By Susan Brink
Los Angeles Times Staff Writer
September 22, 2008
JUST A few years back, it was heresy to suggest that, when it comes to protecting bones, early treatment may not be the answer.
Part of the rite of passage through menopause a decade ago became bone-density screening. Around age 50, many women would position their skeletons under the X-ray eye of new machines that could calibrate the alarming rate at which their bones were being eaten away. On top of that, they began to hear commercials featuring women, often much younger than they, praising a pill for saving them from nursing homes, physical deterioration and crumbling spines.
It was no longer sufficient to get enough calcium and vitamin D and do weight-bearing exercise. Suddenly, there were drugs available, Fosamax being the first in 1995 of a class called bisphosphonates, that could put that lost bone density back, help prevent painful, even deadly, fractures and reduce the number of women going through old age with crooked backs.
A combination of new technology and clever marketing was pushing fear of fractures from geriatric reality to midlife worry. Meanwhile, women were hit with a new word, osteopenia, which sounds like a fearsome disease. The pre-osteoporosis, non-disease condition, named by the World Health Organization in 1992, has a broad enough definition to include about half of all women over 50. "The average bone density for a 60-year-old Caucasian woman would put her in osteopenia," says Dennis Black, an epidemiologist at UC San Francisco who studies the effectiveness of osteoporosis treatments.
Confused about what the new label actually meant, young, healthy women suddenly seemed more worried about their bones than did their mothers and grandmothers -- who really had something to worry about. "Women don't understand what their risk is, one way or the other," says Dr. Ethel Siris, director of the Toni Stabile Osteoporosis Center of Columbia University Medical Center in New York.
Things have changed.
Studies have shown that most women will lose no more than 7% of their bone mass within the decade after menopause. Bisphosphonates have been shown to replace about 8% of bone within five years, so waiting will cost most women nothing. Counter to just about every other preventive healthcare message out there, when it comes to osteoporosis drugs, it's probably better to hold off. "Wait until the risk gets high enough," says Dr. Bruce Ettinger, adjunct clinical investigator at Kaiser Permanente, Northern California.
Even the drug marketers seem to be getting more realistic. "If you look at the TV ads, it's no longer the 45- or 50-year-old who's just finished her workout," says Ettinger. "It's a 65-year-old doing some stretching or gardening."
The current recommendation is that most healthy women get checked for bone loss with a bone-density test at age 65, not the minute they hit menopause, according to the U.S. Preventive Services Task Force. Those with risk factors, such as a family history of the disease, a fracture of their own, smoking, heavy alcohol use or a history of taking corticosteroids, should get a bone-density test around age 60, the 2002 recommendation said. And men should be tested at 70.
A drug's effect
This dramatic shift from early prevention to later prevention is an attempt to save healthy women from decades of pill popping to prevent a disease many may well never have. Like all drugs, these have side effects that can include upper gastrointestinal irritation, ulcers of the esophagus, upset stomach, bone pain and skin rash. But what has many people concerned is that the long-term effects are unknown. One sign of potential trouble is that dentists are seeing more jaw disease among women taking bisphosphonates.
Women, meanwhile, are still confused by the original messages. "Women in their 50s and 60s have grown up in a major transition time in terms of osteoporosis," says Ettinger. "They heard that when you hit 50, you lose bone and you won't get it back. Fosamax was promoting this whole thing, and most of the ob-gyns were on the bandwagon."
The drug arrived on the scene just as the baby-boom generation of women was about to reach a biological turning point, determined to head off the natural decline that comes with aging. Fosamax was the first bisphosphonate approved by the Food and Drug Administration for treatment and prevention of osteoporosis. And it promised to not only stall bone deterioration, but to actually replace bone that was already lost. Women looking no more than 45 years old began warning, through the television screen, "Don't wait for a fracture."
The message was aimed at viewers who probably didn't need the drug. In fact, in 1997 and 2001 letters to Merck & Co., maker of Fosamax, the FDA warned the company, which then changed its promotional language, that its ads were misleading and that its website overstated the benefits of the drug, while understating the risks. The criticism has been unfair, says Ronald Rogers, a Merck spokesman. In an e-mail message, he said, "Merck has consistently marketed Fosamax in accordance with its FDA approved label."
As the risks of drugs became better known, doctors and researchers came to more thoroughly assess the significance of osteopenia -- that new classification that is not a disease. Although women with the condition may be at higher risk than average, the label comes from the world of statistics. At an international conference on osteoporosis in 1992, experts agreed that "normal" bone mass was represented by the average 30-year-old woman, the age of peak bone mass. Below that level, regardless of her age and on a statistical sliding scale, a woman potentially entered a bone danger zone. Using that formula, a 70-year-old woman is measured against the healthy bone mass of a woman four decades her junior. The World Health Organization, at that same 1992 meeting, calculated what are called T-scores and determined that if a woman's score is negative 1 or higher, her bone mass is normal. The closer the negative number is to zero, the healthier the bone. If the T-score is negative 2.5 or lower, she has osteoporosis. And in between those two negative numbers, it's called osteopenia, an indication that bone mass is below the statistical norm, possibly putting the person at increased risk of a future fracture.
By that definition, about a third of women 50 to 64 have osteopenia, as do about two-thirds of those 65 and older, according to an analysis in the November/December 2007 journal Health Affairs.
Osteopenia, by definition for post-menopausal women, is just another word for normal.
Despite the new knowledge of normal, the language from the National Osteoporosis Foundation is stark. The foundation estimates that 10 million Americans now have osteoporosis and says that half of all women, and 25% of men, over age 50 will have an osteoporosis-related fracture in their remaining lifetime.
But few women or men will suffer a fracture in their 50s or 60s, and even fewer will break a hip. "Lifetime risk depends on your point of view," says Black. "A 50% risk of fracture may be a wrist fracture, and those are relatively mild. Fracture of the hip, that may be about 16% or 17%, but that's not something for a 50-year-old woman to get alarmed about."
Nor should a 50-year-old man. Men get osteoporosis too, but generally at later ages. Four times as many women get the disease as men, and they become more vulnerable to bone loss after menopause, when their bodies lose much of their circulating estrogen, a hormone that slows bone loss.
Pinpointing personal risk is a numbers game that has, just this year, gotten a whole lot easier with some online tools that allow a physician, or a woman or man, to check out an individual's risk of a broken bone in the next decade. Two self-assessment tools are now available online.
Both use age, sex and half a dozen other health and lifestyle questions to figure the risk of a fracture in any one of four areas, and also the specific risk of a hip fracture, in the next 10 years. Siris cautions that women should probably discuss the test results with their physicians. "It looks simple, but some women might mislead themselves if they answer the questions incorrectly."
The first tool, called FRAX, is available at shef.ac.uk/FRAX/. Users have to convert their weight and height into metric measures, but it's become familiar enough among osteoporosis specialists to have taken on active-verb status. As Siris says, "At 65, get a bone-density test for sure. If she's not osteoporodic, but is osteopenic, FRAX her."
The other, newer tool -- at fore.org -- calculates in American pounds and inches.
Both risk calculators are more precise if people enter their actual bone-density test results. But they'll work without that number by calculating the risk as though the person had an average (for his or her age) bone density measurement.
The FRAX tool has been approved to be incorporated into the software of bone-density scanning machines, also called DEXA, for dual-energy X-ray absorptiometry. Eventually people getting the scans will get not just a puzzling negative number, but their own likely 10-year risk of an actual fracture.
Those results, says Ettinger, often make people think a whole lot differently about their own risk than hearing that they have a 50% lifetime risk of a broken bone. The risk for a hip fracture within the next 10 years, for example, for a healthy, white 50-year-old woman -- even with osteopenia -- is less than 1%.
Guidelines from the National Osteoporosis Foundation suggest that a 20% 10-year risk of any of four fractures -- wrist, spine, hip or upper arm -- or a 3% risk of a hip fracture is worth treating with drugs.
Hip fractures, the most serious of bone breaks, are a geriatric, not a midlife, epidemic. The average age of a person with a broken hip is 82, with 81% of hip-fracture patients 75 or older, and 43% of patients 85 or older, according to a study in the June 6, 2001, Journal of the American Medical Assn. It is then that the most frightening cycle brought on by osteoporosis is likely to begin: hip fracture, nursing home, loss of independence. About 24% of hip-fracture patients die in the year after their fracture.
Long before people get to that point, the drugs on the market, most of them bisphosphonates, can do some good. But the people for whom drug therapy can have the most benefit are often under-treated. A 2004 U.S. Surgeon General's report found that for 1999 to 2000, only 30% of eligible Medicare beneficiaries 65 and older had received a bone-density test.
And while bisphosphonates are No. 10 in U.S. sales in the top 20 drug categories, at $4.64 billion in 2007, according to market researcher IMS Health figures, it's not at all clear that those who need them most are taking them.
A lot of women don't understand what it means to have osteoporosis. A survey of 60,000 women over age 55, who were recruited through 700 primary-care physicians in the U.S., Canada, Europe and Australia, was reported Sept. 15 at the annual meeting of the American Society for Bone and Mineral Research. It found that more than 11,000 of them reported having a diagnosis of osteoporosis, putting them at known risk for a fracture. But 55% of the women with the diagnosis told researchers that they did not believe that they were at a higher risk of fracture than their undiagnosed peers.
"It seemed as though, regardless of how much risk they're at, they perceived themselves as at no higher risk than other women," says Siris, who presented the findings. "It's not surprising. Women have a lot of competing worries, and this is still a new area of public health interest," she says. "They worried that their back might get curved, but they didn't understand that that means vertebral fractures. Boy, are we not doing a good enough job of educating women."
Women may have been scared off by drug side effects, or the vast unknowns of long-term use. But options have increased. The original treatments were taken in daily doses, patients had to eat before taking them and they had to remain upright for 30 minutes or so after taking them. More than half of the women who were prescribed those drugs stopped taking them within a year.
Newer versions of the drugs now can be taken weekly or monthly. On the horizon are drugs administered by injection every three months, or even once a year in an IV drip, the latter aimed largely at nursing-home patients. And a presentation Sept. 16 at the annual meeting of the American Society for Bone and Mineral Research showed a new Amgen drug, denosumab, awaiting FDA approval, reduced the incidence of spine and hip fractures with no evidence, after a three-year trial, of the jaw-deteriorating side effect seen with bisphosphonates.
The trick now is not to scare every woman into worrying about a test that says she has less bone mass than a healthy 30-year-old -- while getting women who truly are at risk to get tested and do something about it.
Bonnie - Susan should be commended for "stepping out" the way she did in this piece. I cannot recall another reporter, much less research study, that has been as forthcoming about how overblown the osteoporosis issue really is. Bravo!