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The effect of sodium pentaborate (NaB) supplementation on bone density, serum levels of bone turnover markers and inflammation-related microRNAs in postmenopausal women with primary osteoporosis: a triple blind randomized controlled trial.

Protocol summary

Study aim
To determine effect of sodium pentaborate supplementation on bone density, serum levels of bone turnover markers and inflammation-related microRNAs in postmenopausal women with primary osteoporosis
Design
In this triple blind randomized controlled trial with two parallel groups, ninety eligible women will be randomly assigned into the group receiving sodium pentaborate pentahydrate capsule and placebo using random permuted blocks and allocation ratio of 1 : 1.
Settings and conduct
After registration of clinical trial, the researcher will refer to the bone densitometry center at the Sina Educational Hospital and will identify the eligible women. All eligible women who are willing to participate at the study, will be invited to attend at the physical Medicine and Rehabilitation Research Center in a fasting state. After signing a written consent form, questionnaires will be complete. Ten ml of fasting blood sample will be taken for laboratory and genetic tests. Supplements and their placebo will be prepared in identical appearance. Participants, researchers, and statistical analyzer will be blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Postmenopausal women aged 50 to 65 years; Menstrual cessation for at least 12 consecutive months; Bone density between -1 to -2.5 in the lumbar, hip, or femoral neck. Non-inclusion Criteria: Renal diseases and failure; Bone disease other than osteopenia; The use of medications that affect bone metabolism.
Intervention groups
The groups will receive sodium pentaborate pentahydrate or placebo (carboxymethyl cellulose) capsules 5 mg twice daily (every 12 hours) for 6 months.
Main outcome variables
Mean bone density (BMD, T-score, and Z-score); Serum levels of bone turnover markers (Osteocalcin, P1NP, BSAP, CTX); Serum levels of inflammation-related microRNAs (miR422a، miR-133a، miR-21, miR-503)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131009014957N7
Registration date: 2019-03-30, 1398/01/10
Registration timing: prospective

Last update: 2019-03-30, 1398/01/10
Update count: 0
Registration date
2019-03-30, 1398/01/10
Registrant information
Name
Azizeh Farshbaf-khalili
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 9151
Email address
farshbafa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sodium pentaborate (NaB) supplementation on bone density, serum levels of bone turnover markers and inflammation-related microRNAs in postmenopausal women with primary osteoporosis: a triple blind randomized controlled trial.
Public title
The effect of sodium pentaborate (NaB) supplementation on bone density and serum levels of its related markers in postmenopausal women with primary osteoporosis.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal women aged 50 to 65 years Menstrual cessation for at least 12 consecutive months Bone density between -1 to -2.5 in the lumbar or femoral neck
Exclusion criteria:
Renal diseases and renal failure Bone disease other than osteopenia The use of medications that affect bone metabolism
Age
From 50 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Ninety postmenopausal women with primary osteopenia will be randomly assigned into one of the two groups of receiving sodium pentaborate pentahydrate capsule and the group receiving placebo using random permuted blocks with sizes 4 and 6 and allocation ratio of 1 : 1 through RAS (Random Allocation Software).
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, researchers, participants and data analyzer will be blind regarding allocation into the groups. So that, supplements and their placebo will be prepared by the pharmaceutical company in a completely identical manner in terms of shape, color, dose, and odor. For each participant, 3 small opaque packs each containing 120 capsules for two month-use will be provided and placed in a large sealed and opaque pack. Large packs will be be numbered from 1 to 100 and will be opened from No. 1 to 100 in the order of participation of women in the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Department., third floor., central construction number 2., Tabriz University of Medical Sciences., Golgasht Street., Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5143814998
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
IR.TBZMED.REC.1397.945

Health conditions studied

1

Description of health condition studied
Osteopenia
ICD-10 code
M85
ICD-10 code description
Other disorders of bone density and structure

Primary outcomes

1

Description
Bone mineral density
Timepoint
At the baseline (before intervention) and just after completion of the intervention (6 months after beginning the intervention )
Method of measurement
Dual-energy X-ray absorptiometry (DXA)

2

Description
Serum levels of bone turnover markers (osteocalcin، P1NP، BSAP، CTX)
Timepoint
At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention)
Method of measurement
Using the ELISA method

3

Description
Serum levels of osteoporosis MicroRNA (miR422a، miR-133a، miR-21 و miR-503)
Timepoint
At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention )
Method of measurement
Using the Real-Time PCR method

Secondary outcomes

1

Description
serum levels of biochemical factors (steroid (estrogen and testosterone) and thyroid (T3 and T4) hormones, lipid profiles, insulin resistance, FBS, total calcium, 25 (OH) D, BUN and creatinine)
Timepoint
At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention )
Method of measurement
Using Spectrophotometer, ELISA method

2

Description
ُSerum levels of some inflammatory (TNF-α, HS-CRP, IL-6)and oxidative stress indices (TAC, SOD, MDA)
Timepoint
At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention )
Method of measurement
Using Spectrophotometer, Calorie meter, and ELISA method

3

Description
response to treatment based on the frequency of gene polymorphisms (OPG gene rs2062377 polymorphism, RANKL gene rs9533090 polymorphism, LRP5 gene rs3736228 polymorphism, ESR1 gene rs4869742 polymorphism, ZBTB40 gene rs6426749 polymorphism)
Timepoint
Completion of the intervention (6 months after beginning intervention )
Method of measurement
Using PCR-RFLP method

4

Description
nutritional status (mean weight, BMI, waist circumference, waist to hip ratio, appetite score)
Timepoint
At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention )
Method of measurement
Using the Seca digital scale, the Seca wall mounted stadiometer and the VAS questionnaire

5

Description
Body composition analysis score (PBF, MBF, SLM, LBM, VFM, TBW, Mineral)
Timepoint
At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention )
Method of measurement
Using Body Composition Analyzer

6

Description
Adverse events
Timepoint
During Intervention
Method of measurement
Using a checklist

Intervention groups

1

Description
Intervention group: The Sodium Pentaborate group will receive 5 mg capsules twice daily (every 12 hours) for 6 months
Category
Prevention

2

Description
Control group: Placebo group will receive 5 mg capsules twice daily (every 12 hours) containing carboxymethyl cellulose for 6 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation Research Center
Full name of responsible person
Azizeh Farshbaf-Khalili
Street address
Golgasht Street, Attar Neishaboori Ave, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 1134
Fax
+98 41 3337 1134
Email
farshbafa@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
No. 2 Central building of the university, Golgasht street, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Azizeh Farshbaf-Khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 1928
Email
farshbafa@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr, Azizeh Farshbaf-Khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 1928
Email
farshbafa@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Azizeh Farshbaf-Khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitatio
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 1928
Email
farshbafa@tbzmed.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
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis).
When the data will become available and for how long
Starting immediately after publication
To whom data/document is available
Data will be available to researchers as well as to journals.
Under which criteria data/document could be used
The data will be available to researchers upon request and submission of a proposal to perform meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to journals for checking.
From where data/document is obtainable
Refer to the email address (farshbafa@tbzmed.ac.ir).
What processes are involved for a request to access data/document
The requests will be sent by email and data will be available within a week.
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