Use of high cumulative amounts of potent or very potent topical corticosteroids is associated with an increased risk for osteoporosis and major osteoporotic fracture (MOF), according to study findings published in JAMA Dermatology.

Investigators enrolled Danish adults treated with potent or very potent topical corticosteroids from January 1, 2003, to December 31, 2017, in the nationwide retrospective cohort study. The data were analyzed from June 1 to August 31, 2019.

Patients who had filled prescriptions of cumulative amounts corresponding to the equivalent of at least 500 g of mometasone were considered exposed, with filled prescriptions of 200 to 499 g as the reference group. The primary outcome was a diagnosis of osteoporosis or MOF, and hazard ratios (HRs) were calculated and adjusted for age, sex, socioeconomic status, medication use, and comorbidities.

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A total of 723,251 adults treated with the equivalent of at least 200 g of mometasone were included in the analysis (mean [SD] age, 52.8 [19.2] years; 52.8% women). The study authors observed dose-response associations between increased use of potent or very potent topical corticosteroids and the risk for osteoporosis and MOF.

The HRs of MOF were 1.01 (95% CI, 0.99-1.03) for exposure to 500 to 999 g of topical corticosteroid, 1.05 (95% CI, 1.02-1.08) for exposure to 1000 to 1999 g, 1.10 (95% CI, 1.07-1.13) for exposure to 2000 to 9999 g, and 1.27 (95% CI, 1.19-1.35) for exposure to 10,000 g or more. The researchers found a 3% relative risk increase for osteoporosis and MOF per doubling of the cumulative topical corticosteroid dose (HR, 1.03 [95% CI, 1.02-1.04] for both).

The overall population-attributable risk was 4.3% (95% CI, 2.7-5.8) for osteoporosis and 2.7% (95% CI, 1.7-3.8) for MOF. The lowest exposure needed for 1 additional patient to be harmed (454 person-years) was found for MOF with exposure of at least 10,000 g.

“This study shows that use of potent and very potent topical corticosteroids is associated with increased risk of osteoporosis and MOF, with a dose-response effect for cumulative use,” the investigators commented. “Our results remained consistent across a wide range of sensitivity analyses as well as after adjustment for potential confounding factors. However, the absolute risk to the average topical corticosteroid user was low.”

The researchers noted that they lacked data on how many participants were underweight or smoked as well as data on the anatomical locations where the topical corticosteroids were applied.

“Based on these findings, clinicians may need to consider other corticosteroid-sparing therapeutic options for people requiring potent anti-inflammatory treatment on large body surfaces for prolonged periods to limit the risk of osteoporosis,” the study authors advised.

Disclosures: Several authors declared affiliations with pharmaceutical companies. Please see the original reference for a full list of authors’ disclosures.


Egeberg A, Schwarz P, Harsløf T, et al. Association of potent and very potent topical corticosteroids and the risk of osteoporosis and major osteoporotic fractures. JAMA Dermatol. Published online January 20, 2021. doi:10.1001/jamadermatol.2020.4968