Primary Sjögren's Syndrome Prevalence: What if Sjögren was Right After All? Comment on the Article by Maciel et al

may be associated with greater toxicity than denosumab in renal transplant patients, based on the potential nephrotoxicity of zoledronic acid in patients with one kidney, even if the creatinine clearance is above 35 ml/minute. The panel included a nephrologist and the data on the renal toxicity of IV bisphosphonates were reviewed and judged to be low quality. Oral bisphosphonates were recommended conditionally for first-line treatment with a conditional recommendation for IV bisphosphonates as a second choice. We agree that the potential harms and benefits of IV bisphosphonate use in the setting of impaired renal function should be discussed by clinicians and patients before making a treatment decision. VFA by DXA is no longer included as a formal recommendation as it was in the ACR 2010 Recommendations for the Prevention and Treatment of GlucocorticoidInduced Osteoporosis (3). VFA can improve fracture risk assessment and fracture risk reduction in some clinical settings and can be cost effective in certain patient groups (4). Because glucocorticoid use increases vertebral fracture risk disproportionately, we agree with Maricic et al that VFA may have an important role in fracture risk assessment in glucocorticoid-treated patients. However, because there is very little evidence about its use in this setting, the guideline recommended further research in this area. With regard to monitoring for treatment failure, there was a concern that requiring ≥10% bone loss to define treatment failure warranting change of treatment was too stringent. The authors cited the International Society for Clinical Densitometry recommendations, which use a loss in bone density of greater than the LSC to indicate treatment failure. Another concern was that if the ACR guideline stipulated that at least a 10% loss was required to change treatment, this recommendation could potentially result in an insurance company denying payment for a change in osteoporosis drug for any smaller bone loss. We agree with the authors that defining the extent of bone loss associated with an increased fracture risk, and justifying a change in treatment, is an important clinical question, and the panel thought it should be addressed in the guideline. Unfortunately, there is very little evidence about the benefits of changing therapy on fracture risk reduction at different levels of bone loss. After discussing the limited evidence from osteoporosis clinical trials, the panel made a conditional recommendation that a 10% decrease in bone density was clearly associated with significant increase in fracture risk, and the potential benefits of a change in therapy should be discussed with patients. Guidelines deal with typical or average clinical questions, but no guideline can provide direction for every clinical scenario, given the differences in patients’ comorbidities, contraindications, and preferences. The conclusion of this guideline abstract emphasizes that it is meant to provide direction for clinicians and patients making treatment decisions, but should not be used to limit clinician and patient choice or to deny access to therapies. Furthermore, the recommendation is conditional and thus discretionary, and funders should understand the discretionary nature of the recommendation. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the US government.