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May 8, 2019
Romosozumab-aqqg (Evenity) Approved for Treatment of Osteoporosis: In April 2019, the US. Food and Drug Administration (FDA) approved romosozumab-apqg to treat osteoporosis in postmenopausal women at high risk of fracture. The monoclonal antibody blocks the effects of the protein sclerostin and primarily stimulates new bone formation, although it also has antiresorptive activity. Two phase 3 clinical trials demonstrated reductions in bone fractures after 12 months when compared to placebo and to oral alendronate 70 mg daily. The labeling contains a boxed warning that it may increase the risk of MI, stroke and cardiovascular death, which may limit use of the drug because the target population is older women who may be at higher cardiovascular risk. Romosozumab-apqg offers a novel anabolic treatment strategy for women who are at high risk of osteoporotic fracture but is expensive, with a U.S. list price reported to be $21,900 for a full 12-month course of injections.
Upon completion of the chapter, the reader will be able to:
Explain the association between osteoporosis and morbidity and mortality.
Identify risk factors that predispose patients to osteoporosis.
Describe the pathogenesis of fractures in patients with osteoporosis.
List the criteria for diagnosis of osteoporosis.
Recommend appropriate lifestyle modifications to prevent bone loss.
Compare and contrast the effect of available treatment options on reduction of fracture risk.
Recommend an appropriate treatment regimen for a patient with osteoporosis and develop a monitoring plan for the selected regimen.
Educate patients on osteoporosis and drug treatment, including appropriate use, administration, and adverse effects.
Osteoporosis is a common and often silent disorder causing significant morbidity and mortality and reduced quality of life. It is characterized by low bone density and loss of strength in bone tissue resulting in an increased risk and rate of bone fracture. Osteoporosis is responsible for more than 2 million fractures in the United States annually. Approximately 10 million Americans have osteoporosis, and an additional 43 million are classified as having low bone density.1,2 The cost of care is expected to rise to $25.3 billion by 2025. It is estimated that postmenopausal white women have a 50% lifetime chance of developing an osteoporosis-related fracture, whereas men have a 20% lifetime chance.1 Common sites of fracture include the spine, hip, and wrist, although almost all sites can be affected.
The fractures associated with osteoporosis have an enormous impact on individual patients, not only causing initial pain, but also chronic pain, loss of mobility, depression, nursing home placement, and death. Patients with vertebral fractures may also experience height loss, kyphosis, and decreased mobility due to limitations in bending and reaching. These patients are also at greater risk of having a future vertebral fracture. Multiple vertebral fractures may lead to restrictive ...