Fosamax (Alendronate) for Osteoporosis

 


June 20, 1997, Baltimore

Some 30 to 40 percent of postmenopausal women suffer from osteoporosis, the "bone-thinning" disease that results in a bone so brittle and easily fractured that it can break spontaneously. In the U.S. alone, the cost of treating such fractures is about $10 billion a year. A hip fracture can turn a self-sufficient, active woman into one who needs constant care and even cause her death. But a new drug, Alendronate, can reduce the risk of fracture. In five different studies involving 1,602 women, researchers reporting in a recent issue of the Journal of the American Medical Association found that the drug reduced fractures by nearly 30 percent and that those who took the drug also experienced increased bone mineral density. In this InteliHealth interview, Edward E. Wallach, J. Donald Woodruff professor of gynecology at the Johns Hopkins Medical Institutions, says he believes the drug shows great promise.

InteliHealth: How does Alendronate work?

Dr. Wallach: It's a member of a family of drugs called bisphosphonates. These drugs have an effect on the bone matrix. It was first used in patients with Paget's disease, a disease where continued destruction of the bone occurs. The first of these drugs was etidronate, used exclusively for Paget's disease; then doctors started using it to treat osteoporosis. But it was difficult to give, it had to be given for two weeks at three-month intervals. Alendronate can be given on a daily basis, which makes it easy to take. It works on strengthening the bone matrix.

IH: How does it accomplish that?

Dr. Wallach: It prevents three types of fractures: forearm fractures, hip fractures - which is probably the most significant in terms of mobility and mortality - and vertebral collapse. There are two types of cells in bones: osteoblasts, which build bone, and osteoclasts, which cause bone to reabsorb. This drug prevents the reabsorption of bone.

IH: Should most post-menopausal women take this drug?

Dr. Wallach: No. Only those who have osteoporosis or a significant risk for osteoporosis need to take this.

IH: Is Alendronate a better choice for women at risk of osteoporosis than hormone replacement therapy?

Dr. Wallach: It would be ideal if a postmenopausal woman at high risk for osteoporosis would receive both estrogens and Alendronate.

IH: What are Alendronate's side effects, if any?

Dr. Wallach: The most significant side effect is esophageal irritation, which is true of all drugs in this group of compounds. It probably causes acid to enter the esophagus and cause the irritation. But that can be reduced by the way a woman takes the drug. The drug must be taken 30 minutes before eating, since food prevents its absorption. The woman should take it when she first gets up, standing, with a full glass of water. Then she can't lie back down. She should take it 30 minutes before breakfast. But that's kind of difficult for working women. I personally don't know why it can't be taken in the afternoon; I suspect it's because the morning is when there is the longest period of time without food in the digestive tract.

IH: Is it safe in the long term?

Dr. Wallach: The drug has been studied for a number of years. Before it was released, there were three-year studies to evaluate its use, and it's fairly safe. But the length of time on the market is relatively limited, so we don't have long-term data.


Fosamax also Prevents Bone Fractures In Women

September 12, 1997

Women with low bone density but who have not yet had tiny spinal fractures indicative of osteoporosis can take the drug Fosamax to prevent broken bones, a new study suggests.

Women taking Fosamax, also known as alendronate, had a 44% reduced risk of such spinal fractures and a 14% lower risk of broken bones in general, according to the report scheduled to be released Thursday at the American Society for Bone and Mineral Research annual meeting in Cincinnati.

About 200 million women around the world suffer from osteoporosis. In the U.S., the bone-thinning disease is responsible for 1.5 million fractures and 37,500 deaths every year due to fracture-related complications.

The findings of the new study were from the second portion of the Fracture Intervention Trial (FIT). Previously, the study had found that women who did have spinal fractures could reduce their risk of a spine, hip or wrist fracture by 50% by taking Fosamax.

The new study included 4,432 women aged 55 to 81 who had a low bone mineral density but no fractures due to the bone thinning. Preliminary results from 79% of the study participants suggest that those who took alendronate for more than four years had 5% greater bone mineral density in the hip and nearly 7% greater bone mineral density in the spine as women who took a placebo or inactive medication.

Overall, 3.5% of women taking a placebo had spinal fractures compared with just 1.7% of those taking Fosamax.

The finding is important because "after women experience a first spinal fracture, they are twice as likely to fracture their hips and four to five times more likely to suffer additional spinal fractures than women who have had no spinal fracture," said study author Dr. Steven Cummings in a statement released by the University of California, San Francisco. The study is a collaborative effort with researchers from Merck Research Labs, a division of Merck & Co. Inc., the manufacturer of Fosamax.

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