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.

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.

New Old Age

Share your thoughts on this column at the New Old Age blog.

Go to New Old Age »

Related

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.”

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.

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

BBC News - Abuse of painkillers reaches 'epidemic' levels in US

Abuse of prescription painkiller have reached "epidemic" levels in the US, a government report says.

Overdoses of pain relievers cause more deaths than heroin and cocaine combined, the report has found.

It says sales and prescriptions of the drugs rose sharply in recent years and this was linked to the rise in overdoses.

Narcotic painkillers are prescribed to relieve chronic pain but the drugs can be "highly addictive", the report says.

The report, published by the Centers for Disease Control and Prevention (CDC), said fatalities caused by narcotic pain relievers have more than tripled in the last 10 years - equivalent to 40 deaths a day.

Last year, a national survey on drug use and health showed that one in 20 Americans over the age of 12 said they had used painkillers for non-medical reasons.

Named as the fastest growing drug problem facing the US, narcotic painkillers are increasingly used recreationally - for the high they cause.

Surging sales

"Almost 5,500 people start to misuse prescription painkillers every day," said Pamela Hyde, administrator for the Substance Abuse and Mental Health Services Administration, a federal body.

Sales of the drugs to pharmacies and health care facilities have surged more than 300% since 1999, according to figures from the Drug Enforcement Administration.

But prescriptions of the drug have risen sharply too.

The report says enough medicine was prescribed last year to keep every American adult medicated for one month.

Florida was found to have the highest rate of sales of narcotic painkillers per person, almost three times the rate in Illinois, which had the lowest rate.

Officials believe state health policies can help reverse the trend.

The report recommends tracking prescriptions more carefully and cracking down on "pill mills" (clinics that prescribe drugs inappropriately) and "doctor shopping" (when patients collect prescriptions from several doctors).

"This highlights the importance of states getting policies right on preventing drug abuse," CDC Thomas Frieden told the Associated Press news agency.

In 2008, almost 15,000 deaths were caused by prescription painkillers, including the death of actor Heath Ledger.

Study Indicates Nanoparticles Could Help Pain-Relieving Osteoarthritis Drugs Last Longer

http://www.medicalnewstoday.com/releases/236683.php

Lead researcher Michael Morgen, Ph.D., and his colleagues from Bend Research and Pfizer propose to address this challenge with injectable nanoparticles that help retain osteoarthritis drugs in the knee joint. Test results show that 70 percent of the drug nanoparticles remain in the knee cavity after one week. In contrast, for most current formulations, the drug disperses within one to two days. 

In this new process, positively charged nanoparticles carrying a drug attach to the negatively charged, naturally occurring molecules in the knee to form a gel. This gel acts as a depot that slows drug escape from the knee cavity. 

"Current delivery methods do not maintain the drug in the knee for very long, which limits the effectiveness of therapeutic agents," said Dr. Morgen. "We hope that this type of sustained release technology, when used with current or new osteoarthritis drugs, will allow patients to be effectively treated with drug injections every three months instead of once a week." 

Nearly 1 In 4 People With Psoriasis May Have Undiagnosed Psoriatic Arthritis

http://www.medicalnewstoday.com/releases/235928.php

New research from the National Psoriasis Foundation reveals that nearly one in four people with psoriasis - the most common autoimmune disease in the country, affecting as many as 7.5 million Americans - may have undiagnosed psoriatic arthritis, a type of inflammatory arthritis that affects the joints and tendons. This is in addition to the up to 2 million people already diagnosed with the disease. 

The Psoriasis Foundation study found that 22 percent of psoriasis-only participants had significant symptoms of psoriatic arthritis, such as joint pain, pain that moved from one joint to the other; joints that were hot to the touch; and swollen, sausagelike fingers and toes. 

Other key findings revealed that people with psoriatic arthritis are not being diagnosed in a timely manner. Forty-four percent of these respondents said they experienced symptoms for a year or longer before being diagnosed. Nearly one in three reported a delay of two years or longer to receive diagnosis. 

Omega-3 Fatty Acids Shown To Prevent Or Slow Progression Of Osteoarthritis

http://www.medicalnewstoday.com/releases/236143.php

New research has shown for the first time that omega-3 in fish oil could "substantially and significantly" reduce the signs and symptoms of osteoarthritis. 

According to the University of Bristol study, funded by Arthritis Research UK and published in the journal Osteoarthritis and Cartilage, omega-3-rich diets fed to guinea pigs, which naturally develop osteoarthritis, reduced disease by 50 per cent compared to a standard diet. 

The research is a major step forward in showing that omega-3 fatty acids, either sourced from fish oil or flax oil, may help to slow down the progression of osteoarthritis, or even prevent it occurring, confirming anecdotal reports and "old wives' tales" about the benefits of fish oil for joint health.