Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SUNDAY, September 17, 1995 TAG: 9509180082
SECTION: NATL/INTL PAGE: A-14 EDITION: METRO
SOURCE: Associated Press
DATELINE: WASHINGTON LENGTH: Medium
A research report released Tuesday by Dr. Charles Y.C. Pak of the University of Texas, Southwestern Medical Center in Dallas, said the new fluoride formula caused an increase in spinal bone density of more than 4 percent annually among older women who already had severe osteoporosis. The therapy also reduced spinal fractures by about two-thirds.
Pak delivered a report on the study at a meeting of the American Society for Bone and Mineral Research in Baltimore.
Dr. Robert Lindsay, president of the National Osteoporosis Foundation and a professor at the Columbia University medical college in New York, said Pak's study is ``very important'' because it proves that a proper dose of fluoride and calcium, sustained over time, can reduce fracturing.
``The key is the delivery system,'' said Lindsay. ``It appears to give sodium fluoride in a more sustained fashion.''
Earlier studies found that sodium fluoride in combination with calcium citrate will build bone in women with osteoporosis.
But the studies showed that doses of fluoride strong enough to strengthen bones also caused toxic side effects in the stomach. When high doses of fluoride mix with normal hydrochloride acid in the stomach, hydrofluoric acid, a corrosive chemical, is formed.
``That's what they use to etch glass,'' Lindsay said. ``It caused a lot of gastric bleeding.''
Pak said the new form of fluoride avoids this problem by packaging the drug in a gelatin capsule that does not dissolve until it is passed out of the stomach, avoiding most of the acid effect.
In a four-year study, Pak used 110 women who had all suffered severe bone loss, including spontaneous vertebrae fractures. The women were all past childbearing age, the time in life when osteoporosis most commonly strikes.
Half of the women were put on a program of taking the sodium fluoride pill along with calcium citrate. The other half were given calcium citrate and a placebo that resembled the fluoride pill.
After four years, Pak said 85.4 percent of the women on fluoride had experienced no more spinal fractures. Among those on placebo, 56.9 percent escaped fractures. Spinal density increased by more than 4 percent annually and hip bone density by 2.4 percent annually among those on fluoride. The increase was less than 1 percent annually for women taking only calcium citrate.
Pak said other studies with the new fluoride pill show that the increase in bone density is even more dramatic for women whose osteoporosis has not yet become severe. ``The message is to start therapy early,'' he said.
The new pills are not available for general use, but Mission Pharmacal Co. of San Antonio, which developed the drug, has applied for Food and Drug Administration approval to market the product.
by CNB