Los Angeles Times—April 14, 2009
In preliminary studies, 93% of 145 patients who had unhealed bone fractures -- some for as long as six months -- had significant healing after only eight to 12 weeks on the drug, called teriparatide, or Forteo.
An estimated 5% of the 6 million fractures suffered by Americans each year are slow to heal or do not heal at all, and as many as a quarter of the elderly with pelvic and hip fractures die within a year as a result of their injuries.
Others with such injuries enter nursing homes never to come out again, so the drug has great promise for reducing medical costs and improving quality of life, said Dr. Susan Bukata of the University of Rochester Medical Center, lead author of the study. Dr, Bukata was a fellow in Metabolic Bone Diseases at Hospital for Special Surgery in 2003-2004.
"This is a drug with a good clinical track record that has proved to be remarkably safe, and it could have great utility," said Dr. Richard S. Bockman, chief of the endocrine service at Hospital for Special Surgery in New York, who was not involved in the study.
Bukata and her colleagues reported their findings at a February meeting of the Orthopaedic Research Society and are now submitting a report to a major journal.
Teriparatide is a fragment of parathyroid hormone, containing 34 amino acids compared with the 84 in the intact hormone. Studies as early as the 1930s showed that parathyroid hormone injections increase bone density and healing in animals. But because the hormone could not be patented, pharmaceutical companies were loath to expend money on clinical trials.
In 2003, however, Eli Lilly & Co. received approval to market teriparatide under the brand name Forteo for treatment of severe osteoporosis. An estimated half a million people have been treated with the drug.
Many physicians have observed what they believe to be accelerated healing of fractures in the elderly given Forteo for osteoporosis, and some doctors are now using the drug off-label for such purposes, Bockman said.
Bukata and her colleagues studied 145 mostly elderly patients with fractures at a variety of sites. All the fractures had proved resistant to healing, some for more than six months. The researchers found that 135 of the patients had complete healing of their fractures after eight to 12 weeks. Six had only partial healing, "but they were much more comfortable and happy with the results," she said. Only four patients received no benefit from the drug.
The Rochester team is now beginning a placebo-controlled trial of the drug, sponsored by the National Institutes of Health, on victims of pelvic fractures. Such fractures "are very painful and people can't walk for two to three to four months" and often have to be placed in a nursing facility, Bukata said. "We want to get them up and moving as quickly as we can."
The team is also beginning a separate study, also sponsored by NIH, in spinal fractures. So far, "we have seen a fairly rapid response there, in eight weeks or so," she said.
The chief drawback of the treatment is the cost, about $800 per month. But if the patient's stay in a nursing home could be reduced by a week, "that would pay for the drugs," she said.
And perhaps, "with more uses for the drug, maybe it will encourage others to make the product and lower costs," Bockman said.
Read the full story at latimes.com.