Denosumab Versus Zoledronic Acid in Thalassemia-Induced Osteoporosis

• Status: Terminated
• Trial end date: 2019-04-08
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Denosumab; Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Willing to participate in the study

• Age 18 years old or older

• Eastern Cooperative Oncology Group Performance Status less than or equal 2

Exclusion Criteria:

• Age less than 18 years old

• Not willing to participate in the study

• Vulnerable subjects or Eastern Cooperative Oncology Group Performance Status 3 or 4