medwireNews: Treatment with zoledronate once every 18 months significantly reduces the risk for nonvertebral or vertebral fragility fractures, compared with placebo, in postmenopausal women with osteopenia, study findings indicate.
“The reduction in the risk of nonvertebral fracture was similar to that reported previously in patients with osteoporosis who were treated with zoledronate,” Ian Reid (University of Auckland, New Zealand) and co-authors remark.
During the 6-year study, 122 of the 1000 women randomly assigned to receive zoledronate 5 mg at 18-month intervals experienced a nonvertebral or vertebral fragility fracture.
This compared with 190 fragility factures in the 1000 women randomly assigned to receive placebo (normal saline), and resulted in a significant 37% reduced risk for fragility fracture among the women in the zoledronate group.
All of the women in the study had osteopenia, defined as a T score of −1.0 to −2.5 at either the total hip or the femoral neck on either side (mean –1.26 at the total hip and –1.6 at the femoral neck), and were aged 65 years or older (mean 71 years) with a median 10-year hip fracture risk of 2.3% to 2.4%.
Study participants were advised to have a calcium intake of 1 g/day, but calcium supplements were not provided and the use of calcium supplementation was very low, at approximately 2%, the researchers note. In addition, women who were not already taking vitamin D supplements received a single 2.5 mg dose of cholecalciferol before the trial began and 1.25 mg/month thereafter.
Reid and team calculated that 15 women would need to be treated with zoledronate for 6 years to prevent a fragility fracture in one woman.
They found that the treatment effect was independent of baseline vertebral fracture status and was also associated with significantly lower risks for nonvertebral fragility fractures (hazard ratio [HR]=0.66), symptomatic fractures (HR=0.73) and vertebral fractures (odds ratio [OR]=0.45), as well as a reduced likelihood for experiencing height loss of at least 1 cm (OR=0.67).
Writing in The New England Journal of Medicine, Reid et al say that their findings “address an important knowledge gap identified in the recently published American College of Physicians guidelines on osteoporosis, which stated that ‘current evidence is limited for a treatment benefit for women aged 65 years or older with osteopenia.’”
And in an accompanying editorial, Clifford Rosen, from the Maine Medical Center Research Institute in Scarborough, USA, says the results “should have an effect on clinical practice.”
He writes: “Given the effectiveness of infrequent administration of zoledronate in reducing the risk of fragility fracture, this treatment can certainly be added to our armamentarium for treating osteoporosis, and it would represent an approach that would not be hindered by adherence issues.”
By Laura Cowen
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group