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IRCT20201110049334N2 IRCT 2022-05-14 Iran University of Medical Sciences 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 2022-12-31 anticipated 40 Complete https://irct.ir/trial/63433 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: This study is single-blinded. Only the doctor does not know the type of medicine received Method of blinding the doctor: The sealed enveloped medicine created is given to a researcher who does not interfere in choosing the type of medicine. After enrolling the subjects and collecting their baseline information by the doctor, the subjects go to the researcher to get the medicine, and the researcher will give one of the envelopes to the patients, and then the researcher then keeps a form that identifies what medication each patient has taken. 3 major thalassemia. 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 mg per week,and testosterone (Testosterone Enanthate, manufactured by Iran Hormone, Iran) for one year at a dose of 250 mg per 3 to 4 weeks by injection. Intervention 2: Intervention group2: Patients with hypogonadism take testosterone (Testosterone Enanthate, manufactured by Iran Hormone, Iran) for one year at a dose of 250 mg per 3 to 4 weeks by injection. Intervention 3: Control group 1: Patients with hypogonadism who did not receive any treatment. Intervention 4: Control group2: patients without hypogonadism took Bisphosphonate (Alendronate, manufactured by Alborz Daro Company, Iran) for one year and one tablet at a dose of 70 mg per week,and testosterone (Testosterone Enanthate, manufactured by Iran Hormone, Iran) for one year at a dose of 250 mg per 3 to 4 weeks by injection. Yes - There is a plan to make this available What will be shared: All data can be shared after subjects are not identified When: Starting after 2023 To whom: This is available for people working in academic institutions Conditions: There is no limitation Where to obtain: Applicants should apply for the documents or data files only via the email of the main researcher (amirkashani.d@iums.ac.ir) How to obtain: The following should be included in the requested e-mail first name and last name Organizational affiliation Commitment to copyright Reason for request Data usage After approval of the main researcher and the consent of the research members, the data are sent. The final decision will be emailed within two weeks. Comments:
public Davod Amirkashani
No193, zafar St, Modares Highway
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 amirkashani.d@iums.ac.ir Iran University of Medical Sciences scientific Davod Amirkashani
No193, zafar St, Modares Highway.
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 amirkashani.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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) 14 years no limit Male 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 D56.1 Beta thalassemia Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs 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 mg per week,and testosterone (Testosterone Enanthate, manufactured by Iran Hormone, Iran) for one year at a dose of 250 mg per 3 to 4 weeks by injection. Intervention group2: Patients with hypogonadism take testosterone (Testosterone Enanthate, manufactured by Iran Hormone, Iran) for one year at a dose of 250 mg per 3 to 4 weeks by injection. Control group 1: Patients with hypogonadism who did not receive any treatment Control group2: patients without hypogonadism took Bisphosphonate (Alendronate, manufactured by Alborz Daro Company, Iran) for one year and one tablet at a dose of 70 mg per week,and testosterone (Testosterone Enanthate, manufactured by Iran Hormone, Iran) for one year at a dose of 250 mg per 3 to 4 weeks by injection. 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. Iran University of Medical Sciences Approved 2021-12-29 Ethics committee of Iran University of Medical Sciences Hemmat Highway, Next to the Milad Tower Tehran Tehran Iran (Islamic Republic of)