Rebuilding strong bones.
Treatment may help prevent millions of fractures
WITH THE NUMBER OF AMERICANS WITH LOW BONE MASS projected to be at 41 million by 2001, it's no surprise that drug makers are aiming for new and better treatments for osteoporosis. Though such advances stand to help long term care residents in the long run, a more immediate problem remains. According to experts, the disease is undertreated among the long term care population today.
An estimated 90 percent of long term care residents have osteoporosis, which causes an estimated 1.5 million fractures per year. Some 500,000 of these are spinal fractures; another 250,000 are hip fractures--the leading cause of hospital admissions among nursing home residents, according to the National Osteoporosis Foundation (NOP) in Washington, D.C.
What are physicians doing to prevent and treat osteoporosis in long term care residents? Not enough, asserts Elliot N. Schwartz, MD, co-medical director of the Foundation for Osteoporosis Research and Education. "Nursing homes are doing very poorly," he says. The Foundation, which publishes Guidelines of Care on Osteoporosis for the Primary Care Physician on its Web site (www.FORE.org) is collaborating with Merck on guidelines that will address osteoporosis in long term care facilities.
Progress is being made. Last July, the federal National Bone Mass Measurement Act passed, requiring Medicare to cover bone mineral density testing for individuals at risk. In October, the National Institutes of Health and six other federal agencies approved funding for the NIH Osteoporosis and Related Bone Diseases National Resource Center. Last fall, the center launched a national osteoporosis research and education program aimed at consumers and medical professionals.
Increased interest and research has resulted in an "explosion' of new drugs in the last five years, says Joan McGowan, PhD, chief of the Musculoskeletal Diseases branch of the NIH. It also has raised awareness of the single most effective non-pharmaceutical treatment. "Every nursing home patient should be on calcium and vitamin D," say both McGowan and Schwartz. Studies demonstrate a 30 percent reduction in fractures among post-menopausal women who take daily supplements of 1,000 mg. calcium and 800 I.U. of vitamin D, according to FORE.
Yet 75 percent of long term care patients admitted to Schwartz's care are vitamin D-deficient, he says. "Sometimes I see a patient with three or four fractures, and no one is even giving them calcium and vitamin D." For older individuals with little stomach acid--a requirement for the absorption of calcium--Schwartz recommends Calcatrate with D, an over-the-counter calcium citrate supplement.
Calcium and vitamin D supplements should be the first line of defense. But most people over 60 can benefit from a number of other drugs, including estrogen. Estrogen-replacement drugs such as Premarin, Ogen, and Estrace, approved in 1988. are commonly prescribed at the onset of menopause. But studies now show the drugs also are beneficial to women over 60 who have not previously taken them. Schwartz recommends older patients be started out on lower doses, and allowed to adjust gradually to the regimen.
But estrogen therapy is linked to increased risk of uterine and breast cancer. In 1998, the FDA approved Evista (raloxifene hydrochloride), the first in a new class of drugs called selective estrogen receptor modulators (SERMs). SERMs, or "designer estrogens," can selectively act like estrogen in some tissues, but not others.
Increasingly, experts are studying the possibility of using a combination of estrogen therapy or SERMS with Fosamax (alendronate), a biophosphonate approved in 1995 for the treatment of women with osteoporosis. Fosamax, a nonhormonal anti-resorptive drug, has been demonstrated in some clinical trials to restore bone mass.
Fosamax is "far and away the best drug" for osteoporosis, says Schwartz. But it's not perfect. especially for certain groups of older patients. Fosamax actually weakens bones in people who are vitamin D-deficient, according to Schwartz. The deficiency must first be corrected, which could take from one to three months. Also, Fosamax is ineffective unless taken in the morning, 30 minutes before any other food or medicine. And there are side effects to consider. Fosamax can cause gastrointestinal symptoms, making it inappropriate for some people with pre-existing gastrointestinal problems. "In long term care, 30 to 40 percent of elderly individuals will have upper GI complaints," says Schwartz. Physicians may avoid prescribing Fosamax for these patients, or try to increase their tolerance for the drug by introducing it slowly.
For people who can't or won't take estrogen replacement drugs or Fosamax, Miacalcin nasal spray is a good alternative. When taken with 1000 mg. of calcium and 400 I.U. of vitamin D, Miacalcin has been shown to be effective in preventing spinal fractures. Miacalcin is a synthetic form of calcitonin, a hormone produced by the thyroid. Miacalcin in nasal spray form can be taken at any time of day, says Charles H. Chesnut, MD, director of the Osteoporosis Research Group at the University of Washington Medical Center in Seattle. Its only known side effect is nasal irritation in some individuals.
With baby boomers marching toward their golden years, there's much more on the horizon. Interest in preventing and treating osteoporosis is surging. Even more promising than the treatments that have recently earned FDA approval are drugs now in clinical trials that could substantially increase bone density, not merely prevent its loss.
New treatments being tested include the following.
* Parathyroid hormone therapy. ALX1-11, 1, a recombinant human parathyroid hormone, has been shown in clinical trials to stimulate bone formation. Additional preclinical studies demonstrate that the new bone is of normal architecture and strength.
* SomatoKine. The recombinant equivalent of IGF-BP3, a substance found naturally in the body, SomatoKine has shown in clinical trials that it can help rebuild bone and muscle in osteoporotic patients who undergo hip surgery. In clinical trials, patients who took SomatoKine lost only 2 percent bone density in the eight weeks following hip surgery; patients who did not receive the drug lost up to 7 percent.
* Didronel (etidronate) and Actonel (risedronate). Bisphosphonates that are similar to Fosamax, these two drugs produce comparable results but with fewer gastrointestinal side effects than Fosamax. Didronel has been approved in at least 17 other countries for osteoporosis. Actonel, already approved for Paget's Disease, has been submitted to the FDA for approval for osteoporosis and could be available by the end of this year.
* Testosterone-replacement therapy. Woman comprise the majority of osteoporosis patients, but as the life expectancy for men increases, the disease is becoming increasingly prevalent in the male population. The NIH is initiating more research on treatments for men, including the use of testosterone- replacement therapy.
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|Author:||PAUL, KATHERINE J.|
|Publication:||Contemporary Long Term Care|
|Date:||Apr 1, 1999|
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