A single infusion of zoledronic acid in frail older women with cognitive impairment and mobility issues improved both bone density and bone turnover for 2 years, according to research in JAMA Internal Medicine.

The 2-year, randomized, placebo-controlled, double blind study suggests that even the most vulnerable patients can respond well to a bisphosphonate for osteoporosis treatment, according to researchers.

“Trials of younger and healthier elderly suggest that the risk of a devastating hip fracture can be cut in half with such therapy, so it’s important to know if that’s also true, for instance, for seniors in nursing homes,” Susan Greenspan, MD, of the department of medicine at University of Pittsburgh, toldEndocrine Today.

Susan Greenspan

Greenspan and colleagues analyzed data from 181 women aged 65 years or older with osteoporosis, including patients with cognitive impairments and immobility who lived in nursing homes or assisted living facilities, as part of the ZEST study. Participants were enrolled and treated from December 2007 to March 2012. All patients received either 5 mg IV zoledronic acid or placebo, as well as a daily divided dose of vitamin D (800 IU/day) and 1,200 mg/day of elemental calcium. Researchers measured hip and spine bone mineral density, as well as adverse events, such as falls, at 12 and 24 months.

Mean BMD at the hip increased by 2.8% for the treatment group compared with a –0.5% loss for the placebo group at 12 months (P < .001); a 2.6% increase compared with a –1.5% loss was observed for the treatment and placebo groups, respectively, at 24 months (P < .001). The treatment group also had a greater increase in mean spine BMD at 12 months (3% vs. 1.1%; P = .01) and at 24 months (4.5% vs. 0.7%; P < .001). Results were maintained after adjustment for a baseline imbalance in frailty, diabetes and anticonvulsant use, and there were no significant differences between groups in the number of deaths, fractures or cardiac events, according to researchers.

The study marks the first randomized trial of a potent antiresorptive therapy with a group of frail older women. With research now suggesting the drug can be administered to this particular group safely and is well tolerated, a larger trial is needed to determine whether fracture reduction can also be achieved, according to researchers.

“This study has answered those questions and, thereby, sets the stage for the bigger trial, which we hope will be funded by NIH,” Greenspan said. – by Regina Schaffer