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Clinical Trials

Date: 2016-11-12

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the American College of Rheumatology (ACR) and Association of Rheumatology Health Professionals (ARHP) Annual Meeting

Company: Amgen (USA - CA) UCB (Belgium)

Product: romosozumab (CDP7851/AMG 785)

Action mechanism: monoclonal antibody. sclerostin antibody (CDP7851/AMG 785) is a humanized monoclonal antibody that binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation. By binding to and blocking sclerostin, it is designed to increase the amount of bone in the skeleton. With more than 75 million people worldwide suffering from osteoporosis, there is a serious patient need for therapeutics that help build bone.

Disease: osteoporosis in men

Therapeutic area: Bone diseases

Country: Belgium, Colombia, Czech Republic, Denmark, Japan, Mexico, Poland, Russian Federation, Switzerland, USA

Trial details:

  • The BRIDGE (placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis) study is a multi-center, international, randomized, double-blind, placebo-controlled study in men with osteoporosis, defined as low bone mineral density at the spine, total hip or femoral neck.
  • The study evaluated the effectiveness of romosozumab treatment for 12 months, compared with placebo, in increasing BMD at the lumbar spine, as well as the effect on BMD at the femoral neck and total hip at 12 months and on BMD at the lumbar spine, femoral neck, and total hip at six months. A total of 245 men were randomized 2:1 to receive either 210 mg romosozumab subcutaneous (SC) every month (QM) or matched placebo SC QM for the duration of the 12-month treatment period. (NCT02186171)

Latest news:

  • • On November 12, 2016, Amgen and UCB  announced results from the Phase 3 BRIDGE study showing that in men with osteoporosis, romosozumab resulted in significant bone mineral density gains at the lumbar spine, total hip and femoral neck compared to placebo at six and 12 months. The full findings have been presented for the first time at the American College of Rheumatology (ACR) and Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Washington, D.C. , Nov. 11-16, 2016 (abstract #321).
  • The BRIDGE study  involved 245 men with osteoporosis (163 romosozumab, 82 placebo) randomized 2:1 to receive either 210 mg romosozumab or placebo subcutaneously once monthly for 12 months. All patients received daily calcium and vitamin D. The primary endpoint was met, with romosozumab demonstrating a statistically significant increase (12.1 percent; p<0.01) in BMD at the lumbar spine (as assessed by dual energy x-ray absorptiometry) compared with placebo at 12 months. All secondary endpoints were also met with romosozumab showing a statistically significant increase in BMD at total hip (2.5 percent) and the femoral neck (2.2 percent) at 12 months (both p<0.01 compared to placebo). A statistically significant increase in BMD at six months was also seen with romosozumab at all sites examined compared to placebo: lumbar spine (9.0 percent), total hip (1.6 percent), femoral neck (1.2 percent; p<0.01 for all sites). The dual effect of romosozumab was reflected by an increase in P1NP (86 percent median increase from baseline peaking at one month), a marker of bone formation, and a decrease in CTX (31 percent median decrease from baseline at one month), a marker of bone resorption.
  • The overall incidence of adverse events and serious adverse events were balanced between treatment groups. The most frequently reported adverse events (greater than five percent in the romosozumab arm) were nasopharyngitis, back pain, hypertension, headache and constipation. Injection site reactions were reported in 5.5 percent of patients in the romosozumab treatment group and 3.7 percent in the placebo group during the 12-month period. Most injection site reactions were reported as mild in severity. The patient incidence of positively adjudicated cardiovascular serious adverse events was 4.9 percent (8/163) in the romosozumab group and 2.5 percent (2/81) in the placebo group. The patient incidence of positively adjudicated cardiovascular death was 0.6 percent (1/163) in the romosozumab group and 1.2 percent (1/81) in the placebo group.
  • • On March 21, 2016,  UCB and Amgen  announced positive top-line results for romosozumab from the pivotal Phase 3 BRIDGE study. These data showed the study met the primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine (as assessed by dual energy x-ray absorptiometry) in men with osteoporosis treated with romosozumab compared with placebo at 12 months. All secondary endpoints comparing romosozumab with placebo were also met. Patients receiving romosozumab experienced a statistically significant increase in BMD at the femoral neck and total hip at 12 months and a statistically significant increase in BMD at the lumbar spine, femoral neck, and total hip at six months, compared with those receiving placebo.
  • In the BRIDGE study, a total of 245 men were randomized 2:1 to receive either 210 mg romosozumab subcutaneous (SC) every month (QM) or matched placebo SC QM for the duration of the 12-month treatment period.
  • The overall patient incidence of adverse events and serious adverse events (SAEs) was generally balanced between arms. The most frequently reported adverse events (greater than five percent in the romosozumab arm) were nasopharyngitis, back pain, hypertension, headache and constipation. Injection site reactions were reported in 5.5 percent of patients in the romosozumab treatment group and 3.7 percent in the placebo group during the 12-month period. Most injection site reactions were reported as mild in severity. The patient incidence of positively adjudicated cardiovascular (CV) SAEs was 4.9 percent (8/163) in the romosozumab group and 2.5 percent (2/81) in the placebo group. The patient incidence of positively adjudicated cardiovascular death was 0.6 percent (1/163) in the romosozumab group and 1.2 percent (1/81) in the placebo group. Amgen and UCB recently reported the results of the FRAME study in 7,180 postmenopausal women with osteoporosis in which the overall patient incidences of adjudicated AEs were balanced.

Is general: Yes