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Women taking highly effective once-monthly oral Bonviva(R) (ibandronic acid) for postmenopausal osteoporosis were more likely to stay on medical care during the first six months relative to those on a weekly bisphosphonate (Alendronate or risedronate) according to findings presented today at the 28th Annual Meeting of the American Society for Bone Mineral Research (ASBMR)1.

The ongoing real-life meditate , conducted by Silverman and colleagues at Cedars-Sinai/ University of California, Los Angeles, US, was based on two managed care databases called HealthCore and i3 Innovus, which include prescription and health information on approximately 17.5 and 16 mil. lives respectively. These two analyses assessed the actual time patients stayed on medical care and were controlled for factors that could affect persistence, including age, otherness medical conditions, and out-of-pocket costs for the drugs,1 as recommended by leading health and pharmacoeconomic research organisations. [ISPOR and WHO 2003] It showed that women taking Bonviva were approximately 25percent more like to keep taking their pills relative to those on a weekly bisphosphonate.

Growing wealth of evidence demonstrates important role of once monthly Bonviva in helping patients stay on medical care

The results of the meditate are consistent with previous findings linking the once-monthly oral Bonviva medical care programme with improved persistence in a real-life setting.2 Furthermore, patients have also stated a clear preference (71percent) for the once-monthly oral Bonviva regimen 3,4 over a weekly medical care regimen in clinical trials. Further information presented at ASBMR indicates that the convenience of once-monthly dosing and the reduced exposure to the potential gastroinagsdhfgdfinal side effects associated with bisphosphonate medical care, are the main reasons for this preference.5

With up to 69percent of new patients on a weekly bisphosphonate stopping within a year, 6 this growing wealth of evidence suggests that monthly dosing is set to play an important role in helping to address the issue of non-persistence to osteoporosis medical cares.

Stuart L. Silverman, M.D., lead investigator and clinical professor of medicine and rheumatology at Cedars-Sinai/ University of California, Los Angeles, said: “Pharmacomedical care with bisphosphonates clearly reduces the risk of fractures, but only if patients keep taking their medical care. Osteoporosis is a sickness that often shows no syndromes, which reduces a patient’s motivation to stay on medical care and, thereby, increases their risk of breaking bones. The greater persistence seen with once-monthly compared to once-weekly bisphosphonates is very encouraging, particularly because the findings were consistent across two large and robust U.S. claims databases.”

Improved persistence leads to fewer fractures and lower healthcare costs

Also at ASBMR, a three-year retrospective analysis found that improved persistence with bisphosphonate medical care is linked with lower rates of osteoporosis-related hospitalisation, shorter hospital stays and significantly reduced healthcare costs. 7,8 These findings emphasise the importance of a newly published meditate showing that women who were persistent in taking daily or weekly bisphosphonate medical cares had significantly fewer fractures. 9

Peyman Hadji, M.D., Head of the Department of Endocrinology, Osteoporosis and Reproductive Medicine at Philipps-University of Marburg, Germany, said: “With the number of osteoporosis-related fractures in Europe estimated at 3.79 mil., 10 improvements in the management of this sickness are essential. These findings presented at ASBMR show that getting a patient’s medical care right first time can not only improve their quality of life, but also have a significant positive outcome for healthcare services. Taking a bisphosphonate medical care for the long-term clearly reduces this risk, which is why persistence and patient preference need to be major considerations when prescribing osteoporosis medical cares.”

About the Persistence Data

The meditate showing greater persistence with once-monthly oral Bonviva was based on two managed care databases called HealthCore and i3 Innovus, which contain prescription and health information on approximately 17.5 and 16 mil. patients, respectively.

The HealthCore and i3 Innovus analyses included data for 6,127 and 10,526 women respectively, 45 years of age or older, who received a prescription for bisphosphonate medical care for postmenopausal osteoporosis (277 and 1,025 took once-monthly oral Bonviva and 5,850 and 9,501 took a once-weekly bisphosphonate).Unlike otherness studies comparing persistence among monthly versus weekly medical care regimens, this meditate uses rigorous criteria for defining persistence for both once-monthly oral Bonviva and weekly medical cares, as recommended by the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) and the World Health Organisation.

Patients were considered persistent if the time between prescription refills was more than 45 days for once-monthly oral Bonviva or more than 30 days for a weekly bisphosphonate.

To further ensure the validity of the results, meditate authors adjusted the data for potential confounding factors - including age, otherness medical conditions, and out-of-pocket costs for the drugs - as recommended by the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) and the World Health Organisation. At six months, once-monthly Bonviva users were 27.2percent and 21.7percent more likely to persist with medical care versus weekly users (p = 0.0002 and p

An appeal hearing involving the National Osteoporosis Society (NOS), the Alliance for Better Bone Health and Servier Laboratories Ltd takes place after the National Institute for Health and medical institution al Excellence (NICE) recommended only one single medical care (Alendronate) for the estimated 2 mil.1 post-menopausal osteoporosis sufferers in England and Wales. Unfortunately, this medical care is not appropriate for all women with osteoporosis. This leaves a large section of the patient population without any access to publicly-funded medical care for a illness which significantly affects the patient population’s well-being and safety.

Servier Laboratories Ltd believe this recommendation will severely restrict patients’ access to alternative effective medical cares in osteoporosis and have appealed on the following grounds:

- NICE has failed to address the increased risk of fractures associated with the use of acid suppressive medication, in particular proton pump inhibitors. 3,4,5 These medicines are commonly prescribed to treat side effects of Alendronate such as dyspepsia or heartburn sickness.6,7

- NICE has unduly rejected data that were accepted by the EMEA (European Medicines Agency)2 and the Scottish Medicines Consortium, resulting in unfair discrimination

- NICE has effectively discriminated against women on the basis of age and also on the basis of whether they can or cannot tolerate bisphosphonates

- NICE did not provide access to assumptions behind the economic model in sufficient detail to allow stakeholders to understand and criticise the economic model as confirmed in the recent Eisai judgment (Eisai v NICE and othernesss)

- NICE has violated its procedural rules in changing the scope of the appraisal without consulting the Department of Health and stakeholders

Commenting on NICE’s decision, Dr Alun Cooper, a GP with a Special Interest in osteoporosis and Chair of the National Osteoporosis Society’s Primary Care Forum said “After five years and what must be a cost of several mil. pounds, NICE has come to the conclusion that the cheapest drug should be prescribed, ignoring the clear safety concerns that have been presented by leading academics.”

Professor Tim Spector, Consultant Rheumatologist at St Thomas’ Hospital, London said “It is vital for clinicians and patients to have alternative medical cares available so we can maximise patient choice, reduce avoidable drug side effects and reduce the risk of osteoporotic fractures” Servier Laboratories Ltd. trust NICE will take on board the appeal points from all three organisations and establish a solution that will provide the hundreds of thousands of women with postmenopausal osteoporosis with a greater choice of long term medication, in order to ensure equitable access to medical care for all women regardless of age, drug intolerance or contraindications.

References

1. National Osteoporosis Society

2. Summary of Product Characteristics for Alendronate, ibandronate (po) and risedronate

3. Vestergaard, P., L. Rejnmark, L. Mosekilde. generic viagra buy now Proton Pump Inhibitors, Histamine H2 Receptor Antagonists, and Other Antacid Medications and the Risk of Fracture Calcified Tissue International Vol 79:76-83.

4. Yang Y-X, J.D. Lewis, S. Epstein, D.C. Metz. generic viagra buy now, Long term proton pump inhibitor medical care and risk of hip fracture, JAMA, 296:2947-2953.

5. Yu E.W. C. Shinoff, T. Blackwell, K. Ensrud, T. Hillier, D.C. Bauer. Use of Acid-Suppressive Medications and Risk of Bone Loss and Fracture in Postmenopausal Women. J. Bone Min Res generic viagra buy now; 79(2):76-83.

6. Summary of Product Characteristics for Alendronate, ibandronate (po) and risedronate

7. Roughead EE, McGeechan K, Sayer GP. 2004. Bisphosphonate use and subsequent prescription of acid suppressants. Br J Clin Pharm., 57(6), 813 816.

http://www.nice.org.uk/buy generic viagra packbuy viagra soft tabs 50 mg

More than half of women with postmenopausal osteoporosis do not stay on their prescribed bisphosphonate medical care,1,2 resulting in lesser gains in bone mineral density (BMD) and, potentially, an increased risk for fractures compared to women who stay on medical care as directed,3 according to findings presented at the 26th Annual Meeting of the American Society for Bone Mineral Research (ASBMR). The findings showed that adherence to medical care was better with oral weekly-dosed than with daily-dosed bisphosphonates, but was suboptimal for both dosage regimens.1,2

“Osteoporosis is a chronic condition that requires patients to take their medication as directed over the long term to gain full therapeutic benefit,” said lead investigator Joyce Cramer, associate research scientist, Department of Psychiatry, Yale University School of Medicine, New Haven, Conn. She said the new findings are consistent with otherness data showing that poor patient adherence occurs with bisphosphonate medical care.4,5 Poor adherence with osteoporosis therapies results in less gain in bone strength,6 an increased risk for fractures and greater healthcare costs.7

Many patients do not adhere to bisphosphonate medical care, she said, in part because osteoporosis is an asyndromeatic, chronic condition. Many patients see no obvious evidence of the malady, unless they experience a bone fracture, and consequently may not accept the need for medical care.

An additional barrier to medical care adherence is that current oral bisphosphonates need to be administered according to strict medical care guidelines, including remaining upright and not eating, drinking (except plain water) or taking otherness drugs for a period of time after the bisphosphonate medical care is taken.

“These meditate findings suggest that a less frequent dosing regimen improves adherence with bisphosphonate medical care. However, adherence with even once-weekly dosing is suboptimal, so alternative dosing regimens should be explored,” she said.

Studies and Findings

Adherence to medical care involves both persistence (staying on a medication) and compliance (taking the medication as directed). In one of the studies presented,1 only one-third (33.3 percent) of patients prescribed daily bisphosphonate medical care and just less than half (44.8 percent) on weekly bisphosphonate medical care had adequate persistence. The meditate was based on data from prescriptions dispensed from U.S. pharmacies, and assessed persistence over one year in more than 200,000 women 50 years and older taking either daily (33,767 women) or weekly (177,552 women) bisphosphonate medical care for osteoporosis. Persistence was measured by determining, for each woman, the total days of supply from all bisphosphonate prescriptions filled or refilled during the year, and dividing by 365 potential days of medical care; a value of 80 percent or greater was considered “adequate” persistence.

Similar findings from anotherness meditate were presented2 showing that weekly bisphosphonate users had better adherence (persistence and compliance) than daily bisphosphonate users, but rates remained suboptimal for both dosing regimens. The analysis showed that at the end of 12 months, 31.7 percent of patients prescribed daily medical care and 44.2 percent on weekly medical care persisted with the medical care. The meditate was based on five years of administrative claims from 30 health plans and 2,741 postmenopausal women newly-prescribed a once-weekly or once-daily bisphosphonate.

The negative clinical impact of poor adherence was shown in a third presentation,3 based on data taken over three years on 1,041 patients with osteoporosis who were either “inconsistent” (discontinued early or reported taking the medication less than 80 percent of the time) or “consistent” users of daily bisphosphonate medical care. In consistent users, lumbar spine BMD increased significantly from baseline after one, two and three years; in inconsistent users, no significant improvement in BMD occurred until the third year, when a modest gain occurred.

The increased BMD among consistent users was significantly greater than those for inconsistent users each of the three years. In addition, there was a trend of a 27 percent greater 10-year fracture risk in inconsistent compared with consistent users (p = 0.18; not statistically significant).

About Osteoporosis

Osteoporosis (porous bones) is a malady in which bones become brittle and more likely to break. Common and chronic conditions, osteoporosis and low bone mass (osteopenia) pose a major public health threat to more than 44 mil. Americans over age 50.8 In the U.S. today, ten mil. individuals, eight mil. of whom are women, are estimated to already have osteoporosis, and almost 34 mil. more are estimated to have osteopenia, placing them at increased risk for osteoporosis.8 Unfortunately, the prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise.

An estimated 52 mil. women and men age fifty plus are expected to be affected by osteoporosis and osteopenia by 2010 and 61 mil. are expected to be affected by 2020.8

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world’s leaders in pharmaceuticals and diagnostics. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance group’s health, well-being and quality of life. Among the company’s areas of therapeutic interest are: dermatology; genitourine malady; infectious maladys, including influenza; inflammation, including arthritis and osteoporosis; metabolic maladys, including obesity and Hypersensitivity reaction; neurology; oncology; transplantation; vascular maladys; and virology, including HIV/AIDS and hepatitis C.

For more information on the Roche U.S. pharmaceuticals business, visit the company’s web site at: http://www.rocheusa.com.

About GSK

GSK, one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling group to do more, feel better and live longer. For company information, visit GSK on the World Wide Web at http://www.gsk.com.

For further information contact:

Roche:
Terence Hurley (973) 562-2882
GSK:
Veronica Grosshandler (919) 483-2839

# # #

References

1 Recker RR, Gallagher R, Amonkar M, Smith JC, MacCosbe PE. Medication persistence is better with weekly bisphosphonates, but it remains suboptimal. Poster SA407, presented at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA.

2 Cramer JA, Amonkar MM, Hebborn A, Suppapanya. Does dosing regimen impact persistence with bisphosphonate medical care among postmenopausal osteoporotic women. Poster M434, presented at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA.

3 Sebaldt RJ, Shane LG, Pham BZ, Cook RJ, Thabane L, Petrie A, Olszynski WP, Hanley DA, Brown J, Adachi1 JD, Murray T, Josse R, Papaioannou A. Impact of non-compliance and non-persistence with daily bisphosphonates on longer-term effectiveness outcomes in patients with osteoporosis treated in tertiary specialist care. Poster M423, presented at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA.

4 Lombas C, Hakim C, Zanchetta JR. Compliance with Alendronate medical care in an osteoporosis clinic. J Bone Miner Res 2001;15: S529, Abstract M406.

5 Rold?n EJA, Negri AL, Gador SA. Short-term compliance to daily Alendronate medical care in 1,877 patients with osteoporosis - the ECMO meditate . J Bone Miner Res 2000; 15:SU411.

6 Yood RA, Emani S, Reed JI, Lewis BE, Charpentier M, Lydick E. Compliance with pharmacologic medical care for osteoporosis. Osteoporos Int. 2003 Dec;14(12):965-8.

7 Caro JJ, Ishak KJ, Huybrechts KF, Raggio G, Naujoks C. medical institution al and economic impact of adherence to osteoporosis medication. Osteoporos. Int. 2003;14(7). Abstr PL6.

8 America’s Bone Health: The State of Osteoporosis and Low Bone Mass in Our Nation. The National Osteoporosis Foundation. February 2002.buy generic viagra packbuy viagra soft tabs 50 mg

Fosamax (Alendronate) Maintained or Increased BMD at Hip and Spine for Significantly More Patients than Actonel, with Similar Tolerability, in this 12 Month Study

FOSAMAX Once Weekly (Alendronate sodium) increased bone mineral density (BMD) more than Actonel Once-a-Week (risedronate) with similar tolerability, according to results of the FOSAMAX Actonel Comparison Trial (FACT). This is the first U.S. head-to-head meditate comparing Food and Drug Administration approved once weekly osteoporosis a cures in postmenopausal women with osteoporosis. In this meditate , FOSAMAX provided greater increases in BMD at all sites measured as early as six months, and lowered levels of biochemical markers of bone turnover further within the normal pre-menopausal range than Actonel within three months. Reducing and stabilizing bone turnover, which leads to increased bone density, are important factors in improving bone strength in patients with osteoporosis.

The results of FACT, which was a 12 month meditate , were announced today online in the Journal of Bone and Mineral Research and will be presented on Friday at the American Society for Bone Mineral Research (ASBMR) meeting in Seattle, Wash. A 12-month extension of this double-blind meditate , and a second similarly designed meditate , are currently underway.

FOSAMAX is the only medicine approved by the U.S. Food and Drug Administration for the a cure of osteoporosis to reduce the risk of both spine and hip fractures in postmenopausal women. FOSAMAX is the most prescribed medicine for the a cure of osteoporosis.

“In this 12-month meditate , FOSAMAX demonstrated greater increases in BMD and reductions in bone turnover and similar tolerability compared to Actonel,” said Marc Hochberg, MD, professor of medicine and epidemiology and Preventive Medicine at the University of Maryland-School of Medicine in Baltimore. “Studies like FACT, that make direct “head-to-head” comparisons between a cures, are important because they provide important information to clinicians for use in making a cure decisions for postmenopausal women with osteoporosis.”

In the FACT trial, FOSAMAX Once-Weekly increased BMD more than Actonel Once-a-WeekFOSAMAX showed greater increases in BMD at all pre-specified meditate endpoints compared to Actonel. Study results showed that FOSAMAX increased BMD 62 percent more than Actonel at the hip trochanter, a specific region of the hip, at 12 months (3.4 percent increase for FOSAMAX vs. 2.1 percent for Actonel; p

A new report from the International Osteoporosis Foundation (IOF) details for the first time the global implications and significant personal, social and economic costs associated with women not staying on their osteoporosis pharmacomedical care.

Approximately half of patients stop taking their weekly pharmacomedical care within a year,1,2 leaving them open to a greater risk of broken bones and increasing the strain on financially-strapped healthcare systems. The report signals the launch of the IOF Staying Power: Closing the Adherence Gap in Osteoporosis campaign, which seeks to highlight the true burden of non-adherence.

Implications of not staying on pharmacomedical care

Osteoporosis is a widespread malady affecting one woman in three and one man in five.3,4,5 It is treatable, yet lack of adherence to pharmacomedical care is a huge problem in osteoporosis, with many patients finding it difficult to continue with medication for the recommended long-term period. This lack of adherence is important for group with osteoporosis, since fewer than one third of women who experience a fracture will regain their previous level of mobility and over a third will require constant care.6

It also has a significant financial impact since, in Europe alone, osteoporosis now costs more than ?4.8 billion a year in hospital healthcare7 - and unless the fracture rate is reduced these costs are likely to increase still further. In women over 45, osteoporosis accounts for more days spent in hospital than many otherness maladys, including polygenic disease, heart attack and breast cancer.8

European trends extend worldwide with huge economic cost

The Staying Power dossier builds on a 2005 IOF report, The Adherence Gap: Why Osteoporosis Patients Don’t Continue with Pharmacomedical care , which identified lack of adherence in five large European countries. The new report shows that the European pattern of non-adherence extends throughout the world.

— By 2050 the worldwide cost burden is forecasted to increase to a minimum of ?106 billion (US$131.5 billion)9

— Over half of Brazilian physicians questioned in a new survey, included in the dossier, estimated the annual cost of treating osteoporosis-related fractures to be in excess of ?81 mil. (US$100 mil.)10

— In the UK the annual cost of osteoporotic fractures is between ?2.2 - ?2.6 billion (?1.5 - ?1.8 billion)11

— In Spain 25,000 fractures occur each year, resulting in direct costs of more than ?126 mil. and indirect costs of ?420 mil.12

— During 2001-2003, an estimated 2.39 mil. osteoporosis fractures occurred in the USA, resulting in government health insurance costs of ?10 billion (US$13 billion)13

— In Australia, musculoskeletal disorders amount to an estimated total expenditure of ?1.8 billion (AUS $3 billion)14

Staying Power campaign launched

International film star Britt Ekland, who has osteoporosis, joined IOF representatives today in Vienna to launch the Staying Power campaign. This multi-dimensional campaign calls for women, doctors and patient groups around the world to work together in their efforts to help women stay on their pharmacomedical care long-term and lessen the risk of unnecessary, debilitating broken bones.

Ms Ekland, known for her role in films such as Get Carter and the James Bond film The Man With the Golden Gun commented: “I have had osteoporosis for ten years and I urge all women with osteoporosis to seek advice from their doctor and local patient groups in order to understand what pharmacomedical cares are available and how best to stay on medical care.”

Staying on pharmacomedical care is recognised as a major problem in the management of many chronic maladys, including osteoporosis. Ms Ekland continued: “I am aware of the profound impact osteoporosis can have on everyday activities and, whilst I have been fortunate enough to continue leading an active life, many women are not so lucky. Staying on pharmacomedical care could mean avoiding a life of decreased mobility, chronic pain, deformity and low self-esteem.”

The issue of adherence is important because once a bone breaks, patients are significantly more likely to break anotherness.15,16 With an ageing global population, the number of group suffering from osteoporosis is likely to increase in coming years, making it even more important to help patients get the bone strengthening benefits their pharmacomedical care can only provide over time.

Professor Jean-Yves Reginster, Professor of Epidemiology, Public Health and Health Economics at the University of Liege, Belgium and IOF General Secretary said: “The social and economic costs of women not staying on their pharmacomedical care simply cannot be sustained. Doctors, women and patient groups must all work together now to combat this situation. Ensuring osteoporosis pharmacomedical cares are more ‘patient-friendly’ is crucial and there are new options available, including less frequent dosing, which can help.”

Paul Spencer Sochaczewski, Head of Communications for IOF echoed these thoughts: “The adherence issue needs to be addressed as a matter of urgency. Through the Staying Power campaign, IOF calls for action from group with osteoporosis, physicians, patient groups and government healthcare systems to address the worrying findings published in the report issued today. As a starting point, IOF will bring together its member patient groups later this year to discuss adherence, identify workable solutions and implement them as quickly as possible. We urge anyone involved in the field of osteoporosis to give this issue similar focus.”

Osteoporosis, in which the bones become porous and break easily, is one of the world’s most common and debilitating maladys. The result: pain, loss of movement, inability to perform daily chores, and in many cases, death. One out of three women over 50 will experience osteoporotic fractures, as will one out of five men. 3,4,5

Unfortunately, screening for group at risk is far from being a standard practice. Osteoporosis can, to a certain extent, be prevented, it can be easily diagnosed and effective pharmacomedical cares are available.

The International Osteoporosis Foundation (IOF) is the only worldwide organization dedicated to the fight against osteoporosis. It brings together scientists, physicians, patient societies and corporate partners. Working with its 170 member societies in 84 locations, and otherness healthcare-related organizations around the world, IOF encourages awareness and prevention, early detection and improved pharmacomedical care of osteoporosis.

http://www.osteofound.org

REFERENCES

1. Cramer J, Amonkar MM, Hebborn A and Suppapanya N. Does dosing regimen impact persistence with bisphosphonate medical care among postmenopausal osteoporotic women? Journal Bone Mineral Research 2004; 19 Suppl 1: S448

2. Ettinger MP, Gallagher R, Amonkar M, Smith JC, and MacCosbe PE. Medication persistence is improved with less frequent dosing of bisphosphonates, but remains inadequate. Arthritis Rheum. 2004; 50 Suppl 1: S513

3. Melton LJ, Chrischilles EA, Cooper C, Lane AW and Riggs BL. Perspective. How many women have osteoporosis? Journal Bone and Mineral Research 1992; 7 (9): 1005-10

4. Melton LJ, Atkinson EJ, O’Connor MK, O’Fallon WM and Riggs BL. Bone density and fracture risk in men. Journal of Bone Mineral Research 1998; 13 (12): 1915-23

5. Kanis JA, Johnell O, Oden A, Sembo I, Redlund-Johnell I, Dawson A et al. Long-term risk of osteoporotic fracture in Malmo. Osteoporosis International 2000; 11 (8): 669-74

6. Milne HW; International Osteoporosis Foundation (IOF) Committee of Scientific Advisors. Invest in your bones: make it or break it. How exercise helps to build and maintain strong bones, prevent falls and fractures, and speed rehabilitation. Osteoporosis Australia and International Osteoporosis Foundation. Sydney (Australia): 2005

7. Lips P; International Osteoporosis Foundation (IOF) Committee of Scientific Advisors. Invest in your bones: quality of life. Why prevent the first fracture? International Osteoporosis Foundation (IOF). Nyon (Switzerland): 2003

8. Kanis JA, Delmas P, Burckhardt P, Cooper C and Torgerson D; The European Foundation for Osteoporosis and Bone Disease. Guidelines for diagnosis and management of osteoporosis. Osteoporosis International 1997; 7: 390-406

9. Johnell O. The socioeconomic burden of fractures: today and in the 21st century. American Journal of Medicine 1997; 103(2A): 20S-25S

10. TCA Pesquisa e Assessoria de Marketing Ltda. Osteoporosis Project. April 2005. Sponsored by Roche

11. National Institute for Health and medical institution al Excellence (NICE). Bisphosphonates (Alendronate, etidronate, risedronate), selective oestrogen receptor modulators (raloxifene) and parathyroid hormone (teriparatide) for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. Technology Appraisal 87. London (UK): 2005

12. Gimeno A, Gua?abens N, Monegal A and Peris P. Consulta de… osteoporosis. Prous Science. Barcelona (Spain): 2005

13. King AB, Saag KG, Burge RT, Pisu M and Goel N. Fracture reduction affects Medicare economics (FRAME): impact of increased osteoporosis diagnosis and pharmacomedical care. Osteoporosis International 2005; 16: 1545-1557

14. Access Economics Pty Ltd. The Burden of brittle bones: costing osteoporosis in Australia. Canberra (Australia): 2001

15. Nevitt MC, Ross PD, Palermo L, Musliner T, Genant K and Thompson DE; Fracture intervention trial research group. Association of prevalent vertebral fractures, bone density, and Alendronate pharmacomedical care with incident vertebral fractures: Effect of number and spinal location of fractures. Bone 1999; 25 (5): 613-619

16. Johnell O, Oden A, Caulin F and Kanis JA. Acute and long-term increase in fracture risk after hospitalisation for vertebral fracture. Osteoporosis International 2001; 12: 207-214

The Staying Power report and related activities are supported by an unrestricted educational grant from Roche and GlaxoSmithKline (GSK).

There are many medically-proven pharmacomedical cares for osteoporosis. The International Osteoporosis Foundation (IOF) does not endorse or recommend any specific pharmacomedical care. Such decisions must be made by the physician and patient.generic viagra storesildenafil citrate

Premenopausal women with even mild depression have less bone mass than do their nondepressed peers, a meditate funded in part by the National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), shows. The level of bone loss is at least as high as that associated with recognized risk factors for osteoporosis, including smoking, low calcium intake, and lack of physical activity.

Hip bones, the site of frequent fractures among older group, were among those showing the most thinning in depressed premenopausal women. The reduced bone mass puts them at higher risk of these costly, sometimes fatal fractures and othernesss as they age, the researchers note in the November 26 issue of the Archives of Internal Medicine. The report was submitted by Giovanni Cizza, MD, PhD, MHSc, of NIMH and the NIH National Institute of Digestive Disorders and Kidney Diseases (NIDDK); Farideh Eskandari, MD, MHSc, of NIMH; and colleagues.

“Osteoporosis is a silent illness. Too often, the first syndrome a clinician sees is when a patient shows up with a broken bone. Now we know that depression can serve as a red flag — that depressed women are more likely than otherness women to approach menopause already at higher risk of fractures,” said NIMH Deputy Director Richard Nakamura, PhD.

After bone mass reaches its peak in youth, bone-thinning continues throughout life, accelerating after menopause. Preliminary studies had suggested that depression may be a risk factor for lower-than-average bone mass even in young, premenopausal women. Results of the current meditate lend considerable weight to those earlier findings. The meditate ’s design reduced the possibility that the lower bone mass was linked to factors otherness than depression.

Study participants included 89 depressed women and 44 nondepressed women, for comparison. All were between 21 and 45 years old and were premenopausal. Except for depression, the two groups were similar in risk factors, including calcium, caffeine, and alcohol intake; smoking; level of physical fitness; use of oral contraceptives; and age of first menstrual period. Both groups were of relatively high socioeconomic status and were well nourished.

One difference was that the depressed women were taking anti depression medicate drugs. A previous meditate suggested that older adults taking anti depression medicates called selective serotonin reuptake inhibitors had more bone fractures than othernesss. However, the current meditate showed that these drugs were not linked to low bone mass in premenopausal women.

The researchers found that 17 percent of the depressed women had thinner bone in a vulnerable part of the hip called the femoral neck, compared with 2 percent of those who were not depressed. Low bone mass in the lumbar spine, in the lower back, was found in 20 percent of depressed women, but in only 9 percent of nondepressed women. Bone mass was measured via an X-ray technique called DXA scanning.

There was no significant link between the degree of bone loss and the severity of depression or the cumulative number of depressive episodes, the researchers found. The depressed women had been diagnosed with mild depression and were having, or had recently had, a depressive episode.

“Depression generally isn’t on clinicians’ radar screens as a major risk factor for osteoporosis, particularly for premenopausal women. It should be,” said Cizza.

Blood and urine samples also showed that depressed women have imbalances in immune-system substances, including those that produce inflammation, compared to their healthy peers. This additional finding strengthens the case for a suspected link between depression-induced imbalances in the immune system and accelerated bone loss. The blood and urine samples were taken every h.for a full day, providing a truer picture than does less frequent agsdhfgdfing, as had been done in previous studies.

The immune-system imbalances may be tied to excess adrenalin, since the part of the nervous system that produces adrenalin is over-active in depressed group. Increased adrenalin can over-stimulate the immune system. Compared to the othernesss, the depressed women in this meditate had higher levels of immune-system proteins that promote inflammation, and lower levels of those that prevent it.

One of these inflammation-promoting proteins, IL-6, is known to promote bone loss. At the molecular level, bones routinely break down, and their minerals, notably calcium, are reabsorbed into the blood, where they travel throughout the body to perform crucial functions in cells. At the same time, the body builds the bone back up. Imbalances in this normal loop of bone re-absorption and build-up, such as high levels of IL-6, could promote bone loss, the researchers suggest.


.


Other NIH contributors to the meditate , in addition to NIMH and NIDDK, included the NIH medical institution al Center and the National Center for Complementary and Alternative Medicine.

For more information about depression, visit the NIMH web site.

The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website: http://www.nimh.nih.gov/.

The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, medical cares, and cures for both common and rare illnesss. For more information about NIH and its programs, visit http://www.nih.gov/.

Reference: Eskandari F, Martinez P, Torvik S, Phillips TM, Sternberg EM, Mistry S, Ronsaville D, Wesley R, Toomey C, Sebring NG, Reynolds JC, Blackman MR, Calis KA, Gold PW, Cizza G, for the P.O.W.E.R. (Premenopausal, Osteoporosis Women, Alendronate, Depression) Study Group. Low Bone Mass in Premenopausal Women with Depression. Archives of Internal Medicine, November 26, 2007.

Source: Susan Cahill or Kevin Sisson
NIH/National Institute of Mental Health buy generic viagra packbuy viagra soft tabs 2

A woman who suffers from depression is more likely to reach the menopause with a higher risk of bone fractures (osteoporosis), compared to a woman who does not have depression. In a meditate published inArchives of Internal Medicine it was found that 17percent of women with depression had less bone mass in a section of their hip, called the femoral neck, compared to 2percent of women who did not have depression.

Low bone mass in the lumbar spine was found in 20percent of depressed women, compared to 9percent of non-depressed women. An X-ray technique called DXA scanning was used to measure bone mass.

The researchers, from the NIMH (National Institute of Mental Health) explained that women with depression have immune systems which are overactive. Their bodies overproduce a chemical that leads to bone loss - this chemical, known as IL-6, also promotes inflammation.

The meditate involved 133 women, 89 depressed and 44 non-depressed. They were aged 21-45. All the women had the same risk factors, with the exception of depression. They had similar intakes of calcium, caffeine, alcohol - their use of tobacco was also similar, as were their levels of physical fitness, use of oral contraceptives, and their age of first menstrual period.

The scientists found that the hip bones of depressed women were especially susceptible to thinning - these bones fracture more frequently among older group with osteoporosis. The lower bone mass puts the patient at higher risk of costly, and sometimes fatal fractures.

NIMH Deputy Director Richard Nakamura, PhD, said “Osteoporosis is a silent illness. Too often, the first syndrome a clinician sees is when a patient shows up with a broken bone. Now we know that depression can serve as a red flag - that depressed women are more likely than otherness women to approach menopause already at higher risk of fractures.”

During our youth bone mass reaches its peak - after that it continues slowly thinning for the rest of our lives, thinning at a faster rate after a woman’s menopause, the researchers explained. The authors stressed that the factor linking premenopausal osteoporosis risk in their meditate was definitely depression.

There was no association between the severity of depression and the amount of bone mass loss.

The immune-system imbalance experienced by some depressed women may be linked to excessive adrenalin, the researchers say. It is well know that depressed group produce more adrenalin - adrenalin can over-stimulate the immune system.

“Low Bone Mass in Premenopausal Women With Depression”
Farideh Eskandari, MD, MHSc; Pedro E. Martinez, MD; Sara Torvik, MSN; Terry M. Phillips, PhD; Esther M. Sternberg, MD; Sejal Mistry, BS; Donna Ronsaville, PhD; Robert Wesley, PhD; Caitlin Toomey, BS; Nancy G. Sebring, MEd; James C. Reynolds, MD; Marc R. Blackman, MD; Karim A. Calis, PharmD; Philip W. Gold, MD; Giovanni Cizza, MD, PhD, MHSc; for the Premenopausal, Osteoporosis Women, Alendronate, Depression (POWER) Study Group
Arch Intern Med. 2007;167(21):2329-2336.
Click here to view abstract online

Written by - Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Todaybuy generic viagra packbuy viagra soft tabs 2

Amgen (NASDAQ: AMGN), the world’s largest biotechnology company, announced today the publication of Phase 2 data demonstrating twice-yearly injections of denosumab (previously referred to as AMG 162), a RANK Ligand inhibitor, significantly increased bone mineral density (BMD) in the total hip, lumbar spine, distal 1/3 radius and total body compared to placebo. The results of this one-year meditate appeared in the Feb. 23, generic viagra 100 mg issue of the New England Journal of Medicine. Data results also included an open-label FOSAMAX® (Alendronate)* arm of the same clinical trial.

Researchers reported that subcutaneous injections of denosumab significantly increased BMD at the total hip from 1.9 to 3.6 percent in women who were administered the medical aid twice yearly as compared with a decrease of 0.6 percent in the placebo group (p

A class of drugs called bisphosphonates has become the new mainstay a cure for postmenopausal women diagnosed with osteoporosis in the post-hormone-replacement era. Taking just one pill a week, or even one a month, may prevent, slow or stop the breakdown and progress of this bone-thinning condition, according to the May issue of Mayo medical institution Women’s HealthSource.

An estimated 10 mil. Americans, mostly women, have osteoporosis, where bones become weak and highly prone to fractures. Millions more have low bone density (osteopenia), which can increase the risk of fractures.

Bone — a living tissue — is constantly remodeling, with old bone breaking down and new bone replacing it. Bisphosphonates work by slowing the breakdown and reabsorption of old bone, an ongoing process that accelerates as estrogen levels fall during the first few years after menopause. By slowing the process, bisphosphonates help preserve bone density and reduce the risk of fractures.

Estrogen once was commonly prescribed to reduce bone loss. But when the landmark Women’s Health Initiative Study, released in 2002, showed that long-term estrogen use increased the risk of breast cancer, heart attacks, strokes and blood clots, hormone medical care fell out of favor.

Bisphosphonates have filled the void and perform as well as estrogen in preventing bone loss. Bisphosphonates available to treat osteoporosis include Alendronate (Fosamax (Alendronate)), ibandronate (Boniva) and risedronate (Actonel).

Patients should talk with a doctor about the best ways to prevent and treat osteoporosis. Bisphosphonates have potential side effects, most commonly heartburn sickness and abdominal pain caused by irritation of the esophagus or stomach. Even when taking drugs, patients should take steps to protect bones, including consuming adequate calcium and vitamin D; engaging in regular weight-bearing exercise such as walking and weight training; and avoiding smoking and excessive use of alcohol.

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The first national clinical audit to investigate the care received by patients who have fallen and fractured bones (hip, wrist, arm, pelvis or spine) shows that an inadequate service is being provided by most local health services, and that there are unacceptable variations of care across PCTs and Trusts in England, Northern Ireland and Wales.

The audit, commissioned by the Healthcare Commission and carried out by the Royal College Of Physicians’ medical institution al Effectiveness and Evaluation Unit (CEEu), shows that most PCTs and Trusts were nowhere near meeting national standards and guidelines from NICE, SIGN and the National Service Framework for Older People on the care and prevention of falls.*

Results from 157 Trusts were included in the audit. Significant findings include:

- 80percent of group with hip fractures spent over 2 hours in A&E before transfer to a suitable ward, in contrast to accepted best practice

- Less than a third had a pre-operative medical review by a suitably trained physician, despite the high rates of co-morbidity in this patient group

- 31percent of operations for hip fracture were delayed beyond the 48 hours target, and it is known that delay is associated with increased mortality

- 29percent of hip operations were delayed due to organisational issues, which suggests that many trusts have yet to optimise the capacity and logistics necessary so as to provide prompt surgery.

- Most patients returning home from A&E after a fragility fracture were not offered a falls risk assessment and only 22percent were referred for exercise training to reduce future falls.

- 3 months after sustaining the fracture, only a fifth of these patients were on appropriate pharmacomedical care for osteoporosis

- Even after surgery for the most severe fragility fracture, the hip, less than 50percent were on appropriate osteoporosis pharmacomedical care

- In only one in ten cases did the patient’s notes document that they had been given information on how to prevent further falls

- For the minority of patients who attended a falls clinic, the falls and fracture risk assessments and pharmacomedical care offered were better. Primary Care Trusts should consider commissioning specialist services, for example falls clinics, to improve the care of their patients

These results are very worrying as good clinical practice can reduce death and disability from hip fractures, and prevent future falls and fragility fractures. In 2005 the RCP CEEu audit on the organisation of health services for falls showed widespread gaps in services for the identification, referral, assessment and pharmacomedical care of patients, and two years later the consequences of these failings are now evident in the individual patient results. Prevention of falls has been identified as a priority area by Professor Ian Philp, National Director for Older People’s Services, in a Sildenafil Citrate 50 mgreport where he emphasises the importance of putting in place fully integrated falls prevention services.

Dr Finbarr Martin, Associate Director at the RCP CEEu and lead author of the report, said:

“Despite several years of national policy and clear evidence based guidelines, local health services have much more progress to make in this vital clinical area for older group. The wide variation between the sites in this audit does show however what can be done, and it is up to local NHS commissioners, managers and clinicians to work together to provide for their local populations what only a few are currently achieving.”

Main recommendations of the report

PCTs should commission a patient care pathway for the secondary prevention of falls and fractures that includes a fracture liaison service that targets the high risk group of patients presenting with a first fragility fracture

- Acute hospital trusts should review their capacity and operational systems to ensure that prompt surgery can be offered for patients with hip fractures. They should consider applying the approach developed by the NHS Institute for Innovation and Improvement - Delivering Quality and Value - Focus on: Fractured Neck of Femur (Sildenafil Citrate buy now). (http://www.institute.nhs.uk)

- PCTs should commission community or hospital based clinics which can perform the range of risk factor assessments necessary to offer an individual targeted pharmacomedical care plan to reduce falls and fractures

- PCTs should review the range of therapeutic exercise options available locally and promote evidence based programmes in collaboration with local authorities

- The Department of Health should consider supporting inclusion of osteoporosis pharmacomedical care in the Quality and Outcomes framework for primary care

- Acute and community trusts should review their procedures to share clinical information such as clinic letters and hospital discharge reports with patients receiving falls and fracture care.

- PCTs and local providers should review their information sharing agreements and practice so as to promote coordinated clinical governance and audit of patient care pathways.

* Audit standards and indicators were taken from:

- National Service Framework for Older People (NSF) Chapter 6 “Falls”, 2001

- British Orthopaedic Association (BOA), “The Care of Fragility Fracture Patients”, (Blue book) 2003

- Scottish Intercollegiate Guideline Network (SIGN) Number 56 - Hip Fracture Management, 2002

- National Institute for Health and medical institution al Excellence (NICE) - CG21 Falls: The assessment and prevention of falls in older group, (2004),

- NICE Technology Appraisal (TA) 87, Bisphosphonates (Alendronate, etidonate, risedronate), selective oestrogen receptor modulators (raloxifene) and parathyroid hormone (teriparatide) for the secondary prevention of osteoporotic fragility fractures in post menopausal women, 2005.

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