The old may be new again — at least when it comes to preventing fractures in postmenopausal women with low bone mineral density.
A study was published in the December 20 issue of New England Journal of Medicine Provide evidence that once-every 18-month doses of Reclast (zoledronate), a drug that first gained FDA approval in the early 2000s, may help reduce fracture risk among older women. 65 years or older with osteoporosis, a precursor to osteoporosis, a progressive bone erosion condition that affects an estimated 12 million Americans, according to the International Osteoporosis Foundation (IOF). The IOF estimates that more than 30 million American adults (about 80% of them women) have osteoporosis that likely develops into the most serious form of the condition as they age.
Says Ian R. Reed, one of the study’s authors, and deputy dean of the School of Medical and Health Sciences at the University of Auckland in New Zealand.
“It is a neglected patient group, although it is a very large group. We chose to explore the use of zoledronate because its rarity and proven safety recommended it for use in this low-risk group,” says Dr. Reed.
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6-year study shows reduced risk of fragility fractures
Over a six-year period, Reed and colleagues administered four injections of either 5 milligrams (mg) of zoledronate or of saline (the placebo group) to 2,000 women with osteoporosis, which was defined as a bone mineral density, or T-score of -1.0 to -2.5 at the total hip or femoral neck (the part of the bone at the top of the femur) on both sides. A bone density score of -2.5 or worse is usually considered osteoporotic.
Participants who were not already taking a vitamin D supplement were also given 1.25 mg monthly doses of cholecalciferol (vitamin D3). Additionally, women enrolled in the study were advised to maintain their dietary calcium intake of 1g per day (but calcium supplementation was not provided).
The average age of the study participants was 71 years, and their mean T-score was -1.6, with a 10-year median risk of hip fracture of 2.3%. In all, 190 women who received the placebo experienced a fragility fracture, compared to 122 women in the zoledronate group. Overall, zoledronate reduced the risk of fragility fractures among postmenopausal women by more than 60 percent, and also reduced their risk of symptomatic fractures, vertebral fractures and height loss (a common complication of bone density loss) as the condition progressed.
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Research validates treatment for women at moderate to high fracture risk
“[Our] The study shows that anti-resorptive drugs [like zoledronate] Effective beyond the narrow confines of women with osteoporosis,” Reed says. “Therefore, this study opens up the possibility of using this combination of agents in women whose bone density or fracture risk is not necessarily as high as many guidelines recommend. It also validates the practice of treating women at moderate to high risk of fractures even if their bone density is in the osteoporotic range. I suspect [zoledronate] It is a reasonable way forward for older women who want to reduce their fracture risk. Not only is zoledronate effective in reducing fracture risk in a large group of older women, but it also appears to have beneficial effects on cardiovascular disease and cancer risks.”
The results should have an impact on clinical practice
In a comment published in conjunction with the study, Clifford J. Rosen, MDTaken together, the results of the trial … should have an impact on clinical practice. Given the efficacy of non-repeated administration of zoledronate in reducing fragility fracture risk, a senior scientist at the Maine Medical Center Research Institute and Professor of Medicine at Tufts University School of Medicine wrote, Certainly adding this therapy to our armamentarium for treating osteoporosis, and will represent an approach that will not be hampered by adherence issues. Equally important, this experience reminds us that risk assessment and treatment decisions go beyond bone mineral density and should focus specifically on age and past fracture history.”