New Osteoporosis Drug Coming?
2 Positive Studies Published on Experimental Drug Denosumab; FDA Panel Review
By Miranda Hitti
WebMD Health News
Reviewed by Louise Chang, MD

Aug. 11, 2009 — The experimental drug denosumab may be on its way to becoming the newest way to treat osteoporosis.

Denosumab, a biological drug given by injection every six months, looks safe and effective, researchers report in today’s advance online edition of the New England Journal of Medicine.

An FDA advisory panel will meet Aug. 13 to decide whether to recommend denosumab for FDA approval. The FDA often follows the advice of its advisory committees, but it doesn’t have to.
Denosumab Studies

Denosumab works differently than other osteoporosis drugs. It binds to a protein called RANKL, which cells called osteoclasts need to break down bone as part of the bone remodeling process.

The idea behind denosumab is to slow the bone-breakdown process in people whose bones are already dangerously thin.

WebMD first reported on denosumab in September 2008, when news about the drug’s potential to treat osteoporosis in postmenopausal women was presented at the annual meeting of the American Society for Bone and Mineral Research in Montreal.

Now, that trial’s results have been published, along with a separate study in men with prostate cancer taking bone-weakening hormone therapy to treat their cancer.

In both studies, patients got a shot of either denosumab or a placebo every six months for three years. And in both studies, fractures were rarer in patients taking denosumab.

In the postmenopausal osteoporosis study, which included 7,800 women 60-90 years old with osteoporosis, new vertebral fractures occurred in 2.3% of patients taking denosumab, compared with 7.2% of patients taking the placebo.

That’s a difference of 68%, notes researcher Steven Cummings, MD, director of the San Francisco Coordinating Center at the California Pacific Medical Center and a professor of medicine and epidemiology at the University of California at San Francisco.

“It’s more effective for reducing vertebral fractures than I expected … 68% is a very powerful reduction,” Cummings tells WebMD.

In the prostate cancer study, which included more than 1,400 men with prostate cancer on bone-weakening hormone therapy, new vertebral fractures occurred in 1.5% of patients taking denosumab, compared with 3.9% of patients who got the placebo.

“To see this very dramatic 62% decrease in vertebral fractures in three years in this relatively high-risk population of men is very impressive,” researcher Matthew Smith, MD, PhD, tells WebMD. Smith is the director of genitourinary medical oncology at Massachusetts General Hospital Cancer Center.

Denosumab’s Side Effects

Denosumab didn’t show an increased risk of infection or cancer — risks seen with other types of biologic drugs — in either trial.

Denosumab also wasn’t linked to osteonecrosis of the jaw (sometimes called “jawbone death”), which has been reported with other osteoporosis drugs called bisphosphonates.

But eczema and severe cases of a skin infection called cellulitis were more common in women taking denosumab in Cummings’ study. The reason for that isn’t clear.

Denosumab’s safety profile “appeared excellent” in the prostate cancer study, Smith says, adding that the study was the first large study of fracture prevention in men.

“Previously, there had been no large studies to address that problem in men with prostate cancer, and frankly, not in men in any setting,” Smith says.

Both denosumab studies were sponsored by the drug’s maker, Amgen. Smith and Cummings disclose working as consultants for Amgen, and several researchers on both studies are Amgen employees.
Other Opinions

Denosumab “seems at least as efficacious as the currently approved alternatives,” states an editorial published with the studies.

But editorialist Sundeep Khosla, MD, of the Mayo Clinic’s medical school in Rochester, Minn., notes that there haven’t been any head-to-head trials comparing denosumab to other osteoporosis drugs for fracture prevention, that the drug’s longer-term safety isn’t known yet, and that cost could be an issue if denosumab is pricey. Khosla notes no conflicts of interest.

Cummings says there are plans to follow the patients in his study for at least 10 years. He also hopes that patients will be more compliant about taking denosumab than other osteoporosis drugs.

“It’s as effective as any other treatment and can be given twice a year as a simple injection, like a flu shot” and can be given by a nurse or primary care doctor, Cummings says.

Susan Bukata, MD, an osteoporosis specialist and associate professor of orthopaedics at New York’s University of Rochester Medical Center, says denosumab would be “another option” for people who can’t or won’t take other osteoporosis drugs, such as people with kidney failure or gastrointestinal issues.

“There’s definitely a place for this drug,” Bukata says. “I think still, the gold standard is we start on the pills, we start on the generics. But this is certainly a good second-line choice and for some patients … this may be my first-line choice.”

Bukata wasn’t involved in the denosumab trials. She discloses that she expects to soon work on a clinical trial of another Amgen drug.

Source: webmd.com

Click here to read the Web MD Article

Osteoporosis means “porous bone.” If you looked at healthy bone under a microscope, you would see that parts of it look like a honeycomb. If you have osteoporosis, the holes and spaces in the honeycomb are much bigger than they are in healthy bone. This means your bones have lost density, or mass. It also means that the structure of your bone tissues has become abnormal. As your bones become less dense, they become weaker.
From the National Osteoporosis Foundation
For some people affected by the disease, simple activities such as lifting a child, bending down to pick up a newspaper or even sneezing can cause a bone to break. Because osteoporosis is a disease of the bones, it is important to know some basics about your bones. Your bones are made up of three major components that make them both
flexible and strong:

1. Collagen, a protein that gives bones a flexible framework
2. Calcium-phosphate mineral complexes that make bones hard and strong
3. Living bone cells that remove and replace weakened sections of bone

See pictures on what normal bone looks like and what osteoporotic bone looks like

See Pictures and more info

FIVE STEPS TO BONE HEALTH AND OSTEOPOROSIS PREVENTION
from the National Osteoporosis Foundation

EAT RIGHT:
Get your daily recommended amounts of Calcium and Vitamin D.

EXERCISE:
Engage in regular weight-bearing and muscle
strengthening exercise.

MAINTAIN A HEALTHY LIFESTYLE:
Avoid smoking and excessive alcohol consumption.

TALK TO YOUR HEALTHCARE PROVIDER:
Talk to your healthcare provider about bone health.

GET TESTED:
Have a bone density test and take medication when appropriate.

From the National Osteoporosis Foundation
Osteoporosis is a disease in which bones become fragile and more likely to break. If not prevented or if left untreated, osteoporosis can progress painlessly until a bone breaks. These broken bones, also known as fractures, occur typically in the hip, spine, and wrist.

Any bone can be affected, but of special concern are fractures of the hip and spine. A hip fracture almost always requires hospitalization and major surgery. It can impair a person’s ability to walk unassisted and may cause prolonged or permanent disability or even death. Spinal or vertebral fractures also have serious consequences, including loss of height, severe back pain, and deformity.

Millions of Americans are at risk. While women are four times more likely than men to develop the disease, men also suffer from osteoporosis.
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