American College of Physicians (ACP) recently updated it’s 2008 treatment guideline for
treatment of low bone density and osteoporosis in men and women. This update is
also endorsed by American Academy of Family Physicians.
The guidelines
were published online May 8 in the Annals of Internal Medicine along with an
Editorial by Eric S. Orwoll.
According to
International Osteoporotic Foundation (IOF), 1 in 3 women over age 50 will experience
osteoporotic fractures and nearly 200 million women suffer from osteoporosis
worldwide.
The
reviewers searched databases for observational studies, RCTs, meta-analysis and
systematic review from 2 January 2005 to 3 June 2011 and added a machine
learning method from 2014 to 2016 to gather and grade the necessary evidence in
formulating the guidelines.
The target
audience for this update is all physicians and target population is all adult
men and women with low bone density or osteoporosis.
Recommendations:
1) ACP
recommends that pharmacologic treatment with 3 bisphosphonates; alendronate,
risedronate, zoledronic acid, or newer biologic agent denosumab is beneficial
for women who have osteoporosis (T scores ≤ –2.5 or those who have experienced
fragility fractures) (Grade: strong recommendation; high-quality evidence)
Raloxifene,
ibandronate and teriparatide are not advocated as a first-line pharmacologic treatment. Calcitonin which is widely used in osteoporosis was not included in
this guideline.
The role
played by Calcium and Vitamin D supplementation is also not clear. They can be
given with careful dosing strategies to avoid hypercalcemia.
2) The
duration of treatment recommended for women with osteoporosis is 5 years, most
studies included in the analysis continued treatment for 5 years. (Grade: weak
recommendation; low-quality evidence).
Treatment
beyond that period should be based on individual case evaluation.
3) Monitoring
the women for bone density during the duration of treatment is not recommended
as no additional treatment benefit is derived from it.
The guidelines
also advise against the frequent monitoring of women with normal BMD for development
of osteoporosis. Most women who have normal DXA scores are unlikely to develop
osteoporosis in next 15 years.
4) The guideline
also does not support the use of hormone-replacement therapy (HRT), either
estrogen alone or in combination with progesterone as a treatment option in
postmenopausal women with established osteoporosis.
The serious
side effects such as cerebrovascular accidents and venous thromboembolism
outweighs any potential benefits derived from it. Use of selective
estrogen-receptor modulator (SERM) raloxifene is also not advised because of
the harmful side effects.
Eric Orwoll,
MD, Oregon Health and Science University, Portland, Oregon, does not agree with
the ACP on issues regarding the role of HRT in osteoporosis.
He writes in
an accompanying editorial "Estrogen replacement reduces fractures in
postmenopausal women overall, and it is likely to do the same in osteoporotic
women."
"Therefore,
although estrogen should not be the first choice for osteoporosis therapy, if a
woman is using estrogen for other reasons (such as menopausal symptoms),
skeletal benefits can be expected without the addition of a second osteoporosis
drug," Dr Orwoll further added.
5) The ACP
advises the physicians to take their own decision when it comes to treatment of
osteopenic women who are 65 years or older based on patients risk for fractures
and her individual treatment preferences.
6) The
guidelines also urged physician to prescribe generic drugs in an effort to keep
the cost down, as cost is an important aspect of adherence to treatment.
Dr Orwoll
further discussed the exclusion of teriparatide, an anabolic agent from the
treatment guidelines. He opines that it may be a good option in case of
sequential therapy.
FDA recently approved abaloparatide (Tymlos, Radius Health) similar to teriparatide for treating
osteoporosis patients at high risk of fracture.
Dr Orwoll
cautioned about starting the treatment based only on BMD “Clinicians should
take into account more than BMD in judging risk and in guiding therapeutic
decisions………….[That] is absolutely critical."
"Further,
these guidelines are but one of several that exist, [and] clinicians must
carefully examine the considerable differences among them," he added.
Full Text of the article in Annals of Internal Medicine can be accessed here.
Full Text of the article in Annals of Internal Medicine can be accessed here.
Excellent information. But I failed to underhand why there is so negative approach to use of Raloxifen. May clarify in details about ill effects of Raloxifene in details.
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