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

The effect of Bisphosphonate diet with and without testosterone on bone density parameters in male patients with major thalassemia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201110049334N2
Enrollment
40
Registered
2022-05-14
Start date
2022-12-31
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

major thalassemia. Beta thalassemia

Interventions

Intervention 1: Intervention group 1: In this group, patients with hypogonadism took Bisphosphonate (Alendronate, manufactured by Alborz Daro Company, Iran) for one year and one tablet at a dose of 70

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
14 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDavod Amirkashani

Iran University of Medical Sciences

amirkashani.d@iums.ac.ir+98 21 2304 6253

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026