DENVER – The anabolic agent teriparatide reduced the risk of clinical vertebral fractures in women with osteoporosis when compared with the antiresorptive agent risedronate, and the results held up across groups of women with varying fracture histories in a post hoc analysis of data from the VERO trial.
VERO, which pitted teriparatide (Forteo) against risedronate in women with at least two moderate or one severe vertebral fracture, as well as a bone mineral density (BMD) T-score of -1.5 or less, was the first study to compare an anabolic treatment to antiresorptive therapy using fractures as an endpoint, according to Astrid Fahrleitner-Pammer, MD, of the departments of internal medicine, endocrinology, and diabetology at Medical University of Graz (Austria), who presented the study at the annual meeting of the American Society for Bone and Mineral Research.
Dr. Astrid Fahrleitner-Pammer
In the VERO trial, 1,360 women (mean age 72.1 years, 97.3% white) were randomized to 20 µg daily subcutaneous teriparatide or oral weekly risedronate (35 mg) over 2 years. Overall, women in the teriparatide group were at lower risk of vertebral fracture (risk ratio, 0.44; 95% confidence interval, 0.29-0.68).
“I think it’s a great thing to show that [teriparatide] is superior, and the point is we always talk about who is the right patient for an anabolic treatment. There was no difference between the subgroup categories,” Dr. Fahrleitner-Pammer said.
There were no statistically significant between-group differences based on the number of vertebral fractures, severity of vertebral fractures, prior nonvertebral fracture, glucocorticoid use, prior use of osteoporosis drugs, BMD T-score, age, recent bisphosphonate use, or recent clinical vertebral fractures.
“In patients with really established osteoporosis, mainly osteoporosis with two moderate fractures or one severe fracture, they all profit from an anabolic treatment,” Dr. Fahrleitner-Pammer said.
The work underscores the utility of anabolic agents. “I don’t think it’s a question of if, but when to use an anabolic therapy,” Dr. Fahrleitner-Pammer said.
The therapies are limited to 24 months of lifetime exposure because of their warning labels, and patient characteristics should help physicians to decide when to use them. “I wouldn’t start a 50-year-old patient with low BMD without any prevalent fractures. I would try to conserve the bone with an antiresorptive therapy, and if this isn’t enough, the patient will sustain a fracture, and sooner or later then I think it’s a time to switch to an anabolic therapy. If we have an old lady with already prevalent vertebral fractures, the best way is to go for the anabolic therapy first and then conserve the newly formed bone with an antiresorptive therapy,” Dr. Fahrleitner-Pammer said.
The study was funded by Eli Lilly. Dr. Fahrleitner-Pammer has received research funding and unrestricted grants from Eli Lilly and several other pharmaceutical companies and has also been a speaker for Eli Lilly and nine other pharmaceutical companies.