EVENITYTM ARCH Study Results Published in the New England Journal of Medicine
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The study found that through 24 months, postmenopausal women with osteoporosis in the romosozumab treatment group experienced a statistically significant 48.0 percent relative reduction in the risk of a new vertebral (spine) fracture compared with those receiving alendronate alone (6.2 percent versus 11.9 percent, respectively [p<0.001]). At primary analysis, women in the romosozumab treatment group also experienced a statistically significant 27.0 percent relative reduction in the risk of clinical fracture, which includes non-vertebral fracture and clinical vertebral fracture (9.7 percent versus 13.0 percent, respectively [(p<0.001]).
"The ARCH study shows that romosozumab can provide superior fracture risk reduction over alendronate, a commonly used, first-line osteoporosis treatment," said study lead author
At primary analysis, postmenopausal women in the romosozumab treatment group experienced a statistically significant 19.0 percent relative reduction in the risk of non-vertebral fractures (8.7 percent versus 10.6 percent, respectively [p=0.04]). A 38.0 percent relative reduction in the risk of hip fractures was also observed (2.0 percent versus 3.2 percent, respectively [nominal p=0.015]), when compared to those receiving alendronate alone.
Postmenopausal women who received romosozumab achieved greater gains in bone mineral density (BMD) from baseline at all measured sites and at all time points of the study versus those receiving alendronate alone. At month 12, the percentage change from baseline was greater with romosozumab versus alendronate at the lumbar spine (13.7 percent versus 5.0 percent, respectively [p<0.001]) and total hip (6.2 percent versus 2.8 percent, respectively [p<0.001]). In a subset of patients assessed every six months, significant gains were observed beginning at month six (p<0.001) for all sites.
Overall, adverse events and serious adverse events were generally similar between the treatment groups. An imbalance in adjudicated cardiovascular serious adverse events was observed during the 12-month period in 50 patients (2.5 percent) treated with romosozumab versus 38 patients (1.9 percent) treated with alendronate, with cardiac ischemic events and cerebrovascular events accounting for the imbalance.
The percentage of patients with adverse events and serious adverse events throughout the study as well as in the initial 12-month romosozumab treatment period were balanced between the groups, including incidences of osteoarthritis, hypersensitivity, cancer and hypocalcemia. Injection site reactions, mostly mild in severity, were reported in 4.4 percent of patients in the romosozumab treatment group and 2.6 percent in the alendronate group during the initial 12-month period.
During the open-label alendronate period, there were two positively adjudicated events of osteonecrosis of the jaw, one in a patient treated with romosozumab followed by alendronate and one treated with alendronate alone. There were six patients with positively adjudicated events of atypical femoral fracture during the open-label alendronate period, two patients treated with romosozumab followed by alendronate and four treated with alendronate alone.
About the ARCH Study
ARCH (Active-contRolled FraCture Study in Postmenopausal Women with Osteoporosis at High Risk of Fracture) is a Phase 3 multicenter, international, randomized, double-blind, alendronate-controlled study of romosozumab in 4,093 postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history.
Patients were randomized 1:1 to receive either 210 mg romosozumab subcutaneously every month or 70 mg alendronate orally every week for the duration of the 12-month double-blind alendronate-controlled study period. After the double-blind active-comparator study period, patients received alendronate while remaining blinded to their initial treatment assignment. The incidence of new vertebral fracture was assessed at 24 months. The incidence of clinical fracture was assessed at the primary analysis, when 330 fractures occurred or the last patient was on the study for 24 months, whichever was later. In addition, other key fracture endpoints including non-vertebral fracture and hip fracture were assessed at primary analysis.
About Romosozumab
Romosozumab is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the activity of sclerostin, which enables romosozumab to rapidly increase bone formation and reduce bone resorption simultaneously. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis.
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