Comparative Effectiveness Study of Osteoporosis Medications Using Electronic Medical Records

Abstract

Over the last two decades, various drugs have been approved for the treatment of osteoporosis, including alendronate, risedronate, ibandronate, zoledronic acid, estrogen replacement therapy, selective estrogen receptor modulators, denosumab, teriparatide, and abaloparatide. Comparative effectiveness evidence between different osteoporosis medications can provide valuable information for clinical and health policy decision-making. However, data on the comparative effectiveness in clinical settings are limited. Electronic medical records (EMR) database can provide ample longitudinal information on typical patients and is a useful data source for generating comparative effectiveness evidence. However, the feasibility of using EMR to do comparative effectiveness study of osteoporosis drugs has not been well examined before. There are several challenges that need to be addressed before EMR can be used to generate reliable evidence. First, most EMR databases include a relatively small number of patients, which hamper their ability to test the reduction in the risk of fracture between various anti-osteoporosis agents. Second, bone mineral density (BMD) changes, usually examined by dual-energy X-ray absorptiometry (DXA), is a well-recognized proxy of anti-osteoporosis efficacy, but the frequency of DXA test in routine clinical practice has not been well examined as well as its application as a comparative effectiveness endpoint. Third, drug data in most EMR databases are prescription data. Verification studies or manually chart review are typically needed to accurately define the drug exposure. In this project, we examined the feasibility of doing comparative effectiveness research (CER) using the EMR database. First, we examined the frequency and patterns of DXA tests in routine clinical practice and determined whether BMD data were rich enough for CER study. Second, we emulated a hypothetical RCT comparing BMD changes of teriparatide versus denosumab in patients switched from bisphosphonates to answer this clinically important question while conclusive RCT is not currently available. This project highlights the strengths and pitfalls of doing a CER study of osteoporosis medications using EMR. With the appropriate study design and analytical approaches, EMR can be a very useful data source for generating comparative effectiveness evidence of osteoporosis medications.