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NOF supports
approval of revolutionary new therapy
The
National Osteoporosis Foundation (NOF) has supported the
recommendation by the Endocrinologic and Metabolic Drugs
Advisory Committee of the US Food and Drug Administration
(FDA) that the FDA should approve FortéoTM.
FortéoTM
is a new therapy in the fight against osteoporosis
that can stimulate bone formation, increase bone
mass and reduce the risk of bone fractures.
Sandra C. Raymond, NOF Executive Director, said of
the recommendation: "Fortéo offers a new
choice of therapy for women and men suffering from
this debilitating disease. The fact that this
treatment actually builds bone can help those at
risk, since more than 1.5 million bones fracture
each year due to osteoporosis. The recommendation of
this committee is an important step towards
developing new treatments that reduce the risk of
fracture, allowing people to remain active and
strong throughout their lives."
Other medicines approved for osteoporosis prevention
and treatment are classified as anti-resorptive
drugs because they slow bone resorption or
breakdown, the first step in the bone remodelling
process. Rates of resorption increase with menopause
and advancing age, and are associated with bone
loss. Anti-resorptive medications slow the rate of
bone remodelling to a more normal level and reduce
the risk of some osteoporotic fractures.
Fortéo is a parathyroid hormone (PTH) treatment
that stimulates bone formation.
PTH has been found to build bone in men with
osteoporosis and in women on steroid treatment for a
variety of conditions. Data also shows that PTH can
reduce vertebral fractures in women by 65-69 per
cent and also reduces fractures in other parts of
the body.
"This would be the first treatment option to
build substantial amounts of bone for those
suffering osteoporosis by increasing bone
formation," said NOF President C. Conrad
Johnston, Jr., MD.
"This recommendation takes us closer to opening
up a whole new mode of treatment that will increase
bone mass dramatically in individuals with
osteoporosis and reduce the risk of vertebral and
other fractures more than any currently available
treatment."
With more than 350,000 members, NOF is the only
non-profit, voluntary health organisation dedicated
to reducing the widespread prevalence of
osteoporosis through programmes of research,
education and advocacy.
New research underscores validity of bone
density testing recommendations
Research published in The Journal of the American
Medical Association has confirmed the effectiveness
of recommendations made by the NOF in its Physician’s
Guide to Prevention and Treatment of Osteoporosis as
compared to two other instruments.
Scores from the Simple Calculated Osteoporosis Risk
Estimation (SCORE), Osteo-porosis Risk Assessment
Instrument (ORAI) were compared to NOF
recommendations and little variation was found.
In fact, the three had similar rates of accuracy in
identifying women who would benefit from DXA
testing. The study did find, however, that two other
instruments based on Age, Body Size, No Estrogen (ABONE)
and "weight-only" were inadequate for
identifying at risk women who should be screened.
"This important research makes clear that
testing determinations cannot be made based solely
on age, body size, estrogen status or weight,"
said Sandra C. Raymond, Executive Director of NOF.
"The findings demonstrate that osteoporosis
experts are moving toward a consensus in determining
which individuals are at greatest risk for this
preventable and treatable disease."
Lawrence G. Raisz, MD, chairman of NOF’s
Scientific Advisory Board, said: "Overall, the
proportion of women recommended to be screened by
the three different methods is more similar than
different. In fact, the actual number of women
screened according to NOF recommendations is only
slightly higher than with SCORE and ORAI. And, is
that so bad? Simple logic dictates that if you cut
down on the number of tests, you are going to miss
more women who actually have low bone density and
are at significantly greater risk of serious
fractures."
Raisz also pointed out that the ORAI and NOF both
recommend DXA testing for all women over 65. He
said: "It is very important to note that the
research does not tie the recommendation to be
tested to fracture risk. Therefore, you cannot say
that one approach does a better job or is more
accurate with respect to fractures."
Determining fracture risk is vitally important since
the nation spends nearly $14 billion per year on
osteoporotic fractures - fractures of the hip, spine
or other bones.
Ms. Raymond concluded: "BMD testing is a
cost-effective tool that can identify the hundreds
of thousands of men and women who would otherwise
suffer life-threatening fractures. The Foundation’s
goal is to reduce the number of individuals
suffering unnecessarily from this preventable and
treatable disease. NOF’s recommendations guarantee
that a maximum number of people with low bone mass
are identified and treated."
BMD
screening project in Lebanon proving a success
In
October 2000, a nation-wide BMD screening
programme was launched in Lebanon by the
Lebanese Osteoporosis Prevention Society
(LOPS) in collaboration with the Lebanese Red
Cross.
The objective was to provide diagnostic
testing at Red Cross centres throughout the
country for all those with a high risk of
developing osteoporosis. Thanks to funds from
The 206: A Fund in Trust, LOPS was able to
purchase four small Achilles densitometers and
one large Dexa densitometer.
The four small machines are presently being
rotated around Red Cross centres in different
regions of the country, while the larger
machine has been installed at the new LOPS
office in Beirut.
People considered at high-risk for
osteoporosis are now being screened on the
Achilles machines. Should they be diagnosed as
appearing to have osteo-porosis, the Lebanese
Red Cross would then transport the patients to
Beirut for fuller evaluation on the large Dexa
machine at the LOPS office.
The small machines are moved to different Red
Cross centres around the country at regular
intervals, so as to cover as much of Lebanon
as possible.
The fees charged go towards technicians’
sal-aries and towards the cost of running the
machines, transportation and other costs.
The tests are offered to the needy at
much-reduced rates and by the end of May 2001,
more than 2,000 tests had been carried
out on the Achilles machines, while 133 tests
were made by LOPS on the Dexa machine.
More recently, LOPS also began to offer
medication to a limited number of needy
patients who are diagnosed with osteoporosis.
Financing for this part of the project has
been made possible by proceeds from a recent
fundraising event.
In recognition of the hard work and commitment
on the part of the entire LOPS team in
establishing this project, LOPS was awarded
one of the IOF-MSD “Invest in Your Bones”
grants to the value of $10,000.
The Jordanian Osteoporosis Prevention Society
has also been awarded a grant as part of the
“Invest in Your Bones” scheme.
The country’s National Campaign Against
Osteoporosis will benefit.
It is a wide-reaching project that aims to
increase the awareness of the disease.
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