The effect of Bisphosphonate on bone density in patients with major thalassemia

Phase 3

• Conditions: major thalassemia.; Beta thalassemia; D56.1

• Registration Number: IRCT20201110049334N2
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Patients Consent to participate in the study
Male patients with major thalassemia and older than 13.5 years
Patients with hypogonadism (based on blood testosterone, LH and FSH levels) and without hypogonadism
No concomitant underlying disease (including thyroid disease, parathyroid disease, kidney and liver disease and diabetes)

Exclusion Criteria

Patients with abnormal level of liver enzymes (AST and ALT)
Patients with renal disorder
Patients with abnormal levels of calcium, blood phosphorus and vitamin D3
Patients with abnormal levels of thyroid function hormones and diabetes
Patients with abnormal levels of PTH and ALP
Patients with bone density greater than -5.2
Do not take the drug by the patient until the end of the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone density. Timepoint: At the beginning of the study and one year after the intervention. Method of measurement: Bone mineral density (BMD) test by DEXA method.