Osteoporosis is caused by a progressive decrease in bone mass and density which increases the risk of fracture. The reduced, bone mineral density (BMD) impacts the bone architecture and alters the amount and variety of proteins in the bones.
The form of osteoporosis most common in women after menopause is known as primary type 1 or postmenopausal osteoporosis. Senile osteoporosis occurs after age 75 and is seen in both females and males at a ratio of 2:1. Secondary osteoporosis results from chronic predisposing medical problems or disease or prolonged use of medications such as corticosteroids.
Osteoporosis main consequence is the increased risk of bone fractures (fragility fractures). Typical fragility fractures occur in the vertebral column, rib, hip and wrist and other bones. In addition to pain, bone fracture can lead to disability and early mortality. The symptoms of a vertebral collapse comprise sudden back pain, often shooting pain due to nerve root compression and rarely with spinal cord compression. Or cauda equina syndrome. Multiple vertebral fractures lead to a stooped posture, loss of height, and chronic pain with resultant reduction in mobility.
Fractures of the hip usually requires prompt surgery as serious risks are associated with it such as deep vein thrombosis and pulmonary embolism with the risk of mortality.
Bottom line, osteoporosis is a serious disease that needs preventive and effective treatment measures.
We Have News
At the start of the New Year 2014, Amgen (AMGN) brought us good news from Phase 2 trial evaluating its osteoporosis antibody romosozumab (AMG 785/CDP7851). Romosozumab is currently in Phase 3 clinical for osteoporosis in postmenopausal women with low bone mineral density (BMD).
The results are indeed promising. Compared with placebo, given for 12 months romosozumab demonstrates it significantly stimulates bone formation with increased BMD at the lumbar spine, total hip and femoral neck. Significant increases were also observed when BMD was assessed at three months of treatment.
The good news for post menauposal women and Amgen is that the increased BMD in the lumbar spine and hip were significantly greater than those observed with currently used osteoporosis drugs such as FOSAMAX® (alendronate sodium) and FORTEO™/FORSTEO® (teriparatide). BMD gains were significantly greater than active comparators at month 12. Romosozumab treatment achieving a mean increase of 11.3 percent at the lumbar spine compared to increases of 4.1 percent and 7.1 percent at the same region achieved with FOSAMAX and FORTEO, respectively. At the total hip, romosozumab treatment increased BMD 4.1 percent, while gains with FOSAMAX were 1.9 percent and with FORTEO were 1.3 percent (all p<0.001).The largest increases were observed with the romosozumab 210 mg once-monthly dose.
Adverse events were similar across groups, except for mild, generally non-recurring injection site reactions observed more frequently with romosozumab compared to placebo, but with no observed dose-related relationship. Most common adverse events included mild upper respiratory tract infection, pain in the back and joints, and headache. These reactions did not lead to study drug discontinuation or study withdrawal; the safety of romosozumab will be further addressed in subsequent larger studies.1
"There remains a significant need for additional treatment options that form new bone. Romosozumab is designed to stimulate bone formation, which makes it different from most available treatments that reduce bone resorption," said Prof. Dr. Iris Loew-Friedrich, chief medical officer, UCB. "We are encouraged by the emerging efficacy and safety profile, and look forward to further investigating its potential in the ongoing global Phase 3 clinical program."
"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. It is indeed good news.
We long Amgen
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