Fracture Prevention with Infrequent Zoledronate in Women 50 to 60 Years of Age
Abstract
Zoledronate has demonstrated efficacy in fracture prevention for older women with osteoporosis, but its prolonged effects on bone turnover suggest that less frequent dosing may be sufficient. This 10-year, randomized, placebo-controlled trial evaluated whether infrequent zoledronate administration could prevent vertebral fractures in early postmenopausal women. Participants aged 50 to 60 years with bone mineral density T scores between 0 and -2.5 were randomized into three groups: zoledronate at baseline and 5 years, zoledronate at baseline and placebo at 5 years, and placebo at both time points. The primary endpoint was morphometric vertebral fracture, defined by a 20% reduction in vertebral height. At 10 years, zoledronate significantly reduced the risk of vertebral fractures compared to placebo, with a relative risk reduction of approximately 40%. Secondary analyses showed reductions in fragility, major osteoporotic, and overall fractures. Bone mineral density remained stable in zoledronate-treated groups, and markers of bone turnover remained suppressed. Findings suggest that infrequent zoledronate administration provides long-term protection against fractures and bone loss in early postmenopausal women, offering a viable alternative to more frequent dosing regimens.