JAMA: A single intravenous dose of the osteoporosis drug zoledronic acid
improved bone mineral density in a group of frail elderly women living
in nursing homes and long-term-care facilities, according to an article
published online by JAMA Internal Medicine. Nearly 2 million frail elderly Americans live in long-term care
facilities and many of them have osteoporosis and bone fracture rates
higher than less impaired elderly individuals. A hip fracture can be
dire, decreasing mobility, independence and often leading to death,
according to background in the study.
Susan L. Greenspan, M.D., of the University of Pittsburgh, and
coauthors conducted a clinical trial to determine the efficacy and
safety of zoledronic acid to treat osteoporosis in frail elderly women
living in long-term care facilities. Zoledronic acid was chosen because
it can be given in a single intravenous dose and the effect can last for
two years.
The two-year study included 181 women 65 or older with osteoporosis,
including women with cognitive impairment, immobility and multiple
coexisting illnesses, who were living in nursing homes and
assisted-living facilities. Of the women, 89 were assigned to receive a
single 5-mg dose of zoledronic acid and 92 were assigned to receive
placebo, while all participants received daily vitamin D and calcium
supplementation.
The authors measured hip and spine bone mineral density (BMD) at 12
and 24 months, as well as adverse events, which included falls.
The average total hip BMD increased more in the treatment group than
in the placebo group both at 12 months (2.8 percent vs. -0.5 percent)
and at 24 months (2.6 percent vs. -1.5 percent), according to the
results. The average spine BMD also increased more in the treatment
group than placebo group at 12 months (3 percent vs. 1.1 percent) and at
24 months (4.5 percent vs. 0.7 percent).
Overall, in the measure of adverse events, there were no significant
differences in the number of deaths, fractures or cardiac disorders. The
treatment and placebo groups’ fracture rates were 20 percent (18 women)
and 16 percent (15 women), respectively, and mortality rates were 16
percent (14 women) and 13 percent (12 women), respectively. There were
no significant differences between groups in the number of single
fallers but more participants in the treatment group has multiple falls
(49 percent vs. 35 percent), although this difference did not remain
significant after adjusting for baseline frailty, the results indicate.
“In summary, we found that a single infusion of zoledronic acid in
frail, cognitively challenged, less mobile elderly women improved bone
density and reduced bone turnover for two years. This suggests that even
a very frail cohort may benefit. However, prior to changing practice,
larger trials are needed to determine whether improvement in these
surrogate measures will translate into fracture reduction for vulnerable
elderly persons,” the study concludes.
(JAMA Intern Med. Published online April 13, 2015. doi:10.1001/jamainternmed.2015.0747. Available pre-embargo to the media at http://media.jamanetwork.com.)