.88 (95% CI = 2.31-3.59) in women for each SD decrease in BMD. However, the effect was dependent on age, with a significantly higher gradient of risk at age 50 years than at age 80 years. Although the gradient of hip fracture risk decreased with age, the absolute risk still rose markedly with age. For any fracture and for any osteoporotic fracture, the gradient of risk was lower than for hip fractures. At the age of 65 years, the risk of osteoporotic fractures increased in men by 1.41 per SD decrease in BMD (95% CI = 1.33-1.51) and in women by 1.38 per SD (95% CI = 1.28-1.48). In contrast with hip fracture risk, the gradient of risk increased with age. For the prediction of any osteoporotic fracture (and any fracture), there was a higher gradient of risk the lower the BMD. At a z score of -4 SD, the risk gradient was 2.10 per SD (95% CI = 1.63-2.71) and at a z score of -1 SD, the risk was 1.73 per SD (95% CI = 1.59-1.89) in men and women combined. A similar but less pronounced and nonsignificant effect was observed for hip fractures. Data for ultrasound and peripheral measurements were available from three cohorts. The predictive ability of these devices was somewhat less than that of DXA measurements at the femoral neck by age, sex, and BMD value. We conclude that BMD is a risk factor for fracture of substantial importance and is similar in both sexes. Its validation on an international basis permits its use in case finding strategies. Its use should, however, take account of the variations in predictive value with age and BMD.
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              Vertebral fractures and mortality in older women: a prospective study. Study of Osteoporotic Fractures Research Group.

              Osteoporotic fractures, including clinically detected vertebral fractures, are associated with increased mortality. However, only one third of vertebral fractures are diagnosed. It is unknown whether vertebral fractures, whether clinically apparent or not, are associated with greater mortality. To test the hypothesis that women with prevalent vertebral fractures have greater mortality than those without fractures and to describe causes of death associated with vertebral fractures. Prospective cohort study with mean follow-up of 8.3 years. Four clinical centers in the United States. A total of 9575 women aged 65 years or older and enrolled in the Study of Osteoporotic Fractures. Vertebral fractures by radiographic morphometry; calcaneal bone mineral density; demographic, medical history, and lifestyle variables; blood pressure; and anthropometric measures. In a subset of 606 participants, thoracic curvature was measured during a second clinic visit. Hazard ratios for mortality and cause-specific mortality. At baseline, 1915 women (20.0%) were diagnosed as having vertebral fractures. Compared with women who did not have a vertebral fracture, women with 1 or more fractures had a 1.23-fold greater age-adjusted mortality rate (95% confidence interval, 1.10-1.37). Mortality rose with greater numbers of vertebral fractures, from 19 per 1000 woman-years in women with no fractures to 44 per 1000 woman-years in those with 5 or more fractures (P for trend, <.001). In particular, vertebral fractures were related to the risk of subsequent cancer (hazard ratio, 1.4;95% confidence interval, 1.1-1.7) and pulmonary death (hazard ratio, 2.1;95% confidence interval, 1.4-3.0). In the subset of women who underwent thoracic curvature measurements, severe kyphosis was also related to pulmonary deaths (hazard ratio, 2.6;95% confidence interval, 1.3-5.1). Women with radiographic evidence of vertebral fractures have an increased mortality rate, particularly from pulmonary disease and cancer.
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                Author and article information

                Journal
                J Midlife Health
                J Midlife Health
                JMH
                Journal of Mid-Life Health
                Medknow Publications & Media Pvt Ltd (India )
                0976-7800
                0976-7819
                Apr-Jun 2013
                : 4
                : 2
                : 107-126
                Affiliations
                [1]Indian Menopause Society, Hyderabad, India
                Author notes
                Address for Correspondence: Dr. Meeta, Tanvir Hospital, Plot No. 100, Phase-I, Kamalapuri Colony, Hyderabad - 500 073, India. E-mail: drmeeta919@ 123456gmail.com
                [*]

                This is a summary and recommendations from the detailed document on Clinical Practice Guidelines on Menopause published by Jaypees. (R-indicates Recommendation with Grading, the detailed references is listed in the main document. The text of the unpublished references can be procured from Dr. Meeta at drmeeta919@ 123456gmail.com )

                Article
                JMH-4-107
                10.4103/0976-7800.115293
                3785150
                24082708
                df664372-300c-42ad-8160-97101f25fa0c
                Copyright: © Journal of Mid-life Health

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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