WASHINGTON _The U.S. Food and Drug Administration has approved the first-ever, once-a-month drug treatment for postmenopausal osteoporosis, a bone disease that affects 8 million women.
Boniva, made by Roche of Nutley, N.J., and GlaxoSmithKline of Research Triangle Park, N.C., will be available at pharmacies in April in 150-mg tablets that should be taken 12 times a year. Competing products such as Merck's Fosamax and Actonel, by Aventis and Procter & Gamble, are taken once a week.
The FDA approved Boniva late Thursday after a 10-month review, said Theresa Kehoe, the FDA medical officer who reviewed the drug. Terry Hurley, a spokesman for Roche, said the drug would be priced comparably to other osteoporosis medications.
Osteoporosis causes bones to become fragile. Untreated, it can cause stooped posture, gradual loss of height, lower back pain and frequent bone fractures. These fractures occur most often in the hip, spine and wrist, but any bone can be affected.
About 1.5 million osteoporosis-related bone fractures occur each year, according to a 2004 report by the U.S. surgeon general, Dr. Richard Carmona.
Women comprise 80 percent of the 10 million U.S. sufferers. Vulnerability begins after age 35, when bone strength is at its peak, and increases as people age.
While Boniva may prove a welcome option for patients, it's unclear whether its once-monthly regimen will improve long-term compliance with drug usage instructions, said Bess Dawson-Hughes, president of the National Osteoporosis Foundation and a professor of medicine at Tufts University in Medford, Mass.
"It's hard to get those on-the-ground answers before it's approved," she said. "This new drug really puts a lot of interesting and important issues in front of us."
About 50 percent to 60 percent of patients taking osteoporosis medications stop within a year, said Dr. Ronald Emkey, a Reading, Pa., rheumatologist who conducted the clinical trials for Boniva. That's because many sufferers, particularly those in the early stages of the disease, don't experience pain and may not think the medicine is necessary.
Patients also tire of osteoporosis drugs because they must be taken in the morning with a full glass of water and require patients to wait up to an hour before eating or drinking afterwards, he said.
By reducing that ritual to once a month instead of weekly, Emkey said he thinks patients will be more likely to continue taking it.
"The hope now is that this medication will be an incentive to some patients to want to take it for a long time because it only works if you take it," he said.
Reported side effects in trials included upper gastrointestinal disorders, abdominal pain, hypertension, diarrhea and nausea.
The FDA approved Boniva for daily use in 2003, but it was never marketed because studies showed that patients preferred less-frequent dosages, Emkey said.
———
For more information about osteoporosis, go to the National Osteoporosis Web site at http://www.nof.org/
For a copy of the surgeon general's report on osteoporosis go to: http://www.surgeongeneral.gov/library/bonehealth/
———
(c) 2005, Knight Ridder/Tribune Information Services.
GRAPHIC (from KRT Graphics, 202-383-6064): 20050325 OSTEOPOROSIS
Need to map