Bone Drug May Help After Hip Fracture
Osteoporosis Drug Reclast May Cut Bone Fractures, Death Rate After Hip Fracture
Sept. 18, 2007 -- People who start taking the osteoporosis drug Reclast
after a hip fracture may live longer with fewer bone fractures.
Researchers report that news in The New England Journal of
Reclast is given by infusion once a year. The process takes 15 minutes.
Reclast, made by Novartis,
was approved by the FDA in August for the treatment of postmenopausal
osteoporosis. Its active ingredient, zoledronic acid, is also marketed by
Novartis under the brand name Zometa for use in certain cancer patients.
The new Reclast study suggests that taking Reclast after a hip fracture may
also be beneficial, and future research may add more information about which
patients may benefit the most.
Reclast After Hip Fracture
The study included 2,127 hip fracture patients who were about 74 years old,
Fracturing a hip is associated with a higher death rate in elders. It's not
that seniors die of a fractured hip, but being sidelined with a fractured hip
can lead to a downturn in health.
In the study, half of the patients began getting a yearly Reclast infusion
within 90 days of fracturing a hip. The other half of the group got an
injection that contained no medicine.
All of the patients took calcium and vitamin D supplements during the study.
They were typically followed for about two years and were allowed to use
certain other osteoporosis treatments.
During that time, patients who got Reclast were 35% less likely to fracture
any bone and 28% less likely to die.
Reclast Study Details
Reclast didn't totally prevent bone fractures, but bone fractures were rarer
in patients who received Reclast.
Among patients who got Reclast, 8.6% fractured a bone during the study,
compared with nearly 14% of those who got the placebo infusion.
In the Reclast group, 9.6% of patients died during the follow-up period,
compared with roughly 13% of those who got the placebo infusion.
The researchers, who included Kenneth Lyles, MD, of Duke University Medical
Center, report that the most common side effects in patients taking Reclast
were fever, achy muscles, and bone pain.
Lyles and colleagues saw no signs of increased heart or kidney risks, and
they also report no cases of osteonecrosis of the jaw, a rare and painful jaw
The study was funded by Novartis. Lyle and several of his colleagues report
financial ties to Novartis.
The study's results "appear both powerful and compelling," states an
editorial published with the study. The editorialists included Karim Anton
Calis, PharmD, MPH, of the National Institutes of Health.
They call for further studies to track Reclast's long-term results, test
other therapies, and identify groups of hip fracture patients who may benefit
most from Reclast treatment.
In the journal, the editorialists report no potential conflicts of