This is the second post of a two-part series summarizing the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) updated 2020 clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis. This post covers the newer drug romosozumab, switching therapies and communicating risk. (Click here for part 1)
Romosozumab is one of the newest osteoporosis agents on the market. It’s a monoclonal antibody directed against sclerostin. Romosozumab was approved by the FDA in 2019 for postmenopausal women at high-risk of fracture, based on two large trials that showed dramatic increases in bone density through modeling as well as remodeling. The studies also showed significant reductions in radiographic vertebral fractures compared to the placebo and alendronate.
Who should romosozumab be used for?
Romosozumab can safely be used for patients with prior radiation exposure and will likely be used for the very-high-risk group and those who have maxed out on teriparatide or abaloparatide.
Who should NOT use romosozumab?
Romosozumab should not be used inpatients at high-risk for cardiovascular events or who’ve had a recent myocardial infarction or stroke. This is because of reports of a higher serious cardiovascular event when compared to alendronate.
One update to the guidelines is that, in the past, drug holidays weren’t recommended. However, in the 2020 guidelines that’s been changed; if some patients are no longer considered high-risk, they can be transitioned off of the drug. Upon discontinuation of an anabolic agent (such as abaloparatide, romosozumab or teriparatide), patients should switch to a therapy with an antiresorptive agent (such as denosumab or biphosphonates) to prevent loss of bone marrow density (BMD) and fracture efficacy.
For teriparatide and abaloparatide, the FDA recommends treatment be limited to no more than 2 years and for romosozumab, 1 year.
Discontinuation of denosumab, however, can have notably negative effects. Clinical trials have shown a rapid decrease in BMD and a rapid loss of protection from vertebral fractures when denosumab treatment is stopped after 2 or 8 years. Thus, if a patient discontinues denosumab, there should be a transition to an antiresorptive agent for a limited time, such as one infusion of the bisphosphonate zoledronate.
The guidelines emphasize that healthcare personnel should help ensure patients that fully understand the risk of fractures and their consequences — such as pain, disability, loss of independence, or death — when no treatment is given. This is one area where clinical pharmacists can definitely play a role. In a consult, we must take the time to understand the patient’s cultural beliefs, previous treatment experiences, fears and concerns if they seem uncertain about their treatment.
When estimating a patient’s fracture risk, T-score must be combined with clinical risk factors, such as advanced age and previous fracture. Absolute fracture risk is more useful than a risk ratio in developing treatment plans.
Advising providers, empowering patients
Knowing the updated guidelines and effectively communicating changes enables RxLive clinical pharmacists help advise providers and empower patients so the best decisions can be made for optimum patient outcomes. We firmly believe that the time we take to discuss all of a patient’s options and the possible results is invaluable to help them understand and implement their treatment plans.
If we can be of assistance to you as a provider at any time, please contact us.