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Promising Osteoporosis Drug Reduces Fractures, May Impact Immunity

Posted by Jane Akre
Wednesday, August 12, 2009 1:17 PM EST
Category: Major Medical
Tags: Osteoporosis, Amgen, FDA, Prostate Cancer

New osteoporosis drug will go before the FDA on Thursday.

Reduces Spinal Fractures By 62 Percent

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IMAGE SOURCE: IMAGE SOURCE: ©iStockphoto/ spine x-rays/ author: FotografiaBasica

The drug is called denosumab, and it is used to stop the production of cells known as osteoclasts, that breakdown bone leading to osteoporosis.

In two studies, spinal fractures were reduced by two-thirds in women ages 60 to 90. For men undergoing the hormone deprivation that accompanies therapy for prostate cancer, it also worked to reduce spinal fractures.

Denosumab, which if approved will be marketed as Prolia, reportedly has reduced side effects partially because it’s a biological agent rather than a chemical. Because it is difficult to produce, it is likely to be the priciest among the osteoporosis drugs, reports the Los Angeles Times.

Drug maker, Amgen, has not said how much it will cost, but could be at least $2,000 a year.

Problems

Fosamax actually kills osteoclasts, reports the Los Angeles Times. There is a risk of side effects such as stomach and esophageal irritation and jaw necrosis. Foxamax costs about $100 a year.

An advisory committee at the Food and Drug Administration plans to meet Thursday to consider Amgen’s application for approval. This would be the first drug specified for treat men.

But the FDA is concerned denosumab can negatively impact the immune system opening the body to serious infections and cancer. Denosumab inhibits a protein known as RANK Ligant that is involved with bone destruction, reports the Wall Street Journal. That is the same protein that plays a role in boosting the body’s immune system.

In drug trials conducted by Amgen, denosumab was injected in half of a pool of 7,686 women ages 60 to 90. The injections were given every six months for three years. 2.3 percent of those women receiving the drug had a spinal fracture compared to 7.2 percent in the placebo groups. Researchers also noted an increase in bone mineral density compared to the placebo group.

They also note a slightly higher rate of serious infections and certain types of cancer.

The next trial could compare bisphosphonates with denosumab.

Osteoporosis is characterized by porous bone, low bone mass and structural deterioration of bone tissue and affects an estimated 10 million Americans, primarily women.

About 85 to 90 percent of your adult bone mass is acquired by the age of 18 in girls and 20 in boys, reports the National Osteoporosis Foundation. Consuming adequate amounts of calcium, vitamin D, engaging in weight-bearing and muscle strengthening exercise, avoiding smoking and excessive alcohol are all advised to keep bones healthy.

Fracture is the most common problem suffered by post-menopausal women with one in three over the age of 50 experiencing a fracture in her lifetime. Breaking a bone from osteoporosis has more than an eight-out-of- ten chance of breaking another one, making it difficult to walk.

One -third of men will suffer an osteoporosis-related fracture during their lifetime according to the International Osteoporosis Foundation. #


1 Comment

Anonymous User
Posted by Peter
Wednesday, August 12, 2009 1:51 PM EST

Your Lateral of the L-spine is up side down, or you guys had the patient stand on there head!!!!!!!!!!!

Pain Management Clinic
North Western Memorial Hospital

Comments for this article are closed.

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