THOUSAND OAKS (dpa-AFX) - Amgen Inc (AMGN) and UCB on Tuesday announced positive top-line results from a phase 3 trial that evaluated the effect of Romosozumab compared with Teriparatide in postmenopausal women with osteoporosis at high risk for fracture previously treated with bisphosphonate therapy.
According to the companies, the study met the primary endpoint, demonstrating a statistically significant difference in favor of romosozumab in the percent change of total hip bone mineral density through month 12.
The trial, dubbed STRUCTURE, was a Phase 3 randomized, open-label, teriparatide-controlled study that evaluated safety, tolerability and efficacy of romosozumab in women with postmenopausal osteoporosis. A total of 436 patients previously treated with bisphosphonate therapy received either subcutaneous romosozumab (210 mg monthly) or subcutaneous teriparatide (20 mcg daily) through to month 12.
The overall subject incidence of adverse events was generally balanced between arms. Adverse events in patients treated with romosozumab were similar to those previously reported and no new safety signals were detected. Adverse events reported in the romosozumab arm in more than five percent of patients were nasopharyngitis, arthralgia, back pain, headache and fall.
Further analysis of the Phase 3 STRUCTURE study results are ongoing.
Osteoporosis affects many women after menopause as their ability to form new bone cannot counter balance the rate at which bone is being removed. This bone loss leads to weakened bones over time, increasing the potential for a break.
About half of all women over age 50 will have an osteoporosis-related fracture in their remaining lifetime. Additionally, patients with a previous hip fracture have a threefold greater risk of a subsequent fracture within two years.
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