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Denosumab Versus Zoledronic Acid in Thalassemia-Induced Osteoporosis

NCT03040765 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-12-12

No results posted yet for this study

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

Conditions

Interventions

DRUG

Denosumab 60 MG/ML Prefilled Syringe

Denosumab 60 MG/ML will be administered to 20 patients with b-thalassemia major

DRUG

Zoledronic Acid 5Mg/Bag 100Ml Inj

Zoledronic Acid 5Mg/Bag 100Ml Inj will be administered to 20 patients with b-thalassemia major

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Mohamed Yassin · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Qatar

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03040765 on ClinicalTrials.gov