Amgen announced results from a phase 3 study evaluating romosozumab for the treatment of osteoporosis in men, stating that the primary endpoint had been met.1 Romosozumab, an investigational humanized monoclonal anti-sclerostin antibody, increases osteogenesis and decreases bone resorption.2
BRIDGE (placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn) is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial in men aged 55-90 with osteoporosis, defined as bone mineral density (BMD) T-score ≤ 2.50 at the spine or hip, or BMD T-score ≤ 1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral facture.3
Men with histories of hip fracture, severe metabolic bone disease, or recent pharmacologic treatment with agents affecting bone metabolism were excluded.
A total of 245 men were randomized 2:1 to receive either 210 mg romosozumab subcutaneous every month or matched placebo for the duration of the 12-month treatment period.
The trial met its the primary endpoint, demonstrating a statistically significant increase in BMD at the lumbar spine in men treated with romosozumab compared with placebo at 12 months. Secondary endpoints were also met. Patients receiving romosozumab experienced a significant increase in BMD at the femoral neck and total hip at 12 months and au significant increase in BMD at the lumbar spine, femoral neck, and total hip at 6 months, compared with those receiving placebo.
The most frequently reported adverse events were nasopharyngitis, back pain, hypertension, headache and constipation.
Summary and Clinical Applicability
Study data indicated that men with osteoporosis treated with romosozumab for 12 months had increased BMD in the lumbar spine, femoral neck, and total hip compared with placebo. Further study analysis of the BRIDGE trial is ongoing and final data will need to undergo peer review prior to publication.
“While the focus of managing osteoporosis is often on women, osteoporosis in men is also a serious health issue that poses a significant health risk to millions of men worldwide,” said Sean Harper, MD, executive vice president of Research and Development at Amgen in the press release.1
1. Amgen Media Relations. Amgen And UCB Announce Positive Top-Line Results From Phase 3 Study Evaluating Romosozumab In Men With Osteoporosis. Published March 20, 2016. Accessed March 22, 2016. Source Code.
2. Mcclung MR, Grauer A, Boonen S, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014;370(5):412-20.
3. ClinicalTrials.Gov, U.S. National Institutes of Health. A Double-blind Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (BRIDGE). Last updated March 1, 2016. Accessed March 23, 2016. Source Code.
This article originally appeared on MPR