Sep. 16, 1998 BERLIN, GERMANY-- An osteoporosis drug can reduce the risk of hip fractures by 56 percent among women who have never suffered a spinal fracture, according to a University of California San Francisco researcher who announced new results from the landmark Fracture Intervention Trial (FIT) today (Monday, September 14) at an annual scientific meeting.
"These results are dramatic," said Dennis Black, PhD, UCSF professor of medicine and epidemiology, lead author of the study, who will present his findings at the European Congress on Osteoporosis. "No other therapy has been shown to work in such a wide spectrum of women with osteoporosis to reduce the most devastating of fractures--those that occur at the hip."
Hip fractures, the most debilitating, increase a women's risk of requiring nursing home care by 25 percent. Half of the women who suffer a hip fracture are disabled, many permanently, Black said.
The new findings from the FIT study, a 6,000 patient trial, show that the osteoporosis drug, called alendronate, also reduced the likelihood of painful spine fractures by 49 percent in women who have never had a spine fracture. Among women in the study who did not have osteoporosis, fractures were less common. However, this group did achieve increases in bone mineral density.
In a previous arm of FIT, which only included osteoporatic women who had already suffered a spinal fracture, alendronate reduced the risk of hip fractures by 51 percent and the risk of spine fractures by 47 percent.
Other key findings of the FIT analysis to be presented during the European World Congress include:
- Patients with fractures have an increased risk of death that is associated with the type of fracture a woman experiences. Hip fractures were shown to increase the relative risk of death 6.7 times and painful spine fractures 8.6 times.
- The prevalence of "silent" spine fractures, defined as those that increase a woman's risk of subsequent fractures but are only detected by X-ray, increased the incidence of future hospitalization by 29 percent and the risk of death by over one and a half times. These findings could not be explained by other conditions the women may have had, nor by their bone mineral density upon entering FIT.
Another important finding from FIT, reported by Cummings, was that among the small percentage of women who did not gain bone density in the first year of treatment with alendronate, almost all gained bone density in the second year. In clinical trials, 96 percent of women receiving alendronate increased bone mineral density over three years.
"These results show that treatment with alendronate should be continued regardless of change in bone density during the first year," said Cummings. "For the few women who do not have increases in bone mineral density during the first year, almost all will achieve significant gains in bone mineral density in the second year."
An analysis of the safety data from FIT showed that alendronate is well tolerated. Upper gastrointestinal (GI) disease is very common among older women, and the incidence of GI disease among postmenopausal women in FIT was the same regardless of whether they received alendronate or placebo. This was true even among women at the highest risk for GI problems, including those age 75 or older, with a history of upper GI disease, or those who used aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), medicines often associated with upper GI disease.
"The findings are significant because they reveal that, even in women at high risk for upper GI problems, treatment with alendronate did not increase the risk of developing GI side effects," said Douglas Bauer, MD, UCSF assistant professor of medicine, epidemiology and biostatistics. "The study also found that older women frequently have upper GI symptoms, especially indigestion, and that physicians and their patients may often incorrectly assume that these common upper GI symptoms are related to their medicine."
FIT is a collaborative effort of the University of California San Francisco and 11 other academic centers. The initial phase included 2,027 postmenopausal women between the ages of 55 and 82 who had osteoporosis and previous spine fractures, as detected by X-ray. The second phase of FIT included 4,432 women with thin bones but no previous spine fractures.
More than 200 million women worldwide suffer from osteoporosis, a disease in which bone mass progressively decreases, thus increasing fracture risk. Approximately four in 10 women in the United States age 50 or older will suffer an osteoporosis-related fracture. In the United States, osteoporosis results in 1.5 million fractures each year with approximately 250,000 of these hip fractures and costs about $14 billion annually.
Alendronate, which is available as FOSAMAX in 72 countries including the United States, was developed by Merck & Co. Inc., USA which operates in many countries as Merck Sharp & Dohme.
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