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For release Tuesday, March 28

LOSS OF HEIGHT, "DOWAGER'S HUMP" MAY BE PREVENTED WITH VERTEBROPLASTY

SAN DIEGO The pain, height loss and "dowager's hump" caused by osteoporotic fractures of the vertebrae in young and old people may be prevented or even partially reversed in some patients with the help of liquid bone cement and small balloons.

Two non-surgical techniques performed by interventional radiologists -- vertebroplasty, and spine balloon therapy (kyphoplasty) -- offer help to people who have no treatment options other than pain killers, according to information on the procedures being presented here today at the 25th Annual Scientific Meeting of the Society of Cardiovascular & Interventional Radiology (SCVIR).

Multiple vertebral fractures lead to height loss and kyphosis, or "dowager's hump." Vertebroplasty involves injecting a medical grade bone cement into the fractured vertebra to stabilize it, stop the pain and prevent further collapse of the vertebra. Research shows vertebroplasty is more than 80 percent successful in people with osteoporotic vertebral fractures, including young people whose bones have become fragile due to the use of steroids to treat a variety of diseases, such as lupus, asthma and rheumatoid arthritis.

A new approach to vertebroplasty will include the use of cements, currently in development, that will convert to bone or stimulate bone growth. Kyphoplasty, another new approach to vertebroplasty, involves inserting a small balloon at the point where the vertebra has collapsed, inflating the balloon to raise the bone and then injecting cement into the space. Researchers hope the procedure will restore lost height.

Ten million Americans have osteoporosis, a disease that causes 700,000 vertebral fractures annually, according to the National Osteoporosis Foundation. Osteoporosis leads to more than twice the number of vertebral fractures as hip fractures.

"In the near future, we'll likely be using vertebroplasty preventively to treat fragile, osteoporotic vertebrae in some at-risk patients before they fracture," said John M. Mathis, M.D., M.Sc., chairman of the radiology group at Lewis-Gale Medical Center, Salem, Va., and associate clinical professor of radiology, neurosurgery and orthopedic surgery, Johns Hopkins Medical Institutions, Baltimore. Dr. Mathis, who helped introduce vertebroplasty to the United States, is participating in a special session on spine treatments at the SCVIR meeting.

"Vertebroplasty may help prevent severe deformity and gets people up and walking around, and this helps prevent devastating complications such as pneumonia or pulmonary embolism," said Gregg H. Zoarski, M.D., director, diagnostic and interventional neuroradiology, University of Maryland Medical Center, and associate professor of radiology, University of Maryland School of Medicine, Baltimore. "After a vertebra is fractured, typically there's an initial loss of only 20 percent or 30 percent of the height of the vertebra. But over several weeks, fractures may reoccur, and the vertebra pancakes out until eventually there's a 70 to 90 percent loss. Gradually, the back hunches over and the person loses height, especially if several vertebra are involved. If we treat patients soon after each fracture, we can stop the vertebral height loss before deformity occurs."

"It gets people who are often in hospital beds and on constant medication back on their feet, and probably lengthens their lives," said Dr. Mathis.

Consumer information on vertebroplasty is going on-line today at www.scvir.org. The website includes a physician locator service that allows consumers to find an interventional radiologist near them.

Vertebroplasty Widely Available, Results Are Promising

At least four of five patients who have had vertebroplasty report significant pain relief, according to two studies on the procedure being presented at the SCVIR meeting.

In the University of Maryland study, 24 of 30 patients (80 percent) reported significant and durable pain relief two weeks after having vertebroplasty.

"The physicians involved in our study have helped about 400 patients, and we have not had complications in any of them," said Dr. Zoarski, lead author of the University of Maryland study.

"In another study, at St. Vincent Mercy Medical Center in Toledo, Ohio, 95 percent of 45 patients who had vertebroplasty reported significant improvement in pain and motility," said Dr. Mathis. "These two studies are typical of the results we see."

Vertebroplasty also is performed on people with vertebral fractures caused by cancer in the spine.

Several thousand procedures have been performed within the last several years and vertebroplasty is now available across the country.

"We are on the cusp of vertebroplasty becoming the standard of care for compression fractures of the spine," said Dr. Mathis. "Within a few years, more than 100,000 vertebroplasties will be performed every year."

The technique involves making a nick in the skin and inserting a cocktail straw-sized needle into the fractured vertebra using X-ray guidance to follow the progress of the procedure. Bone cement is used to fill tiny holes and crevasses inside the vertebra to shore up the fractured outer bone. The procedure takes less than an hour. The patient only needs to be lightly sedated.

Vertebroplasty most often is used to treat vertebrae in the lower- and mid-spine, which are prone to fracture when they become osteoporotic, or brittle. In a third of the cases, the bone is so weak that the fracture may occur when the patient is simply rolling out of bed or coughing, said Dr. Zoarski. Because the patient can't recall a specific trauma, vertebral fracture frequently is diagnosed incorrectly, he noted.

Patients with vertebral fractures caused by osteoporosis have no other real options than bed rest and pain killers. Surgery to stabilize the fracture with spine screws usually is not possible because the bone is too weak to hold the screws and surgery is risky in these patients.

"About 5 percent to 10 percent of my patients are under 50," said Dr. Mathis. "Young patients do extremely well with vertebroplasty. I treated seven crushed vertebra in one patient who had osteoporosis because of the steroids she had taken to treat lupus. Four years later, at age 39, she remains pain-free."

"It's also significant that we can get rid of the pain in an 80-year-old who might otherwise be put in bed for six weeks and may never get back to the level of activity he or she had previously enjoyed," said Dr. Zoarski.

Spine Balloon May Restore Height

The spine balloon technique (kyphosis) has been performed in about 150 patients nationwide and, although no clinical investigations are yet published on it, early results are promising, according to Dr. Mathis.

The technique is similar to vertebroplasty, except that before the cement is injected, a small balloon is passed through a needle (similar to that used in vertebroplasty) into the inside of the vertebra and expanded. The procedure takes one to two hours and typically is performed while the patient is under general anesthesia.

"Both vertebroplasty and kyphoplasty have a place," said Dr. Mathis. "Vertebroplasty will continue to be extremely useful in treating the majority of these fractures, while kyphoplasty may be helpful in more acutely injured patients who have greater height loss. The most opportune time to use kyphoplasty is soon after the vertebra fractures, so the break is fresh and the bone is more malleable."

Co-authors of a paper on the topic being presented by Dr. Zoarski are: A.P. Snow, P.A.; W.J. Olan, M.D.; M.J. Stallmeyer, M.D., Ph.D.; B.W. Dick, M.D.; and J.R. Hebel, M.D.

An estimated 5,000 people are attending the Annual Scientific Meeting in San Diego, Calif., of SCVIR, a professional society based in Fairfax, Va., for physicians who specialize in minimally invasive interventional procedures.

An interventional radiologist is a physician who has special training to diagnose and treat illness using miniature tools and imaging guidance. Typically, the interventional radiologist performs procedures through a very small nick in the skin, about the size of a pencil tip. Interventional radiology treatments are generally easier for the patient than surgery because they involve no surgical incisions, less pain and shorter hospital stays.

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Editor's note: Study numbers are current as of March 15, and may change.