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Romosozumab Reduced Vertebral Fracture Risk in Older Women With Osteoporosis
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MADRID — Treatment with a novel sclerostin inhibitor, romosozumab, was associated with a reduced rate of vertebral fractures at 12 months compared with placebo in a cohort of post-menopausal women with osteoporosis, according to findings presented at the Annual European Congress of Rheumatology.
Piet Geusens, MD, PhD, of Maastricht UMC in Maastricht, Netherlands and UHasselt and ReumaClinic in Genk, Belgium, noted that romosozumab (UCB & Amgen) has the dual effect of increasing bone formation and reducing bone resorption.
“We wanted to know: What is the effect of such an agent?” he said in a press conference.
The study included 3,589 patients in the romosozumab arm and 3,591 patients who received placebo as part of the Fracture Study in Postmenopausal Women with Osteoporosis trial. The study drug was administered at a dose of 210 mg. Researchers aimed to assess the incidence of new vertebral fracture and lumbar spine bone mineral density at 6 months and 12 months.
Results indicated that at 6 months, new vertebral fractures occurred in 0.8% of patients in the placebo group and in 0.4% of those in the study drug group (relative risk ratio [RRR] = 46%). However, by 12 months, this outcome occurred in 1.8% of those treated with placebo and in 0.5% of those given romosozumab (RRR = 73%). “We followed patients monthly,” Geusens said.
Through 12 months, there were 17 vertebral fractures in the placebo group and three for the study drug group. “All fractures in the romosozumab group occurred in the first 2 months,” Geusens said.
He added that there were no new fractures among patients treated with romosozumab at 2-year follow-up.
For bone mineral density, 6-month results showed an increase of 9.7% for the romosozumab group and 0.4% for those in the placebo group. By 12 months, the increase was 13.3% for the study drug and 0% for placebo. “Within 1 year, we saw a highly significant increase in bone density,” Geusens said.
Findings for 119 women with back pain for more than 12 months indicated the rates of new or worsening fracture incidence through 12 months were 0.5% for placebo and less than 0.1% among patients treated with romosozumab (RRR = 83%).
“Romosozumab treatment for 12 months was associated with rapid and large reductions in clinical vertebral fracture risk compared with placebo,” he concluded. “Clinical vertebral fracture incidence was over five-times lower with romosozumab vs. placebo.” — by Rob Volansky
Reference:
Geusens P, et al. Abstract #OP0048. Presented at: EULAR Annual Congress; June 14-17, 2017; Madrid.
Disclosures: Geusens reports receiving grant or research support from Abbott, Amgen, BMS, Eli Lilly, MDS, Novartis, Pfizer, Roche, UCS, and Will-Pharma; consulting for Amgen and being on the speakers bureau of Amgen.