Endocrinol Metab.  2023 Apr;38(2):260-268. 10.3803/EnM.2023.1663.

Persistence with Denosumab in Male Osteoporosis Patients: A Real-World, Non-Interventional Multicenter Study

Affiliations
  • 1Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 2Division of General Internal Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
  • 3Division of Endocrinology and Metabolism, Department of Internal Medicine, Cheongju St. Mary’s Hospital, Cheongju, Korea

Abstract

Background
Persistence with denosumab in male patients has not been adequately investigated, although poor denosumab persistence is associated with a significant risk of rebound vertebral fractures.
Methods
We retrospectively evaluated 294 Korean male osteoporosis patients treated with denosumab at three medical centers and examined their persistence with four doses of denosumab injection over 24 months of treatment. Persistence was defined as the extent to which a patient adhered to denosumab treatment in terms of the prescribed interval and dose, with a permissible gap of 8 weeks. For patients who missed their scheduled treatment appointment(s) during the follow-up period (i.e., no-shows), Cox proportional regression analysis was conducted to explore the factors associated with poor adherence. Several factors were considered, such as age, prior anti-osteoporotic drug use, the treatment provider’s medical specialty, the proximity to the medical center, and financial burdens of treatment.
Results
Out of 294 male patients, 77 (26.2%) completed all four sequential rounds of the denosumab treatment. Out of 217 patients who did not complete the denosumab treatment, 138 (63.6%) missed the scheduled treatment(s). Missing treatment was significantly associated with age (odds ratio [OR], 1.03), prior bisphosphonate use (OR, 0.76), and prescription by non-endocrinologists (OR, 2.24). Denosumab was stopped in 44 (20.3%) patients due to medical errors, in 24 (11.1%) patients due to a T-score improvement over –2.5, and in five (2.3%) patients due to expected dental procedures.
Conclusion
Our study showed that only one-fourth of Korean male osteoporosis patients were fully adherent to 24 months of denosumab treatment.

Keyword

Osteoporosis; Denosumab; Bone density; Medication adherence

Figure

  • Fig. 1. Kaplan-Meier estimates of persistence with denosumab with 4-, 8-, and 12-week permissible gaps.

  • Fig. 2. Analysis of reasons for denosumab discontinuation. BMD, bone mineral density.

  • Fig. 3. Forest plot of multivariate Cox proportional regression analysis for predicting no-shows of patients. The variables included in the analysis were age, prior anti-osteoporotic drug use, medication-related side effect experience, medical center classification, malignancy history, the treatment provider’s medical specialty, classification of residence, Medical Aid beneficiary status, number of prior hospitalizations, and the treatment provider’s medical specialty. CI, confidence interval.


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