The Food and Drug Administration on Friday approved a new device that can diagnose osteoporosis in 10 seconds by scanning a person's heel using ultrasound, a new technology that is dramatically faster and considerably less expensive than the equipment and procedure now in use.
Currently, a patient suspected of having osteoporosis--an increasing brittleness of the bones--must visit a radiological facility and lie stretched out on a table while a specialized X-ray machine takes 10 minutes or longer to scan selected sites across her body.
The new machine, a portable device known as the Sahara Clinical Bone Sonometer, is manufactured by Hologic Inc. of Waltham, Mass., and already is in widespread use in Europe, Asia and Latin America.
The machine, which will be available to physicians immediately, will cost patients about $40 to use, the company said. Like the X-ray machine, it is intended for women regarded as at risk for the bone fractures that can result from osteoporosis, not as a general screening tool.
There are millions of American women considered at risk, particularly those who have reached menopause. Osteoporosis afflicts millions of women and is linked to an estimated $14 billion in annual health care costs. While men can be stricken, women are four times more likely to develop the disease.
An estimated 23 million American women may be suffering from some degree of decreased bone strength, according to the FDA. While replacement hormones have been shown to substantially reduce the chances of developing osteoporosis, not every woman can or wants to take them; there also are several drugs available to treat the disease. Many experts stress prevention through a calcium-rich diet and weight-bearing exercise.
The lifetime risk of a woman suffering an osteoporosis-related fracture is about 40%, and her chance of developing a hip fracture alone is equal to her combined risk of developing breast, uterine or ovarian cancer, according to the National Osteoporosis Foundation.
There are about 1.5 million fractures annually in the United States that are attributed to osteoporosis, the foundation said.
In addition to fractures, other symptoms may include chronic or acute pain, particularly in the spine, and deformities, such as a stooped posture and loss of height.
The office-based exam requires patients to rest a foot comfortably in the device for a painless, noninvasive ultrasound that measures bone mineral density in the heel bone. Test results are computed by a machine and produced very quickly; the entire procedure takes about a minute, the company said.
Currently, the most widely used method for assessing bones involves a large, specialized X-ray machine that is passed over a patient's body, with results studied and interpreted by a radiologist. Until now, this was the only way to accurately determine a patient's risk of osteoporosis--but such machines and facilities can be inaccessible and expensive, with use of one sometimes costing $100 or more.
"Until now, bone density testing was primarily done at city hospitals that had the space and could afford the X-ray equipment," said Dr. Daniel T. Baran, director of the University of Massachusetts Medical Center's osteoporosis clinic and one of the lead investigators involved in clinical trials of the new device. "Now, with the availability of Sahara systems in doctor's offices, access to bone densitometry is likely to increase, particularly in more rural settings."
"New medical technology like this is important because osteoporosis is a growing health problem, especially among older women," said Dr. Michael A. Friedman, the FDA's lead deputy commissioner.
S. David Ellenbogen, chairman of Hologic, said that with the introduction of the new machine, "we hope to provide office-based physicians with an affordable, portable and simple" tool to identify women at greatest risk so that "physicians and patients can take effective measures to prevent against further bone loss."
The FDA's approval of the machine was based on data from three clinical studies comparing the ultrasound measurements to X-ray bone densitometry. The device proved just as good as the X-ray machine for both diagnosing osteoporosis and predicting fracture risk, the FDA said.