MONDAY, Sept. 30, 2002 (HealthDayNews) -- A laboratory-developed form of vitamin D has shown an impressive bone-building effect in animals and could soon be in preliminary human tests aimed at treatment of osteoporosis, a scientist says.
The molecule was developed in the laboratory of Hector F. DeLuca, chair of biochemistry at the University of Wisconsin, Madison, an acknowledged leader in vitamin D research. He is moving quickly to explore its use as an osteoporosis treatment.
"I've worked with vitamin D compounds since 1951, 300 or 400 of them, and of all the compounds we have examined this is the first one to show evidence of bone building," DeLuca says. The discovery led him to set up a biotechnology company, Deltanoid Pharmaceuticals.
With backing from "a couple of angel investors," and foundation support, Deltanoid expects to submit an Investigational New Drug Application to the U. S. Food and Drug Administration in the next few days, he says. The hope is that the first human tests, for drug safety, can begin by November, with the first tests of effectiveness "late next year," DeLuca says.
If the molecule works as hoped, it would fill a gap in drug therapy for osteoporosis, in which there is a destructive deterioration of bone structure. While several drugs are effective in blocking bone breakdown, "there is not a single one on the other side of the equation, bone buildup," DeLuca says.
Although a report on the molecule appears in tomorrow's issue of the Proceedings of the National Academy of Sciences, DeLuca says "we discovered the compound in 1998 and knew about its selectivity for bone very early. We've been reluctant to talk about it until we had what we regarded as solid clinical data."
That evidence comes first from studies of bone cells grown in the laboratory and then from work with female rats whose ovaries are removed to simulate the loss of hormone production in menopausal women, for whom osteoporosis can be a major problem.
Vitamin D plays an important role in the health of bones and teeth by regulating calcium and phosphate metabolism. The best dietary source is fortified milk, and sunlight also stimulates its production, which is why the childhood weak-bone disease rickets, and its adult counterpart, osteomalacia, can be common in slum dwellers.
DeLuca's studies compared the new compound, whose abbreviated name is 2MD, with a common vitamin D molecule. Even small amounts of 2MD stimulated activity of bone-forming cells in laboratory dishes, while high concentrations of ordinary vitamin D did not, the journal report says. And daily doses of 2MD led to a 9 percent increase in bone mass of the test mice, while ordinary vitamin D had no such effect.
Even if everything goes perfectly, it will be years before a 2MD product could reach the market, DeLuca says. Large-scale trials needed for FDA marketing approval probably will not begin before 2006, he says, adding, "We plan to push hard, but a lot of things can get in the way."
What To Do
You can learn about vitamin D from the National Institutes of Health and about osteoporosis from the National Osteoporosis Foundation.
