For women with osteoporosis, long-term treatment with denosumab is associated with further reductions in nonvertebral fracture rates, according to results published in The Journal of Clinical Endocrinology & Metabolism.

The study included women aged 60 to 90 years with a bone mineral density T-score lower than -2.5 but ≥-4.0 at the lumbar spine or total hip. Participants were randomly assigned 1:1 to either subcutaneous denosumab 60 mg every 6 months (long-term group) or placebo for 3 years (crossover group) as part of the FREEDOM trial (Clinicaltrials.gov identifier: NCT00089791).

Eligible participants could then enroll in the open-label Extension trial (Clinicaltrials.gov identifier: NCT00523341). These participants received subcutaneous denosumab 60 mg every 6 months for 7 years.

The main outcomes were exposure-adjusted subject incidence per 100 subject-years of nonvertebral fracture during denosumab treatment years 1 to 3 and 4 to 7 for all subjects and for years 4 to 10 for the long-term group only. The researchers also measured rate ratios for years 4 to 7 or 4 to 10 compared with 1 to 3.

Among 4074 participants in the Extension study, 2343 were long-term and 1731 were crossover.

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For all participants, the rate of nonvertebral fracture was 2.15 (95% CI, 1.90-2.43) during years 1 to 3 compared with 1.53 (95% CI, 1.34-1.74) during years 4 to 7 of denosumab treatment (rate ratio, 0.72; 95% CI, 0.61-0.86; P <.001).

Among participants in the long-term group, the rate of nonvertebral fracture was 1.98 (95% CI, 1.67-2.34) during years 1 to 3 compared with 1.44 (95% CI, 1.24-1.66) during years 4 to 10 (rate ratio, 0.74; 95% CI, 0.60-0.93; P =.008).

“These data further support the long-term administration of denosumab, a potent antiresorptive therapy, in postmenopausal women with osteoporosis and a hip [bone mineral density] T-score ≤-1.5 to improve bone strength and minimize the risk of fragility fractures,” the researchers wrote.

Disclosure: This study was sponsored by Amgen Inc. Multiple authors disclosed affiliations with pharmaceutical companies. Please see the original reference for complete disclosure information.

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Reference

Ferrari S, Butler PW, Kendler DL, et al. Further nonvertebral fracture reduction beyond 3 years for up to 10 years of denosumab treatment [published online May 24, 2019]. J Clin Endocrinol Metab. doi:10.1210/jc.2019-00271