New U.S. guideline would expand bone density testing

(Reuters Health) – Under a new set of guidelines proposed by an influential U.S. panel, more women would be eligible for bone density tests to detect the bone-thinning disease osteoporosis.

The draft guidelines by the U.S. Preventive Services Task Force (USPSTF), sponsored by the U.S. government’s Agency for Healthcare Research and Quality, call for all women to be screened for osteoporosis starting at age 65. Women who are deemed to have higher risks could start earlier, at any age.

The group’s last guidelines, in 2002, had the same recommendations for all women 65 and older, but said that high-risk women should not begin screening until age 60. The new draft is based on a review of evidence, published in the Annals of Internal Medicine, since the previous guidelines were issued.

About 10 million people in the U.S. over the age of 50 have osteoporosis, according to the National Institutes of Health, most of them women. More than three times as many women are at risk of the disease.

The disease, which typically begins after menopause, increases the risk of broken bones, the most dangerous of which are broken hips, and may cost the health care system as much as $18 billion per year.

It’s unclear how many additional women will now fit the screening criteria, task force chair Dr. Ned Calonge told Reuters Health. “The good news,” he said, is that it’s the minority of women between 50 and 64 who will be at high risk.

“What physicians should do is not pull out the DXA machine,” Calonge said, referring to the device usually used for bone mineral density tests, “but calculate clinical risk factors” in women under 65.

Such scans cost a few hundred dollars each, with DXA machines costing up to $85,000.

Ultrasound, which is cheaper and does not involve radiation, has also been shown to effectively predict fractures, and is also commonly used. However, most diagnostic criteria refer to DXA measurements.

In the new draft, the USPSTF does not recommend testing men for the disease, saying there is not enough evidence to show a benefit. The National Institutes of Health estimates that about 2 million men in the U.S. have osteoporosis, accounting for about one fifth of cases overall.

For women, the draft guidelines are similar to those of the American Congress of Obstetricians and Gynecologists, and also to those of the National Osteoporosis Foundation.

The osteoporosis organization recommends all women be screened starting at age 65, and that doctors use World Health Organization criteria – also used by the USPSTF – to determine if a woman is at higher risk before 65. Such criteria take into account other health conditions, a history of broken bones, and drugs people are taking.

The foundation does, however, recommend that all men be screened starting at the age of 70.

That difference just reflects “different ways of dealing with uncertainty,” Calonge said. “Men do get osteoporosis and osteoporotic fractures. But we don’t feel there’s enough evidence.”

Dr. Mone Zaidi, an osteoporosis researcher at the Mount Sinai School of Medicine in New York, said that while the new draft guidelines are a step in the right direction because they broaden screening criteria, and are appropriate for men, they do not go far enough.

“What we really need to do is capture women much earlier than menopause,” Zaidi, professor of medicine and director of Mount Sinai’s Bone Program, told Reuters Health. “A woman starts losing bone at a maximal rate within two years of menopause.”

Zaidi cited advances in treatment since the USPSTF’s 2002 guidelines. Osteoporosis is typically treated with drugs called bisphosphonates such as Fosamax, Boniva, Reclast, and Actonel.

Such drugs have come under scrutiny by the Food and Drug Administration (FDA) for increasing the risk of heart disease and certain fractures, but the FDA has said it found no such links after reviewing the data.

Evista is also used to treat osteoporosis, although it has been shown to increase the risk of blood clots, according to the USPSTF. Estrogen, which is also sometimes prescribed to prevent fractures, can increase the risk of stroke, heart disease, and breast cancer.

Still, given the availability of safe treatments, “it doesn’t make any clinical or common sense to me to wait until they’ve lost enough to be at a high enough risk or qualify under the old osteoporosis criteria,” Zaidi said.

“In the field, if you go and talk to any ob-gyn, they do a bone density test at menopause,” Zaidi said. “The task force is far behind.”

Calonge, who works at the Colorado Department of Public Health and Environment in Denver, acknowledged that doctors go beyond the evidence in practice all the time.

“From the standpoint of being a clinician, I understand that,” he said. “I think it’s important to know what the evidence supports, and know when you’re exceeding the evidence, and that’s a good time for a frank discussion with your patients.”

SEEKING FEEDBACK

The release of these draft guidelines mark a change in how the USPSTF will put forth its recommendations, Calonge told Reuters Health. In the past, they simply released final versions of their recommendations, but they have been quietly working on ways to release drafts for public comment, before the guidelines were final.

For one month, the draft will be available for comment on the group’s website here. Based on the feedback, the group may change its recommendations.

“We’ve decided that since the miscommunication and the reaction to the breast cancer screening guidelines, that we wanted to accelerate the process,” Calonge said, referring to mammography recommendations released last November that were met with controversy.

The 2002 osteoporosis screening recommendations remain in force until the new ones are finalized, Calonge said. “We’re not recommending clinicians use this recommendation until final release.”

SOURCE: www.annals.org Annals of Internal Medicine, July 5, 2010.

Genes associated with osteoporosis identified

London, May 4 (ANI): Researchers at Jewish General Hospital in Montreal have identified 20 genes associated with osteoporosis and bone weakness, including 13 genes never previously associated with the disease.

Osteoporosis is a highly heritable trait, but this marks the largest international effort to conclusively identify genes linked to the often-devastating bone disorder.

The study”s co-first author is Dr. J. Brent Richards of the Lady Davis Institute for Medical Research at the Jewish General Hospital in Montreal, who collaborated with more than 30 co-authors worldwide.

The results were published recently in the journal Nature Genetics.

The researchers reviewed data collected from nearly 20,000 individuals in five recent international genetic studies. (ANI)

HUNT Biosciences Signs Collaboration Agreement with Tissue Solutions

Major boost to biomarker discovery anticipated
LEVANGER, Norway–(Business Wire)–
HUNT Biosciences AS, the specialized biomarker discovery and validation company,
today announced that it had signed a collaboration agreement with Tissue
Solutions Ltd, a leading international supplier of biological samples for the
pharmaceutical and diagnostics industry.

The collaboration aims to promote the value of the unique HUNT Study, which for
the past 25 years has gathered blood samples from the general population of the
Nord-Trøndelag region in mid-Norway together with detailed phonotype and
environmental data.

According to Per Foss, CEO of HUNT: “We believe that the unique combination of
biomedical and phenotypic information that has been collected over the past 25
years from a general population rather than a specific disease cohort can help
accelerate biomarker discovery and validation. Furthermore, working from a
general population base gives core strengths in a whole range of key public
health areas such as cancer, cardiovascular disease, diabetes, obstructive lung
disease, osteoporosis and mental health. Already HUNT samples are widely used in
academic research, and through this collaboration with Tissue Solutions we aim
to significantly increase our pharma and diagnostic industry customer base.

Tissue Solutions Ltd recently won West of Scotland`s Most Promising Young Life
Science Company and according to CEO Dr Ann Cooreman, their success in rapidly
building up a high quality international client list has been based on being
able to offer a single point to access the entire range of human biological
materials for research and development needs: “We are delighted with this
agreement with HUNT Biosciences which is a natural extension to our services.
Having access to population biobank samples means, for example, that we can
provide samples that predate onset of disease. We are sure both existing and new
customers will share our excitement.”

This agreement follows the recent Norwegian report referring to HUNT Biosciences
as a role model for a proposed future national Norwegian Biobank Company. Foss
also believes this collaboration with Tissue Solutions and Scotland could
provide a major focal point for high quality, ethical tissue provision on the
worldwide stage.

Notes to editors

The HUNT Study and its associated biobank represent a regional cohort of more
than 100.000 individuals and is part of CONOR, the Cohort of Norway. In addition
to professionally stored genetic samples, the HUNT Study comprises more than
3000 clinical variablesincluding 800 environmental exposure variables collected
since the early 1980′s. This unique resource operates as a satellite to the
Norwegian University of Science and Technology ( NTNU) in Trondheim and is
situated in a new, specially designed National Biobank building with
state-of-the-art infrastructure, storing samples from 250 000 CONOR
participants. The Norwegian authorities have earned the population`s trust
through a well-established framework and rigorous routines for protection of
personal information. Based on this trust and the unique system of unambiguous
personal identification numbers, the HUNT Study offers integration of biobank
data with other national registries on clinical information and medical
end-points, as well as genealogical and family linkage information.

Genetics:

DNA from about 250.000 individuals (CONOR) and 15.000 RNA samples

Immortalized cells for cell line production from 50.000 individuals

Genetic expression analysis from tumor biopsies can also be provided from
selected HUNT participants

Phenotype:

Precise information on health status and extensive lifestyle data

Cross-linkage to local clinical endpoints and national registries:

“Medical Birth”. “Cause of Death”, Prescription Registry”, “Cancer Registry” and
other validated clinical endpoint registries on myocardial infarction, venous
tromboembolism, stroke and factures based on local hospital records.

Environment:

Coverage of more than 800 exposure variables

Prospective information due to long observation period.

The HUNT Study is also an integrated part of three EU projects in FP 6 and FP 7
and its role in EU funded medical research is expected to be further extended
and deepened in the Framework 7 programs. HUNT cooperates actively with a number
of European biobanks, and the CONOR consortium signed a bilateral national
agreement with UK Biobank in 2005, including the development of integrated
solutions for data management and automated sample handling.

Corporate Inquiries
HUNT Biosciences AS
Per A Foss, CEO
Mobile: +47 95124048
Email: per.a.foss@huntbiosciences.com
or
Media Inquiries
Schwartz Communications
Richard Hayhurst
Tel: +44 (0) 7950 878 218
Email: rhayhurst@schwartz-pr.co.uk

Copyright Business Wire 2010

Gene behind gum disease, osteoporosis, arthritis identified

Washington, Aug 31 (ANI): An international team of researchers have identified a gene that is common in the development of gum disease, rheumatoid arthritis, and osteoporosis.

Experts at Hospital for Special Surgery say that their findings about the gene, called interferon regulator factor-8 (IRF-8), may lead to new treatments in future.

“The study doesn’t have immediate therapeutic applications, but it does open a new avenue of research that could help identify novel therapeutic approaches or interventions to treat diseases such as periodontitis, rheumatoid arthritis or osteoporosis,” said Nature magazine quoted Dr. Baohong Zhao, a research fellow in the Arthritis and Tissue Degeneration Program at Hospital for Special Surgery located in New York City, as saying.

The researchers discovered that downregulation of IRF-8 (meaning that the gene produces less IRF-8 protein) increases the production of cells called osteoclasts that are responsible for breaking down bone.

In humans and animals, bone formation and bone resorption are closely coupled processes involved in the normal remodelling of bone. Enhanced development of osteoclasts, however, can create canals and cavities that are hallmarks of diseases such as periodontitis, osteoporosis and rheumatoid arthritis.

The genome-wide study showed that the expression of IRF-8 was reduced by 75 percent in the initial phases of osteoclast development.

The genetically engineered mice deficient in IRF-8 had decreased bone mass and severe osteoporosis.

The researchers concluded that IRF-8 suppresses the production of osteoclasts.

“This is the first paper to identify that IRF-8 is a novel key inhibitory factor in osteoclastogenesis (production of osteoclasts),” said Zhao.

“We hope that the understanding of this gene can contribute to understanding the regulatory network of osteoclastogenesis and lead to new therapeutic approaches in the future,” Zhao added.

The study has been published in the journal Nature Medicine. (ANI)

Now, test that predicts when a woman will reach menopause

Washington, May 26 (ANI): Scientists have made a new discovery that might be of great help for women planning to have babies later in life.

For the first time, scientists have been able to identify the genetic factors that influence the age at which natural menopause occurs.

It is hoped that this can allow women in their late 30s and early 40s to pinpoint accurately how long they have left in which to conceive and when they should start trying for a baby.

Lisette Stolk, a researcher from Erasmus University Medical Centre in the Netherlands, said at the annual conference of the European Society of Human Genetics that a greater understanding of the factors influencing age at menopause might also help to improve the clinical treatment of infertile women.

Stolk and colleagues analysed genetic data from nine studies involving 10,339 menopausal women.

They found 20 single letter changes in the genetic code that were associated with having an early menopause.

The variants, known as single nucleotide polymorphisms (SNPs), were located at four different sites on chromosomes 19 and 20, two of the coiled packages of DNA that house the genes.

None of the variants had been identified before. What effect they have is unclear, but the scientists suspect they influence the ovaries or the brain.

“We found that the 20 SNPs were all related to a slightly earlier menopause and women who had one of them experienced menopause nearly a year earlier than others,” said Stolk.

“We know that ten years before menopause women are much less fertile, and five years before many are infertile. In Western countries, where women tend to have children later in life and closer to menopause, age at menopause can be an important factor in whether or not a particular woman is able to become a mother,” Stolk added.

Other effects of earlier menopause include an increased risk of the bone disease osteoporosis, the joint disease osteoarthritis and of heart disease, although it can also offer some protection against the risk of breast cancer. (ANI)