The effect of two different doses of Alendronate on the treatment of osteopenia based on fracture risk assessment (FRAX) in menopauses women who referred to Alzahra hospital during 2014-17
Comparison of the efficacy of 35 mg weekly versus 70 mg weekly Alendronate for the treatment of osteopenia based on FRAX (Fracture risk assessment) index in menopaused females
Design
Randomized clinical trail, with parellel group, single blinded, with 70 participants in each group
Settings and conduct
Menopause females referring to Rheumatology outpatient clinic of Alzahra Hospital with the diagnosis osteopenia based on FRAX assessment will be included through simple sampling and then allocated to each group of either 35 mg weekly Alendronate use or 70 mg weekly Alendronate use for 2 years. FRAX assessment will be reevaluated at the end of the study
Participants/Inclusion and exclusion criteria
Inclusion:
- Menopausal state
- Osteopenia (hip or spine T-score -2.5 to -1)
- Normal serum levels of vitamin D, Calcium, Phosphorus, Alkaline phosphatase
- Lacking history of pathological or traumatic fractures
- Lacking the diagnosis of malignancy
Unmet criteria:
- The impossibility to determine FRAX index due to any reason
- Osteoprosis (T-score worse than -2.5)
- Osteopenia (hip or spine T-score -2.5 to -1) plus pathological fracture
Intervention groups
1) Treatment with 70 mg weekly Alendronate (Osteophus; CIPLA; India) for two years
2) Treatment with 35 mg weekly Alendronate (Osteophus; CIPLA; India) for two years
Main outcome variables
FRAX
Hip T-score
Spine T-score
Hip Z-score
Spine Z-score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043111N1
Registration date:2019-10-28, 1398/08/06
Registration timing:retrospective
Last update:2019-10-28, 1398/08/06
Update count:0
Registration date
2019-10-28, 1398/08/06
Registrant information
Name
Negar Botlani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3641 4877
Email address
negarbotlani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2017-12-20, 1396/09/29
Actual recruitment start date
2015-04-04, 1394/01/15
Actual recruitment end date
2018-02-25, 1396/12/06
Trial completion date
2018-05-29, 1397/03/08
Scientific title
The effect of two different doses of Alendronate on the treatment of osteopenia based on fracture risk assessment (FRAX) in menopauses women who referred to Alzahra hospital during 2014-17
Public title
Assessment of two doses of Alendronate on the treament of osteopenia on menopaused females
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal state
Osteopenia (hip or spine T-score -2.5 to -1)
Normal serum levels of vitamin D, Calcium, Phosphorus, Alkaline phosphatase
Lacking history of pathological or traumatic fractures
Lacking the diagnosis of malignancy
Exclusion criteria:
The impossibility to determine FRAX index due to any reason
Osteoprosis (T-score worse than -2.5)
Osteopenia (hip or spine T-score -2.5 to -1) plus pathological fracture
Age
From 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
140
Actual sample size reached:
152
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization; individual; using Random allocation software as those with odd number are allocated to one and with even number to the other group
Blinding (investigator's opinion)
Single blinded
Blinding description
The clinical investigator who evaluates FRAX index will be blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezarjarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2017-05-26, 1396/03/05
Ethics committee reference number
IR.MUI.REC.1396.3.639
Health conditions studied
1
Description of health condition studied
Osteopenia
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Hip FRAX
Timepoint
Immediately before intervention and within 2 years following intervention
Method of measurement
Bone mineral densitometry
2
Description
Spine FRAX
Timepoint
Immediately before intervention and within 2 years following intervention
Method of measurement
Bone mineral densitometry
3
Description
Hip T-score
Timepoint
Immediately before intervention and within 2 years following intervention
Method of measurement
Bone mineral densitometry
4
Description
Spine T-score
Timepoint
Immediately before intervention and within 2 years following intervention
Method of measurement
Bone mineral densitometry
Secondary outcomes
1
Description
Hip Z-score
Timepoint
Immediately before intervention and within 2 years following intervention
Method of measurement
Bone mineral densitometry
2
Description
Spine Z-score
Timepoint
Immediately before intervention and within 2 years following intervention
Method of measurement
Bone mineral densitometry
Intervention groups
1
Description
Intervention group: Treatment with 70 mg weekly Alendronate for 2 years
Category
Treatment - Drugs
2
Description
Intervention group: Treatment with 35 mg weekly Alendronate for 2 years
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology outpatient clinic of Alzahra Hospital
Full name of responsible person
Mansour Karimifar
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
۶8174673461
Phone
+98 31 3668 0048
Email
karimifar@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Karimifar
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
karimifar@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Karimifar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
karimifar@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Karimifar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
karimifar@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Karimifar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
karimifar@med.mui.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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, patients' densitometry is recorded and they would be followed for two years. Then as they will be followed for a longer duration, the patients'records will be provided only following the connection to the study responsible rheumatologist.
When the data will become available and for how long
The data accessibility due to the long-term follow-up is not possible.
To whom data/document is available
Rheumatologist professors
Under which criteria data/document could be used
For long-term follow-up study by the permission of rheumatologist responsible for the study
From where data/document is obtainable
The rheumatologist responsible for the study
What processes are involved for a request to access data/document
It should be connected to the rheumatologist responsible for the study