Zoledronic Acid Safe, Effective for 3 Years in Frail Women With Osteoporosis

Older, frail women with osteoporosis experienced improvements in bone mineral density over 3 years after treatment with a single dose of zoledronic acid, according to research presented at the American Society for Bone and Mineral Research (ASBMR) 2014 Annual Meeting.

“Although nearly 85% of frail seniors residing in long-term care facilities have osteoporosis, the pivotal osteoporosis trials have systematically excluded fragile, functionally-impaired women. As a result, the vast majority are not treated even though they are at greatest risk for fracture,” Susan L. Greenspan, MD, of the University of Pittsburgh in Pennsylvania, and colleagues wrote in an abstract.

To examine the safety and efficacy of a single dose of zoledronic acid in this patient population, the researchers conducted a double blind, randomized, placebo-controlled trial involving women living in a nursing home or assisted living facility.

Participants had osteoporosis and vitamin D levels exceeding 20 ng/dL but were not taking antiresorptive agents. Those with cognitive impairment, immobility, and multiple diseases and medications were included.

Researchers administered a single dose of zoledronic acid 5 mg or placebo IV plus 1,200 mg of daily calcium and 800 IU of vitamin D. They were evaluated for 2 years with a 1-year extension if participants opted to continue. Hip and spine bone mineral density (BMD) changes and safety were assessed after 36 months.

A total of 141 (mean age, 85.4 years) of the 181 women randomly assigned to treatment or placebo consented to the 1-year extension. The zoledronic acid group included more women with diabetes, falls history and slow gait speed. Forty-nine percent of participants completed all 36 months.

Results revealed significantly greater percent changes in BMD at the total hip, femoral neck and spine in the zoledronic acid group vs. the placebo group (P<.01 for all). Adjusted differences were 5.4, 6.2 and 4.5 percentage points, respectively.

Adverse events did not differ significantly at 3 years, according to the data.

“This trial of single-dose zoledronic acid for osteoporosis in cognitively impaired, frail osteoporotic women is the first to demonstrate that it is safe and effective in preserving/improving skeletal integrity over 3 years. Future studies are needed to determine if BMD improvement translates into fracture reduction,” the researchers wrote.

Reference

1. Greenspan S et al. Abstract FR0398. Presented at: American Society for Bone and Mineral Research 2014 Annual Meeting; Sept. 12-15, 2014; Houston, Texas.