Concepts in Osteoporosis Care: Coverage, Sequencing, and Comparative Effectiveness

Dr. Lewiecki:
I’m giving a session about current concepts of osteoporosis, and there’s a few things I’d like to emphasize that are not always appreciated.   

One is that osteoporosis is a lifelong disease, so once that diagnosis is made, it sticks with the patient forever.  This is actually very important, not only for patients to understand that the disease is treatable but not curable, but for interactions with insurance companies and drug coverage.  For example, if a patient is diagnosed with osteoporosis because of a T score that’s -2.5 or below and treatment is effective and the T score becomes greater than -2.5, the patient still has osteoporosis.  They just have treated osteoporosis.  Unfortunately, some DEXA reports, for a follow-up DEXA in that situation, may report that the patient has osteopenia.  It’s possible that the drug they’re on is not approved for the treatment of osteopenia and may be denied if that diagnosis goes from osteoporosis to osteopenia, and this is a particular concern in patients treated with denosumab where cessation of treatment may result in a rapid decline of bone density and can be very harmful to the patient.   

Another important concept I’d like to emphasize is the importance of sequence of therapy.  So for patients at very high fracture risk, it’s ideal to begin treatment with an osteoanabolic agent followed by an antiresorptive agent.  Doing the reverse order—an antiresorptive agent later followed by an anabolic agent—may result in an attenuation or delay of the anabolic effect, so ideally, if we’re able to do it for those very high-risk patients, starting with an anabolic agent is the best. 

There have been advances in our understanding of osteoporosis medications, and one of the ones I’d like to highlight here is comparative effectiveness.  We have a number of randomized controlled trials that show that osteoanabolic agents are superior to bisphosphonates for reduction of fracture risk in patients at high risk and very high risk of fractures, and that’s why we prefer initiating therapy with an anabolic agent in those particular patients.  We have real-world evidence that has recently been reported that some antiresorptive drugs are better than others, and two different studies have shown that denosumab is superior to alendronate and superior to zoledronic acid for reducing fracture risk.  We have a better understanding of the consequences of discontinuation of denosumab where there may be a rapid decline in bone density that can be partially mitigated by bisphosphonate therapy but not completely, at least in patients who have been on long-term denosumab.   

I’m often asked about emerging therapies for osteoporosis, and I like to say now that there are none.  There are zero emerging therapies because the osteoporosis treatment clinical pipeline is essentially shut down because of the prohibitively expensive and time-consuming process of doing registration trials for osteoporosis drugs, and our hope to unstrangle this pipeline for drug development is that there may be a change, I hope, in FDA guidance where bone mineral density will be accepted as a surrogate for fractures as a primary endpoint in osteoporosis drug registration trials.  So stay tuned on this one. 

Announcer:
That was Dr. Michael Lewiecki talking about his presentation at the 2024 Congress of Clinical Rheumatology that focused on current concepts in the management of osteoporosis. To access this and other episodes in our series, visit Living Rheum on ReachMD dot com, where you can Be Part of the Knowledge. Thanks for listening!