A Possible New Drug for Postmenopausal Osteoporosis

Tibin K. Titus, Mercer University College of Pharmacy

Postmenopausal osteoporosis occurs due to estrogen deficiency resulting in an increase of mature osteoclasts, which will increase bone resorption into the blood. [1] Simultaneously, there is a decrease in calcium absorption and increase in calcium excretion through the gut. [1] Romosozumab is a new monoclonal antibody that is in development for treatment of osteoporosis in postmenopausal women at increased risk of fractures. [2] In a previous trial, romosozumab reduced the risk of fracture compared to placebo; however, it has not been compared with an active comparator. [2] This study was conducted with an active comparator, alendronate, to compare the two drugs for fracture prevention in postmenopausal women with osteoporosis. [3]

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Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis

Long Buu Huynh, Mercer University College of Pharmacy

Osteoporosis, or “porous bone”, is a bone disease characterized by a loss of bone mass and change in bone structure. There are no symptoms since osteoporosis is a silent condition. Risk factors that can cause osteoporosis are lifestyle choices, certain diseases, medications, and age. [1] Romosozumab is a medication used to help increase bone formation and decrease bone resorption. Alendronate is classified as an antiresorptive agent and used as first-line therapy for osteoporosis. The aim of this study is to investigate the effectiveness of romosozumab followed by alendronate compared with alendronate alone in postmenopausal women with osteoporosis and a previous fracture. [2]

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Protection from Osteoporosis for Two Years with One Shot?

The balance between collagen and mineral components that make up bone is delicate to maintain bone strength and stiffness. Imbalances in these components can impair bone quality and reduce strength, leading to osteoporosis. Increasing bone mass decreases bone fracture risk. Bone mass can be increased by modifying lifestyle factors or by medication administration.1

Zoledronic acid (Reclast®, Zometa®) is a bisphosphonate indicated by the Food and Drug Administration (FDA) for postmenopausal, male, and glucocorticoid-induced osteoporosis. Bisphosphonates decrease osteoclast maturation, number, recruitment, bone adhesion, and lifespan and indirectly increase bone mineral density. Zoledronic acid is administered intravenously (IV) and is 40% excreted, compared to 50-65% of other oral bisphosphonates. Zoledronic acid also has fewer gastrointestinal side effects and is used in patients who have intolerances to oral bisphosphonates.1

The American College of Obstetricians and Gyencologists’ guidelines for osteoporosis recommend any FDA-approved therapy be used including raloxifene, bisphosphonates, parathyroid hormone, denosumab, or calcium. No treatment algorithm or preferential treatment is suggested.2 The Medical Services Commission recognizes that bisphosphonates have the largest body of randomized controlled trial evidence of all therapies in osteoporosis. However, cost effectiveness is low with zoledronic acid and it is therefore recommended to be reserved for high-risk patients unable to tolerate oral therapy.3

According to the University of Michigan Health System guidelines, the World Health Organization’s Fracture Risk Assessment Tool (FRAX) should be used to assess the need for treatment. Medication is recommended to begin in patients with 10-year fracture risks greater than 3% at the hip or 20% total. Zoledronic acid is only recommended to reduce hip and vertebral fracture risk in post-menopausal women and glucocorticoid-induced osteoporosis.4

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