Frail, older women may only require a single dose of the osteoporosis drug Reclast to develop bone strength, a brand-new study suggests.
Higher bone density did not equate into less fractures among these high-risk females, who were living in nursing houses and assisted-living centers throughout the research study, the researchers added.
” Two surprising findings emerged,” said research study author Dr. Susan Greenspan, a teacher of medication at the University of Pittsburgh.
The drug improved bone strength in the frail and extremely old along with it did in more youthful and more robust senior citizens, however there was no association between increasing bone density and lowering fractures, she stated.
” We initially desired to see if frail seniors could even tolerate such treatment, and whether it would enhance bone density. However, we had expected to see a positive pattern of fewer fractures. If anything, there were more fractures in the treatment group,” Greenspan stated, although “that could well be just an opportunity finding.”
Greenspan hopes that the U.S. National Institutes of Health, which moneyed this trial, will fund a larger study to see if treatment with Reclast (zoledronic acid) will actually decrease the threat of fractures.
If a bigger trial found that treatment with Reclast did minimize fractures, “it would require rethinking the technique to fracture avoidance in this large and growing population, specifically since these are the people who also are at the highest threat of both fracture and its repercussions,” Greenspan explained.
The study was published online April 13 in the journal JAMA Internal Medicine.
Dr. Robert Lindsay, chief of the Osteoporosis Center at Helen Hayes Hospital in West Haverstraw, N.Y., and author of an accompanying journal editorial, said Reclast has actually been shown to lower fractures in people with osteoporosis, but a number of aspects may discuss why the number of fractures did not decrease in this research study, even though bone density increased in these older frail women.
Fractures in the elderly occur not just since the bones are weak, but also due to the fact that people in this group are vulnerable to falls, he said. “Both risks are high in this population. The research study informs us that dealing with one side of the formula, bad bones, can only do so much when the danger of injury is high, due to the fact that the patients studied were quite frail.”
Weakened bones and osteoporosis prevail amongst the nearly 2 million American women living in these care centers. These women are at high risk for damaged bones and hip fractures that can hinder their mobility, limit their independence and hasten death, Greenspan stated.
The expense of the drug can be anywhere from $5,800 to $7,000, depending upon where it is given (normally administered in a medical facility or clinic) and what insurance coverage is covering the drug. According to Medicare, Reclast is covered for recipients. In addition, the majority of insurance plans cover the drug.
For the research study, Greenspan and her colleagues assigned 181 women with osteoporosis, aged 65 and older, to a single infusion of Reclast or a placebo. All of the women were likewise provided vitamin D and calcium supplements. Some of these senior citizens likewise struggled with psychological disability, immobility and other medical conditions, the researchers noted.
After a year and once again after 2 years, the scientists measured the womens bone density at their hip and spinal column. They likewise tracked any falls or other unfavorable occasions.
After a year, females provided Reclast saw bone density at the hip increase an average of 2.8 percent, compared to a small decrease in bone density among ladies given a placebo. At two years, bone density increased 2.6 percent among females provided the drug, but decreased 1.5 percent amongst those offered placebo, the researchers discovered.
The average bone density at the spine likewise increased among women treated with Reclast more than women offered the placebo. At 12 months bone density increased 3 percent amongst Reclast users versus 1.1 percent in the placebo group. At 24 months, the increases were 4.5 percent versus 0.7 percent, respectively.
However Greenspans group found no substantial difference in the variety of fractures, heart issues or deaths among women who received the drug or the placebo. Among women treated with Reclast, 20 percent had fractures, as did 16 percent of those treated with placebo. Amongst those offered the drug, 16 percent passed away, as did 13 percent of those offered placebo.
More ladies treated with the drug had numerous falls than did ladies offered the placebo (49 percent versus 35 percent), although this distinction was not substantial after taking into account frailty at the start of the study, the researchers stated. The variety of single falls was comparable among females in both groups, they included.
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For the research study, Greenspan and her associates appointed 181 females with osteoporosis, aged 65 and older, to a single infusion of Reclast or a placebo. All of the ladies were also offered vitamin D and calcium supplements. The typical bone density at the spine likewise increased amongst women treated with Reclast more than women provided the placebo. Greenspans group found no considerable difference in the number of fractures, heart issues or deaths among females who got the drug or the placebo. Amongst ladies treated with Reclast, 20 percent had fractures, as did 16 percent of those treated with placebo.