Highlights
- •The presentation, treatment, and outcomes of various diseases may differ between men and women.
- •Denosumab-associated hypocalcemia is more prevalent than previously thought.
- •Denosumab-treated men have more comorbidities than women.
- •Gender per se is not a predictor of denosumab-associated hypocalcemia.
Abstract
Objective
It is well recognized that the presentation, treatment, and outcomes of various diseases
may differ between men and women. We recently reported a 7.4% rate of denosumab-associated
hypocalcemia in community-dwelling osteoporotic patients. This study sought to investigate
the role of gender in this complication.
Study design
Retrospective community-dwelling cohort.
Method
The databases of a large health maintenance organization were searched for adult patients
treated with denosumab for osteoporosis in 2010-2018. Rates and predictors of denosumab-associated
hypocalcemia (serum calcium ≤8.5 mg/mL) were analyzed by gender.
Results
The cohort included 1871 women and 134 men. Compared with the women, the men were
characterized by older median age (81 vs. 77 years, p = 0.005), higher likelihood to receive denosumab as a first-line treatment (22% vs.
6%, p < 0.001), less treatment with calcium supplements (42% vs. 53%, p = 0.012), and lower median eGFR level (66.1 vs. 79.8 mL/min/1.73m2, p < 0.001). Denosumab-associated hypocalcemia developed in 133 women (7.1%) and 16
men (11.9%) (p = 0.04); the drug was discontinued in 75% and 61%, respectively. The strongest predictors
of hypocalcemia in women were levels of pretreatment albumin-adjusted serum calcium
(OR 0.08, 95% CI (0.04, 0.14)) and creatinine (OR 2.43, 95% CI (1.45, 4.05)). There
were no predictors in men. On propensity matching of 126 men and 126 women, gender
was not a predictor of hypocalcemia.
Conclusion
Denosumab-treated men were significantly older than treated women and had a lower
eGFR and more advanced osteoporosis. These findings suggest that selection bias rather
than male genderper se underlies the higher rate of denosumab-associated hypocalcemia in men.
Keywords
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Article info
Publication history
Published online: July 04, 2020
Accepted:
July 3,
2020
Received in revised form:
June 20,
2020
Received:
April 9,
2020
Identification
Copyright
© 2020 Elsevier B.V. All rights reserved.