drugset / Trial / NCT02854722

The Deferasirox-calcium-vitamin D3 Therapy for Postmenopausal Osteoporosis (PMOP)

NCT02854722

RandomizedParallel-groupOpen-labelTreatment

Summary

In 2006, Weinberg proposed a hypothesis that iron accumulation was a risk factor for osteoporosis. Osteoporosis is a common complication in various diseases, such as hemochromatosis, African hemosiderosis, thalassemia, and sickle cell disease, which all share iron accumulation as a common denominator. Moreover, a 3-year retrospective longitudinal study has shown that iron accumulation was also associated with osteoporosis in healthy adults and especially that it can increase the risk of fractures in postmenopausal women. Based on these observations, iron chelation therapy may have a promising future in the treatment of iron accumulation-related osteoporosis by removing iron from the body. The purpose of this study is to determine whether the addition of the iron chelator, deferasirox, to standard therapy for postmenopausal osteoporosis, is safe and effective.

Timeline

Start
2018-01-15
Primary completion
2019-06-15
Completion
2020-06-15

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferasirox Unknown 10 mg/kg Oral
Background Calcium carbonate Other / unclassified 500 mg
Background Cholecalciferol Other / unclassified 800 iu