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Once-yearly osteoporosis drug significantly reduced fracture rate over 3 years
Investigators reported a similar incidence of adverse events between zoledronic acid and placebo, including rates of jaw osteonecrosis.
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A once-yearly treatment for postmenopausal osteoporosis significantly reduced the incidence of osteoporotic spine and hip fractures over 3 years, according to results of a phase 3 prospective, randomized study.
Dennis M. Black, PhD, and colleagues at numerous centers in the United States, Europe, Asia and South America, investigated the safety and efficacy of Reclast [zoledronic acid; Novartis] for reducing the risk of fracture in 7,765 women with postmenopausal osteoporosis. They published their results in the New England Journal of Medicine.
Reclast is a bisphosphonate that is administered only once each year as a 15-minute infusion. The drug is currently being reviewed by the FDA for treating postmenopausal osteoporosis.
The study, called the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial, included women aged 65 to 89 years with postmenopausal osteoporosis in 27 countries. Primary endpoints were new morphometric vertebral and hip fractures over 3 years compared to placebo. Secondary endpoints included non-spine fractures, changes in bone mineral density (BMD), changes in markers of bone turnover and overall safety, according to a press release from Novartis announcing the study findings.
Investigators found that treatment with zoledronic acid significantly reduced the incidence of hip, spine and wrist fractures. Specifically, patients treated with the drug had a 70% reduction in spine fractures and a 41% reduction in hip fractures.
At 3 years follow-up, the placebo group had a 10.9% incidence of vertebral fractures vs. 3.3% for the zoledronic acid group. Also at 3 years, the placebo group had a 2.5% incidence of hip fractures vs. 1.4% for the zoledronic acid group, according to the study.
In addition, treatment with zoledronic acid showed a sustained effect on spine fractures over 3 years. Zoledronic acid-treated patients had a 60% reduction in spine fractures at 1 year follow-up, a 71% reduction at 2 years and a 70% reduction at 3 years, according to the study.
Regarding secondary outcome measures, treatment with zoledronic acid reduced the risk of non-spine fractures by 25%, all clinical fractures by 33% and clinical spine fractures by 77%. It also significantly improved spine BMD by 6.7% and hip BMD by 6% compared to placebo patients, according to the press release.
Investigators found a similar incidence of adverse events between zoledronic acid and placebo, including rates of jaw osteonecrosis.
"Taken together with the sustained decrease in fracture risk, these findings support the view that the magnitude of reduction in bone remodeling associated with zoledronic acid during a 3-year period improves bone strength without adversely affecting remodeling capacity," the study authors reported.
For more information:
- Black DM, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. New Engel J Med. 2007;356:1809-1822.