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Once A Year Drug Reduces Fractures In Elderly

Bone Up on Osteoporosis

According to 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.

Osteoporosis is a major public health threat for an estimated 44 million Americans, or 55 percent of the people 50 years of age and older.

Of the 10 million Americans estimated to have osteoporosis, eight million are women and two million are men.

An estimated 345,000 Americans are hospitalized each year with a hip fracture, and as the Baby Boomers age, that number is certain to grow.

Significant risk has been reported in people of all ethnic backgrounds.

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 - people who weigh less and have less muscle have a higher risk.
  • physical inactivity
  • excess caffeine intake
  • excess alcohol use
  • smoking
  • insufficient dietary calcium and vitamin D
  • certain medications
  • family history of bone disease

The goals of managing osteoporosis are to decrease pain, prevent fractures, and minimize further bone loss.

Always consult your physician for more information.

[September 2007] One annual injection of the medication zoledronic acid (Reclast®) not only reduces the number of new hip fractures for older users, it can also save their lives.

Picture of an elderly woman using a walker during a physical therapy sessionSo finds the first Reclast trial to show improvement in mortality. Previous studies had shown a reduced risk of fracture and improved bone density in patients with osteoporosis but not a significant drop in mortality.

"We changed the fracture rate and, when we analyzed the data, we had a significant mortality reduction. We never dreamed we'd have that," says study author Dr. Kenneth W. Lyles.

The study results were presented at the American Society of Bone and Mineral Research annual meeting in Honolulu. Dr. Lyles is professor of medicine and vice chairman for clinical research in the department of medicine at Duke University Medical Center in Durham, N.C.

The study was released early by the New England Journal of Medicine to coincide with the presentation.

Prevention That Does Not Interfere With Bone Repair

"This is the first test of using this to prevent further fractures in elderly patients, and the reason that is a big deal is people weren't sure if zoledronic acid inhibited osteoclasts [cells] which are needed for repair" of the initial fracture, explains Dr. Paul Brandt, an associate professor of neuroscience and experimental therapeutics with the Texas A&M Health Science Center College of Medicine.

"This study shows that it [Reclast®]doesn't interfere with that process [bone repair] and does give the beneficial effect of reducing further fracture rates," says Dr. Brandt, who was not involved in the trial. This means that people who suffer a hip fracture can receive the drug while recovering without adverse effects on bone healing.

Reclast was approved in August by the US Food and Drug Administration (FDA) to treat osteoporosis in postmenopausal women.

The drug is a bisphosphonate, a class of drugs which also includes Fosamax®, Actonel®, and Boniva®. These medications - the most commonly used treatments for osteoporosis - work by slowing the body's natural reabsorption of bone.

While the drugs are effective, there has been a problem with getting patients to take them as they should. In fact, participants in this latest trial either could not or would not take oral bisphosphonate medication.

Dramatic Results

For this study, more than 2,100 men and women were randomized to receive Reclast or a placebo within 90 days after surgery for a hip fracture. Participants were followed for an average of almost two years. Findings include:

  • study participants taking Reclast had a 35 percent reduced risk of bone fracture when compared to the placebo group
  • bone mineral density increased in the Reclast group
  • study participants taking Reclast were 28 percent less likely to die when compared to the placebo group

Study Design and Side Effect Issues

There were some concerns about the design of the trial. For example, patients in the placebo arm did not receive another medication, although many did receive bone-boosting vitamin D. Ideally study participants randomized to a placebo group receive a medication with similar effects as the medication being studied.

Patients on a Reclast regimen will also need to take vitamin D and calcium, study authors added, and some will experience flu-like symptoms which can be alleviated with a nonsteroidal anti-inflammatory drug.

"This [Reclast] appears to be the most potent of the bisphosphonates. It reduced bone turnover more and had a significant effect on fracture rate. The once-a-year dose obviously is attractive," says Dr. Stephen Honig, director of the Osteoporosis Center at the New York University Hospital for Joint Diseases. "This combination makes it potentially a very important drug. The caveat is the potential side effects. Other studies have found atrial fibrillation."

This study found similar rates of atrial fibrillation in both groups, indicating that Reclast may not have a significant effect of causing atrial fibrillation.

Always consult your physician for more information.

 

 

 

  
 
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