Osteoporosis- Part I
(3/11/08)- Osteoporosis may be conceptualized either as a disease or a risk factor for fracture.
The National Osteoporosis Foundation recommends the following guidelines:
Treat postmenopausal women and men 50 and older who have thinning bones, but not osteoporosis yet, if they have at least a 20 percent risk of any major fracture in the next decade, or at least a 3 percent risk of a hip fracture.
Check for osteoporosis risk factors in postmenopausal women and men 50 and over, to see who needs a bone test before their senior years.
A bone test for anyone who has any type of fracture after age 50, or who has conditions associated with bone loss, such as rheumatoid arthritis.
For adults over 50, 1,200 milligrams a day of calcium and 800 to 1,000 international units a day of Vitamin D, more D than the government recommends.
Do regular weight bearing and muscle-strengthening exercise
The National Osteoporosis Foundation has published new guidelines that encourage men age 70 and older to get routine bone-density checks. One expert says 25% of hip fractures occur in men and treating those who are at risk for osteoporosis can aid in prevention. In the U.S. alone, some 10 million people have osteoporosis but 34 million are estimated to have osteopenia. With the population rapidly aging, the government estimates half of Americans over 50 will be at risk of fractures from too-thin bones by 2020.
(12/1/02)- The FDA has approved the first drug created to stimulate the growth of new bone. The drug will be sold under the name of Forteo (teriparatide), and is manufactured by Eli Lilly & Co. The drug works by increasing the action of the bone-building cells called the osteoblasts. This in turn causes bones to become denser and thus more resistant to fracturing.
The drug is injected daily, but it will have a special warning because in laboratory tests it caused cancerous bone tumors in rats. No evidence of the cancer has shown up so far in the 2,000 people who were involved in the clinical test. According to Dr. Eric Coleman, a team leader in the division of metabolic and endocrine drug products at the FDA it is "the first drug approved that stimulates bone formation instead of slowing the breakdown of bone."
The agency said that some patients developed mild side effects, including nausea, dizziness and leg cramps. There are approximately 10 million Americans who suffer from osteoporosis, of which 80% are women.
The National Institute of Health held public meetings on October 23 and 24 in Bethesda, Md. to discuss questions that have arisen recently about the safety and value of hormone replacement therapy. To see more about the meetings please go to the FDA site at http://www.fda.gov/cder/drug/safety/WHI_statement.htm
The meetings were held to address the confusion that has arisen as a result of the federal study (the Woman's Health Initiative) that found increased health risks from the hormone replacement therapy that has been taken for many years by millions of women.
Among the groups that participated in the meeting were health professionals, researchers, doctors, drug companies, federal agencies and also members of the public. The concern about the hormone replacement therapy was maximized as a result of the health institutes abruptly halting a large clinical trial of Premipro, a combination of estrogen and progestin made by Wyeth (formerly American Home Products).
It was determined that women taking the drug had a slightly higher rate of breast cancer, heart attacks and strokes than those taking a placebo. These detriments were found to outweigh the benefits of a slight decrease in the incidence of hip fractures and colon cancer.
Less publicity was given to the fact that the trial is continuing for the women who were taking only the estrogen. Prempro is approved for the prevention of osteoporosis and for the relief of symptoms of menopause. The label for Prempro had called attention to the fact that studies did indicate possible risks of heart attacks, strokes and breast cancer. The FDA is now also examining the new data.
A new research study published in the June, 2002 issue of the Journal of the American College of Nutrition demonstrates that osteoporosis patients should receive their calcium in the form of calcium phosphate. The study shows that as calcium intake increases without a corresponding increase in phosphorus, total phosphorus absorption falls and the risk for phosphorus deficiency rises.
A research team headed by Dr. Ian Reid of the University of Auckland in New Zealand found that an annual four-milligram dose of the drug, zoledronic acid, was as effective at strengthening bones as any of the current drugs being used in connection with osteoporosis.
The study was done on a small group, namely only 351 volunteers, and also did not involve studying whether or not the treatment actually prevented fractures from occurring. It will take up to 5 years of further studies to see if this treatment will actually help prevent fractures from occurring. The study was paid for by Novartis, the makers of Zometa, which is the brand name for zoledronic acid.
An interesting development seems to be taking place in connection with Eli Lilly and Co.'s osteoporosis drug Evista , which is generically known as raloxifene. According to a study done at the University of California at San Diego and elsewhere, the drug sharply reduced (40%) the number of heart attacks and strokes among the older women taking the drug.
Recent research also pointed to a sharply lower rate of breast cancer among women taking the drug. Since it hit the U.S. market in 1998 Evista has not met the sales figures that were originally projected for the drug. Lilly can not promote the drug for any of these other uses since the FDA has approved it only in connection with osteoporosis. Scientists at Emory University in Atlanta are now conducting a much larger study on Evista and its effect on strokes and heart attacks in older woman.
The consensus conclusion after a 3-day NIH Consensus Development Conference on Osteoporosis Prevention, Diagnosis, and Therapy was that "nutrition, exercise, and medicines can play important roles in the prevention and treatment of osteoporosis".The panel was chaired by Anne Kilbanski, M.D., professor of medicine at Harvard Medical School in Boston.
Osteoporosis is commonly the result of bone loss," said Dr. Klibanski. "It may also occur in individuals who do not achieve adequate bone mass during childhood and adolescence." The press release from the NIH went on to state: "She added that bone mass attained during childhood is perhaps the most important determinant of life-long skeletal health, a fact that is under-appreciated. Achieving optimum bone mass early in life reduces the impact of bone loss related to aging. Genetic factors exert a strong influence on peak bone mass, but controllable environmental and lifestyle factors also play a role. These include good nutrition, particularly adequate calcium and vitamin intakes. Only 10 percent of girls and 25 percent of boys between ages 9 and 17 obtain an adequate amount of calcium in their diet through the consumption of dairy products and vegetables."
One of the other key points brought out by the panel was that exercise early in life results in higher bone mass later in life. Although hormone replacement has become a possible treatment it has not been proven that estrogen alone or in combination with other treatments is effective in reducing the incidence of fractures. More research has to be done in connection with the new classes of drugs such as bisphosphonates and selective estrogen receptor modulators.
New technologies have proven to be effective detectors of loss of bone mineral, which is a key predictor of osteoporotic fracture. Ultrasound of the heel and also dual energy X-ray absorptiometry (DXA) have been proven effective in predicting hip fractures.
For further information on osteoporosis please see: Osteoporosis-Part II by Dr. Susan Rubin
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updated March 11, 2008
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