Fluoride in tea is not a health risk

Current tea consumption is unlikely to provide fluoride intakes that exceed safe limits for adults and children according to a new study just presented to the Nutrition Society by Dr Carrie Ruxton, independent public health nutritionist.

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Commenting on the research study, author and member of the Tea Advisory Panel (TAP), Dr Carrie Ruxton notes: “Current tea intakes do not provide enough fluoride to meet the Recommended Daily Amount (RDA) for this mineral, and the potential dental health benefits of fluoride cannot be accessed unless tea consumption increases to 3-4 servings/day from the current intake of 1-2 servings a day.

“This latest study helps to put the record straight in the context of a 2013 study that measured the fluoride content of 38 tea bags and concluded that economy versions of tea represented a risk to dental and skeletal health. These conclusions were somewhat surprising given that official bodies view fluoride as a means to deliver dental health benefits when recommended amounts are consumed. Public Health England (PHE), for example, is clear about the benefits of water fluoridation and recommends that the practice is extended.”

Dr Tim Bond from TAP adds: “The 2013 study was also flawed in several respects. Firstly, tea was brewed for 2 minutes – longer than the typical brewing time of 30-40 seconds. Secondly, 2g of dry tea was added to 100ml of water making the infusion more concentrated that a typical tea bag in a cup or mug. Thirdly, the study compared the fluoride intake with the US Dietary Reference Intake rather than the EU Safe Upper Level.

“This latest study replicated the situation of a typical cup or mug of tea in that a single tea bag was added to 240ml of boiling water and brewed for 40 seconds. Tea bags from 49 retail brands were analysed.

“Average fluoride content of black blended tea in this study was 4.91mg/litre and similar to the findings of the 2013 study. However, according to the 2014 NDNS figures, average tea consumption in the UK is 395ml daily and intakes at the safe upper level of intake are 1155ml daily. Fluoride intakes from tea (which is estimated to provide 70% of the UK’s fluoride intake) will likely be lower than the safe upper level of 7mg daily (5mg in children) even among those people with intakes of tea at the higher end of the population. Moreover, this latest study shows that current average intakes of tea do not provide the RDA for fluoride suggesting that tea intake should increase to access the benefits of fluoride for dental health.”

About the Tea Advisory Panel
The Tea Advisory Panel: The Tea Advisory Panel is supported by an unrestricted educational grant from the UK Tea Council, the trade association for the tea industry. The Panel has been created to provide media with impartial information regarding the health benefits of tea. Panel members include nutritionists; dieticians and doctors

Love your bones – real men build their strength from within!

World Osteoporosis Day falls on October 20, 2014, and within the motto of “Love your Bones,” this year’s theme is “Real men build their strength from within.” Real Men Build Their Strength from Within This theme was chosen to bring attention to the fact that although osteoporosis is more common in women, one in five men aged 50 and over worldwide will suffer an osteoporotic fracture. Read this brochure – A Man’s Guide to Osteoporosis Prevention here:  WOD14-patient_brochure 2

Older adults should eat diary and exercise to decrease risk of bone and muscle loss

Combining four nutrients found in diary products with regular exercise can help ward off muscle wasting and bone disease, according to researchers in Switzerland, France and North America.

Calcium, inorganic phosphate, vitamin D and protein interact together with physical activity to maintain healthy muscles and bones, say the experts in an article published in the Journal of the American College of Nutrition

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“While bone health is often associated with calcium alone, Calcium’s interactions with inorganic phosphate, vitamin D, and protein are important components of beneficial dairy consumption,” says the article.

“Combined vitamin D and calcium supplementation has been shown to reduce the incidence of hip and other non-vertebral fractures among older populations, with some studies suggesting that vitamin D actually leads to lower rates of falling in subjects. Dietary protein, while often associated solely with muscle recovery, also promotes bone formation by stimulating both Ca and Pi intestinal absorption and the production of a bone growth factor. And while vitamin D deficiency is associated with muscle weakness, vitamin D and protein supplementation are required together to improve strength.

“Combining the four above-mentioned nutrients with physical activity decreases the likelihood of bone and muscle degeneration-related injury in older adults. Dairy products are a convenient way to work them into a diet, as they contain Ca, Pi, and protein at levels comparable to recommended intakes, and are fortified with vitamin D.”

Majority of adults risk bone health from chronic Vitamin D deficiency

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An estimated 50-70% of adults are at risk of the bone disease, osteoporosis and other health problems, as a result of a deficiency in vitamin D. 
 
The International Osteoporosis Foundation (IOF) today published evidence of what is describes as “a major public health issue” with a global map of vitamin D status worldwide. 
“The map and accompanying publication[1] confirm that vitamin D insufficiency is a major public health issue in both the developing and industrialized world, with more than one third of all the populations studied, showing insufficient levels of vitamin D[2],” says the IOF. 
 
DSM, the life science company, which contributed to developing the data and the map, strongly supports IOF’s call for healthcare decision makers to take immediate action to address vitamin D insufficiency as a priority public policy issue, and emphasize the role of supplementation as a key tool for addressing this problem.
 
Key findings include:
 
·         Overall, insufficient vitamin D levels were detected in more than one third of the study population[3]
·         Vitamin D insufficiency affects both the developing world and industrialized world
·         The main source of vitamin D is sunlight, but even in sunny countries, vitamin D levels are generally low and below recommended levels (taking India as example: a sunny country; yet, with  low vitamin D status)
·         Rates of vitamin D insufficiency are higher amongst women than men
·         It is estimated that 50 -70 % of the European adult population have insufficient levels of vitamin D
·         In US adults, vitamin D insufficiency estimates range from 20% (non-Hispanic whites) – 70 % (non-Hispanic blacks).
·         Older people are especially at risk for vitamin D insufficiency, including older women who are a risk group for osteoporosis, and those living indoors in institutionalised care.  
 
Osteoporosis is a serious chronic disease which affects hundreds of millions of people worldwide. Vitamin D improves bone mineral density, which lowers risk of fracture, whilst also improving muscle strength, balance, and leg function which decreases the risk of falling and sustaining a fracture in the first place. As a consequence, vitamin D insufficiency has been linked to a higher risk of osteoporotic fractures.
 
Studies show that adequate vitamin D can reduce the risk of falls and fractures by around 30%[4].  In Germany, research indicated that regular vitamin D supplements can help achieve healthcare cost savings of between Euro 585-778 million in one country alone[5].
Judy Stenmark, CEO of the International Osteoporosis Foundation commented: “IOF urges people at risk of osteoporosis and generally all seniors aged 60 years and older to ensure optimal levels of vitamin D. In these high risk groups IOF recommends 800-1000 IU/day supplementation for fall and fracture prevention.  With the launch of these maps, we are calling on health professionals to be aware of the status of vitamin D insufficiency within their own country and urge them to take simple and inexpensive steps to correct it. This will ultimately improve, and even save, lives.”
 
Prof. Heike Bischoff-Ferrari, DrPH, Director Centre on Aging and Mobility, University of Zurich added: “The reality is that natural production of vitamin D through sunlight decreases with age, and it is very difficult to achieve sufficient vitamin D through diet alone, especially in the senior population. The good news is that vitamin D supplementation offers an effective, inexpensive, and safe public health strategy that can make a significant difference to people’s health and quality of life, by reducing 30% of falls and hip fracture4.” 
 
Dr Manfred Eggersdorfer, Senior Vice President Nutrition Science & Advocacy DSM commented: “The maps are a major advance in the fight against vitamin D deficiency. We know that vitamin D deficiency is linked to serious diseases such as rickets in children and osteoporosis in the elderly, but our understanding of the scale and extent of the problem was far too limited. We now have a much better understanding of the picture of vitamin D insufficiency, and confirmation of its importance as a global public health issue.
 
The map has also created a very clear picture as to where the vitamin D insufficiency knowledge gaps exist and where further research is required. Dr Eggersdorfer added, “There is far too little data available, for example, in relation to adolescents and young people, and across the developing world in general. These maps are an important starting point, but it is essential that research continues to better understand the scale of vitamin D insufficiency.”
 
DSM joins IOF in calling on healthcare policymakers to raise awareness of vitamin D insufficiency and to take action to ensure intake of recommended vitamin D levels, including through safe and effective measures such as food fortification, access to proper supplements and better consumer education.
 
 About the map – drawing on scientific studies from across the world, the maps color code levels of vitamin D status based on national scientific data, with green indicating an optimal/desirable vitamin D status, and yellow as (in-) adequate or suboptimal. Orange highlights vitamin D blood levels below 50 nmol/l which are considered insufficient, and red indicates severe vitamin D deficiency (below 25nmol/l) based on a sliding scale[6].  The maps will be updated annually and provide researchers, medical practitioners and policymakers with an invaluable resource in the fight against vitamin D deficiency.
 
The maps can be found on the website of the International Osteoporosis Foundation at www.iofbonehealth.org.
 
Additional country findings include:
 
·         In Germany 57% of men and 58% of women had vitamin D status below recommended levels, rising to 75% amongst 65-79 year olds
·         UK studies focused on older people reveal that nearly two thirds of women (57%), and half of men (49%) are not getting enough vitamin D
·         In the Netherlands, around half of all study participants had sub-optimal vitamin D levels
·         In the US, around 30% of the study population has sub-optimal vitamin D levels, rising to around 70% amongst participants with black skin color, highlighting skin color as a risk factor for vitamin D insufficiency.  Overall the US vitamin D status was significantly higher compared to other regions, which may in part, be attributable to the routine fortification of foods with vitamin D (such as milk, juice and cereals)
·         The Middle East revealed lower vitamin D status compared to Europe which could result from cultural factors such as clothing and lifestyle.
·         Asia showed a widespread insufficient vitamin D status across different countries. with a few exceptions (vitamin D status was ranked desirable in Taiwan, Thailand and Vietnam )
·         Most regions offer some data, however no informa
tion was available for Central America, South America (except Brazil) and much of Africa.
·         The most striking data gaps are found in children and adolescents
 
For further information and interview requests with Professor Heike Bischoff-Ferrari (University of Zurich) and Dr. Manfred Eggersdorfer, DSM, please contact:
 
 
DSM – Bright Science. Brighter Living.™
Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM’s 22,000 employees deliver annual net sales of around €9 billion. The company is listed on NYSE Euronext. More information can be found at www.dsm.com
 
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High dose Vitamin D needed to protect against bone fracture

New York: Higher doses of Vitamin D are needed to protect older adults against bone fractures, according to an analysis of several recent clinical trials.
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The New England Journal of Medicine which examined 11 such trails reveals a protective effect for high dose vitamin D supplementation against the risk of fracture in older men and women. While 800 international units (IU) or more of the vitamin was associated with reduced fracture risk, lower doses did not appear to be effective.
“Vitamin D supplementation is an efficient intervention for a costly injury that affects thousands of older adults each year,” remarked senior author and Tufts University School of Medicine professor Bess Dawson-Hughes, MD.
 “The average recovery is long and painful and deeply impacts quality of life. After a fracture, older patients may only regain partial mobility, resulting in a loss of independence that is personally demoralizing and that can place added stress on family members and caregivers.”
Dr Dawson-Hughes and her colleagues analyzed data from 31,022 individuals age 65 and older who were assigned to receive up to 2,000 IU oral vitamin D or a placebo in one of 11 randomized, controlled trials. Those who received the vitamin had a modest 10 percent lower risk of hip fracture and a 7 percent reduction in nonvertebral fracture overall; however, a stronger effect emerged for higher dose vitamin D when the participants were analyzed according to dosage. Among those whose vitamin D was among the top 25 percent of subjects at a median of 800 IU per day, there was a 30 percent lower adjusted risk of hip fracture and a 14 percent lower risk of nonvertebral fractures in comparison with those whose vitamin D intake was lowest.
 “Taking between 800 IUs and 2,000 IUs of vitamin D per day significantly reduced the risk of most fractures, including hip, wrist and forearm in both men and women age 65 and older,” stated Dr Dawson-Hughes, who is the director of the Bone Metabolism Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University. “Importantly, we saw there was no benefit to taking vitamin D supplements in doses below 800 IUs per day for fracture prevention.”
“Evaluation of individual-level data is the gold-standard of meta-analysis,” noted lead author Heike Bischoff-Ferrari, MD, DPh, who is the director of the Centre on Aging and Mobility at the University of Zurich and Waid City Hospital, and a visiting scientist at the Bone Metabolism Laboratory.
 “Our results make a compelling contribution to the existing data on vitamin D and fracture risk in men and women age 65 and older, whose vulnerability to bone density loss and osteoporosis leave them prone to fractures resulting from thinning bones.”
High dose vitamin D is available at The Vitality Shop UK
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Scientists create jaw bone from stem cells

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New York: Scientists have created part of the jaw bone for the first time in the lab using human adult stem cells.

The technique, which created the joint, may be useful for other areas of the body.

The Columbia University study appears in Proceedings of the National Academy of Sciences.

The bone which has been created in a lab, by scientists at Columbia University is called the temporomandibular joint (TMJ). This joint which is complex to repair can be damaged by defects at birth, arthritis or injury. Treatment is notoriously difficult as the joint has a complex structure and is difficult to replicate using bone grafts.

Scientists used human stem cells taken from bone marrow which were then planted into a “tissue scaffold” in the shape of a human jaw bone.

The cells were then cultured nutrients found during natural bone development.

Lead researcher Dr Gordana Vunjak-Novakovic said: “The availability of personalised bone grafts engineered from the patient’s own stem cells would revolutionise the way we currently treat these defects.”

She said the new technique could also be applied to other bones in the head and neck, including skull bones and cheek bones, which are similarly difficult to graft.

She stressed that the joint created in the lab was bone only, and did not include other tissue, such as cartilage which the team is also working on.

OSTEOPOROSIS & BONE HEALTH

MRI scans give early arthritis alert

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New York: MRI-like scanners can detect the debilitating disease, osteoarthritis, at a stage when it can be treated with nutraceuticals, a conference has been told.

The test, a form of the MRI scan used in hospitals every day, could catch osteoarthritis when it is still in the early stages, preventing or reducing damage to the joints.

Treatment usually consists of a powerful drugs with horrible side-effects, physiotherapy and, in some cases, replacement of the affected knee, hip or other joint.

Normally doctors relying on physical examinations and X-rays for diagnosis, which means the disease it not caught early enough.

Osteoarthritis damages the cushioning material between the bones including cartilage.

Researcher Dr Alexej Jerschow, of New York University, used the MRI scanner to measure levels of glycosaminoglycan, the compound that makes the cartilage tough and elastic.

Chocolate may increase bone health risk

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Sydney: Scientists have discovered that chocolate may increase the likelihood of osteoporosis and bone fractures in women.

In a new study published in the American Journal of Clinical Nutrition women who ate chocolate every day were found to have less dense bones than those who ate it less than once a week. according to scientists at the University of Western Australia.

Chocolate containing high levels of flavanols has recently been found to have beneficial health effects, particularly on the cardivascular system. But most chocolates do not contain high levels of this substance and manufacturers rarely label their products with health information.

In the Australian study, scientists monitored the amount of chocolate eaten over several weeks by 1,001 women aged 70 to 85. They then measured the bone density and strength of each woman using X-rays. The researchers found the women who ate chocolate less than once a week had significantly stronger bones than those who consumed the treat on a daily basis. Low bone density was found in the hips, neck, tibia and heel bones of the women surveyed.

The researchers believe the findings may be because chocolate contains oxalate, which can reduce calcium absorption, and sugar, which is linked to calcium excretion. Calcium is vital for maintaining healthy bones.

Men with low-testosterone suffer increase in bone fractures

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Sydney: Elderly men with low levels of testosterone are more than twice as likely to suffer bone fractures as those with higher amounts of the sex hormone, researchers in Australia found.

A study of men at least 60 years old found a quarter had testosterone deficiency linked to a two-fold increase in the risk of bone fractures caused by osteoporosis, according to researchers at Sydney’s Garvan Institute of Medical Research. The finding may enable doctors to identify susceptible elderly men and devise strategies to prevent bone fractures.

Osteoporosis, when bones thin and break easily, affects 10 million Americans and is generally considered a women’s disease. While women’s bones become fragile after menopause when they stop producing estrogen, men’s weaken at a later age and can cause just as much damage. In Australia, 30 percent of the 110,000 osteoporosis-induced fractures that occur each year are in men.

John Eisman, Professor Medicine at the University of New South Wales and director of Garvan’s bone and mineral programme said: “Osteoporosis in men is basically ignored. This is something that gives us more insight into why they might have problems, why they might be likely to fracture.”

In the US, for example, two million men have the disease and another 12 million are at risk for it, the National Osteoporosis Foundation estimates. Treating patients with osteoporosis medicines including Eli Lilly & Co.’s Evista and Forteo, Merck & Co.’s Fosamax and Procter & Gamble Co.’s Actonel may prevent fragility fractures if the disease is diagnosed early, previous studies have shown.

Each year, about 329,000 hip fractures occur in the U.S. About 20 percent of the people die within six to 12 months after breaking hips, according to a study published in November in the Journal of the American Medical Association.

Men’s testosterone levels are usually about 300 to 1,000 nanograms per deciliter of blood, according to the U.S. National Institutes of Health. A quarter of men over 60 had levels of 294 nanograms or less in the Garvan study, which followed 609 men aged over 60 years between January 1989 and December 2005.

Even after adjusting for factors known to alter fracture risk, including age, weight, fracture history, smoking status and calcium intake, the risk of fracture was more than doubled in men with low testosterone compared with men with high levels of the hormone, according to the study. The results were published yesterday in the Archives of Internal Medicines.

“Men with lower testosterone might be getting a double whammy,” Eisman said. “Their bones are worse and their muscles are a bit weaker, both of which are likely then to contribute to their risk of fractures.”

While testosterone supplements may assist those deficient in the hormone, other treatments may also help, he said.

“Importantly, reducing alcohol consumption, avoiding smoking, maintaining an active lifestyle, getting sunlight exposure and eating a diet rich in calcium will also help to minimize risk,” Eisman said.

The research is part of the Dubbo Osteoporosis Epidemiology Study, which started in 1989 and recruited all men and women 60 years or older living in Dubbo, a regional city of 32,000 predominantly white people in Australia’s New South Wales state.

Bones act as an organ – new research reveals

Even though bones seem to be metabolically inactive structures, nothing could be further from the truth. In fact, bones are rebuilt constantly through the action of cells known as osteoblasts while old bone is destroyed by other cells known as osteoclasts. Bones also produce red and white blood cells, help maintain blood pH and store calcium.

However, exciting new research published in this month’s edition of the magazine Cell, has shown that bones also act as an endocrine organ. Not only do bones produce a protein hormone, osteocalcin that regulates bone formation, but this hormone also protects against obesity and glucose intolerance by increasing proliferation of pancreatic beta cells and their subsequent secretion of insulin. Osteocalcin was also found to increase the body’s sensitivity to insulin and as well as reducing its fat stores.

Hormones function as chemical messengers that allow the body to precisely coordinate metabolism, reproduction and other essential biological processes that involve multiple organs.

“The skeleton used to be thought of as just a structural support system. This opens the door to a new way of seeing the bones,” said Dr. Gerard Karsenty, chairman of the department of genetics and development at Columbia University Medical Center in NYC, who headed the team that made the discovery.

Osteocalcin is not new to science: Its existence has been known for 50 years, “but its function was never understood,” observed Karsenty. However, researchers have long known that people with diabetes tend to have low levels of osteocalcin, but until now no one understood the significance.

Based on their knowledge of skeletal biology and endocrinology, the research team hypothesized that there might be a relationship between skeletal biology and endocrine regulation because of the long-known observation that obesity protects against osteoporosis in mammals. Additionally, it was known that people with untreated type 2 diabetes have low osteocalcin levels, which made this hormone an appealing target for their research efforts.

To do this research, the scientists designed an elegant series of experiments using several groups of mice. The first group of experimental mice had their osteoblast gene, called Esp, genetically deactivated, or “knocked out”. Esp encodes a receptor-like protein tyrosine phosphatase called OST-PTP that increases beta-cell proliferation and insulin secretion in the pancreas, which results in hypoglycemia. But these so called “knock-out mice” lacked all functional Esp genes, so their insulin secretion and sensitivity decreased causing them to become obese and then to develop Type 2 diabetes when fed a normal diet. Type 2 diabetes occurs when the body becomes resistant to insulin, the hormone that regulates sugar metabolism.

A second group of experimental mice were genetically engineered to over-produce osteocalcin. These mice showed lower-than-normal blood glucose levels and higher insulin levels than did normal mice that were fed a normal diet. Additionally, these “overproducer mice” also showed increased insulin sensitivity. This is probably the most exciting result because typically, excess blood insulin decreases tissues’ sensitivity to the hormone, which makes insulin treatment difficult for diabetics. Further, the team found that treating the “knock-out mice” with osteocalcin helped regulate their blood sugar and insulin.

Additionally, the investigators reported that mice with one functional copy of Esp showed a significant reversal of their metabolic abnormalities, which provides “genetic evidence that Esp and osteocalcin lie in the same regulatory pathway and that [the] Esp-/- mice metabolic phenotype is caused by a gain-of-activity of this hormone.”

Interestingly, mice that are genetically programmed to overeat and mice that were fed fatty diets were prevented from suffering both obesity and diabetes when given high levels of osteocalcin. Karsenty is now determining whether giving osteocalcin to his diabetic “knock-out mice” will reverse the disease. This research shows promise for treating human diabetics as well.

Finding a substance that increases beta cell proliferation, says Karsenty, “is a holy grail for diabetes research.” Thus, if what’s true for mice also proves true for humans, “then we have inside us a hormone that does precisely this.”

“The findings could have important implications for the treatment of diabetes. Osteocalcin has a triple-punch effect, in that it raises both insulin levels and insulin uptake while keeping fat at bay. That makes it a promising therapy for middle-aged people who want to fight type 2 diabetes,” Karsenty said.

Additionally, this study also reveals that the skeleton is an important part of the endocrine system.

“To our knowledge this study provides the first in vivo evidence that [the] skeleton exerts an endocrine regulation of energy metabolism and thereby may contribute to the onset and severity of metabolic disorders,” the authors wrote in their paper.

Once a year 15 minute therapy cuts risk of broken bones in post-menopausal women, new study finds

San Francisco: A study published today for a treatment that is given just once a year has been shown to significantly decrease the risk of broken hips and other broken bones, caused by post-menopausal osteoporosis.1

The study published in the New England Journal of Medicine on 3rd May found that the active treatment zoledronic acid 5mg (Aclasta) cut the risk of broken hips by 41% and the risks of breaks to the spine (vertebrae) by 70% compared to patients on no treatment (placebo). Broken bones at other parts of the body, such as wrists, were cut by 25%.

Zoledronic acid 5mg was given as a short infusion (at least 15 minutes) once a year in the three year study. All patients received daily calcium and vitamin D supplements which are essential for good bone health.

The authors state: “A once-yearly infusion of zoledronic acid (5mg) during a 3-year period was associated with a significant and sustained decrease in the risk of vertebral, hip, and other fractures. An annual infusion of zoledronic acid (5 mg) may provide a promising approach to reducing fracture risk. “1

The three-year study was carried out in 7,765 post-menopausal women, aged 65 to 89, from 27 countries including the UK. Approximately half received zoledronic acid 5mg and half placebo.

British women who took part in the study were treated at centres in Aberdeen, Sheffield, Liverpool and Glasgow.

The pharma, Novartis, is currently seeking a licence for zoledronic acid 5mg (Aclasta®) for post menopausal osteoporosis in the UK.

Over the three years, 88 (2.5%) of the women in the placebo group suffered a hip fracture compared to 52 (1.4%) of the women in the zoledronic acid 5mg group.

The researchers, led by Professor Dennis Black, of the University of California, San Francisco, said “During a 3-year period, an annual infusion of zoledronic acid 5mg significantly reduced the risk of fracture at all key osteoporotic fracture sites, including the two primary end points, vertebral and hip fractures.” 1

“A regimen of infusions once a year appears to ensure that patients will have a full treatment effect for at least 12 months.1

Despite the availability of effective treatments for osteoporosis, poor adherence to drug regimens reduces the benefits and presents a major challenge for health professionals. 4

Figures from the National Osteoporosis Society say that over 60,000 hip and 120,000 vertebral fractures take place each year in the UK. 22

The UK’s National Osteoporosis Society says that around one in five (18%) people die within three months of having a broken hip accounting for around 14,000 deaths per year in this country alone. A woman with a vertebral fracture has a four times higher risk of death than a woman with no vertebral fractures. 2

One of the authors of the study, Professor Richard Eastell, Professor of Bone Metabolism at Sheffield UniversityÂ’s School of Medicine and Biomedical Sciences, said the findings provided potential good news for thousands of women suffering from osteoporosis.

Professor Eastell pointed out that “The ability to only have the treatment once a year does mean that it simplifies the whole regimen. You don’t have to remember every day to take this medication. There is no doubt that Aclasta reduces vertebral fracture, hip fracture and other breaks.”

Professor David Reid, Professor of Rheumatology at the University of Aberdeen, who led one of the UK centres involved in the study said that the hip fracture data was particularly relevant.

“Preventing hip fractures remains the holy grail of treating osteoporosis, as we know that six months after a hip fracture, nearly a fifth of patients will be dead. Reducing hip fractures by 41% is therefore highly clinically significant.”

Study Details

In this double-blind, placebo-controlled trial, 3889 patients were randomly assigned to receive a single 15-minute 5mg infusion of zoledronic acid and 3876 were assigned to receive a placebo infusion at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. 1 All patients in the study also received daily calcium and vitamin D supplementation.

Primary end points were new vertebral fractures (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes.

Treatment with zoledronic acid 5mg reduced the risk of vertebral fracture by 70% over a 3-year period, as compared with placebo (3.3% in the zoledronic-acid 5mg group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid 5mg group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83).

Over the three years, 88 (2.5%) of the women in the placebo group suffered a hip fracture compared to 52 (1.45%) of the women in the zoledronic acid 5mg group.

The figures for vertebral fracture were 310 women (10.9%) in the placebo group versus 92 (3.3%) on zoledronic acid 5mg.

Secondary fracture endpoints of nonvertebral, and clinical (symptomatic) vertebral fractures were reduced by 25% and 77%, respectively (P<0.001 for all comparisons). Zoledronic acid 5mg was also associated with a significant improvement in bone mineral density and bone metabolism markers.

The majority of adverse events seen with the active treatment, including flu-like symptoms, were transient and resolved shortly after the treatment. Adverse events were similar in the two study groups. However, serious atrial fibrillation was seen more frequently in the zoledronic-acid 5mg group (1.3% vs. 0.5% patients, P<0.001). The observed association might be due to chance but is being further studied in other trials of zoledronic acid 5mg.

Risks of Osteoporosis

Osteoporosis is a long-term disease with consequences such as broken bones that only become apparent long after the condition starts. 2

Osteoporosis, which literally means “porous bone,” is a disease in which the density and quality of bone are reduced. As the bones become more porous and fragile, the risk of fracture is greatly increased. 2

One in two women will suffer a fracture after the age of 50. 2

The lifetime risk of fracture in women at age 50 years is greater than the risk of breast cancer or cardiovascular disease. 2

On the basis of current trends, hip fracture rates in the UK may increase from approximately 46,000 in 1985 to 117,000 in 2016. 2

The most common osteoporotic fracture sites are: lower vertebral fracture (120,000), hip (60,000) and wrist (50,000). 2

Compliance Issues

The total number of women prescribed medication for osteoporosis in the UK is approximately 480,000. 2

One year after an osteoporotic fracture, the majority of patients are not prescribed any pharmaceutical agents for the prevention of a further fracture. 2

A retrospective analysis of a large US population of bisphosphonate users (>35,000 women) who were followed for 2 years demonstrated a significant association with adherence to bisphosphonate therapy and risk of osteoporotic fractures3.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the GroupÂ’s businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 101,000 associates and operate in over 140 countries around the world. For more information, please visit www.novartis.com

References

1. Black et al. Once-yearly Zoledronic Acid 5mg for Treatment of Postmenopausal Osteoporosis. New England Journal of Medicine 2007 356;18; 1809-1822
2. National Osteoporosis Society. Osteoporosis facts and figures (version 1.1). www.nos.org.uk (Accessed April 2007)
3. Siris et al. Adherence to bisphosphonate therapy and fracture rates in osteoporosis women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clin Proc 2006; 81 (8): 1013 – 1022.
4. Compston. Treatments for Osteoporosis- Looking beyond the HORIZON. New England Journal of Medicine 2007 356; 18; 1878-1880

UK pharmacy Boots launches new test for bone disease

London: UK pharmacy Boots is to launch a new service to detect the risk of the bone disease osteoporosis.

This disease which makes more susceptible to breaks fand fractures affects three times more women than breast cancer (1).

Boots is trialing a new in-store osteoporosis screening service that will be in selected stores in Bournemouth and Birmingham for two months during March and April. This new service will offer Boots customers a painless, 10 minute bone density x-ray scan of the hip and spine whilst fully clothed, to identify their risk of osteoporosis

The Boots Osteoporosis Screening Service could be the latest addition to the current portfolio of Boots Pharmacy services available in-store. This new initiative sees Boots partner with New Medical Ltd the medical screening company that specialises in scanning for osteoporosis. The in-store scan will be performed by a qualified radiographer or nurse specially trained to use the specialist Dual Energy X-ray Absortiometry (DEXA) scanning system that uses less than one tenth of the x-rays used in a routine chest x-ray. Customers will receive their results straight after the scan and will be given advice about diet, exercise and other lifestyle changes as well as treatment options. They will also be advised to visit their GP to discuss the results if necessary.

Alex Gourlay, Boots Healthcare Director comments:” This screening trial is an exciting project and the first of its kind. It demonstrates Boots’ commitment to providing relevant healthcare services to its customers and tackling the health issues that affect people’s everyday lives. It is estimated that osteoporosis affects 3 million people in the UK alone. The success of this trial could mean that osteoporosis screening could become an in-store service available at more Boots stores nationwide in the future.”

Dr David Berger from New Medical Ltd, says: “It is exciting for us to be teaming up with Boots on this project to make advanced diagnostic technology more accessible. Early detection is vital if people are to prevent osteoporosis from developing and reduce their chance of debilitating fractures. A simple bone density scan is a sensible precaution for anyone who may be at risk.”

Who is at risk?

Women who have been through the menopause are at greatest risk of developing osteoporosis and osteoporosis-related fractures. The Boots Osteoporosis Screening Service will be available to the following ‘at risk’ groups of people:

All post-menopausal women

Females over the age of 40 that display at least one of the ‘at risk’ symptoms including excessive weight loss, infrequent menstruation or who are menopausal before the age of 45

Men over the age of 60

Any individual following referral by their GP
As a precaution pregnant women and anyone under the age of 18 will be excluded from screening.

Harley Street body MOT centre opens

London: A brand new health check, designed to reveal which parts of your body are not working as well as they could, has launched in London by leading physiotherapy practice, ES Physical Health.

The first of its kind, the musculo-skeletal MoT will show where a little corrective maintenance is needed to prevent possibly un-noticed physical anomalies or abnormalities becoming critical.

Libby Sharp, founder of ES Physical Health, which has clinics in both Harley Street and Camberwell, South London, says “With most of us leading sedentary lives we use only approximately 60% of the available range of motion in most joints such as our hips, knees, shoulders and spine.

“Add the aging process to this lack of use, and one day you find you simply cannot look round over your shoulder to reverse your car as you once could. ItÂ’s important to identify bad postural habits and anomalies as early as possible to prevent irreversible degenerative changes.”

Who would benefit? Anyone who has ever had a back problem is an obvious candidate –even if it was several years ago and you feel you have made a full recovery. Also, if you’ve had an accident – a break or sprain or any kind of sporting injury – you’ll benefit from finding out if you’ve fully recovered a normal range of motion, strength and stability, and that there are no residual signs of neural tension and hypersensitivity.

If you donÂ’t get your range of motion, strength and stability back up to as near normal as possible it is highly likely that you will suffer from degenerative change which will havea limiting effect on your lifestyle. What is there to gain? Through a series of top to toe tests we will note and record small, adverse anomalies in balance, gait pattern and range of motion which, if ignored, could present problems in the future.

By identifying problems and weaknesses we can advise simple interventions such as exercise, muscle stretches and postural alignment. If the MoT can pick up small problems which can be treated conservatively we can expect the person to be able to remain pain-free and able to function normally with both daily living and sporting activities for much longer than if problems or niggles are just ‘pushed under the carpet’.

As we live for much longer in the west than ever before, we need to remain
fit and healthy well into later life to enjoy ourselves to the full. We need to avoid aches and pains and especially surgery, such as hip and knee
replacements. What’s in the report? The written report highlights the important findings using an easy to understand ‘traffic lights’ system to emphasise severe, moderate and mild abnormalities, plus black to denote normal findings. As far as possible we use objective measuring tools and validated tests.

Based on your results we will suggest a range of possibilities – these might include physiotherapy if pain and loss of movement is present; Pilates to improve core stability, balance and co-ordination; a gym routine to improve strength and stamina; a consultation with our Podiatrist for corrective orthoses to improve lower limb biomechanics, and a consultation with our dietician / nutritionist for advice on weight loss or nutrition for competitive sports people.

We aim for a tailor-made programme to suit each individual to correct and overcome any problem which comes to light as a result of the MoT. Where, how long, and how much? ItÂ’s currently available at ES Physical HealthÂ’s clinic in Harley Street,and will soon also be available at their practice in Camberwell. It takes
just over an hour, and costs ÂŁ150. ES Physical Health is at 22 Harley Street London. T: + 44(0)20 7907 1900.

British hospital’s used stolen body parts in patients

London: Twenty-five British hospitals have bought tissue which may have been taken from diseased corpses in the UK body snatchers scandal.

And at least 40 British patients have been given transplants using body parts plundered by the mafia gang who stole more than 1,000 bodies from US funeral parlours. Most of the parts have been used in bone and dental grafts.

The body of veteran BBC broadcaster Alistair Cooke was among those stolen. and there are fears that potentially inadequate screening may have exposed British patients to HIV or syphilis.

The Medicines and Healthcare Products Regulatory Agency yesterday named the 25 hospitals where potentially contaminated body parts were grafted into British patients.

It revealed that 82 pieces of bone had been bought to be used in procedures such as hip operations and were distributed to the hospitals by the Swindon-based firm Plus Orthopaedics.

A spokesman for the health watchdog said the risk of catching an infection from the stolen bones was ‘negligible’ as they had been sterilised.

Normally, once tissue has been removed from a donor’s body and screened for disease, it is soaked in various solutions to prevent transmission of bacteria and viruses.

Nevertheless affected patients have been contacted and offered screening for diseases.

The scandal emerged in October last year when it was discovered hat the New Jersey-based company Biomedical Tissue Services (BTS) had been selling bones, ligaments and skin for use in transplants which had allegedly been removed illegally from corpses.

Bone is said to have been taken illegally from American corpses at funeral parlours without consent and without the necessary checks to make sure the bodies were free of disease. Cooke, whose Radio 4 programme Letter From America ran for 58 years, died from lung cancer aged 95 last December.

His bones were cut out and sent to BTS before he was cremated.

BTS owner Michael Mastromarino, who faces body harvesting charges, is said to have paid ÂŁ500 per corpse.

The company, which has been shut down, supplied bones and other body parts to the NHS. Many of the bones supplied by BTS were recalled after the scandal broke.

The Medicines and Healthcare Products Regulatory Agency, which ensures medicines and medical devices are safe, has tracked down affected patients in the UK and alerted their doctors. It initially-thought 77 parts had been sent to the UK but has now increased the figure to 82.

‘We ensured that affected hospitals were contacted, advising them that the infection risk was negligible, so that clinicians could decide what advice they should give to their patients,’ a spokesman said.

Campaigners called for tougher controls on the import of human body parts into the UK.

Professor Stephen Wigmore, chairman of the ethics committee of the British Transplantation Society, said: ‘No one would want to think they’d received tissue from someone from whom it had been taken against their will. It’s cases like this that highlight holes in the law.’

The scandal has exposed a growing trade in bones and tissue which are harvested abroad and shipped to Britain.

Shortages of organs and tissue from this country have been blamed on the fall-out from Alder Hey and the Bristol babies scandal, where organs were removed without consent.

There are currently no laws governing the import and export of body parts into the UK.

The Government organisation responsible, the Human Tissue Authority, said yesterday that it does not know which countries import skin, bone and ligaments to Britain, nor does it know the quantities shipped.

The American scam was uncovered when a funeral parlour owner in Brooklyn discovered records of the bone theft and called in police.

It was found that the bones of some corpses had been replaced with plastic pipes.

In the case of Cooke, documents listed the cause of death as a heart attack and lowered his age to 85, investigators said.

Mastromarino and three others have pleaded not guilty to the charges

Calcium fails to prevent fractures in children

Tasmania: Calcium supplements have very little benefit for preventing fractures in childhood and later adulthood, concludes a study carried out by the Menzies Research Institute.

Children taking such supplements are have only small improvements in bone density, which are unlikely to reduce fracture risk, says the report published in the British Medical Journal, and other approaches could be more beneficial such as increasing vitamin D concentrations and eating more fruit and vegetables.

Osteoporosis is a major public health problem, particularly in women, and low bone mineral density is an important risk factor for osteoporotic fractures. Bone density worsens for women after the menopause, so intervention in childhood to maximise peak bone mass by improving factors such as diet and physical activity can minimise the impact of bone loss related to age.

The researchers analysed the findings of 19 different studies involving 2,859 children collectively aged between three and 18. They included randomised trials of calcium supplementation in healthy children that lasted at least three months and which measured bone outcomes after at least six months of follow-up.

They found there was a small effect on total body bone mineral content and upper limb bone mineral density – children taking the supplements only had 1.7% better bone density in their upper limbs than children not taking the supplements.

However, there was no effect at important sites in the body for fracture in later life – namely the hip and lumbar spine. After children stopped taking calcium supplements, the effect persisted at the upper limb, but disappeared for total body bone mineral content.

The authors conclude: “The small effect of calcium supplementation on bone mineral density in the upper limb is unlikely to reduce the risk of fracture, either in childhood or later life, to a degree of major public health importance. It may be appropriate to explore alternative nutritional interventions, such as increasing vitamin D concentrations and intake of fruit and vegetables.”

Contact:
Tania Winzenberg, Musculoskeletal Epidemiologist, Menzies Research Institute, Tasmania, Australia.

UK patients implanted with stolen body parts, authorities admit

London: London: UK patients have been implanted with stolen body parts which may be potentially contaminated, the country’s Medicines and Healthcare Products Regulatory Authority has confirmed.

Over 70 pieces of bone have been grafted into the patients in 20 hospitals in the UK after they were imported from the New Jersey company Biomedical Tissue Services (BTS). The company which has now been shut down and is under investigation by the US Food & Drug Administration.

The imported bones were harvested by the firm from corpses in US funeral parlours without the deceased family’s consent and without proper checks to ensure the bodies were disease free. The stolen bodies included that of veteran broadcaster Alistair Cooke, who died of cancer last year, aged 95.

Although many of the bones were recalled after a safety alert, 77 implants had already been grafted into the hips and jaw bones of British patients. These patients have been offered screening for diseases such as HIV, hepatitis and syphillis which can be transmitted from the bones of the dead.

The scandal has exposed a growing trade in body tissue, bones and ligaments which are harvested in the US and exported around the world. In the US it is illegal to sell bodies directly to the US tissue banks which take ownership of the bodies after death but they sell them on to commercial companies who harvest, store and process the samples.

Imports to the UK have increased as there is a shortage of these parts which are used to repair serious fractures and as dental implants.

The UK government responsible for monitoring this trade, the Human Tissue Authority does not know which countries export skin, bone and ligaments to Britain or even the quantities.

The export of the particularly batch to Britain by BTS is confirmed by the Medicines and Healthcare products REgulatory Authority, the agency responsible for ensuring the safety of medical treatments. They said the patients had received what is known as allografts to fill holes in jaws and hip bones.

Regulators say the chance of infection is low as the bones were steralised prior to implantation.

The company BTS was forced to close last autumn after allegations that it had forged consent forms and other documents to gain access to dead bodies from undertakers.

Among the bodies desecrated was that of Alistair Cooke, whose bones were stolen and recyled. The US authories also claim that BTS did not carry out proper screening of the bodies. Also the bones of elderly people may not be suitable for transplants as they are more likely to have degenerative bone diseases such as osteroporosis.

The director of the company, Michael Mastromarina, a dentist who lost his practising licence because of drug addiction, and two assistants, face criminal charges including soliciting undertakers to prove illegally body parts such as tendons, skin and bone from corpses.

Joint healthcare campaign launches in UK

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London: Health Perception, the UKÂ’s leading glucosamine specialists, have initiated a new consumer awareness campaign called JUMP 4 JOINTS! This has been developed specifically to draw attention to the importance of looking after oneÂ’s joints from an early age in order to enjoy overall health and mobility later on in life.

Many people are totally unaware of just how vulnerable their joints are. Inevitably, they donÂ’t worry about the health of their joints until problems occur. These could be anything from the complaining elbow of an amateur tennis player to the more extreme pain caused by repetitive use of certain joints over time, and the onset of osteoarthritis.

According to the Arthritis Research Campaign, more than 7 million adults in the UK have long-term health problems due to arthritis and related conditions. The cost to the nation is estimated in the region of ÂŁ6.5 billion when absence due to illness, consultations, prescription drugs and secondary care rheumatology costs, disability allowances and community and social services are taken into account.

The first step of the campaign is a free 24-page booklet that is packed with expert advice and valuable information on nutrition and exercise, as well as interesting facts on joints and how they work.

Whether suffering discomfort now, or seeking to avoid it in the future, JUMP 4 JOINTS! could help. One of the contributors, GP Dr Rob Hicks, clearly lists various ways to improve joint health and recommends keeping active. “It saddens me when I hear people say that having Osteoarthritis means they “can’t do” the things they want to do anymore, or that they “just have to live with it” because this doesn’t have to be the case.”

David Wilkie, founder and managing director of Health Perception is keen to draw attention to the benefits that supplements such as glucosamine can bring to joint husbandry. “As a former Olympic swimmer, I have personally felt the pressure of sport at the highest level and the associated stresses and strains on the body and its joints. It was for this reason that I originally decided to introduce glucosamine into the U.K. I had seen many of the world’s top athletes using glucosamine, a naturally occurring product in the body commonly referred to today as the ‘building blocks of the connective tissues’, to help their joints with excellent results, but it was a relatively unknown product here at home.”

In the guide, Naturopath Miriam Elkan has compiled a list of ‘The Good and the Bad’ foods for joint health and explains that: “Caring for your joints means taking care of everything else and everything else taking care of your joints. If you care for your joints you are also looking after your heart, your lungs and your weight.”

A special four-page easy-to-follow Jump 4 Joints! Workout has been devised by Pilates Consultant and Chartered Physiotherapist, Beverley Skull, to help improve overall joint mobility. She also focuses on four main areas of fitness, namely strength, aerobic capacity, flexibility, and agility & balance, along with an explanation on the overall benefits of exercise to promote a healthy active life. This is reinforced by David Wilkie’s swimming feature and Karl Frew’s introduction to ‘Rebounding’, which, according to NASA is ‘the most efficient and effective exercise yet devised by man’.

This publication has something for everyone, including a handy index to guide the consumer through the myriad of information available, with a whoÂ’s who and whatÂ’s what in the world of joint health and culminates with the chance to win a break for two in Iceland.

The Jump 4 Joints! booklet is available free by calling 0845 330 5518 or by visiting the dedicated website www.jump4joints.co.uk

Low oestrogen linked to hip fractures in men

New York: Low levels of the hormone oestrogen have been linked to an increased risk of hip fractures in older men, a new study in the US reveals.

The new study which is published in the May issue of the American Journal of Medicine, also states that those with low levels of oestrogen and testosterone are at the greatest risk. This study is the first to report the link between low estrogen and hip fracture in a study group of men from the general population followed over time.

It also found that men with low estrogen levels have an increased risk for future hip fracture, and those with both low estrogen and low testosterone levels have the greatest risk.

The study, of 793 men who had their hormone levels measured nbetween 1981 and 1983 and had no history of hip fracture, was conducted by Shreyasee Amin, MD at the National Heart, Lung and Blood Institute’s Framingham Heart Study www.framingham.com/heart. The men were monitored until 1999.

Thirty-nine men in the study experienced a low trauma hip fracture, such as that sustained by a fall. Those with low estrogen levels had 3.1 times the risk of hip fracture compared to men with high estrogen levels. There was no significant increase in hip fracture risk for men with low testosterone levels alone. But those both low estrogen and low testosterone levels had the greatest risk, with 6.5 times the risk of hip fracture compared to the men who had both estrogen and testosterone levels in the high range or midrange.

Though many people associate testosterone with men and estrogen with women, men possess both hormones, according to Dr Amin, who now works at the Mayo Clinic.

The researchers who undertook this study knew that low estrogen levels had been associated with low bone mineral density in elderly men, but any link to hip fracture, an important health risk in the elderly, was unknown. Hip fractures are worrisome in the elderly, especially in men, explains Dr. Amin. Up to 50 percent of men require institutionalized care after the fracture. Hip fracture also is linked to higher levels of mortality: up to 37 percent of men die within one year of fracture.

Routine tests on hormones are not performed in most countries and this study indicates the importance of such testing.