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Romosozumab Phase 2 Data Published In New England Journal Of Medicine Show Significant Increases In Bone Mineral Density At Both Spine And Hip
Date:1/1/2014

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"Broken bones due to osteoporosis are common and can have a significant impact on the patient, her family and the healthcare system, yet the seriousness of this health event remains underappreciated, with only two-in-10 women receiving follow-up testing or treatment after they have broken a bone," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "With its bone-forming ability, romosozumab may result in new treatment strategies to help manage this disease."

Study Design
The study was a Phase 2, multicenter, international, randomized, placebo-controlled, parallel-group, eight-arm study of 419 postmenopausal women aged 55 to 85 years with BMD T-score <–2.0 at the lumbar spine, total hip or femoral neck and >–3.5 at all three sites. Study participants were randomly assigned to receive subcutaneous romosozumab monthly (70, 140, or 210 mg) or every three months (140 or 210 mg), subcutaneous placebo, or oral FOSAMAX (70 mg weekly) or subcutaneous FORTEO (20 μg daily), both of which were open-label.1 

The primary endpoint was percentage change from baseline in lumbar spine BMD at 12 months. Secondary endpoints included percentage changes in BMD and in bone turnover markers at other sites.1

About Osteoporosis
Osteoporosis affects many women after menopause2,3 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.4,5

About half of all women over age 50 will have an osteoporosis-related fracture in their remaining lifetime.6 Only 24 percent of women who suffered an osteoporotic fracture received treatment during the following year.7*  

According to the National Osteoporosis Foundation, those who have sustained a
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SOURCE Amgen
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