drugset / Trial / NCT04085419

Osteoporosis in Primary Hyperparathyroidism

NCT04085419

Phase 4 Unknown 40 enrolled University Medical Centre Ljubljana
RandomizedParallel-groupOpen-labelTreatment

Summary

Investigators will prospectively include 40 postmenopausal women with secondary osteoporosis due to primary hyperparathyroidism who have refused surgery. Participants will be randomized in two groups and treated either with zoledronic acid 5 mg iv once a year or with denosumab 60 mg sc every 6 months. Investigators will compare the effect of both drugs on bone turnover markers and basic laboratory parameters after 3, 12 and 24 months of treatment, and on the bone mineral density after 12 and 24 months of treatment. All participants will take cholecalciferol 800 - 1000 IU daily.

Timeline

Start
2019-05-08
Primary completion
2023-05
Completion
2023-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Denosumab Monoclonal antibody 60 mg Subcutaneous
Comparator Zoledronic acid Other / unclassified 5 mg Intravenous