Anew guideline from the ACR for glucocorticoid-induced osteoporosis is on the horizon.
A Sunday afternoon clinical symposium described how the draft guideline, which has not yet been approved by the ACR, expands on the 2010 guideline to consider the fracture risk and treatment options among new patient populations and how the recommendations vary based on glucocorticoid (GC) dose.
“We wanted to look at clinical decision-making over time because clinicians do not make decisions about this just once. Risk factors are changing and we need to rethink the care,” said Lenore Buckley, MD, MPH, an Adult and Pediatric Rheumatologist at Yale School of Medicine.
Approximately 1 percent of the United States population is receiving GC therapy to manage inflammatory and other conditions. Osteoporosis, and consequent fractures, are considered a major comorbidity of the therapy. An estimated 15 and 7.6 percent of vertebral and non-vertebral fractures, respectively, have been attributed to GC treatment.
In her opening remarks for Glucocorticoid-Induced Osteoporosis Prevention and Treatment: A New ACR Clinical Guideline, Dr. Buckley reviewed the studies over the last 15 years that have helped clinicians realize that fracture risk depends on the daily and cumulative dose of GC and varies depending on the anatomical site.
In particular, a 2011 study found that FRAX, a tool to calculate the 10-year fracture risk in adults 40 to 90 years old, only generates accurate risk associated for patients taking GC if their dose is 2.5-7.5 mg/day, and if they are taking doses above or below that range, clinicians need to adjust the fracture risk. For example, patients taking more than 7.5 mg/day of GC have a 20 percent increase in hip fracture compared with those in the 2.5-7.5 mg/day range.
Dr. Buckley led attendees through a whirlwind tour of the draft guideline recommendations. All patients taking a GC should receive a baseline fracture risk assessment, either using the FRAX tool for adults age 40 and older or a bone mineral density (BMD) test for those younger than 40. FRAX has been refined to take into account the dose of GC, rather than assuming the 2.5-7.5 mg/day dose range, and as a result some adults age 40 and older will have higher or lower risk than previously estimated.
The guideline recommends all patients taking GC therapy receive an optimal range of calcium and vitamin D. For those at moderate to high risk of fracture, the guideline recommends adding oral bisphosphonate or another treatment for osteoporosis.
Mary Beth Humphrey, MD, PhD, Associate Professor of Rheumatology and Immunology at the University of Oklahoma Health Sciences Center, presented a series of case studies to demonstrate how the new recommendations would impact care. Using the refined FRAX tool, a 55-year-old woman with rheumatoid arthritis taking 2.5 mg a day of prednisone was found to be at low risk of fracture, whereas a similar patient taking 5 mg a day of prednisone had moderate risk, and a 65-year-old patient receiving this same dose had high risk because of her increased age.
The new guideline includes treatment recommendations for some groups not included in the previous guideline, for which Dr. Humphrey presented case studies. These include two categories of adults under the age of 40 — those with low bone mass and those without low bone mass who are losing bone mass very rapidly. Recommendations also encompass four special patient populations: children ages 4 to 17, a group that had not previously been considered; organ transplant patients; women of childbearing potential at moderate to high risk who are not planning to become pregnant; and adults 30 years and older receiving very high-dose GC therapy.
Finally, the guideline considers several special clinical scenarios: Patients who sustain a fracture or significant loss of BMD despite taking an oral bisphosphonate; patients who remain at moderate to high risk despite taking an oral bisphosphonate; and patients who discontinue GC use.
“Research has shown us that bone density loss is rapid and happens in the first 6 months, but almost as important, it showed us that it is reversible,” Dr. Buckley said.
Timothy E. McAlindon, MD, MPH, Chief of Rheumatology at Tufts University School of Medicine, explained how the new guideline was created using the GRADE (Grading of Assessment, Development and Evaluation) methodology. In the first stage, experts asked for public comment to help them develop clinical questions, also known as PICO (population, intervention, comparator, and outcomes) questions. A literature review team then scoured studies published through April 2016, and using a total of 85 studies, created an evidence table for each PICO question. Dr. McAlindon and Dr. Buckley then worked with the experts who made the guideline framework and voted on the recommendations.