For women on osteoporosis drug “holiday,” bone testing at one year offers little benefit

For women with osteoporosis who are embarking on a “holiday” from taking a bone-building drug, the message from a study released today is “Bon voyage—see you in two years or so.”

After menopause, loss of bone (osteoporosis) can lead to crippling fractures of the hip and spine. Drugs called bisphosphonates—alendronate (Fosamax) was the first on the market in the mid-1990s—slow bone loss. But after taking these drugs for a number of years, the balance can begin to tip from help to harm. Bisphosphonate pills can cause burning in the esophagus, especially if they aren’t taken exactly as directed. In addition, a small number of bisphosphonate users have developed bone loss in the jaw and, counterintuitively, broken their legs.

Thus was born the bisphosphonate drug holiday, where after three to five years a woman stops taking the drugs for a while. During that time, a reservoir of bisphosphonate that had become part of the bones slowly trickles out. This helps preserve bone strength and lowers the chance of fracture. It takes a decade for the stored-up bisphosphonate in the body to decline by half.

“For many women, stopping therapy—a drug holiday—is appropriate,” says endocrinologist Dr. David Slovik, associate professor of medicine at Harvard Medical School and medical editor of Osteoporosis: A guide to prevention and treatment, a Harvard Medical School Special Health Report. “What we have not had a good grasp on is when to restart treatment if need be.” That’s where the new report, published this week in JAMA Internal Medicine, comes in.

Checking in

After a woman starts a drug holiday, her doctor monitors her bone density, a measure of bone strength. If and when it starts to decline, she might then start taking a bisphosphonate again.

As part of the Fracture Intervention Trial Long-term Extension (FLEX), women older than 60 with low bone mineral density who had taken alendronate for four or five years were slotted at random into one of two groups. One group continued to take alendronate for five more years, while the other group took an inactive placebo pill. Doctors checked their bone density one to three years later.

Over the course of the five-year trial, about one in five of the women taking the placebo broke a bone. Their age and bone density when they started taking the placebo was enough to predict who would be the most likely to have fractures. Measuring bone density after one year added no information that would have helped doctors identify who was at risk and perhaps should start taking a bisphosphonate again.

“It doesn’t surprise me that there wasn’t a tremendous change in bone density after a year,” Dr. Slovik says. “Unless someone goes on a drug known to accelerate bone loss, you would not see much of a change in that period in most women.” Drugs that speed bone loss include anti-inflammatory steroid drugs like prednisone and some cancer drugs.

A reason why bone health may not decline in the first year or so of a drug holiday is that stored bisphosphonate is being released from the bones—the equivalent of an internal time-release medication tablet.

How often to test?

Dr. Slovik advises women on drug holidays to consider testing every two years. That involves a dual x-ray absorptiometry (DXA) test, which uses x-rays to measure the density of bone. Blood tests can also pick up a spike in chemicals released as bone starts to break down.

Women covered by Medicare can get a DXA test every two years. For younger women, the frequency of testing is largely at their doctors’ discretion.

Osteoporosis risk—and, therefore, a decision about if and when a woman should have her bone density checked—is a sliding scale. Women who had a fracture in the past and have low bone density when starting bisphosphonate therapy tend to lose bone density more quickly and are therefore at highest risk of breaking a bone. They may be advised against taking a drug holiday.

“Older age and hip density at discontinuation of treatment are the major factors,” Dr. Slovik says. “This study is saying that bone density testing a year later doesn’t make a lot of sense.”

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For women on osteoporosis drug “holiday,” bone testing at one year offers little benefit

For women with osteoporosis who are embarking on a “holiday” from taking a bone-building drug, the message from a study released today is “Bon voyage—see you in two years or so.”

After menopause, loss of bone (osteoporosis) can lead to crippling fractures of the hip and spine. Drugs called bisphosphonates—alendronate (Fosamax) was the first on the market in the mid-1990s—slow bone loss. But after taking these drugs for a number of years, the balance can begin to tip from help to harm. Bisphosphonate pills can cause burning in the esophagus, especially if they aren’t taken exactly as directed. In addition, a small number of bisphosphonate users have developed bone loss in the jaw and, counterintuitively, broken their legs.

Thus was born the bisphosphonate drug holiday, where after three to five years a woman stops taking the drugs for a while. During that time, a reservoir of bisphosphonate that had become part of the bones slowly trickles out. This helps preserve bone strength and lowers the chance of fracture. It takes a decade for the stored-up bisphosphonate in the body to decline by half.

“For many women, stopping therapy—a drug holiday—is appropriate,” says endocrinologist Dr. David Slovik, associate professor of medicine at Harvard Medical School and medical editor of Osteoporosis: A guide to prevention and treatment, a Harvard Medical School Special Health Report. “What we have not had a good grasp on is when to restart treatment if need be.” That’s where the new report, published this week in JAMA Internal Medicine, comes in.

Checking in

After a woman starts a drug holiday, her doctor monitors her bone density, a measure of bone strength. If and when it starts to decline, she might then start taking a bisphosphonate again.

As part of the Fracture Intervention Trial Long-term Extension (FLEX), women older than 60 with low bone mineral density who had taken alendronate for four or five years were slotted at random into one of two groups. One group continued to take alendronate for five more years, while the other group took an inactive placebo pill. Doctors checked their bone density one to three years later.

Over the course of the five-year trial, about one in five of the women taking the placebo broke a bone. Their age and bone density when they started taking the placebo was enough to predict who would be the most likely to have fractures. Measuring bone density after one year added no information that would have helped doctors identify who was at risk and perhaps should start taking a bisphosphonate again.

“It doesn’t surprise me that there wasn’t a tremendous change in bone density after a year,” Dr. Slovik says. “Unless someone goes on a drug known to accelerate bone loss, you would not see much of a change in that period in most women.” Drugs that speed bone loss include anti-inflammatory steroid drugs like prednisone and some cancer drugs.

A reason why bone health may not decline in the first year or so of a drug holiday is that stored bisphosphonate is being released from the bones—the equivalent of an internal time-release medication tablet.

How often to test?

Dr. Slovik advises women on drug holidays to consider testing every two years. That involves a dual x-ray absorptiometry (DXA) test, which uses x-rays to measure the density of bone. Blood tests can also pick up a spike in chemicals released as bone starts to break down.

Women covered by Medicare can get a DXA test every two years. For younger women, the frequency of testing is largely at their doctors’ discretion.

Osteoporosis risk—and, therefore, a decision about if and when a woman should have her bone density checked—is a sliding scale. Women who had a fracture in the past and have low bone density when starting bisphosphonate therapy tend to lose bone density more quickly and are therefore at highest risk of breaking a bone. They may be advised against taking a drug holiday.

“Older age and hip density at discontinuation of treatment are the major factors,” Dr. Slovik says. “This study is saying that bone density testing a year later doesn’t make a lot of sense.”

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For women on osteoporosis drug “holiday,” bone testing at one year offers little benefit

For women with osteoporosis who are embarking on a “holiday” from taking a bone-building drug, the message from a study released today is “Bon voyage—see you in two years or so.”

After menopause, loss of bone (osteoporosis) can lead to crippling fractures of the hip and spine. Drugs called bisphosphonates—alendronate (Fosamax) was the first on the market in the mid-1990s—slow bone loss. But after taking these drugs for a number of years, the balance can begin to tip from help to harm. Bisphosphonate pills can cause burning in the esophagus, especially if they aren’t taken exactly as directed. In addition, a small number of bisphosphonate users have developed bone loss in the jaw and, counterintuitively, broken their legs.

Thus was born the bisphosphonate drug holiday, where after three to five years a woman stops taking the drugs for a while. During that time, a reservoir of bisphosphonate that had become part of the bones slowly trickles out. This helps preserve bone strength and lowers the chance of fracture. It takes a decade for the stored-up bisphosphonate in the body to decline by half.

“For many women, stopping therapy—a drug holiday—is appropriate,” says endocrinologist Dr. David Slovik, associate professor of medicine at Harvard Medical School and medical editor of Osteoporosis: A guide to prevention and treatment, a Harvard Medical School Special Health Report. “What we have not had a good grasp on is when to restart treatment if need be.” That’s where the new report, published this week in JAMA Internal Medicine, comes in.

Checking in

After a woman starts a drug holiday, her doctor monitors her bone density, a measure of bone strength. If and when it starts to decline, she might then start taking a bisphosphonate again.

As part of the Fracture Intervention Trial Long-term Extension (FLEX), women older than 60 with low bone mineral density who had taken alendronate for four or five years were slotted at random into one of two groups. One group continued to take alendronate for five more years, while the other group took an inactive placebo pill. Doctors checked their bone density one to three years later.

Over the course of the five-year trial, about one in five of the women taking the placebo broke a bone. Their age and bone density when they started taking the placebo was enough to predict who would be the most likely to have fractures. Measuring bone density after one year added no information that would have helped doctors identify who was at risk and perhaps should start taking a bisphosphonate again.

“It doesn’t surprise me that there wasn’t a tremendous change in bone density after a year,” Dr. Slovik says. “Unless someone goes on a drug known to accelerate bone loss, you would not see much of a change in that period in most women.” Drugs that speed bone loss include anti-inflammatory steroid drugs like prednisone and some cancer drugs.

A reason why bone health may not decline in the first year or so of a drug holiday is that stored bisphosphonate is being released from the bones—the equivalent of an internal time-release medication tablet.

How often to test?

Dr. Slovik advises women on drug holidays to consider testing every two years. That involves a dual x-ray absorptiometry (DXA) test, which uses x-rays to measure the density of bone. Blood tests can also pick up a spike in chemicals released as bone starts to break down.

Women covered by Medicare can get a DXA test every two years. For younger women, the frequency of testing is largely at their doctors’ discretion.

Osteoporosis risk—and, therefore, a decision about if and when a woman should have her bone density checked—is a sliding scale. Women who had a fracture in the past and have low bone density when starting bisphosphonate therapy tend to lose bone density more quickly and are therefore at highest risk of breaking a bone. They may be advised against taking a drug holiday.

“Older age and hip density at discontinuation of treatment are the major factors,” Dr. Slovik says. “This study is saying that bone density testing a year later doesn’t make a lot of sense.”

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Gene variant puts women at higher risk of Alzheimer's than it does men, study finds

The scientists arrived at their findings by analyzing data on large numbers of older individuals who were tracked over time and noting whether they had progressed from good health to mild cognitive impairment -- from which most move on to develop Alzheimer's disease within a few years -- or to Alzheimer's disease itself.

The discovery holds implications for genetic counselors, clinicians and individual patients, as well as for clinical-trial designers. It could also help shed light on the underlying causes of Alzheimer's disease, a progressive neurological syndrome that robs its victims of their memory and ability to reason. Its incidence increases exponentially after age 65. An estimated one in every eight people past that age in the United States has Alzheimer's. Experts project that by mid-century, the number of Americans with Alzheimer's will more than double from the current estimate of 5-6 million.

According to the Alzheimer's Association, it is already the nation's most expensive disease, costing more than $200 million annually. (The epidemiology of mild cognitive impairment is fuzzier, but this gateway syndrome is clearly more widespread than Alzheimer's.)

The number of women with Alzheimer's far exceeds that of men with the condition. That's partly because women on average live longer than men. But greater longevity explains only part of women's increased susceptibility to Alzheimer's. "Even after correcting for age, women appear to be at greater risk," said Michael Greicius, MD, assistant professor of neurology and neurological sciences and medical director of the Stanford Center for Memory Disorders.

Greicius was the senior author of a study, to be published April 14 in the Annals of Neurology, in which he and his colleagues analyzed records on more than 8,000 people, most of them older than 60, who have been monitored over time at any one of about 30 Alzheimer's centers nationwide. Postdoctoral scholar Andre Altmann, PhD, was the lead author.

The records were stored in two large, publicly available repositories. In one, the researchers analyzed clinical assessments of 5,000 people whose test results were normal at the outset and 2,200 people who had initially showed signs of mild cognitive impairment. In both groups, being an ApoE4 carrier increased the likelihood of Alzheimer's disease, as expected. But a closer look revealed that among those who initially tested normal, this increased risk was only marginal for men, whereas women who carried the ApoE4 variant had close to twice the likelihood of progressing to mild cognitive impairment or Alzheimer's disease as those who didn't.

"Our study showed that, among healthy older controls, having one copy of the ApoE4 variant confers a substantial Alzheimer's disease risk in women, but not in men," Greicius said.

The second repository holds imaging data and measurements of several biochemical substances from spinal fluid that can serve as useful biomarkers of impending mild cognitive impairment and eventual Alzheimer's disease. Analysis of 1,000 patients' records from this database not only confirmed ApoE4's differential effect on women versus men, but also yielded clues that may help investigators begin to explore, and perhaps someday explain, the molecular mechanisms linking ApoE4 to Alzheimer's disease, Greicius said.

The ApoE gene is a recipe for a protein important for shuttling fatty substances throughout the body. This is particularly important in the central nervous system, as brain function depends on rapid rearrangement of such fatty substances along and among nerve cell membranes. The ApoE gene comes in three varieties -- ApoE2, ApoE3 and ApoE4 -- depending on inherited variations in the gene's sequence. As result, the protein that the gene specifies also comes in three versions, whose structures and fatty-substance-shuttling performance differ.

Most people carry two copies of the ApoE3 gene variant (one from each parent). But about one in five people carries at least one copy of ApoE4, and a small percentage have two ApoE4 copies. Numerous studies going back to the early 1990s have confirmed that ApoE4 is a key risk factor for Alzheimer's disease, with a single copy of ApoE4 increasing that risk twofold or fourfold. Carrying two copies confers 10 times the risk of Alzheimer's.

One of those many studies, published in 1997 in The Journal of the American Medical Association, suggested that female ApoE4 carriers are more at risk for Alzheimer's than male carriers are. But for various reasons, that study wasn't followed up, and both clinicians and scientists designing clinical trials tend to dismiss this distinction to this day, Greicius said. "I'd been practicing for five years before I ever heard of this paper, which had essentially been ignored for 10 years already," he said.

But on unearthing the 1997 paper, Greicius became curious. In 2012, an imaging study by his group showed provocative differences in brain function in female versus male ApoE4 carriers even when they were still completely asymptomatic. "Brain connectivity in the ApoE4 men didn't differ much from normal. But connectivity in the ApoE4 women did," he said. "That convinced me that this is a real phenomenon."

The pooled data of numerous dedicated Alzheimer's centers continuously accumulates, yielding ever-larger population samples for enterprising researchers to mine. There lies the beauty of the large government- and industry-supported repositories to which Greicius and his team turned.

Drug developers designing clinical trials for Alzheimer's are already paying plenty of attention to whether or not their trial participants carry a copy of the ApoE4 variant, as previous trials have showed a differential effect on carriers versus noncarriers. Greicius said they would do well also to differentiate between a candidate drug's effect on male versus female ApoE4 carriers. Meanwhile, basic researchers can take a cue from his findings and ask themselves, "Why the difference?" The effort to answer that question may reveal an important molecular mechanism, or set of them, that explains the differential effect. "Now we can work toward understanding the cause of this sex difference, which may reveal new potential drug targets, "Altmann said.

Greicius, who in addition to his research spends about one-fifth of his time seeing patients, said that the differential male/female ApoE4 effect implies that clinicians need to take different approaches to patients with this gene variant, depending on their sex. "These days, a lot of people are getting genotyped either in the clinic or commercially. People come to me and say, 'I have an ApoE4 gene, what should I do?' If that person is a man, I would tell him that his risk is not increased much if at all. If it's a woman, my advice will be different."

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Regular aerobic exercise increases memory area of the brain in older women

Hippocampus is a focus of interest become involved because it the area of the brain in dementia research in verbal memory and learning is, but it is very sensitive to the effects of aging and neurological damage.

The researchers tested the effects of various types of exercises on the hippocampal volume of 86 women who said they had mild memory problems, known as mild cognitive impairment - and a common risk factor for dementia.

All the women were aged between 70 and 80 years old and self-employed lived at home.

As many of them were allocated equal either twice per hour long sessions of aerobic exercise (brisk walk); or strength training, such as lunges, squats and weights; or balance and muscle toning exercises for a period of six months.

The size of their hippocampus was the beginning and end of the period of six months to determine, by means of MRI scans, verbal memory and learn that capacity was assessed before and after using a validated test (RAVLT).

Only 29 of the women had before and after the MRI images, but the results showed that the overall volume of the hippocampus in the group, which completed the full six months of aerobic training is significantly greater than that of those who take the course, balance and muscle toning exercises lasted.

No such difference in hippocampal volume on strength training when compared with the balance and muscle, muscle in those seen group.

But despite an earlier finding in the same sample of women improves, that aerobic exercise was verbal memory, there some evidence that an increase of in hippocampal volume was associated with poorer verbal memory.

Say this suggests that the relationship between brain volume and cognitive performance is complex and requires further research, the authors.

But the increased risk for dementia, at the very least, aerobic exercise seems slow the shrinkage of the hippocampus and the volume in a group of women, they say.

And they recommend regular aerobic exercise to avoid mild cognitive decline, what is particularly important, given the mounting evidence indicating that regular exercise good for cognitive function and overall condition of the brain and the rising toll of dementia is.

Worldwide, afflicted, the new case of dementia every four seconds, with the number of those diagnosed will rise to set more than 115 million in 2050, they point out.

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Drink milk? Women who do can delay knee osteoarthritis.

OA is a common degenerative joint disease that causes pain and swelling of the joints in the hand, hip or knee. According to the Centers for disease control and prevention (CDC) nearly 27 million affects Americans age 25 and older, prevalent knee OA, and heavy women on OA. While medical suggests obesity, joint injuries and repeated use of some sports out as risk factors for incident light knee OA, the risks associated with OA progression remain unclear.

"Milk consumption plays an important role in the bone health," explained lead author Bing Lu, M.D., P.h.., of the Brigham and women's Hospital in Boston, Massachusetts, "Our study is the largest study on the impact of the dairy intake in the progression of knee OA study."

For the present study, 2,148 participants (3.064 knee) were recruited for the Osteoarthritis initiative with knee OA. At the beginning of the study of dietary data collection and common width was measured by X-ray to evaluate progression of OA. Topics 888 women and 1,260 had follow-up at 12, 24, 36 and 48 months.

As the consumption of milk by no less than 3, 4-6 and 7 (8 oz) more glasses per week increased, decreased the joint width for women also 0.38 mm, 0.29 and 0.29 mm and 0.26 mm, respectively. Results persisted even adjusted for body mass index (BMI), disease and dietary factors. No association between milk consumption and common broad decline was reported in men.

"Our results show that women who drink often milk can reduce the progression of OA," concludes Dr. Lu. "Further studies of milk intake and delay OA progression are required."

In a related editorial SeniorLife also published arthritis care & Research, Shivani Sahni, Ph.d., and Robert McLean, D.Sc., mph, from Harvard member organization Hebrew Institute for aging research agree "with the aging population and the increase in life expectancy, an urgent need for effective methods to the management of OA is there. "The study of Lu et al. provides the first evidence that more and more non-fat or low-fat milk consumption progression of OA among women can reduce are burdened by OA of the knee, which can lead to functional disability."

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