NOF Clinician's Guide to Prevention and Treatment of Osteoporosis | National Osteoporosis Foundation

http://nof.org/professionals/clinical-guidelines

NOF Clinician's Guide to Prevention and Treatment of Osteoporosis

The Clinician's Guide to Prevention and Treatment of Osteoporosis is intended to inform clinical decision making for the management of men and women at high fracture risk. It integrates the expression of a patient's fracture risk as a 10-year probability (the output from FRAX^®) with current clinical recommendations for the management of osteoporosis.

According to the Clinician's Guide, healthcare providers should consider FDA-approved medical therapies in postmenopausal women and men aged 50 years and older, based on the following:

A hip or vertebral (clinical or morphometric) fracture
T-score ≤ -2.5 at the femoral neck or spine after appropriate evaluation to exclude secondary causes
Low bone mass (T-score between -1.0 and -2.5 at the femoral neck or spine) AND a 10-year probability of a hip fracture ≥ 3% OR a 10-year probability of a major osteoporosis-related fracture ≥ 20% based on the US-adapted WHO algorithm
Clinician's judgment and/or patient preferences may indicate treatment for people with 10-year fracture probabilities above or below these levels

The printed version of the Clinician's Guide was published in 2008. NOF will periodically make revisions to the online version. Visit our website regularly to see if an updated online version of the Clinician's Guide is available.

A single print copy of the 2008 Clinician's Guide is available at no charge. A pack of 10 copies is available for $15. To request a free print copy or to purchase quantities, please complete the order form. You can also purchase quantities of the 2008 print version from NOF's online store.

January 2010 online updates to the 2008 Clinician's Guide include revisions to the following:

Chapter 3: Diagnosis and Management

Biochemical markers (page 14)
Use of WHO Fracture Risk Algorithm (FRAX^®) in the US (pages 14-15)

Chapter 5: Pharmacologic Therapy

Updated FDA indications for zoledronic acid (page 22)
Updated FDA indication for parathyroid hormone (page 24)

Download the Clinician's Guide to Prevention and Treatment of Osteoporosis

Access FRAX^® - WHO Fracture Risk Assessment Tool

Nearly 1 in 20 US adults over 50 have fake knees

CHICAGO — Nearly 1 in 20 Americans older than 50 have artificial knees, or more than 4 million people, according to the first national estimate showing how common these replacement joints have become in an aging population.

Doctors know the number of knee replacement operations has surged in the past decade, especially in baby boomers. But until now, there was no good fix on the total number of people living with them.

The estimate is important because it shows that a big segment of the population might need future knee-related care, said Dr. Daniel Berry, president of the American Academy of Orthopedic Surgeons and chairman of orthopedic surgery at the Mayo Clinic in Rochester, Minn. He was not involved in the research.

People with knee replacements sometimes develop knee infections or scar tissue that require additional treatment. But also, even artificial knees wear out, so as the operations are increasingly done on younger people, many will live long enough to almost certainly need a second or even third knee replacement.

The new estimate comes in an analysis being presented Friday at the academy's annual meeting in San Francisco.

"These data are sobering because we didn't know what an army of people we've created over the last decade," said Elena Losina, lead author of the analysis and co-director of the Orthopedics and Arthritis Center for Outcomes Research at Harvard's Brigham and Women's Hospital. "The numbers will only increase, based on current trends."

Replacement joints can greatly improve quality of life for people with worn-out knees, but they're not risk-free and it's a major operation that people should not take lightly, she said.

Modern knee replacements in the United States date back to the 1970s. Since then, advances in materials and techniques, including imaging scans to create better-fitting joints, have made the implants more durable and lifelike, surgeons say.

Losina and colleagues came up with their estimate by analyzing national data on the number of knee replacements done from 1998-2009, U.S. census data, death statistics and national health surveys.

For example, in 2009, more than 600,000 knee replacement operations were done nationwide. The study estimate includes people who had knee replacement operations that year and in previous years who are still living.

Overall, 4.5 million Americans are living with artificial knees. That includes an estimated 500,000 who have had at least two replacement operations on the same knee.

Knee replacements are most common in people older than 80 — 1 in 10 people in this age range have them, the study found. Though they're less prevalent in people younger than that, there are still more than half a million Americans in their 50s with the artificial joints, and based on current trends, operations in that age group are expected to increase.

According to the federal Agency for Healthcare Research and Quality, knee replacements tripled in people ages 45 to 64 between 1997 and 2009.

Doctors think two trends have contributed to that increase: the nation's obesity epidemic and amateur athletes who don't adjust workouts to spare aging or even injured joints. Both can lead to or worsen arthritis, the main reason for replacing knees.

Osteoporosis Medication Linked to Unusual Thigh Fractures - Experts Recommend Taking a 'Holiday' From Bisphosphonates to Prevent Broken Bones

- By Laird Harrison - WebMD Health News Reviewed by Laura J. Martin, MD - - Feb. 8, 2012 -- Some drugs used to strengthen bones may increase the risk of an unusual type of fracture if patients take them for many years, a new study shows. - - Overall, most people with osteoporosis, a loss of bone density over time, will suffer fewer broken bones if they take bisphosphonates, a category of drugs including Actonel, Atelvia, Boniva, and Fosamax that are used to treat the disease. - - But a very small proportion of those who take the drugs may experience an unusual femur (thighbone) fracture if they take the drugs on a long-term basis. - - Still, "we're preventing way more fractures than we're causing," says Richard M. Dell, MD, an orthopedic surgeon at Kaiser Permanente Medical Center in Cypress, Calif. He presented his findings today at the Annual Meeting of the American Academy of Orthopaedic Surgeons. - - The fractures are called "atypical femur fractures" and sometimes happen after a fall but often without any noticeable cause. - - The fractures happen in about three to seven out of 10,000 people, mostly women in their 60s and 70s. About a third of the people who suffer from this type of fracture feel pain before it happens. - - About seven years ago, researchers began to notice that many of the people who experience these unusual fractures were taking bisphosphonates. - - And they found that about 20% of the people who have this type of fracture in one leg also go on to experience a similar fracture in the opposite leg. - - A Visual Guide to Osteoporosis - Study Details - - Dell and his colleagues studied a group of patients with such fractures to see what happened if they stopped taking bisphosphonates after the initial atypical fracture. - - They collected information on all femur fractures over a period of three years in patients older than 45 years insured by Kaiser Permanente in California, which amounted to about 2.6 million patients. - - Dell and his colleagues found 126 patients who were taking bisphosphonates when they had an initial atypical thigh fracture. Of those who continued taking the bisphosphonates for three or more years after the first fracture, 53.8% also broke their thigh bone in the opposite leg. - - But of those who stopped taking the bisphosphonates, 19.3% experienced a second fracture in the opposite leg. - - In other words, those who stopped taking the bisphosphonates within one year of the first fracture reduced their risk of having a second atypical fracture by almost 66%. - - 'Drug Holiday' - - But why should a medication that makes bones stronger actually increase the risk of this type of unusual fracture? - - Although bones may not appear to change in adults, in reality microscopic amounts of old bone are constantly being removed and replaced by new bone. During youth, more bone is added than is taken away, but starting in middle age there may be more bone loss than gain. - - Bisphosphonates work by slowing the process in older people so that the old bone material stays in place. The problem is that the old bone may start to weaken. "Bisphosphonates delay the repair process," Joseph Lane, MD, a professor of orthopedic surgery at Weill Cornell Medical College in New York, tells WebMD. "Initially the bone is stronger, but eventually it's weaker." The new study adds evidence that this may be happening. - - Lane, who was not involved in the research, recommends that patients taking bisphosphonates stop after five years for a drug holiday. Then he tests the patients to see how dense their bones are and does additional tests to help determine if there is a need for further bisphosphonate therapy. - -

Potential Biomarker Identified For Osteoarthritis

Henry Ford Hospital researchers have identified for the first time two
molecules that hold promise as a biomarker for measuring cartilage
damage associated with osteoarthritis. Researchers say the concentration of two molecules called non-coding
RNAs in blood were associated with mild cartilage damage in 30 patients
who were one year removed from reconstruction surgery to repair an
anterior cruciate ligament, or ACL, injury. The findings are described as significant in the ongoing and tedious
search of biomarkers for osteoarthritis, the most common form of
arthritis that afflicts an estimated 27 million Americans aged 25 and
older. It is caused by the normal aging process or wear and tear of a
joint. The study was being presented Saturday at the annual Orthopaedic
Research Society in San Francisco. "Our results suggest we have identified a long-awaited biomarker for
this leading cause of disability," says Gary Gibson, Ph.D., director of
Henry Ford's Bone and Joint Center and the study's lead author. "For various pathology reasons associated with the variability of the
disease and challenging blood biochemistry, developing a biomarker for
osteoarthritis has been very elusive. But we believe our work shows
great promise. The next step is to expand the number of patients studied
and determine whether the degree in blood concentration can determine if
the cartilage damage will worsen over time. "Our ultimate goal is to develop a biomarker that can be used in the
development of future treatments to prevent the progression of the
disease," he added.

Disaggreement with recent BMD Testing Interval study

You may have heard about the study "Bone Density Testing Interval and Transition to Osteoporosis in Older Women" (Gourlay et. al., NEJM, Jan 19, 2012) which analyzed post-menopausal women enrolled in SOF (Study of Osteoporotic Fractures). This study concluded that estimated BMD testing intervals can be as long as 17 years for those with normal BMD or "mild osteopenia" (defined in this article as a T-score of less than -1.0 and greater than -1.5) and 5 years for "moderate osteopenia" (T-score of less than or equal to -1.5 and greater than -2.0). The article has generated a great deal of interest in the lay press and medical wire services

An unfortunate media spin is that this study proves that DXA testing is being over used in postmenopausal women. There is concern that this will lead to complacency on the part of individuals for both initial DXA testing and follow up studies at a time when screening rates in the Medicare population remain inappropriately low at 13% per year. Insurance coverage for follow up DXA studies and a legislative agenda that seeks to ensure adequate DXA reimbursement could also be threatened.

A number of responses to the article have already appeared in the media including comments from Drs. Felicia Cosman and Jeffery Curtis. ISCD has also fielded a number of calls from concerned members as well as other sister societies.

We felt that a rapid response to ISCD members would be appropriate to assist you in talking with your patients, local media and/or insurers. The Scientific Advisory Committee (SAC) of ISCD will be asked to draft a more detailed response to the question of testing intervals, which will appear on the ISCD web site at a later date.

To briefly review the NEJM report and its limitations:

The study population consists of post-menopausal women ≥67 yrs of age. Certainly, women who reach that age with normal or mildly low BMD are unlikely to have rapid bone loss as they are many years out from menopause. The study does not address testing intervals in recently post-menopausal women where rates of bone loss are much more rapid, or women with additional illnesses or requiring medications that adversely affect bone in whom more frequent testing may be appropriate.
The importance of fracture risk assessment, as part of BMD measurement must be emphasized. It is clear that a singular focus on BMD (without inclusion of other clinical risk factors as is being done with FRAX and other fracture risk calculators) will not recognize many patients as being at increased fracture risk.
In this regard, the NEJM study evaluated only clinical vertebral fractures. Unappreciated vertebral compression fractures are not uncommon in patients with densitometric osteopenia. Since a sizable percentage of postmenopausal women (14-30%) have morphometric vertebral body compression fracture in the setting of densitometric osteopenia (and thus have clinical osteoporosis), many of these patients would not have been identified in this study and simply carried as "osteopenia" with lengthy intervals between DXA testing.
The NEJM study did not utilize FRAX to identify osteopenic patients at high risk for fracture. Although they include some of the risk factors as covariates, they were not weighted as in FRAX. In fact, in their analysis they found that some covariates such as fracture after age 50, current smoking, use of steroids, and RA did not predict transition to a T-score of <-2.5 thus implying that they should not influence testing intervals.
Additionally, this study did not consider women with low spine BMD. As low lumbar spine BMD is associated with increased fracture risk, clinicians must consider this site in making recommendations to minimize fracture risk.
The authors imply that DXA testing is over utilized: "Recent controversy over the harms of excessive screening for other chronic diseases reinforces the importance of developing a rational screening program for osteoporosis that is based on the best available evidence rather than on health care marketing, advocacy, and public beliefs that have encouraged over testing and overtreatment in the United States." In fact, recent data compiled by Alison King and Donna Fiorentino, in a study of Medicare part B claims data for 2002-2008, demonstrate that over a 7 year period 47.9% of female beneficiaries did not have a single DXA study and 25.4% were tested only once (Health Affairs doi: 10.1377/hlthaff.2011.0233). A copy of this study can be found on the ISCD web site, which is linked here: http://www.iscd.org/Visitors/positions/Advocacy.cfm

The positive point to take from the NEJM study is that for elderly women with normal or mildly low bone mass, rapid bone loss over the next several years is unlikely unless additional medical conditions intervene. The study does not address BMD testing frequency intervals in younger post-menopausal women or men regardless of their baseline bone density.

Sincerely,

Andrew Laster MD, FACR, CCD Sarah L. Morgan MD, RD, CCD

Chair, ISCD Public Policy Committee ISCD President

Osteoporosis Is So Slow, Bone Density Tests Can Wait, Study Says - NYTimes.com

Bone loss and osteoporosis develop so slowly in most women whose bones test normal at age 65 that many can safely wait as long as 15 years before having a second bone density test, researchers report in a new study.

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Michael Nagle for The New York Times

Dr. Ethel S. Siris, director of the Toni Stabile Osteoporosis Center, stands in front of a bone density scanner at the Columbia University Medical Center New York-Presbyterian Hospital.

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Health Guide: Osteoporosis

The study, published in Thursday’s issue of The New England Journal of Medicine, is part of a broad rethinking of how to diagnose and treat the potentially debilitating bone disease that can lead to broken hips and collapsing spines.
A class of drugs, bisphosphonates, which includes Fosamax, have been found to prevent fractures in people with osteoporosis. But medical experts no longer recommend the medicines to prevent osteoporosis itself. They no longer want women to take them indefinitely, and no longer consider bone density measurements the sole defining factor in deciding if a woman needs to be treated.
Now, with the new study, researchers are asking whether frequent bone density measurements even make sense for the majority of older women whose bone density is not near a danger zone on initial tests, recommended at age 65.
“Bone density testing has been oversold,” said Steven Cummings, the study’s principal investigator and an emeritus professor of medical epidemiology and biostatistics at the University of California, San Francisco.
The study followed nearly 5,000 women ages 67 and older for more than a decade. The women had a bone density test when they entered the study and did not have osteoporosis. (In a separate national study by the Centers for Disease Control and Prevention, about 70 percent of women over age 65 did not have osteoporosis.)
The researchers report that fewer than 1 percent of women with normal bone density when they entered the study, and fewer than 5 percent with mildly low bone density, developed osteoporosis in the ensuing 15 years. But of those with substantially low bone density at the study’s start, close to the cutoff point for osteoporosis of fewer than 2.5 standard deviations from the reference level, 10 percent progressed to osteoporosis in about a year.
Dr. Margaret Gourlay, the study’s lead author and a family practice specialist and osteoporosis researcher at the University of North Carolina, said she and her colleagues were surprised by how slowly osteoporosis progressed in women.
Medicare pays for a bone density test every two years and many doctors have assumed that is the ideal interval, although national guidelines recommend them only at “regular intervals.”
“I think this will change the way doctors think about screening,” Dr. Gourlay said.
The results, said Joan A. McGowan, director of the division of musculoskeletal diseases at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, “provide telling evidence that you are not going to fall off a cliff if you have normal bone density in your 60s or early 70s, that you are not going to have osteoporosis in the next five years unless something else happens.”
For example, said Dr. McGowan, who was not involved in the study, a woman who had to take high doses of corticosteroids for another medical condition would lose bone rapidly. But the findings “cover most normal women,” she said.
Bone density screening took off after Fosamax, the first bisphosphonate, was approved at the end of 1995. For the first time, doctors had a specific treatment that had been shown to prevent fractures in people with osteoporosis.
For years doctors were overly enthusiastic, prescribing it for women whose bone density was lower than normal but not in a danger zone, keeping women on the drug indefinitely. They even gave a name, osteopenia, to lower than normal bone density, although it was not clear it had real clinical significance.
Now, osteoporosis experts consider osteopenia to be a risk factor, not a disease, and its importance varies depending on a patient’s age, said Dr. Ethel S. Siris, an osteoporosis researcher at Columbia University who was not involved in the study.
Doctors are more likely to prescribe bisphosphonates for older patients and recommend against them for most younger postmenopausal women with osteopenia.
The experts also generally recommend that most people on bisphosphonates take them for just five years at a time, followed by a drug holiday of undetermined length. The idea is to reduce the risk of rare but serious side effects, including unusual thighbone fractures and loss of bone in the jaw.
A risk calculator, FRAX, can help determine whether treatment is recommended. It assesses a combination of risk factors: whether a parent has had a hip fracture, the age of the patient, steroid use, bone density at the hip, and whether the person has broken a bone after age 50, an especially important indicator. Nearly half who break a hip already had already broken another bone, Dr. Siris said.
“If you are an older individual, a man or a woman, who already broke a major bone — spine, hip, shoulder, or pelvis or wrist — take it very seriously and get treated,” she said. “If you have relatively good bone density then you are not at risk now.”

via nytimes.com

Vitamin D has mixed effects on cancer, broken bones | Reuters

(Reuters Health) - Extra vitamin D and calcium may offer some protection against fractures in elderly people, but have little or no impact on cancer risk, according to a fresh look at the medical evidence.

Some research has suggested that vitamin D, with or without calcium, might help stave off cancer, but recent trials have slashed those hopes.
"It turns out that as a group, all of the micronutrient supplements have been disappointing," said Dr. Michael Pollak, who heads the division of cancer prevention at McGill University in Montreal, Canada, and was not involved in the new work.
"Even one of the best candidates, which is vitamin D, is certainly no slam dunk," he told Reuters Health.
The new report, out Monday in the Annals of Internal Medicine, was commissioned by the government-backed U.S. Preventive Services Task Force to inform its public recommendations.
It pulls together 19 gold standard experiments -- so-called randomized controlled trials -- on vitamin D with or without calcium. The trials lasted anywhere from seven months to seven years and ranged in size from a few thousand participants to tens of thousands.
Only three of them reported on cancer, however. While one small study found some protection against cancer in postmenopausal women taking vitamin D and calcium, the larger studies found no benefits.
"I don't have confidence in any of the findings because they could be chance findings," lead researcher Mei Chung, of Tufts Medical Center in Boston, told Reuters Health.
Last month, another randomized controlled trial was published in the Journal of Clinical Endocrinology and Metabolism. Although it wasn't included in Chung's report, it confirms her results.
In that study, among seniors taking 800 IU of vitamin D daily for a few years, 32 out of every 100 died during the study, while 33 out of every 100 people who did not get the supplement died.
That small difference could easily have been due to chance, the researchers found. There were no differences in deaths from cancer or heart disease either, just as calcium also proved unhelpful.
According to Chung, one large U.S. study, known as the Women's Health Initiative, also showed that women taking the supplements had higher rates of kidney and bladder stones.
Marji McCullough, a nutritional scientist at the American Cancer Society, said her organization does not advise dietary supplements to prevent cancer.
"Various researchers have recommended that, but large consensus panels have not," she told Reuters Health. "There is no compelling evidence currently that taking supplements will lower your cancer risk."
The Institute of Medicine recommends that most adults get 1,000 to 1,200 milligrams (mg) of calcium per day and 600 to 800 IU of vitamin D. It sets a recommended upper limit at 2,000 mg of calcium and 4,000 IU of vitamin D.
However, Chung's team did find a small reduction in fracture risk among elderly people living in an institution such as a nursing home, with extra vitamin D and calcium preventing two out of every 100 expected fractures.
But the risk reduction was smaller for people living on their own, and might have been due to chance, she added.
Chung, who is assistant director of the Evidence-based Practice Center at Tufts, said that in an earlier report from 2009, which looked at several possible health benefits, only the fracture benefit was convincing.
Pollak said it's possible that a few people who have low levels of vitamin D may get some benefit from it, but that doesn't warrant everybody taking extra vitamins.

via reuters.com

Zoledronic Acid May Boost Survival With Certain Type Of Breast Cancer.

HealthDay (12/8, Gardner) reports, "A drug developed to treat osteoporosis appears to boost survival in women with certain types of breast cancer, according to two new studies," to be presented at the San Antonio Breast Cancer Symposium this week. The researchers "looked at premenopausal women with estrogen receptor-positive breast cancer receiving either" zoledronic acid (Reclast and Zometa) "plus hormone therapy or a placebo plus hormone therapy for three years." The study found "that women receiving zoledronic acid had a 28 percent reduced risk for recurrence and a 36 percent reduced risk for dying."

Study: Bone Drugs May Increase Longevity of Replaced Joints

Common Drugs May Help Some People Limit Repeat Surgeries - Dec. 6, 2011 -- New research may help hip and knee replacements last longer in patients who take commonly prescribed bone-loss drugs. - - Joint replacement surgeries help millions live with less pain, but many people who have them eventually need repeat procedures when the implants loosen over time. - - Now a new study suggests that commonly prescribed osteoporosis drugs may extend the life of replacement joints, but researchers say it is not yet clear which patients will benefit most from the treatment. - - The study examined outcomes among patients in the U.K. who took oral osteoporosis drugs in the class known as bisphosphonates, such as Actonel, Atelvia, Boniva, and Fosamax.

Some Rheumatoid Arthritis Drugs Not Linked To Serious Infections

http://www.medicalnewstoday.com/articles/237317.php

According to a study published early in JAMAto coincide with its presentation at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Scientific Meeting, researchers have discovered that overall tumor necrosis factor-α antagonists medication is not linked to an increased risk of hospitalization for serious infections in comparison to using nonbiologic medications. Although tumor necrosis factor (TNF)-α antagonists have revolutionized the treatment of autoimmune diseases, safety concerns remain regarding their use for treating autoimmune disease, such as rheumatoid arthritis and psoriasis.

Dr. Jacobs - Recent Arthritis News

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