Once-a-Year Osteoporosis Treatment on the Horizon
Annual injections of a common osteoporosis medication greatly reduced older women's risk for fractures, according to a report in the New England Journal of Medicine (NEJM).
The findings could open the door to US Food and Drug Administration (FDA) approval of once-a-year zoledronic acid.
"We've been waiting for this for a long time,” says Paul Brandt, Ph.D., an assistant professor of neuroscience and experimental therapeutics at Texas A&M Health Science Center College of Medicine in Houston. “This
is really exciting stuff.
"Here we've got something we can give to patients when they're in the clinic with a 15-minute IV, and it lasts for a whole year," says
Dr. Brandt, who was not involved in the study.
"The FDA hasn't
approved it for a single-year injection, but I hope
it will,” he notes. “It sure is going to
be a good kick in the right direction."
Dr.
Steven R. Goldstein, at the New York University School
of Medicine, says, "This is a very attractive alternative
for a significant number of people who cannot or will
not take traditional antiresorptive medication. But
this is not for everybody.
“This study was in older people, so in a select group of patients this would be a very nice alternative but it's not going to be a sea change, nor should younger people be running towards this methodology," explains
Dr. Goldstein.
The new study was funded by the medication's maker, Novartis Pharma. One outside expert agreed the new medication formulation could change the way people care for their bones.
Many women already take bone-preserving pills called oral bisphosphonates, but they are not for everyone, explains Dr. Nanette Santoro at Montefiore Medical Center in the Bronx, NY.
"For now, women who do not tolerate oral bisphosphonates well but who are good candidates will be able to take the medication in a relatively convenient form," says Dr. Santoro. "For
the future, this may be a harbinger of how this class
of medication will be given years from now."
Osteoporosis primarily affects women in their postmenopausal years, although it can afflict men as well. As bones thin and become more fragile, they break more easily, causing severe disability and even death.
Bisphosphonates, a class of medications that includes zoledronic acid, are the most commonly used treatment for osteoporosis. They work by slowing the body's natural reabsorption of bone.
But there has been one enduring problem with bisphosphonates: patients don't take the medications as they should.
"The big concern has been in patient compliance," confirms Dr. Brandt. "The
monthly pills run into problems where women start to
forget. It's also a pain to take these drugs. You have
to sit upright and there's a risk of acid reflux, esophageal
damage."
Women also have to take the pills with a full glass of water while fasting.
According to background information in the paper, most women appear to be taking less than 80 percent of their prescribed pills by 12 months.
Previous research had shown that one annual injection of zoledronic acid improved bone density for at least one year in postmenopausal women with osteoporosis.
The current study looks at how well annual injections do three years out.
Almost
4,000 postmenopausal women were randomly assigned to
receive a single 15-minute infusion of zoledronic acid
or a placebo (inactive substance) at baseline,
and then 12 months and 24 months later. Participants
were followed out to the 36-month point.
Treatment with zoledronic acid reduced the risk of vertebral fractures by 70 percent (3.3 percent of women in the treatment arm and 10.9 percent of women in the placebo arm suffered such fractures) over three years, the team reported. It also reduced the risk of hip fracture by 41 percent (1.4 percent of women in the zoledronic acid group vs. 2.5 percent in the placebo arm).
Meanwhile, nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25 percent, 33 percent, and 77 percent, respectively.
Women in the treatment arm also experienced significant improvement in bone mineral density and bone metabolism markers.
There was a slight downside to the injections: women in the zoledronic acid group experienced more incidents of an irregular heart rhythm called atrial fibrillation. Other side effects were similar in both groups.
Always consult your physician for more information.
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Osteoporosis, or porous bone, is a disease in which there is a loss of bone mass and destruction of bone tissue.
This process causes weakening of the bones and makes them more likely to break. The bones most often affected are the hips, spine, and wrists.
Osteoporosis affects over 10 million Americans, with women four times more likely to develop osteoporosis than men. Another 34 million have low bone mass and therefore have an increased risk for osteoporosis.
Estrogen deficiency is one of the main causes of bone loss in women during and after menopause.
Women may lose up to 20 percent of their bone mass in the five to seven years following menopause.
Other risk factors for osteoporosis include:
aging
Bones become less dense and weaker with age.
race
Caucasian and Asian women are most at risk, although all races may develop the disease.
body weight and bone structure
People who weigh less and have small body frames are more at risk for developing osteoporosis.
lifestyle factors
The following lifestyle factors may increase a person's risk of osteoporosis:
Osteoporosis
is often called the "silent disease" because persons
with osteoporosis may not develop any symptoms.
Some may have pain in their bones and muscles, particularly in their back. Occasionally, a collapsed vertebra may cause severe pain, decrease in height, or deformity in the spine.
The symptoms of osteoporosis may resemble other bone disorders or medical problems.
Always consult your physician for more information.
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