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IRCT20131009014957N7 IRCT 2019-03-30 Tabriz University of Medical Sciences The effect of sodium pentaborate (NaB) supplementation on bone density and serum levels of its related markers in postmenopausal women with primary osteoporosis. 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. 2019-06-22 anticipated 90 Complete https://irct.ir/trial/38415 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 Osteopenia. Intervention 1: Intervention group: The Sodium Pentaborate group will receive 5 mg capsules twice daily (every 12 hours) for 6 months. Intervention 2: Control group: Placebo group will receive 5 mg capsules twice daily (every 12 hours) containing carboxymethyl cellulose for 6 months. Yes - There is a plan to make this available What will be shared: Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis). When: Starting immediately after publication To whom: Data will be available to researchers as well as to journals. Conditions: 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. Where to obtain: Refer to the email address (farshbafa@tbzmed.ac.ir). How to obtain: The requests will be sent by email and data will be available within a week. Comments:
public Dr. Azizeh Farshbaf-Khalili
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 1928 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr, Azizeh Farshbaf-Khalili
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 1928 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 50 years 65 years Female Renal diseases and renal failure Bone disease other than osteopenia The use of medications that affect bone metabolism M85 Other disorders of bone density and structure Prevention Placebo Intervention group: The Sodium Pentaborate group will receive 5 mg capsules twice daily (every 12 hours) for 6 months Control group: Placebo group will receive 5 mg capsules twice daily (every 12 hours) containing carboxymethyl cellulose for 6 months. 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). 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. 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. 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. ُ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. 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. 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. 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. Adverse events. Timepoint: During Intervention. Method of measurement: Using a checklist. Tabriz University of Medical Sciences Approved 2019-02-25 Ethics committee of Tabriz University of Medical Sciences Research Department., third floor., central construction number 2., Tabriz University of Medical Sciences., Golgasht Street., Azadi Avenue Tabriz East Azarbaijan Iran (Islamic Republic of)