June 27, 2000 -- Cecilia, Angela, and Mary are three sisters who once shared the same room, the same wardrobe, and the same enthusiasm for jacks and porcelain-faced dolls. In July of 1999 they shared something else: All three women, now in their 70s, had fractured bones of the spinal column. These three diminutive sisters are among the 10 million Americans with the bone-wasting disease osteoporosis.
Cecilia says she won't ever take estrogen, even though it may protect her bones; Angela says Fosamax, a drug approved for treatment of osteoporosis, upsets her stomach; and Mary is using Evista, one of the new, so-called designer estrogens that doesn?t promote breast cancer and does reduce fracture risk.
But all three of these women may someday treat their osteoporosis with a drug that is now used to lower cholesterol, and if they do, they may also be protecting their hearts and reducing the chance that they will have a stroke.
In less than a week, two respected medical journals -- The Lancet and The Journal of American Medical Association (JAMA) -- each published studies suggesting that the class of cholesterol-lowering drugs called statins may also cut the risk of fractures by half.
A total of four human studies and one animal study have all reached that same conclusion, a conclusion that has osteoporosis experts asking for confirmation. Because the human studies were based on conclusions reached by analyzing medical records, no one is willing to suggest just yet that the statins should be used to treat osteoporosis.
But if the findings are confirmed by further research, that is just what could happen, says Felicia Cosman, MD, clinical director of the National Osteoporosis Foundation. She says that older women are at risk for both heart disease and osteoporosis, so a single pill that could treat both conditions would be a major breakthrough.
Future studies will compare how a specific statin works when compared to an accepted treatment for osteoporosis, says Cosman. These studies are needed because sometimes the conclusions of studies based on medical records are disproved when tested further. Estrogen met this fate when many medical record studies suggested that estrogen protected women from heart attacks, but recently more research has found that when women already had heart disease, estrogen didn't keep their disease from progressing.
JAMA editorialist Steven R. Cummings, MD, professor of medicine and epidemiology at the University of California, San Francisco, tells WebMD that even though he is enthusiastic about a possible role for statins, he is opposed to using the drugs for osteoporosis before the findings are confirmed.
"It is far too early to rely upon statins for fracture protection. We've got good, well-proven drugs that can be used for fracture prevention," Cummings says.
On their own in study after study, statins have a stellar track record. Clinical evidence suggests that statins can prolong life in the face of heart attack, reduce the risk of stroke, and lower blood pressure. Nonetheless, Philip S. Wang, MD, DrPH, lead author of one of the JAMA studies, says it is far too soon to "consider [statins] as the one-pill solution."
Yet, the prospect is attractive, and even as he urges restraint, Cummings says that UCSF is in the planning stages of a study on using statins for osteoporosis. He says the trial is being planned with the assistance of Gregory Mundy, MD, PhD, the author of the rat study published in Science late last year.
Mundy, professor of medicine at the University of Texas Health Science Center San Antonio, tells WebMD that he is "tremendously pleased with all these studies. Firstly, because they suggest that statins are effective in humans and secondly, they show that they may be effective at [the normal cholesterol-lowering doses]."
Since publishing his animal work, Mundy says he had been pursuing the concept of a "bone statin", which would be delivered by a skin patch. The skin patch could potentially keep more of the drug working in the body because it would avoid breakdown by the stomach and intestines. But these recent studies suggest the skin patch may not be needed to protect against fractures because the oral form seems to work for fracture prevention.
Mundy says he is especially encouraged by the JAMA paper from Christoph R. Meier, MD, PhD, of the University Hospital of Basel Switzerland, because that study suggests that statins may begin to make a difference quickly -- in a few weeks to a few months.
Meier's group studied nearly 4,000 fracture patients aged 50 to 89 and compared their statin use to patients of the same age range and gender with no fractures. They found that current statin use reduced fracture risk by 45%, while recent statin use reduced the risk by 33%, and any history of statin use reduced risk by 13%.
In the second JAMA paper, Philip S. Wang MD, DrPH, of Brigham and Women's Hospital in Boston, studied data collected from New Jersey residents aged 65 or older who were enrolled in Medicare, Medicaid, or the Pharmacy Assistance for the Aged and Disabled program. They identified 1,222 patients who had hip fractures in 1994 and compared their statin use to 4,888 healthy people.
"We found that statin use for 180 days prior was associated with a 50% reduction in hip fracture risk, and use of statins in the prior three years was associated with a 43% decrease in risk," Wang tells WebMD.
Cummings says that although the data from this cluster of studies is very encouraging, there are factors that need to be considered For example, when drugs seem to work quickly, it may be because the people taking them were at low risk to begin with, he says. "But on the other hand, people who adhere to medications over the long haul are the ones who tend to have the best prognosis and best health status," he says.
Wang says that since published data from statin studies for cholesterol control suggest that "each statin has a slightly different effect on [cholesterol], it is possible that each would also work differently on bone."
- More studies are coming out showing that statin drugs, which are designed to lower cholesterol levels, may also be effective in treating osteoporosis.
- Researchers say there is room for caution, however, because the types of studies completed to date have been conducted by analyzing medical records, and the findings may not hold up in future research.
- In addition to lowering cholesterol, statins can also reduce the risk of stroke, lower blood pressure, and prolong the life of heart attack patients. Because older women are at risk for both heart disease and osteoporosis, a single pill that could treat both conditions would be a major breakthrough.