This is an archive page. The links are no longer being updated.

Date: March 13, 1998
FOR IMMEDIATE RELEASE
Contact: FOOD AND DRUG ADMINISTRATION, Sharon Snider:301­827­6242  
Broadcast Media: 301­827­3434, Consumer Inquiries:800­532­4440

FDA Approves First Ultrasound Device For Diagnosing Osteoporosis

Promises to Help Early Detection/Treatment Efforts for Millions of Older Americans

This is the first device for diagnosing osteoporosis which does not involve the use of x­rays. It is intended to be used for women at risk of bone fracture, not as a general screening tool.

The Sahara Clinical Bone Sonometer, manufactured by Hologic, Inc., of Waltham, Mass., estimates bone strength using ultrasound measurements. The portable device transmits high frequency sound waves through the patient's heel for about 10 seconds and automatically analyzes the results.

"Prevention should be our first line of defense against osteoporosis, and that's why I've urged children and teenagers especially girls­­to drink plenty of low­fat or fat­free milk. But early diagnosis is also important," said HHS Secretary Donna E. Shalala. "This new test can be done easily in many doctors' offices. Early diagnosis and treatment will improve the quality of life for millions of Americans who are at risk of fractures related to this condition."

"New medical technology like this is important because osteoporosis is a growing health problem, especially among older women," said FDA Lead Deputy Commissioner Michael A. Friedman, M.D.

An estimated 23 million women in the United States may be suffering from some degree of decreased bone strength. Aside from obvious fractures such as those of the hip, symptoms of less obvious fractures may include chronic or acute pain, particularly in the spine, and deformities such as a stooped posture and loss of physical stature.

Current treatments exist which can slow the development of osteoporosis, particularly if initiated at earlier stages of the condition.

FDA's approval of the sonometer was based on data from three clinical studies comparing the ultrasound measurements to x­ray bone densitometry measurements: a study of 2,208 healthy women of all ages to establish normal values for the device; a study of 247 women of all ages including groups of women with and withouta history of fracture to compare performance of this device to more traditional methods of measuring bone strength; and a study of 212 women which demonstrated the ability of this device to select women at high risk for future fractures.

The ultrasound device was shown to be as good as x­ray bone density measurements for diagnosing osteoporosis and predicting fracture risk.