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

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History
# Registration date Revision Id
2 2023-08-04, 1402/05/13 274057
1 2022-05-14, 1401/02/24 226094
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  • Protocol summary

    Determining the effect of Bisphosphonate with and without Testosterone on hematological parameters and bone density in male patients with Thalassemia major
    Determining the effect of Bisphosphonate with and without Testosterone on bone density parameters in male patients with Thalassemia major
    تعیین اثر داروی بیسفوسفونات با و بدون تستوسترون بر شاخص های هماتولوژیک و تراکم استخوان بیماران مذکر مبتلا به تالاسمی ماژور
    تعیین اثر داروی بیسفوسفونات با و بدون تستوسترون بر شاخص های تراکم استخوان بیماران مذکر مبتلا به تالاسمی ماژور
    A clinical trial with parallel groups, single-blinded, randomized (permuted block randomization), phase 3 on 80 patients with major Thalassemia, using www.sealedenvelope.com for randomization.
    A Quasi experimental study with parallel, single blinded groups on 40 patients with major Thalassemia.
    کارآزمایی بالینی با گروه های موازی، یک سو کور، تصادفی شده (بلوک های جایگشتی)، فاز 3 بر روی 80 بیمار مبتلا به تالاسمی ماژور، برای تصادفی سازی از وب سایت www.sealedenvelope.com استفاده می شود.
    مطالعه نیمه تجربی با گروه های موازی، یک سور کور بر روی 40 بیمار مبتلا به تالاسمی ماژور
    This study is conducted in Aliasghar Children's Hospital. Patients with major Thalassemia and eligible are randomly assigned to two groups. In the first group, patients take Bisphosphonate. In the second group, patients take Bisphosphonates and Testosterone. In this study, the doctor did not know the type of drug received.
    This study conducted in Aliasghar Children's Hospital. Patients with major Thalassemia and eligible divided to four groups. In the first Intervention group, patients with hypogonadism took Alendronate and testosterone, In the second Intervention group, Patients with hypogonadism took testosterone, In the first control group, patients with hypogonadism who did not receive any treatment, In the Second control group,patients without hypogonadism took Alendronate. In this study, the doctor did not know the type of drug received.
    این مطالعه در بیمارستان کودکان علی اصغر انجام می شود. بیماران مبتلا به تالاسمی ماژور و واجد شرایط به صورت تصادفی به دو گروه اختصاص می یابند. در گروه اول بیماران داروی بیسفوسفونات دریافت می کنند. در گروه دوم بیماران بیسفوسفونات و تستوسترون دریافت می کنند. در این مطالعه پزشک از نوع داروی دریافتی اطلاعی ندارند.
    این مطالعه در بیمارستان کودکان علی اصغر انجام شد. بیماران مبتلا به تالاسمی ماژور و واجد شرایط به صورت تصادفی به چهار گروه تقسیم شدند. در گروه مداخله اول بیماران مبتلا به هیپوگنادیسم تستوسترون و آلندرونیت دریافت کردند، در گروه مداخله دوم بیماران مبتلا به هیپوگنادیسم تستوسترون دریافت کردند، در گروه کنترل اول: بیماران مبتلا به هیپوگنادیسم هیچگونه درمانی دریافت نکردند، در گروه کنترل دوم: بیماران بدون هیپوگنادیسم داروی آلندرونیت دریافت کردند. در این مطالعه پزشک از نوع داروی دریافتی اطلاعی ندارند.
    In the first Intervention group, patients take Bisphosphonate (Alendronate, manufactured, Iran) for one year and one tablet at a dose of 70 mg per week. In the second Intervention group, Patients take Bisphosphonate (Alendronate, Iran) for one year, 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.
    In the first Intervention group, patients with hypogonadism took Alendronate and testosterone, In the second Intervention group, Patients with hypogonadism took testosterone, In the first control group, patients with hypogonadism who did not receive any treatment, In the Second control group,patients without hypogonadism took Alendronate.
    در گروه مداخله اول بیماران داروی بیسفوسفونات (آلندرونیت ، ایران) را به مدت یک سال و هفته ای یک قرص با دوز 70 میلی گرم دریافت می کنند. در گروه مداخله دوم بیماران داروی بیسفوسفونات (آلندرونیت، ایران) را به مدت یکسال، هفته ای یک قرص با دوز 70 میلی گرم و داروی تستوسترون انانتات (تستوسترون انانتات، ایران) را به مدت یک سال با دوز 250 میلی گرم هر 3 تا 4 هفته به صورت تزریقی دریافت خواهند کرد.
    در گروه مداخله اول بیماران مبتلا به هیپوگنادیسم تستوسترون و آلندرونیت دریافت کردند، در گروه مداخله دوم بیماران مبتلا به هیپوگنادیسم تستوسترون دریافت کردند، در گروه کنترل اول: بیماران مبتلا به هیپوگنادیسم هیچگونه درمانی دریافت نکردند، در گروه کنترل دوم: بیماران بدون هیپوگنادیسم داروی آلندرونیت دریافت کردند.
    Hematological parameters (Hemoglobin, Hematocrit and Ferritin); Bone density
    Bone density
    میزان شاخص های هماتولوژیک ( هموگلوبین، هماتوکریت، فریتین); میزان تراکم استخوان
    میزان تراکم استخوان

  • General information

    Randomized
    Not randomized
    80
    40
    empty
    38
    empty
    2021-12-31, 1400/10/10
    empty
    2022-12-31, 1401/10/10
    empty
    2022-12-31, 1401/10/10
    empty
    Unfortunately, we did not reach the desired sample size, and following that because random allocation was not ethical the design of the study and the number of subjects were changed
    empty
    متاسفانه به دلیل اینکه به حجم نمونه دلخواه نرسیدیم , و به دنبال آن چون تخصیص تصادفی اخلاقی نبود به طورکلی طراحی مطالعه و تعداد افراد مورد مطالعه تغییر کرد
    The effect of Bisphosphonate on hematological parameters in patients with major thalassemia
    The effect of Bisphosphonate on bone density in patients with major thalassemia
    اثر بیسفوسفونات بر شاخص های هماتولوژیک بیماران مبتلا به تالاسمی ماژور
    اثر بیسفوسفونات بر تراکم استخوان بیماران مبتلا به تالاسمی ماژور
    The effect of Bisphosphonate diet with and without testosterone on hematological parameters and bone density in male patients with major thalassemia
    The effect of Bisphosphonate diet with and without testosterone on bone density parameters in male patients with major thalassemia
    بررسی اثر رژیم دارویی بیسفوسفونات با و بدون تستوسترون بر شاخص های هماتولوژیک و تراکم استخوان بیماران مذکر مبتلا به تالاسمی ماژور
    بررسی اثر رژیم دارویی بیسفوسفونات با و بدون تستوسترون بر شاخص های تراکم استخوان بیماران مذکر مبتلا به تالاسمی ماژور
    In this study, the block randomization method is used with blocks of sizes six and four. The website https://www.sealedenvelope.com is used to create a randomization sequence. Each random sequence generated contains a unique code for concealment. The drug regimen is placed in envelopes according to random sequence, and after sealing it on the envelopes, the specific number created by the site is written and the envelopes are randomly placed in a box.
    در این مطالعه از روش تصادفی سازی بلوکی با سایز بلوک های شش و چهارتایی استفاده می شود. از وب سایت https://www.sealedenvelope.com برای تهیه توالی های تصادفی استفاده می شود. هر یک از توالی های تصادفی ایجاد شده حاوی یک کد منحصر به فرد برای پنهان سازی است. رژیم دارویی مطابق با توالی تصادفی در پاکتهایی گذاشته می شود و پس از مهر و موم کردن آن بر روی پاکت ها، عدد اختصاصی ایجاد شده توسط سایت نوشته میشود و پاکت ها به ترتیب تصادفی در یک جعبه قرار داده می شوند.
    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.
    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.
    این مطالعه یک سو کور است. فقط پزشک از نوع داروی دریافتی اطلاع ندارد. روش کور سازی پزشک: پاکت های دارویی مهرو موم ایجاد شده در اختیار محققی که دخالتی در انتخاب نوع دارو ندارد قرار میگیرد. افراد پس از اینکه وارد مطالعه شدند و اطلاعات baseline آنها توسط پزشک جمع آوری شد برای گرفتن دارو نزد محقق می روند و محقق یکی از پاکتها را به بیماران خواهد داد و پس از آن برگه ای نزد محقق محفوظ است و مشخص میکند که هر بیمار باچه کدی چه دارویی گرفته است.
    این مطالعه یک سو کور است. فقط پزشک از نوع داروی دریافتی اطلاع ندارد. روش کور سازی پزشک: پاکت های دارویی مهرو موم ایجاد شده در اختیار محققی که دخالتی در انتخاب نوع دارو ندارد قرار میگیرد. افراد پس از اینکه وارد مطالعه شدند و اطلاعات baseline آنها توسط پزشک جمع آوری شد برای گرفتن دارو نزد محقق می روند و محقق یکی از پاکتها را به بیماران خواهد داد و پس از آن برگه ای نزد محقق محفوظ است و مشخص میکند که هر بیمار باچه کدی چه دارویی گرفته است.

  • Primary outcomes

    #1
    Hematological indicators: Hemoglobin, Hematocrit and Ferritin
    Bone density
    شاخص های هماتولوژیک: هموگلوبین، هماتوکریت و فریتین
    تراکم استخوان
    Laboratory tests
    Bone mineral density (BMD) test by DEXA method
    تست های آزمایشگاهی
    دانسیتومتری استخوان (BMD) به روش دگزا
    #2
    Bone density
    empty
    تراکم استخوان
    empty
    At the beginning of the study and one year after the intervention
    empty
    در شروع مطالعه و یک سال پس از مداخله
    empty
    Bone mineral density (BMD) test by DEXA method
    empty
    دانسیتومتری استخوان (BMD) به روش دگزا
    empty

  • Intervention groups

    #1
    Intervention group 1: In this group, patients take Bisphosphonate (Alendronate, manufactured by Alborz Daro Company, Iran) for one year and one tablet at a dose of 70 mg per week.
    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.
    گروه مداخله اول: در این گروه بیماران داروی بیسفوسفونات (آلندرونیت ، ساخت شرکت البرز دارو، ایران) را به مدت یک سال و هفته ای یک قرص با دوز 70 میلی گرم دریافت می کنند
    گروه مداخله اول: در این گروه بیماران مبتلا به هیپوگنادیسم داروی بیسفوسفونات (آلندرونیت ، ساخت شرکت البرز دارو، ایران) را به مدت یک سال و هفته ای یک قرص با دوز 70 میلی گرم و داروی تستوسترون (تستوسترون انانتات، ساخت شرکت ایران هورمون، ایران) را به مدت یک سال با دوز 250 میلی گرم هر 3 تا 4 هفته به صورت تزریقی دریافت کردند.
    #2
    Intervention group2: Patients take Bisphosphonate (Alendronate, manufactured by Alborz Drug Company, Iran) for one year, 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.
    گروه مداخله دوم بیماران داروی بیسفوسفونات (آلندرونیت، ساخت شرکت البرز دارو، ایران) را به مدت یکسال، هفته ای یک قرص با دوز 70 میلی گرم و داروی تستوسترون انانتات (تستوسترون انانتات، ساخت شرکت ایران هورمون، ایران) را به مدت یک سال با دوز 250 میلی گرم هر 3 تا 4 هفته به صورت تزریقی دریافت می کنند.
    گروه مداخله دوم: بیماران مبتلا به هیپوگنادیسم داروی تستوسترون (تستوسترون انانتات، ساخت شرکت ایران هورمون، ایران) را به مدت یک سال با دوز 250 میلی گرم هر 3 تا 4 هفته به صورت تزریقی دریافت کردند.
    #3
    empty
    Treatment - Drugs
    empty
    Control group 1: Patients with hypogonadism who did not receive any treatment
    empty
    گروه کنترل اول: بیماران مبتلا به هیپوگنادیسم که هیچگونه درمانی دریافت نکردند.
    #4
    empty
    Treatment - Drugs
    empty
    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.
    empty
    گروه کنترل دوم: بیماران بدون هیپوگنادیسم داروی بیسفوسفونات (آلندرونیت ، ساخت شرکت البرز دارو، ایران) را به مدت یک سال و هفته ای یک قرص با دوز 70 میلی گرم و داروی تستوسترون (تستوسترون انانتات، ساخت شرکت ایران هورمون، ایران) را به مدت یک سال با دوز 250 میلی گرم هر 3 تا 4 هفته به صورت تزریقی دریافت کردند.

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hosein Keivani
    Full name of responsible person - Persian: حسین کیوانی
    Street address - English: Shahid Hemmat Highway next to the Milad tower
    Street address - Persian: بزرگراه همت جنب برج میلاد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۴۹۶۱۴۵۳۵
    Phone: +98 21 8670 2503
    Fax:
    Email: keivani.h@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hosein Keivani
    Full name of responsible person - Persian: حسین کیوانی
    Street address - English: Shahid Hemmat Highway next to the Milad tower
    Street address - Persian: بزرگراه همت جنب برج میلاد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 8670 2503
    Fax:
    Email: keivani.h@iums.ac.ir
    Web page address:

Protocol summary

Study aim
Determining the effect of Bisphosphonate with and without Testosterone on bone density parameters in male patients with Thalassemia major
Design
A Quasi experimental study with parallel, single blinded groups on 40 patients with major Thalassemia.
Settings and conduct
This study conducted in Aliasghar Children's Hospital. Patients with major Thalassemia and eligible divided to four groups. In the first Intervention group, patients with hypogonadism took Alendronate and testosterone, In the second Intervention group, Patients with hypogonadism took testosterone, In the first control group, patients with hypogonadism who did not receive any treatment, In the Second control group,patients without hypogonadism took Alendronate. In this study, the doctor did not know the type of drug received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male patients with major thalassemia and older than 13.5 years, Patients with hypogonadism and without hypogonadism. Exclusion criteria: Patients with abnormal levels of liver enzymes, Patients with abnormal levels of thyroid function hormones and diabetes, and Patients with a bone density greater than -5.2.
Intervention groups
In the first Intervention group, patients with hypogonadism took Alendronate and testosterone, In the second Intervention group, Patients with hypogonadism took testosterone, In the first control group, patients with hypogonadism who did not receive any treatment, In the Second control group,patients without hypogonadism took Alendronate.
Main outcome variables
Bone density

General information

Reason for update
Unfortunately, we did not reach the desired sample size, and following that because random allocation was not ethical the design of the study and the number of subjects were changed
Acronym
IRCT registration information
IRCT registration number: IRCT20201110049334N2
Registration date: 2022-05-14, 1401/02/24
Registration timing: registered_while_recruiting

Last update: 2023-08-05, 1402/05/14
Update count: 1
Registration date
2022-05-14, 1401/02/24
Registrant information
Name
Davood Amirkashani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6253
Email address
amirkashani.d@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-31, 1401/10/10
Expected recruitment end date
2022-12-31, 1401/10/10
Actual recruitment start date
2021-12-31, 1400/10/10
Actual recruitment end date
2022-12-31, 1401/10/10
Trial completion date
2022-12-31, 1401/10/10
Scientific title
The effect of Bisphosphonate diet with and without testosterone on bone density parameters in male patients with major thalassemia
Public title
The effect of Bisphosphonate on bone density in patients with major thalassemia
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 14 years old
Gender
Male
Phase
3
Groups that have been masked
  • Care provider
  • Investigator
Sample size
Target sample size: 40
Actual sample size reached: 38
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway, Next to the Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-12-29, 1400/10/08
Ethics committee reference number
IR.IUMS.FMD.REC.1400.557

Health conditions studied

1

Description of health condition studied
major thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia

Primary outcomes

1

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

3

Description
Control group 1: Patients with hypogonadism who did not receive any treatment
Category
Treatment - Drugs

4

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Aliasghar Children's Hospital
Full name of responsible person
Davod Amirkashani
Street address
No.193, Zafar St, Modares Highway.
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
amirkashani.d@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keivani
Street address
Shahid Hemmat Highway next to the Milad tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
keivani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Davod Amirkashani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No193, zafar St, Modares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
amirkashani.d@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Davod Amirkashani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No193, zafar St, Modares Highway.
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
amirkashani.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Davod Amirkashani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No193, zafar St, Modares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
amirkashani.d@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after subjects are not identified
When the data will become available and for how long
Starting after 2023
To whom data/document is available
This is available for people working in academic institutions
Under which criteria data/document could be used
There is no limitation
From where data/document is obtainable
Applicants should apply for the documents or data files only via the email of the main researcher (amirkashani.d@iums.ac.ir)
What processes are involved for a request to access data/document
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.
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