drugset / Trial / NCT03040765

Denosumab Versus Zoledronic Acid in Thalassemia-Induced Osteoporosis

NCT03040765

Phase 3 Terminated 17 enrolled Hamad Medical Corporation
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is to compare the two medications Denosumab and Zoledronic Acid For Patients With Beta Thalassemia Major Induced Osteoporosis. Patients with B-thalassemia major induce osteoporosis will undergo baseline assessment of the bone densitometry by Dual-energy X-ray absorptiometry scan as a standard of care by the radiology department, then a blood test for bone specific Alkaline phosphatase and type-1 Carboxy Telopeptide will be measured by the chemistry lab. Patients with B-Thalassemia Major induced osteoporosis, who are 18 years of age or more and willing to participate in the study will be enrolled after consenting by the primary investigator in hematology outpatient clinic. Patients with osteoporosis will receive one of the two medications, at the end of the year Dual-energy X-ray absorptiometry scan will be done to compare the response of the two medications. The potential risks include the drug-related side effects

Timeline

Start
2018-05-14
Primary completion
2019-04-08
Completion
2019-04-08

Publications

Drugs

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