FDA Approves New Drug to Fight Osteoporosis : Medicine: Bone loss affects up to 25 million Americans, especially post-menopausal women. Treatment would be an alternative to hormones.
WASHINGTON — The Food and Drug Administration Monday approved the first non-hormonal drug to treat osteoporosis, a progressive and often crippling bone disease that may afflict as many as 25 million Americans.
The approval offers the first drug alternative to hormone replacement therapy for post-menopausal women, who are particularly susceptible to the condition. Although studies have shown that hormones protect against both osteoporosis and heart disease, hormones also have been associated with an increased risk of cancer of the breast and uterus.
“Until recently, the only treatments . . . were hormonal,” said Dr. Ethel Siris, director of osteoporosis programs at the Center for Women’s Health at Columbia-Presbyterian Medical Center in New York and one of the researchers. “Finally, there is a new treatment choice women can discuss with their physicians.”
Calling the drug “highly effective,” she said it “increased the amount of bone in women in clinical trials” and “reduced the risk of new spinal fractures.”
In other action Monday, the FDA approved:
* A computer system to help doctors more reliably double-check Pap smears for signs of cervical cancer in women. The AutoPap QC system is to replace the random method of rescreening Pap smears that laboratories now use.
* A plug to stop bleeding in patients who have undergone balloon angioplasty. The one-inch-long cylinder made of bovine collagen is designed to be inserted into the groin artery that doctors use for threading catheters into cardiac vessels.
* The Androderm skin patch to treat testosterone deficiency in men, a condition known as hypogonadism. When applied to the back, abdomen, thigh or upper arm, the patch delivers doses of testosterone, the hormone responsible for developing male characteristics during and after puberty.
* A laser device that can be used to remove scarring on the cornea of the eye. Called an excimer laser, it breaks up tissues left on the cornea after healing of injuries or disease. Such tissue can obscure vision.
* A flexible metal tube that can be used to correct severe portal hypertension, which occurs among patients with advanced liver disease. The tube is placed between the portal and hepatic veins in the liver to relieve high blood pressure that can occur in a diseased organ.
But the most far-reaching decision involved the osteoporosis drug. In osteoporosis, bone loss can lead to spinal fractures. They, in turn, gradually collapse the bones of the spine, causing height loss, pain and a deformed back known as “dowager’s hump.” Osteoporosis is caused by an imbalance in the body’s bone-rebuilding cycle that generally occurs after menopause, when estrogen levels drop. During the first five years after menopause, women may lose as much as 25% of their bone mass.
Bone loss can occur without symptoms, and the disease often can go unrecognized. In many cases, it is not diagnosed until one or more fractures have occurred.
An estimated 8 million American women are known to suffer from osteoporosis, and an additional 17 million people--men and women--have low bone mass, making them especially vulnerable to the disease.
“Because women with osteoporosis may find it difficult to conduct normal daily activities, such as getting in and out of a car, or getting dressed, many women can feel isolated and dependent on others,” said Deborah T. Gold, assistant professor of medical sociology at Duke University Medical Center.
The drug, alendronate sodium, or Fosamax, is manufactured by Merck & Co. It was approved for use in post-menopausal women and for the treatment of Paget’s disease, a chronic bone disorder that affects up to 1.3 million Americans and may result in enlarged and deformed bones.
The drug was studied in 1,827 post-menopausal women in five clinical trials conducted in 16 countries. The studies showed a statistically significant increase in bone mass in the spine and hip in patients on the drug.
