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One-Shot Osteoporosis Treatment in the Works

Experimental Treatment Improves Bone With One Shot Every Six Months
By
WebMD Health News

Oct. 5, 2004 (Seattle) -- Researchers are working on a new treatment for the bone-wasting disease osteoporosis that can be given once every six months.

Michael McClung, MD, director of the Oregon Osteoporosis Center in Portland, Ore., says that one-shot treatment with the experimental drug called AMG-162 improved bone density better than the osteoporosis treatment Fosamax. He presented his research at the 26th annual meeting of the American Society of Bone and Mineral Research.

AMG-162 has a potent effect on preventing bone breakdown, which indicates that it has the potential to be a promising new osteoporosis treatment that can be given in a very convenient form, says McClung.

The drug helps combat cells responsible for bone breakdown. It does this by inactivating a substance called RANKL, which is responsible for the formation, activation, and survival of bone-chewing cells.

New Osteoporosis Treatment Findings

McClung reported on a number of studies aimed at finding the best and safest dose of AMG-162 as an osteoporosis treatment.

More than 400 post-menopausal women with osteoporosis received injections of various doses at three-month intervals or six-month intervals. After 12 months the researchers compared bone mineral density -- an indirect indicator of bone strength -- at the hips of these women with bone density in women who took either 70 milligrams a week of Fosamax or placebo.

McClung says all the doses of AMG-162 increased bone mineral density by 4% to 7%, which is as good as the 5% increase seen in women taking Fosamax. But the 60-milligram injection once every six month was "significantly more effective than once-weekly [Fosamax]," he says. Moreover, he says that measurements taken in the arm and other parts of the body showed similar results.

"This study demonstrates that AMG-162 significantly improves bone mineral density in post-menopausal patients experiencing bone loss," McClung reported in a formal presentation of the results.

"These results are very surprising," says Uri Liberman, MD, PhD, a professor of physiology and medicine at Tel Aviv University in Israel. It is surprising that the drug continues to be active for as long as six months. This will make the drug a strong competitor with other osteoporosis treatments, he notes.

However, we know that current osteoporosis treatments are very safe. "We have 10 years of experience with them. The question will remain as to what the side effects are going to be with this [osteoporosis treatment]," says Liberman, who was not involved in the study.

"This is a major development," Clifford Rosen, MD, a past president of the ASBMR, clinical professor of nutrition at the University of Maine, and director of the Maine Center for Osteoporosis Research, Bangor, tells WebMD. "What AMG-162 does is it removes the excess bad guys that are responsible for bone loss," he explains. Rosen also wasn't involved in the study.

Easy Osteoporosis Treatment, but Is It Safe?

Rosen says that the ease of administration is a major plus for AMG-162 in that it won't require frequent doctor visits and it appears to eliminate the stomach side effects seen with osteoporosis treatments like Fosamax.

"The cost is anybody's guess," Rosen says, noting that drugs developed by biotechnology companies have never been inexpensive. And he echoes Liberman's concern about potential toxicity. "We don't have long-term safety data," he says.

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