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Results Announced From Phase III Study of Forteo (Teriparatide) in Postmenopausal Women With Back Pain Caused by Vertebral Fractures
The study showed no difference between Forteo and risedronate in terms of the primary endpoint of at least a 30% reduction in worst back pain from baseline to 6 months of therapy. However, statistically significant differences were observed in favor of Forteo in some exploratory measures, including greater increases in bone mineral density (BMD) and fewer patients with new vertebral fractures.
The study was published in the August issue of Osteoporosis International.
At 6 months, more than half of the patients in both treatment groups reported a 30% or greater reduction in worst back pain (Forteo, 59.2% vs. risedronate, 57.4%; P = 0.64). There were no statistically significant differences between treatments in the secondary and exploratory endpoints of at least a 30% reduction in worst or average back pain at 6, 12, or 18 months; quality of life; disability; days of bed rest; days of disability; and amount of concomitant analgesics used.
Significantly fewer patients treated with Forteo experienced worsening of average back pain between 6 and 18 months compared with patients treated with risedronate (23.6% vs. 30.6%, respectively; P = 0.04). In addition, significantly fewer patients treated with Forteo had one or more new vertebral fractures at 18 months versus the risedronate group (4.4% vs. 9.4%, respectively; P = 0.01).
Among patients with new vertebral fractures, those treated with Forteo had less-severe new fractures compared with patients who received risedronate, as measured by spine radiographs (P = 0.04). There was no significant difference between treatment groups in the number of patients with new nonvertebral fractures.
Forteo is indicated for men and postmenopausal women with osteoporosis who are at high risk for fractures, and for men and women with osteoporosis due to several months’ use of glucocorticoid drugs (such as prednisone) who are at high risk for fractures.
For more information, visit the Eli Lilly Web site.