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. 2018 May 22;19(1):160.
doi: 10.1186/s12891-018-2076-9.

A population-based study of the risk of osteoporosis and fracture with dutasteride and finasteride

Tony Antoniou  1   2   3   4 , Erin M Macdonald  5 , Zhan Yao  5 , Tara Gomes  6   7   5 , Mina Tadrous  7   5   8 , Joanne M-W Ho  9   10 , Muhammad M Mamdani  6   7   5   8   11 , David N Juurlink  7   5   12 ; Canadian Drug Safety and Effectiveness Research Network
Affiliations

A population-based study of the risk of osteoporosis and fracture with dutasteride and finasteride

Tony Antoniou et al. BMC Musculoskelet Disord. .

Abstract

Background: Dutasteride is a potent inhibitor of 5-alpha reductase enzymes that reduces concentrations of dihydrotestosterone to a greater extent than finasteride. Whether this has adverse implications for bone health is unknown. We compared the risk of osteoporosis and fractures in older men treated with dutasteride or finasteride.

Methods: We conducted a population-based retrospective cohort study with high-dimensional propensity score matching of Ontario men aged 66 years or older who started treatment with dutasteride or finasteride between January 1, 2006 and December 31, 2012. The primary outcome was a diagnosis of osteoporosis within 2 years of treatment initiation. A secondary outcome was osteoporotic or fragility fractures.

Results: We studied 31,615 men treated with dutasteride and an equal number of men treated with finasteride. Dutasteride-treated patients had a lower incidence of osteoporosis than those receiving finasteride [2.2 versus 2.6 per 100 person years; hazard ratio (HR) 0.82; 95% confidence interval (CI) 0.72 to 0.93]. This effect was no longer statistically significant following adjustment for specialty of prescribing physician (HR 0.90; 95% CI 0.78 to 1.02)]. There was no differential risk of fractures with dutasteride (HR 1.04; 95% 0.86 to 1.25).

Conclusions: Despite differential effects on 5-alpha reductase, dutasteride is not associated with an increased risk of osteoporosis or fractures in older men relative to finasteride. These findings suggest that dutasteride does not adversely affect bone health.

Keywords: 5-alpha Reductase inhibitors/adverse effects; Dutasteride; Finasteride; Osteoporosis/physiopathology.

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Conflict of interest statement

Ethics approval and consent to participate

ICES is a prescribed entity under section 45 of Ontario’s Personal Health Information Protection Act. Section 45 authorizes ICES to collect personal health information, without consent, for the purpose of analysis or compiling statistical information with respect to the management of, evaluation or monitoring of, the allocation of resources to or planning for all or part of the health system. Projects conducted under section 45, by definition, do not require review by a Research Ethics Board. This project was conducted under section 45, and approved by ICES’ Privacy and Compliance Office. Ethics approval was obtained from the Research Ethics Board of Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. This study is based on the analysis of administrative health care data and, as such, patient consent was not required.

Competing interests

Tony Antoniou has no conflicts of interest. Erin MacDonald has no conflicts of interest. Zhan Yao has no conflicts of interest. Tara Gomes has no conflicts of interest. Mina Tadrous has no conflicts of interest. Joanne M-W Ho has no conflicts of interest. During the past three years, Muhammad M. Mamdani has served on advisory boards and/or received honoraria from Astra Zeneca, Bristol-Myers Squibb, Eli Lilly and Company, Glaxo Smith Kline, Hoffman La Roche, Novartis, Novo Nordisk and Pfizer. David N. Juurlink has no conflicts of interest.

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