Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2017

Conditions
Thalassemia MajorOsteoporosis
Interventions
DRUG

Denosumab

"Patients will be randomly assigned, in a 1:1 fashion, to the two therapeutic arms (Group A, Group B, respectively), upon enrollment in the study.~The effect of denosumab on lumbar spine BMD (bone mineral density) in patients with Thalassemia Major and Osteoporosis as compared with control at 12 months will be evaluated."

DRUG

Placebo

"Patients will be randomly assigned, in a 1:1 fashion, to the two therapeutic arms (Group A, Group B, respectively), upon enrollment in the study.~The effect of denosumab on lumbar spine BMD (bone mineral density) in patients with Thalassemia Major and Osteoporosis as compared with control at 12 months will be evaluated."

Trial Locations (1)

11526

"General Hospital of Athens Laikon", Athens

All Listed Sponsors
lead

Ersi Voskaridou

OTHER

NCT02559648 - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis | Biotech Hunter | Biotech Hunter