WEDNESDAY, Nov. 27, 2002 (HealthDayNews) -- The U.S. Food and Drug Administration has approved a drug that stimulates new bone formation in people suffering from osteoporosis.
Unlike current treatments aimed at stopping additional bone deterioration in people with osteoporosis, the new drug, called Teriparatide, actually builds bone.
In a study involving 1,637 postmenopausal women and 437 men all with some degree of osteoporosis, patients who received 20 mcg's of teriparatide a day, along with calcium and vitamin D supplements, showed significant increases in bone mineral density at the spine and hip -- compared with participants taking only the supplements.
Because animal studies with teriparatide resulted in a higher incidence of bone cancer among the experimental rats, the FDA says the possibility cannot be ruled out that people treated with the teriparatide may face an increased risk of osteosarcoma, although there were no reports of the cancer in the human studies. A black box warning in the drug's label outlines this safety concern.
About 10 million Americans -- 80 percent of them women -- suffer from osteoporosis, which is a progressive thinning of bones.
Here is the FDA Talk Paper announcing the approval. The FDA has more information about osteoporosis here.
