Eli Lilly and Co. announced data from a Phase 3 trial comparing the effects of Forteo (teriparatide [rDNA origin] injection) and risedronate on back pain in postmenopausal women with osteoporotic vertebral fractures. The study showed no difference between Forteo and risedronate on the primary endpoint of at least a 30% reduction in worst back pain from baseline to six months of therapy, as assessed by a numeric rating scale in each treatment group. However, there were statistically significant differences in favor of Forteo in some exploratory measures, including greater increases in bone mineral density (BMD) and fewer patients with new vertebral fractures. The results of the study are published in the August issue of Osteoporosis International.
“With many available options to treat osteoporosis, this study is important because it compares two established osteoporosis medicines in a direct head-to-head design,” said lead investigator Peyman Hadji, M.D., department head, endocrinology, osteoporosis, and reproductive medicine at Philipps-University of Marburg.
At six months, more than half of patients in both treatment groups reported a 30% or greater reduction in worst back pain (Forteo — 59.2%, risedronate — 57.4%; p=0.64). (A 30% or greater reduction is considered a clinically meaningful change.) 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 six, 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 a worsening of average back pain between six and 18 months (23.6% vs. 30.6% of risedronate-treated patients; p=0.04). Significantly fewer patients treated with Forteo had one or more new vertebral fractures at 18 months (4.4% vs. 9.4% of risedronate-treated patients; p=0.01). Among patients with new vertebral fractures, those treated with Forteo had overall less severe new fractures compared to those who received risedronate, as measured by spine radiograph (p=0.04). There was no significant difference between treatment groups in the number of patients with new nonvertebral fractures.
Additional findings included:
- patients treated with Forteo had a greater average increase in BMD at the lumbar spine (+7.80 +/- 0.5% vs. +2.63 +/- 0.5% in risedronate-treated patients; p < 0.001) and at the femoral neck (+2.11 +/- 0.4% vs. +0.77 +/- 0.4%, respectively; p=0.02) at 18 months
- patients in the Forteo group had significantly less height loss compared to the risedronate group at 18 months (0.44 centimeters vs. 0.70 centimeters; p < 0.05).
“The study provides additional information regarding the use of Forteo in patients who are considered at high risk for osteoporotic fractures,” said Bruce Mitlak, M.D., Distinguished Medical Fellow, Bone Muscle and Joint Platform, Eli Lilly and Company. “The results may help guide healthcare professionals in treating severe osteoporosis.”
In the study, the overall safety profile was consistent with the known Forteo safety profile seen in this patient population. The overall incidence of serious adverse events, treatment-emergent adverse events and adverse events leading to discontinuation were similar between the Forteo and risedronate treatment groups. There were nine deaths in the study (four in the Forteo group and five in the risedronate group), but none of the deaths were considered related to treatment.
Forteo is used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones (fractures). Forteo is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures). Forteo can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments.
During the drug testing process, the medicine in Forteo caused some rats to develop osteosarcoma, which, in humans, is a serious but rare bone cancer. Osteosarcoma has been reported rarely in people who took Forteo, and it is unknown if people who take Forteo have a higher chance of getting the disease. Before patients take Forteo, patients should tell their healthcare provider if they have Paget’s disease of bone, are a child or young adult whose bones are still growing or have had radiation therapy.
Date: August 7, 2012
Source: Eli Lilly and Co.
Filed Under: Drug Discovery