Abstract
Osteoporosis affects over 10 million Americans over 50. Bisphosphonate therapy, mainly alendronate, is amongst the most prescribed treatments for the disease. The use of alendronate and other bisphosphonates has been associated with depressive symptoms in recent case reports. In this study we quantified this association by analyzing over 100,000 adverse events reports from the Food and Drug Administration Adverse Events Reporting System (FAERS) and the World Health Organization’s (WHO) global database for adverse drug reactions, ADRs, VigiAccess. We found that alendronate therapy is significantly associated with depression and anxiety when compared to other first-line osteoporosis treatments. The reported risk of depressive ADRs was found to be over 14-fold greater in patients taking alendronate under the age of 65 and over fourfold greater for patients over 65 compared to the control. Several hypotheses concerning the molecular mechanism of the observed association of alendronate and depressive symptoms were discussed.
Highlights
Osteoporosis affects over 10 million Americans over 50
In 2014, the National Osteoporosis Foundation estimated that 10.2 million Americans suffer from osteoporosis, and 43.4 million have low bone mineral density
Alendronate, zoledronate, risedronate, ibandronate, denosumab and teriparatide were recommended first-line therapies based on the Endocrine S ociety[19], the American Academy of Family P hysicians[20], the National Osteoporosis F oundation[21] guidelines
Summary
Osteoporosis affects over 10 million Americans over 50. Bisphosphonate therapy, mainly alendronate, is amongst the most prescribed treatments for the disease. We found that alendronate therapy is significantly associated with depression and anxiety when compared to other first-line osteoporosis treatments. Amongst the most common drug therapies for osteoporosis, as recommended by the American College of Physicians, are bisphosphonates, including alendronate, zoledronate, ibandronate and risedronate. A 2010 report demonstrated an association between the bisphosphonates as a class and depressive symptoms in humans, reporting a reported odds ratio (ROR) of 2.3 (2.1–2.5) in WHO database, while in was not significant for alendronate 1.3 (0.7–2.5) in the Lareb database[14]. We take a closer look at each individual bisphosphonate, and evaluate their individual ADR associations by analyzing the osteoporosis subset of over 15 million post marketing adverse drug event reports in the FAERS database. We perform a similar analysis of the World Health Organization global database for adverse drug reactions
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