Korean J Clin Pharm.  2022 Sep;32(3):185-190. 10.24304/kjcp.2022.32.3.185.

Evaluation of Clinical Outcomes by Therapeutic Dosing Interval of Denosumab (Prolia ^® ) and Calcium-Vitamin D Prescriptions

• Kim Y
• Kim J
• Doh H
• Jeong YM
• Lee J
• Lee JY
• Lee E

• KMID: 2533898
• DOI: http://doi.org/10.24304/kjcp.2022.32.3.185

Abstract

Background
Denosumab (Prolia^®) is administered every 6 months for osteoporosis treatment. Co-administration of calcium and vitamin D is required to minimize hypocalcemia risk. We evaluated clinical outcomes based on the administration interval of denosumab and co-prescription with calcium-vitamin D combination products.
Methods
A retrospective study was conducted using electronic medical records from 668 patients who started denosumab therapy between January 1 and December 31, 2018, at Seoul National University Bundang Hospital. Clinical outcomes, as measured by changes in T-score, were evaluated by the intervals and concurrent prescriptions with calcium–vitamin D combination products.
Results
Of the 668 patients, 333 patients met the eligibility criteria. These patients were divided into two groups based on appropriateness of the administration interval: “Appropriate” (304 patients, 91.3%) and “Inappropriate” (29 patients, 8.3%). T-score changes were significantly higher in the “Appropriate” than in the “Inappropriate” group (0.30±0.44 vs. 0.13±0.37, p=0.048). At the beginning of the treatment, 221 patients (66.4%) were prescribed calcium-vitamin D combination products, but the changes in T-scores were not significantly different by the prescription status of the product (0.29±0.46 vs. 0.28±0.38, p=0.919).
Conclusion
T-scores were significantly improved in patients with appropriate administration intervals. No significant changes in T-scores were observed by the prescription status with calcium-vitamin D combination products. For optimal treatment outcomes, prescribers should encourage adherence to the approved prescription information on dosage and administration, and pharmacists should provide medication counseling for patients.

Keyword

Osteoporosis; denosumab; drug utilization review